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TR 388 Rat Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                      ETHYLENETHIOUREA                                   DATE: 09/09/94       
EXPERIMENT: 05076 TEST: 01                                                                                     TIME: 21:03:12       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01ES82151            ROUTE: DOSED FEED                                                                  NTP C#: 03372        
PATHOLOGIST: J. TOFT                         S. EUSTIS                                                         CAS: 96-45-7         
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Battelle Columbus                                      ETHYLENETHIOUREA                                   DATE: 09/09/94      
EXPERIMENT: 05076 TEST: 01                                                                                     TIME: 21:03:12      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01ES82151            ROUTE: DOSED FEED                                                                  NTP C#: 03372       
PATHOLOGIST: J. TOFT                         S. EUSTIS                                                         CAS: 96-45-7        
 
 
 
 
 
                                                    RATS(FISCHER344)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                      ETHYLENETHIOUREA                                   DATE: 09/09/94       
EXPERIMENT: 05076 TEST: 01                                                                                     TIME: 21:03:12       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01ES82151            ROUTE: DOSED FEED                                                                  NTP C#: 03372        
PATHOLOGIST: J. TOFT                         S. EUSTIS                                                         CAS: 96-45-7         
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                        IN THE ANALYSIS OF THE STUDY OF ETHYLENETHIOUREA
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Benign
                                                           Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Clitoral/Preputial Gland      Adenoma
                                                           Carcinoma or Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                                                           Carcinoma or Adenoma
                             Skin: Subcutaneous Tissue     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
                                                            Neurofibroma, or Fibroma
                             Testes                        Adenoma
                             Thymus                        Thymoma Benign
                             Thyroid Gland: C-Cell         Adenoma
                                                           Carcinoma or Adenoma
                             Thyroid Gland: Follicular Cell
                                                           Adenoma
                                                           Carcinoma
                                                           Carcinoma or Adenoma
                             Zymbal's Gland                Carcinoma
                                                           Carcinoma or Adenoma
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                      ETHYLENETHIOUREA                                   DATE: 09/09/94       
EXPERIMENT: 05076 TEST: 01                                                                                     TIME: 21:03:12       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01ES82151            ROUTE: DOSED FEED                                                                  NTP C#: 03372        
PATHOLOGIST: J. TOFT                         S. EUSTIS                                                         CAS: 96-45-7         
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                        IN THE ANALYSIS OF THE STUDY OF ETHYLENETHIOUREA
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Mammary Gland                 Carcinoma
                                                           Fibroadenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Carcinoma
                                                           Carcinoma or Adenoma
                             Thyroid Gland: Follicular Cell
                                                           Adenoma
                                                           Carcinoma
                                                           Carcinoma or Adenoma
                             Zymbal's Gland                Carcinoma
                                                           Carcinoma or Adenoma
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE   1
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/100 (1%)   0/49 (0%)    2/149 (1%)   1/100 (1%) |  3/99 (3%)    6/49 (12%)   2/147 (1%)   2/100 (2%) |
|ADJUSTED (b)           |   2.0%         0.0%         1.9%         3.6%      |   5.6%        18.2%         2.2%         4.4%      |
|TERMINAL (d)           |  0/37 (0%)    0/22 (0%)    0/52 (0%)    0/20 (0%)  |  3/54 (6%)    6/33 (18%)   2/93 (2%)    1/34 (3%)  |
|FIRST INCIDENCE (DAYS) |   707          ---          453          719       |   740 (T)      740 (T)      740 (T)      637       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.521      P=0.634N     P=0.619      P=0.668    |  P=0.306N     P=0.066      P=0.266N     P=0.674N   |
|INCIDENTAL TUMOR       |  P=0.646      P=0.624N     P=0.649      P=0.739N   |  P=0.244N     P=0.066      P=0.266N     P=0.573N   |
|LOGISTIC REGRESSION    |  P=0.623      P=0.626N     P=0.636      P=0.694    |  P=0.234N     P=0.066      P=0.266N     P=0.576N   |
|COCHRAN-ARMITAGE       |  P=0.616                                           |  P=0.139N                                          |
|FISHER EXACT           |               P=0.671N     P=0.646      P=0.751N   |               P=0.036 *    P=0.320N     P=0.495N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 53/100 (53%) 24/49 (49%)  70/148 (47%) 46/100 (46%)| 10/99 (10%)   3/49 (6%)   18/148 (12%) 11/100 (11%)|
|ADJUSTED (b)           |  82.9%        75.7%        70.6%        78.3%      |  16.9%         8.5%        17.1%        19.0%      |
|TERMINAL (d)           | 27/37 (73%)  15/22 (68%)  26/52 (50%)   9/20 (45%) |  7/54 (13%)   2/33 (6%)   10/93 (11%)   2/34 (6%)  |
|FIRST INCIDENCE (DAYS) |   507          497          453          486       |   592          699          550          564       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.024 *    P=0.147N     P=0.366N     P=0.086    |  P=0.090      P=0.204N     P=0.525      P=0.246    |
|INCIDENTAL TUMOR       |  P=0.489N     P=0.248N     P=0.207N     P=0.419N   |  P=0.531      P=0.262N     P=0.439      P=0.545N   |
|LOGISTIC REGRESSION    |  P=0.493      P=0.260N     P=0.232N     P=0.519N   |  P=0.331      P=0.247N     P=0.447      P=0.475    |
|COCHRAN-ARMITAGE       |  P=0.220N                                          |  P=0.397                                           |
|FISHER EXACT           |               P=0.387N     P=0.226N     P=0.198N   |               P=0.319N     P=0.388      P=0.510    |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE   2
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/100 (3%)   1/49 (2%)    6/148 (4%)   3/100 (3%) |  0/99 (0%)    0/49 (0%)    2/148 (1%)   0/100 (0%) |
|ADJUSTED (b)           |   5.8%         2.4%         8.6%         7.3%      |   0.0%         0.0%         1.9%         0.0%      |
|TERMINAL (d)           |  1/37 (3%)    0/22 (0%)    3/52 (6%)    0/20 (0%)  |  0/54 (0%)    0/33 (0%)    1/93 (1%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   619          580          617          438       |   ---          ---          638          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.376      P=0.535N     P=0.437      P=0.500    |  P=0.743N       (e)        P=0.359        (e)      |
|INCIDENTAL TUMOR       |  P=0.593      P=0.646N     P=0.464      P=0.645N   |  P=0.569N       (e)        P=0.377        (e)      |
|LOGISTIC REGRESSION    |  P=0.560      P=0.580N     P=0.459      P=0.648    |  P=0.662N       (e)        P=0.330        (e)      |
|COCHRAN-ARMITAGE       |  P=0.584                                           |  P=0.660N                                          |
|FISHER EXACT           |               P=0.601N     P=0.473      P=0.659N   |                 (e)        P=0.358        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 54/100 (54%) 25/49 (51%)  75/148 (51%) 47/100 (47%)| 10/99 (10%)   3/49 (6%)   20/148 (14%) 11/100 (11%)|
|ADJUSTED (b)           |  83.1%        76.3%        73.6%        78.5%      |  16.9%         8.5%        18.8%        19.0%      |
|TERMINAL (d)           | 27/37 (73%)  15/22 (68%)  28/52 (54%)   9/20 (45%) |  7/54 (13%)   2/33 (6%)   11/93 (12%)   2/34 (6%)  |
|FIRST INCIDENCE (DAYS) |   507          497          453          438       |   592          699          550          564       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.027 *    P=0.175N     P=0.488N     P=0.087    |  P=0.096      P=0.204N     P=0.408      P=0.246    |
|INCIDENTAL TUMOR       |  P=0.431N     P=0.319N     P=0.331N     P=0.405N   |  P=0.543N     P=0.262N     P=0.332      P=0.545N   |
|LOGISTIC REGRESSION    |  P=0.527N     P=0.316N     P=0.365N     P=0.490N   |  P=0.353      P=0.247N     P=0.326      P=0.475    |
|COCHRAN-ARMITAGE       |  P=0.194N                                          |  P=0.418                                           |
|FISHER EXACT           |               P=0.433N     P=0.350N     P=0.198N   |               P=0.319N     P=0.275      P=0.510    |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE   3
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone                                                                                                                             |
|     Chondrosarcoma                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/100 (0%)   0/50 (0%)    0/150 (0%)   0/100 (0%) |  0/100 (0%)   2/50 (4%)    0/150 (0%)   0/100 (0%) |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         5.7%         0.0%         0.0%      |
|TERMINAL (d)           |  0/37 (0%)    0/22 (0%)    0/52 (0%)    0/20 (0%)  |  0/54 (0%)    1/34 (3%)    0/93 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          735          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.414N     P=0.148        (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.329N     P=0.099        (e)          (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.395N     P=0.137        (e)          (e)      |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.326N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.110        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone                                                                                                                             |
|     Osteosarcoma or Osteoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/100 (1%)   0/50 (0%)    2/150 (1%)   0/100 (0%) |  1/100 (1%)   0/50 (0%)    0/150 (0%)   0/100 (0%) |
|ADJUSTED (b)           |   1.0%         0.0%         1.4%         0.0%      |   1.4%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/37 (0%)    0/22 (0%)    0/52 (0%)    0/20 (0%)  |  0/54 (0%)    0/34 (0%)    0/93 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   416          ---          381          ---       |   658          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.408N     P=0.649N     P=0.635      P=0.506N   |  P=0.475N     P=0.618N     P=0.405N     P=0.535N   |
|INCIDENTAL TUMOR       |  P=0.360N     P=0.638N     P=0.643      P=0.469N   |  P=0.390N     P=0.701N     P=0.445N     P=0.445N   |
|LOGISTIC REGRESSION    |  P=0.217N     P=0.632N     P=0.700      P=0.381N   |  P=0.440N     P=0.660N     P=0.432N     P=0.499N   |
|COCHRAN-ARMITAGE       |  P=0.401N                                          |  P=0.444N                                          |
|FISHER EXACT           |               P=0.667N     P=0.649      P=0.500N   |               P=0.667N     P=0.400N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE   4
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/98 (7%)    1/49 (2%)    1/145 (1%)   3/99 (3%)  |  4/98 (4%)    0/49 (0%)    3/141 (2%)   4/94 (4%)  |
|ADJUSTED (b)           |  15.4%         3.6%         1.7%         4.6%      |   7.5%         0.0%         3.4%         5.8%      |
|TERMINAL (d)           |  4/36 (11%)   0/22 (0%)    0/49 (0%)    0/20 (0%)  |  4/53 (8%)    0/34 (0%)    3/88 (3%)    0/30 (0%)  |
|FIRST INCIDENCE (DAYS) |   507          703          713          527       |   740 (T)      ---          740 (T)      548       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.413N     P=0.146N     P=0.011N*    P=0.330N   |  P=0.174      P=0.134N     P=0.244N     P=0.465    |
|INCIDENTAL TUMOR       |  P=0.279N     P=0.146N     P=0.009N**   P=0.218N   |  P=0.347      P=0.134N     P=0.244N     P=0.626N   |
|LOGISTIC REGRESSION    |  P=0.266N     P=0.174N     P=0.009N**   P=0.179N   |  P=0.332      P=0.134N     P=0.244N     P=0.611    |
|COCHRAN-ARMITAGE       |  P=0.243N                                          |  P=0.353                                           |
|FISHER EXACT           |               P=0.187N     P=0.008N**   P=0.161N   |               P=0.193N     P=0.307N     P=0.616    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/98 (2%)    1/49 (2%)    1/145 (1%)   1/99 (1%)  |  1/98 (1%)    0/49 (0%)    2/141 (1%)   0/94 (0%)  |
|ADJUSTED (b)           |   3.9%         2.1%         1.4%         2.0%      |   1.4%         0.0%         2.3%         0.0%      |
|TERMINAL (d)           |  1/36 (3%)    0/22 (0%)    0/49 (0%)    0/20 (0%)  |  0/53 (0%)    0/34 (0%)    2/88 (2%)    0/30 (0%)  |
|FIRST INCIDENCE (DAYS) |   552          395          695          650       |   658          ---          740 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.515N     P=0.712N     P=0.386N     P=0.602N   |  P=0.521N     P=0.618N     P=0.668      P=0.535N   |
|INCIDENTAL TUMOR       |  P=0.398N     P=0.700      P=0.357N     P=0.508N   |  P=0.461N     P=0.727N     P=0.643      P=0.452N   |
|LOGISTIC REGRESSION    |  P=0.376N     P=0.730N     P=0.366N     P=0.502N   |  P=0.442N     P=0.659N     P=0.645      P=0.506N   |
|COCHRAN-ARMITAGE       |  P=0.416N                                          |  P=0.411N                                          |
|FISHER EXACT           |               P=0.742N     P=0.356N     P=0.496N   |               P=0.667N     P=0.634      P=0.510N   |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE   5
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  9/98 (9%)    2/49 (4%)    2/145 (1%)   4/99 (4%)  |  5/98 (5%)    0/49 (0%)    5/141 (4%)   4/94 (4%)  |
|ADJUSTED (b)           |  19.0%         5.6%         3.0%         6.6%      |   8.8%         0.0%         5.7%         5.8%      |
|TERMINAL (d)           |  5/36 (14%)   0/22 (0%)    0/49 (0%)    0/20 (0%)  |  4/53 (8%)    0/34 (0%)    5/88 (6%)    0/30 (0%)  |
|FIRST INCIDENCE (DAYS) |   507          395          695          527       |   658          ---          740 (T)      548       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.347N     P=0.177N     P=0.008N**   P=0.292N   |  P=0.277      P=0.093N     P=0.312N     P=0.591    |
|INCIDENTAL TUMOR       |  P=0.195N     P=0.195N     P=0.006N**   P=0.167N   |  P=0.480      P=0.107N     P=0.325N     P=0.461N   |
|LOGISTIC REGRESSION    |  P=0.179N     P=0.220N     P=0.006N**   P=0.136N   |  P=0.472      P=0.107N     P=0.329N     P=0.531N   |
|COCHRAN-ARMITAGE       |  P=0.178N                                          |  P=0.504                                           |
|FISHER EXACT           |               P=0.224N     P=0.005N**   P=0.121N   |               P=0.127N     P=0.391N     P=0.526N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/98 (4%)    0/50 (0%)    4/149 (3%)   2/100 (2%) |  0/99 (0%)    1/50 (2%)    1/150 (1%)   0/99 (0%)  |
|ADJUSTED (b)           |   8.4%         0.0%         5.7%         3.9%      |   0.0%         2.9%         1.1%         0.0%      |
|TERMINAL (d)           |  1/37 (3%)    0/22 (0%)    1/51 (2%)    0/20 (0%)  |  0/54 (0%)    1/34 (3%)    1/93 (1%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   628          ---          661          619       |   ---          740 (T)      740 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.605      P=0.165N     P=0.466N     P=0.504N   |  P=0.612N     P=0.408      P=0.608        (e)      |
|INCIDENTAL TUMOR       |  P=0.406N     P=0.191N     P=0.393N     P=0.298N   |  P=0.612N     P=0.408      P=0.608        (e)      |
|LOGISTIC REGRESSION    |  P=0.491N     P=0.172N     P=0.427N     P=0.385N   |  P=0.612N     P=0.408      P=0.608        (e)      |
|COCHRAN-ARMITAGE       |  P=0.423N                                          |  P=0.495N                                          |
|FISHER EXACT           |               P=0.188N     P=0.397N     P=0.332N   |               P=0.336      P=0.602        (e)      |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE   6
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/98 (2%)    2/50 (4%)    1/149 (1%)   2/100 (2%) |  0/99 (0%)    0/50 (0%)    1/150 (1%)   0/99 (0%)  |
|ADJUSTED (b)           |   3.9%         9.1%         0.8%         2.9%      |   0.0%         0.0%         1.1%         0.0%      |
|TERMINAL (d)           |  0/37 (0%)    2/22 (9%)    0/51 (0%)    0/20 (0%)  |  0/54 (0%)    0/34 (0%)    1/93 (1%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   692          733 (T)      585          596       |   ---          ---          740 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.571      P=0.477      P=0.389N     P=0.594    |  P=0.836        (e)        P=0.608        (e)      |
|INCIDENTAL TUMOR       |  P=0.530N     P=0.483      P=0.338N     P=0.602N   |  P=0.836        (e)        P=0.608        (e)      |
|LOGISTIC REGRESSION    |  P=0.588N     P=0.470      P=0.359N     P=0.685    |  P=0.836        (e)        P=0.608        (e)      |
|COCHRAN-ARMITAGE       |  P=0.557N                                          |  P=0.771N                                          |
|FISHER EXACT           |               P=0.415      P=0.347N     P=0.682N   |                 (e)        P=0.602        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/98 (6%)    2/50 (4%)    5/149 (3%)   4/100 (4%) |  0/99 (0%)    1/50 (2%)    2/150 (1%)   0/99 (0%)  |
|ADJUSTED (b)           |  12.0%         9.1%         6.5%         6.7%      |   0.0%         2.9%         2.2%         0.0%      |
|TERMINAL (d)           |  1/37 (3%)    2/22 (9%)    1/51 (2%)    0/20 (0%)  |  0/54 (0%)    1/34 (3%)    2/93 (2%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   628          733 (T)      585          596       |   ---          740 (T)      740 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.535      P=0.390N     P=0.300N     P=0.571N   |  P=0.602N     P=0.408      P=0.365        (e)      |
|INCIDENTAL TUMOR       |  P=0.361N     P=0.418N     P=0.218N     P=0.282N   |  P=0.602N     P=0.408      P=0.365        (e)      |
|LOGISTIC REGRESSION    |  P=0.460N     P=0.407N     P=0.252N     P=0.415N   |  P=0.602N     P=0.408      P=0.365        (e)      |
|COCHRAN-ARMITAGE       |  P=0.391N                                          |  P=0.462N                                          |
|FISHER EXACT           |               P=0.454N     P=0.235N     P=0.361N   |               P=0.336      P=0.362        (e)      |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE   7
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/100 (1%)   1/49 (2%)    7/150 (5%)   3/100 (3%) |  0/99 (0%)    0/50 (0%)    2/150 (1%)   0/100 (0%) |
|ADJUSTED (b)           |   2.7%         2.7%         9.5%         7.5%      |   0.0%         0.0%         2.2%         0.0%      |
|TERMINAL (d)           |  1/37 (3%)    0/22 (0%)    2/52 (4%)    0/20 (0%)  |  0/54 (0%)    0/34 (0%)    2/93 (2%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   733 (T)      646          632          631       |   ---          ---          740 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.170      P=0.635      P=0.093      P=0.185    |  P=0.746        (e)        P=0.365        (e)      |
|INCIDENTAL TUMOR       |  P=0.361      P=0.620      P=0.107      P=0.301    |  P=0.746        (e)        P=0.365        (e)      |
|LOGISTIC REGRESSION    |  P=0.355      P=0.600      P=0.100      P=0.247    |  P=0.746        (e)        P=0.365        (e)      |
|COCHRAN-ARMITAGE       |  P=0.367                                           |  P=0.662N                                          |
|FISHER EXACT           |               P=0.551      P=0.103      P=0.311    |                 (e)        P=0.362        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/100 (1%)   1/49 (2%)    8/150 (5%)   3/100 (3%) |  0/99 (0%)    0/50 (0%)    2/150 (1%)   0/100 (0%) |
|ADJUSTED (b)           |   2.7%         2.7%        11.0%         7.5%      |   0.0%         0.0%         2.2%         0.0%      |
|TERMINAL (d)           |  1/37 (3%)    0/22 (0%)    2/52 (4%)    0/20 (0%)  |  0/54 (0%)    0/34 (0%)    2/93 (2%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   733 (T)      646          632          631       |   ---          ---          740 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.181      P=0.635      P=0.064      P=0.185    |  P=0.746        (e)        P=0.365        (e)      |
|INCIDENTAL TUMOR       |  P=0.386      P=0.620      P=0.074      P=0.301    |  P=0.746        (e)        P=0.365        (e)      |
|LOGISTIC REGRESSION    |  P=0.362      P=0.600      P=0.067      P=0.247    |  P=0.746        (e)        P=0.365        (e)      |
|COCHRAN-ARMITAGE       |  P=0.388                                           |  P=0.662N                                          |
|FISHER EXACT           |               P=0.551      P=0.067      P=0.311    |                 (e)        P=0.362        (e)      |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE   8
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/100 (1%)   0/50 (0%)    3/150 (2%)   2/100 (2%) |  2/100 (2%)   0/50 (0%)    2/150 (1%)   0/100 (0%) |
|ADJUSTED (b)           |   2.5%         0.0%         5.4%         4.5%      |   3.7%         0.0%         1.8%         0.0%      |
|TERMINAL (d)           |  0/37 (0%)    0/22 (0%)    2/52 (4%)    0/20 (0%)  |  2/54 (4%)    0/34 (0%)    1/93 (1%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   720          ---          713          604       |   740 (T)      ---          637          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.207      P=0.602N     P=0.435      P=0.402    |  P=0.317N     P=0.345N     P=0.491N     P=0.345N   |
|INCIDENTAL TUMOR       |  P=0.328      P=0.624N     P=0.455      P=0.565    |  P=0.219N     P=0.345N     P=0.478N     P=0.345N   |
|LOGISTIC REGRESSION    |  P=0.268      P=0.618N     P=0.430      P=0.458    |  P=0.253N     P=0.345N     P=0.517N     P=0.345N   |
|COCHRAN-ARMITAGE       |  P=0.356                                           |  P=0.232N                                          |
|FISHER EXACT           |               P=0.667N     P=0.475      P=0.500    |               P=0.443N     P=0.525N     P=0.249N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/100 (1%)   0/50 (0%)    3/150 (2%)   3/100 (3%) |  2/100 (2%)   0/50 (0%)    2/150 (1%)   1/100 (1%) |
|ADJUSTED (b)           |   2.5%         0.0%         5.4%         6.4%      |   3.7%         0.0%         1.8%         2.3%      |
|TERMINAL (d)           |  0/37 (0%)    0/22 (0%)    2/52 (4%)    0/20 (0%)  |  2/54 (4%)    0/34 (0%)    1/93 (1%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   720          ---          713          604       |   740 (T)      ---          637          713       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.072      P=0.602N     P=0.435      P=0.217    |  P=0.665      P=0.345N     P=0.491N     P=0.645N   |
|INCIDENTAL TUMOR       |  P=0.151      P=0.624N     P=0.455      P=0.366    |  P=0.505N     P=0.345N     P=0.478N     P=0.574N   |
|LOGISTIC REGRESSION    |  P=0.116      P=0.618N     P=0.430      P=0.273    |  P=0.575N     P=0.345N     P=0.517N     P=0.599N   |
|COCHRAN-ARMITAGE       |  P=0.168                                           |  P=0.530N                                          |
|FISHER EXACT           |               P=0.667N     P=0.475      P=0.311    |               P=0.443N     P=0.525N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE   9
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/100 (1%)   0/50 (0%)    3/150 (2%)   3/100 (3%) |  2/100 (2%)   0/50 (0%)    2/150 (1%)   1/100 (1%) |
|ADJUSTED (b)           |   2.5%         0.0%         5.4%         6.4%      |   3.7%         0.0%         1.8%         2.3%      |
|TERMINAL (d)           |  0/37 (0%)    0/22 (0%)    2/52 (4%)    0/20 (0%)  |  2/54 (4%)    0/34 (0%)    1/93 (1%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   720          ---          713          604       |   740 (T)      ---          637          713       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.072      P=0.602N     P=0.435      P=0.217    |  P=0.665      P=0.345N     P=0.491N     P=0.645N   |
|INCIDENTAL TUMOR       |  P=0.151      P=0.624N     P=0.455      P=0.366    |  P=0.505N     P=0.345N     P=0.478N     P=0.574N   |
|LOGISTIC REGRESSION    |  P=0.116      P=0.618N     P=0.430      P=0.273    |  P=0.575N     P=0.345N     P=0.517N     P=0.599N   |
|COCHRAN-ARMITAGE       |  P=0.168                                           |  P=0.530N                                          |
|FISHER EXACT           |               P=0.667N     P=0.475      P=0.311    |               P=0.443N     P=0.525N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/100 (0%)   2/50 (4%)    2/150 (1%)   0/100 (0%) |  0/100 (0%)   0/50 (0%)    0/150 (0%)   0/100 (0%) |
|ADJUSTED (b)           |   0.0%         8.1%         3.8%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/37 (0%)    1/22 (5%)    2/52 (4%)    0/20 (0%)  |  0/54 (0%)    0/34 (0%)    0/93 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          705          733 (T)      ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.481N     P=0.128      P=0.316        (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.439N     P=0.126      P=0.316        (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.438N     P=0.120      P=0.316        (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.321N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.110      P=0.359        (e)      |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE  10
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/100 (1%)   0/50 (0%)    2/150 (1%)   0/100 (0%) |  0/100 (0%)   0/50 (0%)    1/150 (1%)   0/100 (0%) |
|ADJUSTED (b)           |   2.7%         0.0%         3.8%         0.0%      |   0.0%         0.0%         1.1%         0.0%      |
|TERMINAL (d)           |  1/37 (3%)    0/22 (0%)    2/52 (4%)    0/20 (0%)  |  0/54 (0%)    0/34 (0%)    1/93 (1%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   733 (T)      ---          733 (T)      ---       |   ---          ---          740 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.566N     P=0.604N     P=0.618      P=0.623N   |  P=0.836        (e)        P=0.608        (e)      |
|INCIDENTAL TUMOR       |  P=0.566N     P=0.604N     P=0.618      P=0.623N   |  P=0.836        (e)        P=0.608        (e)      |
|LOGISTIC REGRESSION    |  P=0.566N     P=0.604N     P=0.618      P=0.623N   |  P=0.836        (e)        P=0.608        (e)      |
|COCHRAN-ARMITAGE       |  P=0.401N                                          |  P=0.770N                                          |
|FISHER EXACT           |               P=0.667N     P=0.649      P=0.500N   |                 (e)        P=0.600        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/100 (1%)   2/50 (4%)    4/150 (3%)   0/100 (0%) |  0/100 (0%)   0/50 (0%)    1/150 (1%)   0/100 (0%) |
|ADJUSTED (b)           |   2.7%         8.1%         7.7%         0.0%      |   0.0%         0.0%         1.1%         0.0%      |
|TERMINAL (d)           |  1/37 (3%)    1/22 (5%)    4/52 (8%)    0/20 (0%)  |  0/54 (0%)    0/34 (0%)    1/93 (1%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   733 (T)      705          733 (T)      ---       |   ---          ---          740 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.376N     P=0.315      P=0.295      P=0.623N   |  P=0.836        (e)        P=0.608        (e)      |
|INCIDENTAL TUMOR       |  P=0.347N     P=0.312      P=0.295      P=0.623N   |  P=0.836        (e)        P=0.608        (e)      |
|LOGISTIC REGRESSION    |  P=0.330N     P=0.303      P=0.295      P=0.623N   |  P=0.836        (e)        P=0.608        (e)      |
|COCHRAN-ARMITAGE       |  P=0.196N                                          |  P=0.770N                                          |
|FISHER EXACT           |               P=0.258      P=0.335      P=0.500N   |                 (e)        P=0.600        (e)      |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE  11
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/100 (0%)   0/50 (0%)    1/150 (1%)   0/100 (0%) |  1/100 (1%)   1/50 (2%)    2/150 (1%)   0/100 (0%) |
|ADJUSTED (b)           |   0.0%         0.0%         1.9%         0.0%      |   1.9%         2.9%         2.2%         0.0%      |
|TERMINAL (d)           |  0/37 (0%)    0/22 (0%)    1/52 (2%)    0/20 (0%)  |  1/54 (2%)    1/34 (3%)    2/93 (2%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          733 (T)      ---       |   740 (T)      740 (T)      740 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.823        (e)        P=0.568        (e)      |  P=0.395N     P=0.655      P=0.684      P=0.592N   |
|INCIDENTAL TUMOR       |  P=0.823        (e)        P=0.568        (e)      |  P=0.395N     P=0.655      P=0.684      P=0.592N   |
|LOGISTIC REGRESSION    |  P=0.823        (e)        P=0.568        (e)      |  P=0.395N     P=0.655      P=0.684      P=0.592N   |
|COCHRAN-ARMITAGE       |  P=0.770N                                          |  P=0.275N                                          |
|FISHER EXACT           |                 (e)        P=0.600        (e)      |               P=0.557      P=0.649      P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/100 (0%)   0/50 (0%)    1/150 (1%)   0/100 (0%) |  0/100 (0%)   1/50 (2%)    3/150 (2%)   4/100 (4%) |
|ADJUSTED (b)           |   0.0%         0.0%         1.9%         0.0%      |   0.0%         2.6%         3.2%         8.1%      |
|TERMINAL (d)           |  0/37 (0%)    0/22 (0%)    1/52 (2%)    0/20 (0%)  |  0/54 (0%)    0/34 (0%)    3/93 (3%)    2/34 (6%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          733 (T)      ---       |   ---          700          740 (T)      544       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.823        (e)        P=0.568        (e)      |  P=0.016 *    P=0.393      P=0.234      P=0.041 *  |
|INCIDENTAL TUMOR       |  P=0.823        (e)        P=0.568        (e)      |  P=0.030 *    P=0.299      P=0.234      P=0.034 *  |
|LOGISTIC REGRESSION    |  P=0.823        (e)        P=0.568        (e)      |  P=0.053      P=0.369      P=0.234      P=0.065    |
|COCHRAN-ARMITAGE       |  P=0.770N                                          |  P=0.058                                           |
|FISHER EXACT           |                 (e)        P=0.600        (e)      |               P=0.333      P=0.214      P=0.061    |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE  12
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/100 (0%)   0/50 (0%)    2/150 (1%)   0/100 (0%) |  1/100 (1%)   2/50 (4%)    5/150 (3%)   4/100 (4%) |
|ADJUSTED (b)           |   0.0%         0.0%         3.8%         0.0%      |   1.9%         5.5%         5.4%         8.1%      |
|TERMINAL (d)           |  0/37 (0%)    0/22 (0%)    2/52 (4%)    0/20 (0%)  |  1/54 (2%)    1/34 (3%)    5/93 (5%)    2/34 (6%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          733 (T)      ---       |   740 (T)      700          740 (T)      544       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.723        (e)        P=0.316        (e)      |  P=0.087      P=0.334      P=0.272      P=0.113    |
|INCIDENTAL TUMOR       |  P=0.723        (e)        P=0.316        (e)      |  P=0.125      P=0.286      P=0.272      P=0.105    |
|LOGISTIC REGRESSION    |  P=0.723        (e)        P=0.316        (e)      |  P=0.200      P=0.310      P=0.272      P=0.182    |
|COCHRAN-ARMITAGE       |  P=0.663N                                          |  P=0.247                                           |
|FISHER EXACT           |                 (e)        P=0.359        (e)      |               P=0.258      P=0.230      P=0.184    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/100 (1%)   4/50 (8%)    4/150 (3%)   0/100 (0%) | 26/100 (26%)  8/50 (16%)  33/150 (22%) 17/100 (17%)|
|ADJUSTED (b)           |   1.9%        17.4%         7.7%         0.0%      |  39.7%        22.7%        31.9%        34.8%      |
|TERMINAL (d)           |  0/37 (0%)    3/22 (14%)   4/52 (8%)    0/20 (0%)  | 18/54 (33%)   7/34 (21%)  25/93 (27%)   8/34 (24%) |
|FIRST INCIDENCE (DAYS) |   698          728          733 (T)      ---       |   431          700          622          565       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.243N     P=0.061      P=0.290      P=0.594N   |  P=0.407      P=0.042N*    P=0.137N     P=0.426N   |
|INCIDENTAL TUMOR       |  P=0.200N     P=0.056      P=0.305      P=0.480N   |  P=0.295N     P=0.079N     P=0.229N     P=0.190N   |
|LOGISTIC REGRESSION    |  P=0.201N     P=0.052      P=0.292      P=0.542N   |  P=0.204N     P=0.094N     P=0.214N     P=0.098N   |
|COCHRAN-ARMITAGE       |  P=0.102N                                          |  P=0.133N                                          |
|FISHER EXACT           |               P=0.043 *    P=0.335      P=0.500N   |               P=0.119N     P=0.281N     P=0.084N   |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE  13
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/100 (1%)   4/50 (8%)    5/150 (3%)   0/100 (0%) | 27/100 (27%)  9/50 (18%)  35/150 (23%) 17/100 (17%)|
|ADJUSTED (b)           |   1.9%        17.4%         9.6%         0.0%      |  41.4%        25.5%        33.9%        34.8%      |
|TERMINAL (d)           |  0/37 (0%)    3/22 (14%)   5/52 (10%)   0/20 (0%)  | 19/54 (35%)   8/34 (24%)  27/93 (29%)   8/34 (24%) |
|FIRST INCIDENCE (DAYS) |   698          728          733 (T)      ---       |   431          700          622          565       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.263N     P=0.061      P=0.196      P=0.594N   |  P=0.478      P=0.053N     P=0.147N     P=0.375N   |
|INCIDENTAL TUMOR       |  P=0.219N     P=0.056      P=0.207      P=0.480N   |  P=0.240N     P=0.098N     P=0.241N     P=0.155N   |
|LOGISTIC REGRESSION    |  P=0.217N     P=0.052      P=0.195      P=0.542N   |  P=0.152N     P=0.118N     P=0.227N     P=0.075N   |
|COCHRAN-ARMITAGE       |  P=0.105N                                          |  P=0.090N                                          |
|FISHER EXACT           |               P=0.043 *    P=0.230      P=0.500N   |               P=0.155N     P=0.304N     P=0.062N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/100 (1%)   4/50 (8%)    6/150 (4%)   0/100 (0%) | 27/100 (27%)  9/50 (18%)  37/150 (25%) 21/100 (21%)|
|ADJUSTED (b)           |   1.9%        17.4%        11.5%         0.0%      |  41.4%        25.5%        35.9%        41.3%      |
|TERMINAL (d)           |  0/37 (0%)    3/22 (14%)   6/52 (12%)   0/20 (0%)  | 19/54 (35%)   8/34 (24%)  29/93 (31%)  10/34 (29%) |
|FIRST INCIDENCE (DAYS) |   698          728          733 (T)      ---       |   431          700          622          544       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.282N     P=0.061      P=0.130      P=0.594N   |  P=0.171      P=0.053N     P=0.205N     P=0.464    |
|INCIDENTAL TUMOR       |  P=0.237N     P=0.056      P=0.138      P=0.480N   |  P=0.525      P=0.098N     P=0.318N     P=0.416N   |
|LOGISTIC REGRESSION    |  P=0.231N     P=0.052      P=0.129      P=0.542N   |  P=0.398N     P=0.118N     P=0.302N     P=0.228N   |
|COCHRAN-ARMITAGE       |  P=0.108N                                          |  P=0.281N                                          |
|FISHER EXACT           |               P=0.043 *    P=0.155      P=0.500N   |               P=0.155N     P=0.393N     P=0.204N   |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE  14
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Papilloma Squamous or Papilloma                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/100 (1%)   0/50 (0%)    2/150 (1%)   1/100 (1%) |  1/100 (1%)   0/50 (0%)    3/150 (2%)   1/100 (1%) |
|ADJUSTED (b)           |   1.4%         0.0%         3.3%         5.0%      |   1.3%         0.0%         2.7%         2.9%      |
|TERMINAL (d)           |  0/37 (0%)    0/22 (0%)    1/52 (2%)    1/20 (5%)  |  0/54 (0%)    0/34 (0%)    1/93 (1%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   633          ---          696          733 (T)   |   654          ---          494          734       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.471      P=0.619N     P=0.613      P=0.671    |  P=0.524      P=0.623N     P=0.494      P=0.690    |
|INCIDENTAL TUMOR       |  P=0.573      P=0.748N     P=0.641      P=0.739    |  P=0.626      P=0.701N     P=0.360      P=0.700N   |
|LOGISTIC REGRESSION    |  P=0.555      P=0.639N     P=0.632      P=0.733    |  P=0.635      P=0.662N     P=0.426      P=0.754    |
|COCHRAN-ARMITAGE       |  P=0.614                                           |  P=0.627                                           |
|FISHER EXACT           |               P=0.667N     P=0.649      P=0.751N   |               P=0.667N     P=0.475      P=0.751N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/100 (1%)   1/50 (2%)    2/150 (1%)   1/100 (1%) |  1/100 (1%)   1/50 (2%)    3/150 (2%)   1/100 (1%) |
|ADJUSTED (b)           |   1.4%         2.7%         3.3%         5.0%      |   1.3%         2.4%         2.7%         2.9%      |
|TERMINAL (d)           |  0/37 (0%)    0/22 (0%)    1/52 (2%)    1/20 (5%)  |  0/54 (0%)    0/34 (0%)    1/93 (1%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   633          646          696          733 (T)   |   654          652          494          734       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.601      P=0.626      P=0.613      P=0.671    |  P=0.639      P=0.620      P=0.494      P=0.690    |
|INCIDENTAL TUMOR       |  P=0.614N     P=0.545      P=0.641      P=0.739    |  P=0.520N     P=0.522      P=0.360      P=0.700N   |
|LOGISTIC REGRESSION    |  P=0.631N     P=0.599      P=0.632      P=0.733    |  P=0.535N     P=0.574      P=0.426      P=0.754    |
|COCHRAN-ARMITAGE       |  P=0.577N                                          |  P=0.547N                                          |
|FISHER EXACT           |               P=0.557      P=0.649      P=0.751N   |               P=0.557      P=0.475      P=0.751N   |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE  15
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Parathyroid Gland                                                                                                                |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/90 (2%)    2/48 (4%)    2/137 (1%)   1/54 (2%)  |  1/93 (1%)    2/48 (4%)    2/139 (1%)   0/79 (0%)  |
|ADJUSTED (b)           |   4.8%         7.6%         4.2%         4.5%      |   2.0%         5.9%         2.4%         0.0%      |
|TERMINAL (d)           |  1/34 (3%)    1/22 (5%)    2/48 (4%)    0/12 (0%)  |  1/50 (2%)    2/34 (6%)    2/84 (2%)    0/29 (0%)  |
|FIRST INCIDENCE (DAYS) |   701          692          733 (T)      728       |   740 (T)      740 (T)      740 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.599N     P=0.499      P=0.571N     P=0.722N   |  P=0.319N     P=0.367      P=0.676      P=0.609N   |
|INCIDENTAL TUMOR       |  P=0.593N     P=0.502      P=0.548N     P=0.714N   |  P=0.319N     P=0.367      P=0.676      P=0.609N   |
|LOGISTIC REGRESSION    |  P=0.643N     P=0.483      P=0.568N     P=0.682    |  P=0.319N     P=0.367      P=0.676      P=0.609N   |
|COCHRAN-ARMITAGE       |  P=0.490N                                          |  P=0.225N                                          |
|FISHER EXACT           |               P=0.433      P=0.519N     P=0.685N   |               P=0.267      P=0.647      P=0.541N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 34/100 (34%) 10/48 (21%)  35/145 (24%) 22/99 (22%) | 47/100 (47%) 27/49 (55%)  71/147 (48%) 42/100 (42%)|
|ADJUSTED (b)           |  48.9%        39.9%        42.7%        52.2%      |  63.9%        65.6%        63.0%        64.3%      |
|TERMINAL (d)           |  9/37 (24%)   8/22 (36%)  13/52 (25%)   6/20 (30%) | 29/54 (54%)  20/34 (59%)  52/92 (57%)  15/34 (44%) |
|FIRST INCIDENCE (DAYS) |   435          382          276          555       |   466          610          372          462       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.414      P=0.042N*    P=0.100N     P=0.411N   |  P=0.073      P=0.436N     P=0.271N     P=0.188    |
|INCIDENTAL TUMOR       |  P=0.137N     P=0.084N     P=0.061N     P=0.047N*  |  P=0.283N     P=0.366      P=0.485N     P=0.366N   |
|LOGISTIC REGRESSION    |  P=0.157N     P=0.073N     P=0.062N     P=0.076N   |  P=0.225N     P=0.361      P=0.513N     P=0.315N   |
|COCHRAN-ARMITAGE       |  P=0.101N                                          |  P=0.146N                                          |
|FISHER EXACT           |               P=0.072N     P=0.062N     P=0.045N*  |               P=0.225      P=0.472      P=0.285N   |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE  16
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/100 (1%)   0/48 (0%)    1/145 (1%)   0/99 (0%)  |  0/100 (0%)   1/49 (2%)    2/147 (1%)   5/100 (5%) |
|ADJUSTED (b)           |   1.7%         0.0%         0.9%         0.0%      |   0.0%         2.9%         1.8%        10.4%      |
|TERMINAL (d)           |  0/37 (0%)    0/22 (0%)    0/52 (0%)    0/20 (0%)  |  0/54 (0%)    1/34 (3%)    1/92 (1%)    1/34 (3%)  |
|FIRST INCIDENCE (DAYS) |   678          ---          603          ---       |   ---          740 (T)      603          576       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.479N     P=0.619N     P=0.673N     P=0.584N   |  P=0.003 **   P=0.408      P=0.360      P=0.017 *  |
|INCIDENTAL TUMOR       |  P=0.360N     P=0.638N     P=0.666N     P=0.486N   |  P=0.034 *    P=0.408      P=0.376      P=0.060    |
|LOGISTIC REGRESSION    |  P=0.416N     P=0.644N     P=0.676N     P=0.527N   |  P=0.014 *    P=0.408      P=0.315      P=0.033 *  |
|COCHRAN-ARMITAGE       |  P=0.419N                                          |  P=0.014 *                                         |
|FISHER EXACT           |               P=0.676N     P=0.651N     P=0.503N   |               P=0.329      P=0.353      P=0.030 *  |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 35/100 (35%) 10/48 (21%)  36/145 (25%) 22/99 (22%) | 47/100 (47%) 28/49 (57%)  73/147 (50%) 47/100 (47%)|
|ADJUSTED (b)           |  49.8%        39.9%        43.1%        52.2%      |  63.9%        68.0%        64.2%        68.8%      |
|TERMINAL (d)           |  9/37 (24%)   8/22 (36%)  13/52 (25%)   6/20 (30%) | 29/54 (54%)  21/34 (62%)  53/92 (58%)  16/34 (47%) |
|FIRST INCIDENCE (DAYS) |   435          382          276          555       |   466          610          372          462       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.457      P=0.034N*    P=0.095N     P=0.369N   |  P=0.014 *    P=0.509N     P=0.335N     P=0.062    |
|INCIDENTAL TUMOR       |  P=0.105N     P=0.067N     P=0.055N     P=0.033N*  |  P=0.525N     P=0.287      P=0.545      P=0.500    |
|LOGISTIC REGRESSION    |  P=0.128N     P=0.058N     P=0.057N     P=0.058N   |  P=0.484N     P=0.281      P=0.505      P=0.519    |
|COCHRAN-ARMITAGE       |  P=0.081N                                          |  P=0.364N                                          |
|FISHER EXACT           |               P=0.057N     P=0.057N     P=0.033N*  |               P=0.161      P=0.390      P=0.556N   |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE  17
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basosquamous Tumor Benign                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/100 (1%)   2/50 (4%)    1/150 (1%)   0/100 (0%) |  0/100 (0%)   0/50 (0%)    0/150 (0%)   0/100 (0%) |
|ADJUSTED (b)           |   1.4%         7.4%         1.9%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/37 (0%)    1/22 (5%)    1/52 (2%)    0/20 (0%)  |  0/54 (0%)    0/34 (0%)    0/93 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   628          674          733 (T)      ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.269N     P=0.303      P=0.679N     P=0.536N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.204N     P=0.242      P=0.670N     P=0.429N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.210N     P=0.272      P=0.672N     P=0.497N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.182N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.258      P=0.641N     P=0.500N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/100 (3%)   0/50 (0%)    2/150 (1%)   2/100 (2%) |  1/100 (1%)   1/50 (2%)    0/150 (0%)   0/100 (0%) |
|ADJUSTED (b)           |   6.8%         0.0%         1.7%         5.1%      |   1.4%         2.9%         0.0%         0.0%      |
|TERMINAL (d)           |  2/37 (5%)    0/22 (0%)    0/52 (0%)    0/20 (0%)  |  0/54 (0%)    1/34 (3%)    0/93 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   640          ---          585          654       |   658          740 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.520      P=0.230N     P=0.332N     P=0.676N   |  P=0.310N     P=0.639      P=0.405N     P=0.535N   |
|INCIDENTAL TUMOR       |  P=0.585N     P=0.278N     P=0.321N     P=0.558N   |  P=0.263N     P=0.592      P=0.445N     P=0.445N   |
|LOGISTIC REGRESSION    |  P=0.624      P=0.255N     P=0.324N     P=0.586N   |  P=0.265N     P=0.610      P=0.432N     P=0.499N   |
|COCHRAN-ARMITAGE       |  P=0.615N                                          |  P=0.262N                                          |
|FISHER EXACT           |               P=0.293N     P=0.316N     P=0.500N   |               P=0.557      P=0.400N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE  18
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/100 (1%)   0/50 (0%)    2/150 (1%)   0/100 (0%) |  0/100 (0%)   0/50 (0%)    1/150 (1%)   0/100 (0%) |
|ADJUSTED (b)           |   1.9%         0.0%         2.6%         0.0%      |   0.0%         0.0%         1.1%         0.0%      |
|TERMINAL (d)           |  0/37 (0%)    0/22 (0%)    0/52 (0%)    0/20 (0%)  |  0/54 (0%)    0/34 (0%)    1/93 (1%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   698          ---          634          ---       |   ---          ---          740 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.490N     P=0.627N     P=0.607      P=0.594N   |  P=0.836        (e)        P=0.608        (e)      |
|INCIDENTAL TUMOR       |  P=0.348N     P=0.624N     P=0.654      P=0.480N   |  P=0.836        (e)        P=0.608        (e)      |
|LOGISTIC REGRESSION    |  P=0.430N     P=0.630N     P=0.634      P=0.542N   |  P=0.836        (e)        P=0.608        (e)      |
|COCHRAN-ARMITAGE       |  P=0.401N                                          |  P=0.770N                                          |
|FISHER EXACT           |               P=0.667N     P=0.649      P=0.500N   |                 (e)        P=0.600        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/100 (0%)   0/50 (0%)    2/150 (1%)   0/100 (0%) |  2/100 (2%)   0/50 (0%)    0/150 (0%)   0/100 (0%) |
|ADJUSTED (b)           |   0.0%         0.0%         2.6%         0.0%      |   3.1%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/37 (0%)    0/22 (0%)    1/52 (2%)    0/20 (0%)  |  0/54 (0%)    0/34 (0%)    0/93 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          503          ---       |   694          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.735N       (e)        P=0.323        (e)      |  P=0.243N     P=0.360N     P=0.138N     P=0.313N   |
|INCIDENTAL TUMOR       |  P=0.712N       (e)        P=0.325        (e)      |  P=0.163N     P=0.478N     P=0.179N     P=0.179N   |
|LOGISTIC REGRESSION    |  P=0.648N       (e)        P=0.336        (e)      |  P=0.208N     P=0.387N     P=0.148N     P=0.253N   |
|COCHRAN-ARMITAGE       |  P=0.663N                                          |  P=0.205N                                          |
|FISHER EXACT           |                 (e)        P=0.359        (e)      |               P=0.443N     P=0.159N     P=0.249N   |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE  19
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/100 (4%)   0/50 (0%)    6/150 (4%)   2/100 (2%) |  3/100 (3%)   1/50 (2%)    1/150 (1%)   0/100 (0%) |
|ADJUSTED (b)           |   8.6%         0.0%         6.7%         5.1%      |   4.4%         2.9%         1.1%         0.0%      |
|TERMINAL (d)           |  2/37 (5%)    0/22 (0%)    1/52 (2%)    0/20 (0%)  |  0/54 (0%)    1/34 (3%)    1/93 (1%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   640          ---          503          654       |   658          740 (T)      740 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.582N     P=0.158N     P=0.599      P=0.537N   |  P=0.118N     P=0.505N     P=0.152N     P=0.176N   |
|INCIDENTAL TUMOR       |  P=0.368N     P=0.189N     P=0.624N     P=0.379N   |  P=0.073N     P=0.638N     P=0.193N     P=0.076N   |
|LOGISTIC REGRESSION    |  P=0.431N     P=0.173N     P=0.627      P=0.428N   |  P=0.087N     P=0.553N     P=0.168N     P=0.126N   |
|COCHRAN-ARMITAGE       |  P=0.403N                                          |  P=0.082N                                          |
|FISHER EXACT           |               P=0.194N     P=0.621N     P=0.341N   |               P=0.593N     P=0.177N     P=0.123N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/100 (2%)   3/50 (6%)   10/150 (7%)   1/100 (1%) |  0/100 (0%)   0/50 (0%)    2/150 (1%)   1/100 (1%) |
|ADJUSTED (b)           |   4.2%        13.6%        13.0%         3.8%      |   0.0%         0.0%         2.0%         1.2%      |
|TERMINAL (d)           |  1/37 (3%)    3/22 (14%)   2/52 (4%)    0/20 (0%)  |  0/54 (0%)    0/34 (0%)    1/93 (1%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   640          733 (T)      594          723       |   ---          ---          713          600       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.430N     P=0.272      P=0.077      P=0.635N   |  P=0.311        (e)        P=0.362      P=0.505    |
|INCIDENTAL TUMOR       |  P=0.224N     P=0.223      P=0.087      P=0.517N   |  P=0.514        (e)        P=0.333      P=0.731    |
|LOGISTIC REGRESSION    |  P=0.279N     P=0.239      P=0.078      P=0.574N   |  P=0.399        (e)        P=0.354      P=0.476    |
|COCHRAN-ARMITAGE       |  P=0.202N                                          |  P=0.398                                           |
|FISHER EXACT           |               P=0.207      P=0.078      P=0.500N   |                 (e)        P=0.359      P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE  20
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/100 (2%)   2/50 (4%)    6/150 (4%)   1/100 (1%) |  1/100 (1%)   0/50 (0%)    1/150 (1%)   1/100 (1%) |
|ADJUSTED (b)           |   4.7%         6.6%         7.1%         1.7%      |   1.9%         0.0%         1.1%         2.6%      |
|TERMINAL (d)           |  0/37 (0%)    0/22 (0%)    1/52 (2%)    0/20 (0%)  |  1/54 (2%)    0/34 (0%)    1/93 (1%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   712          642          503          634       |   740 (T)      ---          740 (T)      726       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.418N     P=0.487      P=0.285      P=0.600N   |  P=0.477      P=0.592N     P=0.635N     P=0.668    |
|INCIDENTAL TUMOR       |  P=0.231N     P=0.399      P=0.313      P=0.435N   |  P=0.555      P=0.592N     P=0.635N     P=0.744    |
|LOGISTIC REGRESSION    |  P=0.293N     P=0.446      P=0.303      P=0.556N   |  P=0.506      P=0.592N     P=0.635N     P=0.693    |
|COCHRAN-ARMITAGE       |  P=0.277N                                          |  P=0.599                                           |
|FISHER EXACT           |               P=0.407      P=0.312      P=0.500N   |               P=0.667N     P=0.641N     P=0.751N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/100 (4%)   6/50 (12%)  17/150 (11%)  2/100 (2%) |  1/100 (1%)   0/50 (0%)    3/150 (2%)   2/100 (2%) |
|ADJUSTED (b)           |   8.6%        23.6%        20.9%         5.5%      |   1.9%         0.0%         3.1%         3.8%      |
|TERMINAL (d)           |  1/37 (3%)    4/22 (18%)   4/52 (8%)    0/20 (0%)  |  1/54 (2%)    0/34 (0%)    2/93 (2%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   640          642          503          634       |   740 (T)      ---          713          600       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.296N     P=0.115      P=0.033 *    P=0.503N   |  P=0.211      P=0.592N     P=0.510      P=0.411    |
|INCIDENTAL TUMOR       |  P=0.095N     P=0.068      P=0.037 *    P=0.307N   |  P=0.402      P=0.592N     P=0.486      P=0.605    |
|LOGISTIC REGRESSION    |  P=0.132N     P=0.082      P=0.033 *    P=0.425N   |  P=0.317      P=0.592N     P=0.502      P=0.492    |
|COCHRAN-ARMITAGE       |  P=0.089N                                          |  P=0.356                                           |
|FISHER EXACT           |               P=0.070      P=0.031 *    P=0.341N   |               P=0.667N     P=0.475      P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE  21
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/100 (2%)   3/50 (6%)    7/150 (5%)   1/100 (1%) |  1/100 (1%)   0/50 (0%)    1/150 (1%)   1/100 (1%) |
|ADJUSTED (b)           |   4.7%        10.9%         8.9%         1.7%      |   1.9%         0.0%         1.1%         2.6%      |
|TERMINAL (d)           |  0/37 (0%)    1/22 (5%)    2/52 (4%)    0/20 (0%)  |  1/54 (2%)    0/34 (0%)    1/93 (1%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   712          642          503          634       |   740 (T)      ---          740 (T)      726       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.371N     P=0.270      P=0.207      P=0.600N   |  P=0.477      P=0.592N     P=0.635N     P=0.668    |
|INCIDENTAL TUMOR       |  P=0.207N     P=0.202      P=0.227      P=0.435N   |  P=0.555      P=0.592N     P=0.635N     P=0.744    |
|LOGISTIC REGRESSION    |  P=0.240N     P=0.231      P=0.220      P=0.556N   |  P=0.506      P=0.592N     P=0.635N     P=0.693    |
|COCHRAN-ARMITAGE       |  P=0.212N                                          |  P=0.599                                           |
|FISHER EXACT           |               P=0.207      P=0.227      P=0.500N   |               P=0.667N     P=0.641N     P=0.751N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/100 (1%)   0/50 (0%)    1/150 (1%)   0/100 (0%) |  0/100 (0%)   0/50 (0%)    2/150 (1%)   0/100 (0%) |
|ADJUSTED (b)           |   2.7%         0.0%         0.9%         0.0%      |   0.0%         0.0%         2.0%         0.0%      |
|TERMINAL (d)           |  1/37 (3%)    0/22 (0%)    0/52 (0%)    0/20 (0%)  |  0/54 (0%)    0/34 (0%)    1/93 (1%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   733 (T)      ---          619          ---       |   ---          ---          694          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.504N     P=0.604N     P=0.679N     P=0.623N   |  P=0.754        (e)        P=0.360        (e)      |
|INCIDENTAL TUMOR       |  P=0.426N     P=0.604N     P=0.670N     P=0.623N   |  P=0.672N       (e)        P=0.333        (e)      |
|LOGISTIC REGRESSION    |  P=0.440N     P=0.604N     P=0.671N     P=0.623N   |  P=0.700N       (e)        P=0.348        (e)      |
|COCHRAN-ARMITAGE       |  P=0.420N                                          |  P=0.663N                                          |
|FISHER EXACT           |               P=0.667N     P=0.641N     P=0.500N   |                 (e)        P=0.359        (e)      |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE  22
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 87/100 (87%) 44/50 (88%) 133/150 (89%) 85/100 (85%)|                                                    |
|ADJUSTED (b)           |  98.8%        97.8%       100.0%       100.0%      |                                                    |
|TERMINAL (d)           | 36/37 (97%)  21/22 (95%)  52/52 (100%) 20/20 (100%)|                                                    |
|FIRST INCIDENCE (DAYS) |   372          444          381          438       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.264N     P=0.280      P=0.006 ** |                                                    |
|INCIDENTAL TUMOR       |  P=0.254      P=0.596N     P=0.384      P=0.299    |                                                    |
|LOGISTIC REGRESSION    |  P=0.384      P=0.497      P=0.354      P=0.393    |                                                    |
|COCHRAN-ARMITAGE       |  P=0.321N                                          |                                                    |
|FISHER EXACT           |               P=0.543      P=0.418      P=0.419N   |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thymus                                                                                                                           |
|     Thymoma Benign                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/79 (0%)    0/45 (0%)    0/120 (0%)   2/87 (2%)  |  0/89 (0%)    0/44 (0%)    0/131 (0%)   0/85 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         6.7%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/31 (0%)    0/19 (0%)    0/44 (0%)    1/19 (5%)  |  0/51 (0%)    0/31 (0%)    0/80 (0%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          604       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.024 *      (e)          (e)        P=0.175    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.043 *      (e)          (e)        P=0.214    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.045 *      (e)          (e)        P=0.237    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.053                                           |    (e)                                             |
|FISHER EXACT           |                 (e)          (e)        P=0.273    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE  23
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 21/98 (21%)  10/46 (22%)  41/143 (29%) 12/100 (12%)| 21/98 (21%)  17/49 (35%)  26/137 (19%) 18/99 (18%) |
|ADJUSTED (b)           |  41.3%        33.9%        49.3%        32.6%      |  31.9%        44.2%        26.7%        34.3%      |
|TERMINAL (d)           | 12/37 (32%)   4/21 (19%)  15/51 (29%)   3/20 (15%) | 13/54 (24%)  13/34 (38%)  22/92 (24%)   8/34 (24%) |
|FIRST INCIDENCE (DAYS) |   507          642          486          538       |   424          581          558          564       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.458N     P=0.406N     P=0.117      P=0.413N   |  P=0.375      P=0.218      P=0.159N     P=0.378    |
|INCIDENTAL TUMOR       |  P=0.053N     P=0.552N     P=0.151      P=0.131N   |  P=0.241N     P=0.084      P=0.312N     P=0.410N   |
|LOGISTIC REGRESSION    |  P=0.078N     P=0.548N     P=0.128      P=0.118N   |  P=0.206N     P=0.088      P=0.291N     P=0.367N   |
|COCHRAN-ARMITAGE       |  P=0.025N*                                         |  P=0.141N                                          |
|FISHER EXACT           |               P=0.564      P=0.132      P=0.056N   |               P=0.064      P=0.381N     P=0.347N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/98 (3%)    1/46 (2%)    0/143 (0%)   0/100 (0%) |  4/98 (4%)    1/49 (2%)    3/137 (2%)   1/99 (1%)  |
|ADJUSTED (b)           |   8.1%         4.8%         0.0%         0.0%      |   6.3%         2.9%         3.3%         2.9%      |
|TERMINAL (d)           |  3/37 (8%)    1/21 (5%)    0/51 (0%)    0/20 (0%)  |  1/54 (2%)    1/34 (3%)    3/92 (3%)    1/34 (3%)  |
|FIRST INCIDENCE (DAYS) |   733 (T)      733 (T)      ---          ---       |   674          740 (T)      740 (T)      740 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.117N     P=0.522N     P=0.071N     P=0.248N   |  P=0.307N     P=0.365N     P=0.242N     P=0.303N   |
|INCIDENTAL TUMOR       |  P=0.117N     P=0.522N     P=0.071N     P=0.248N   |  P=0.208N     P=0.491N     P=0.313N     P=0.175N   |
|LOGISTIC REGRESSION    |  P=0.117N     P=0.522N     P=0.071N     P=0.248N   |  P=0.226N     P=0.402N     P=0.277N     P=0.218N   |
|COCHRAN-ARMITAGE       |  P=0.067N                                          |  P=0.171N                                          |
|FISHER EXACT           |               P=0.618N     P=0.066N     P=0.119N   |               P=0.459N     P=0.321N     P=0.181N   |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE  24
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 23/98 (23%)  11/46 (24%)  41/143 (29%) 12/100 (12%)| 23/98 (23%)  18/49 (37%)  28/137 (20%) 18/99 (18%) |
|ADJUSTED (b)           |  46.0%        37.8%        49.3%        32.6%      |  34.1%        46.9%        28.8%        34.3%      |
|TERMINAL (d)           | 14/37 (38%)   5/21 (24%)  15/51 (29%)   3/20 (15%) | 13/54 (24%)  14/34 (41%)  24/92 (26%)   8/34 (24%) |
|FIRST INCIDENCE (DAYS) |   507          642          486          538       |   424          581          558          564       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.355N     P=0.395N     P=0.193      P=0.316N   |  P=0.496      P=0.240      P=0.130N     P=0.491    |
|INCIDENTAL TUMOR       |  P=0.030N*    P=0.537N     P=0.251      P=0.084N   |  P=0.143N     P=0.082      P=0.280N     P=0.259N   |
|LOGISTIC REGRESSION    |  P=0.043N*    P=0.540N     P=0.221      P=0.068N   |  P=0.124N     P=0.097      P=0.249N     P=0.249N   |
|COCHRAN-ARMITAGE       |  P=0.011N*                                         |  P=0.076N                                          |
|FISHER EXACT           |               P=0.555      P=0.227      P=0.026N*  |               P=0.069      P=0.345N     P=0.230N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/98 (1%)    1/46 (2%)   27/143 (19%) 57/100 (57%)|  1/98 (1%)    0/49 (0%)   18/137 (13%) 57/99 (58%) |
|ADJUSTED (b)           |   2.7%         4.8%        35.3%        87.4%      |   1.9%         0.0%        18.8%        86.6%      |
|TERMINAL (d)           |  1/37 (3%)    1/21 (5%)   11/51 (22%)  14/20 (70%) |  1/54 (2%)    0/34 (0%)   16/92 (17%)  26/34 (76%) |
|FIRST INCIDENCE (DAYS) |   733 (T)      733 (T)      466          391       |   740 (T)      ---          597          469       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.630      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.592N     P=0.003 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.630      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.592N     P=0.002 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.630      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.592N     P=0.002 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.538      P<0.001 **   P<0.001 ** |               P=0.667N     P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE  25
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/98 (4%)    2/46 (4%)   13/143 (9%)  70/100 (70%)|  2/98 (2%)    1/49 (2%)    4/137 (3%)  25/99 (25%) |
|ADJUSTED (b)           |   6.7%         5.1%        17.6%        96.8%      |   3.7%         2.9%         4.2%        48.2%      |
|TERMINAL (d)           |  1/37 (3%)    0/21 (0%)    6/51 (12%)  18/20 (90%) |  2/54 (4%)    1/34 (3%)    3/92 (3%)   12/34 (35%) |
|FIRST INCIDENCE (DAYS) |   512          497          552          391       |   740 (T)      740 (T)      721          462       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.641N     P=0.103      P<0.001 ** |  P<0.001 **   P=0.659N     P=0.595      P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.620      P=0.110      P<0.001 ** |  P<0.001 **   P=0.659N     P=0.562      P<0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.640      P=0.109      P<0.001 ** |  P<0.001 **   P=0.659N     P=0.584      P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.625      P=0.106      P<0.001 ** |               P=0.742N     P=0.509      P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/98 (5%)    3/46 (7%)   39/143 (27%) 85/100 (85%)|  3/98 (3%)    1/49 (2%)   22/137 (16%) 67/99 (68%) |
|ADJUSTED (b)           |   9.3%         9.6%        47.1%       100.0%      |   5.6%         2.9%        22.8%        89.7%      |
|TERMINAL (d)           |  2/37 (5%)    1/21 (5%)   16/51 (31%)  20/20 (100%)|  3/54 (6%)    1/34 (3%)   19/92 (21%)  27/34 (79%) |
|FIRST INCIDENCE (DAYS) |   512          497          466          391       |   740 (T)      740 (T)      597          462       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.590      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.481N     P=0.005 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.520      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.481N     P=0.004 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.514      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.481N     P=0.004 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.499      P<0.001 **   P<0.001 ** |               P=0.593N     P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE  26
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Tongue                                                                                                                           |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/100 (1%)   0/50 (0%)    1/150 (1%)   1/100 (1%) |  1/100 (1%)   1/50 (2%)    3/150 (2%)   1/100 (1%) |
|ADJUSTED (b)           |   1.4%         0.0%         1.4%         5.0%      |   1.3%         2.4%         2.7%         2.9%      |
|TERMINAL (d)           |  0/37 (0%)    0/22 (0%)    0/52 (0%)    1/20 (5%)  |  0/54 (0%)    0/34 (0%)    1/93 (1%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   633          ---          696          733 (T)   |   654          652          494          734       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.487      P=0.619N     P=0.687N     P=0.671    |  P=0.639      P=0.620      P=0.494      P=0.690    |
|INCIDENTAL TUMOR       |  P=0.601      P=0.748N     P=0.656N     P=0.739    |  P=0.520N     P=0.522      P=0.360      P=0.700N   |
|LOGISTIC REGRESSION    |  P=0.563      P=0.639N     P=0.670N     P=0.733    |  P=0.535N     P=0.574      P=0.426      P=0.754    |
|COCHRAN-ARMITAGE       |  P=0.599                                           |  P=0.547N                                          |
|FISHER EXACT           |               P=0.667N     P=0.641N     P=0.751N   |               P=0.557      P=0.475      P=0.751N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Tongue                                                                                                                           |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/100 (1%)   0/50 (0%)    1/150 (1%)   1/100 (1%) |  1/100 (1%)   0/50 (0%)    3/150 (2%)   1/100 (1%) |
|ADJUSTED (b)           |   1.4%         0.0%         1.4%         5.0%      |   1.3%         0.0%         2.7%         2.9%      |
|TERMINAL (d)           |  0/37 (0%)    0/22 (0%)    0/52 (0%)    1/20 (5%)  |  0/54 (0%)    0/34 (0%)    1/93 (1%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   633          ---          696          733 (T)   |   654          ---          494          734       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.487      P=0.619N     P=0.687N     P=0.671    |  P=0.524      P=0.623N     P=0.494      P=0.690    |
|INCIDENTAL TUMOR       |  P=0.601      P=0.748N     P=0.656N     P=0.739    |  P=0.626      P=0.701N     P=0.360      P=0.700N   |
|LOGISTIC REGRESSION    |  P=0.563      P=0.639N     P=0.670N     P=0.733    |  P=0.635      P=0.662N     P=0.426      P=0.754    |
|COCHRAN-ARMITAGE       |  P=0.599                                           |  P=0.627                                           |
|FISHER EXACT           |               P=0.667N     P=0.641N     P=0.751N   |               P=0.667N     P=0.475      P=0.751N   |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE  27
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    | 15/100 (15%) 13/50 (26%)  28/150 (19%) 10/100 (10%)|
|ADJUSTED (b)           |                                                    |  24.4%        34.1%        26.6%        21.6%      |
|TERMINAL (d)           |                                                    | 11/54 (20%)   9/34 (26%)  20/93 (22%)   5/34 (15%) |
|FIRST INCIDENCE (DAYS) |                                                    |   494          679          312          570       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.373N     P=0.216      P=0.438      P=0.518N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.140N     P=0.112      P=0.310      P=0.327N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.135N     P=0.124      P=0.312      P=0.233N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.050N                                          |
|FISHER EXACT           |                                                    |               P=0.081      P=0.282      P=0.196N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    | 16/100 (16%) 13/50 (26%)  29/150 (19%) 11/100 (11%)|
|ADJUSTED (b)           |                                                    |  25.1%        34.1%        27.3%        22.5%      |
|TERMINAL (d)           |                                                    | 11/54 (20%)   9/34 (26%)  20/93 (22%)   5/34 (15%) |
|FIRST INCIDENCE (DAYS) |                                                    |   480          679          312          570       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.409N     P=0.265      P=0.469      P=0.515N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.148N     P=0.132      P=0.307      P=0.326N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.076N     P=0.145      P=0.325      P=0.217N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.060N                                          |
|FISHER EXACT           |                                                    |               P=0.108      P=0.309      P=0.204N   |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE  28
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/100 (0%)   0/50 (0%)    0/150 (0%)   1/100 (1%) |  0/100 (0%)   0/50 (0%)    2/150 (1%)   0/100 (0%) |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         3.7%      |   0.0%         0.0%         2.1%         0.0%      |
|TERMINAL (d)           |  0/37 (0%)    0/22 (0%)    0/52 (0%)    0/20 (0%)  |  0/54 (0%)    0/34 (0%)    1/93 (1%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          722       |   ---          ---          720          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.169        (e)          (e)        P=0.432    |  P=0.749        (e)        P=0.365        (e)      |
|INCIDENTAL TUMOR       |  P=0.242        (e)          (e)        P=0.520    |  P=0.672N       (e)        P=0.333        (e)      |
|LOGISTIC REGRESSION    |  P=0.169        (e)          (e)        P=0.423    |  P=0.733N       (e)        P=0.356        (e)      |
|COCHRAN-ARMITAGE       |  P=0.230                                           |  P=0.663N                                          |
|FISHER EXACT           |                 (e)          (e)        P=0.500    |                 (e)        P=0.359        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/100 (2%)   1/50 (2%)    6/150 (4%)   7/100 (7%) |  1/100 (1%)   0/50 (0%)    1/150 (1%)   6/100 (6%) |
|ADJUSTED (b)           |   3.6%         3.3%         5.8%        15.6%      |   1.9%         0.0%         0.7%         9.8%      |
|TERMINAL (d)           |  0/37 (0%)    0/22 (0%)    1/52 (2%)    0/20 (0%)  |  1/54 (2%)    0/34 (0%)    0/93 (0%)    1/34 (3%)  |
|FIRST INCIDENCE (DAYS) |   628          696          395          640       |   740 (T)      ---          494          565       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.012 *    P=0.706N     P=0.292      P=0.035 *  |  P=0.001 **   P=0.592N     P=0.648N     P=0.040 *  |
|INCIDENTAL TUMOR       |  P=0.073      P=0.704      P=0.310      P=0.125    |  P=0.012 *    P=0.592N     P=0.761N     P=0.141    |
|LOGISTIC REGRESSION    |  P=0.048 *    P=0.728N     P=0.320      P=0.135    |  P=0.004 **   P=0.592N     P=0.708N     P=0.062    |
|COCHRAN-ARMITAGE       |  P=0.042 *                                         |  P=0.003 **                                        |
|FISHER EXACT           |               P=0.742N     P=0.312      P=0.085    |               P=0.667N     P=0.641N     P=0.059    |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE  29
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/100 (2%)   1/50 (2%)    6/150 (4%)   8/100 (8%) |  1/100 (1%)   0/50 (0%)    3/150 (2%)   6/100 (6%) |
|ADJUSTED (b)           |   3.6%         3.3%         5.8%        18.7%      |   1.9%         0.0%         2.7%         9.8%      |
|TERMINAL (d)           |  0/37 (0%)    0/22 (0%)    1/52 (2%)    0/20 (0%)  |  1/54 (2%)    0/34 (0%)    1/93 (1%)    1/34 (3%)  |
|FIRST INCIDENCE (DAYS) |   628          696          395          640       |   740 (T)      ---          494          565       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.004 **   P=0.706N     P=0.292      P=0.018 *  |  P=0.003 **   P=0.592N     P=0.502      P=0.040 *  |
|INCIDENTAL TUMOR       |  P=0.036 *    P=0.704      P=0.310      P=0.078    |  P=0.026 *    P=0.592N     P=0.385      P=0.141    |
|LOGISTIC REGRESSION    |  P=0.020 *    P=0.728N     P=0.320      P=0.068    |  P=0.011 *    P=0.592N     P=0.445      P=0.062    |
|COCHRAN-ARMITAGE       |  P=0.019 *                                         |  P=0.009 **                                        |
|FISHER EXACT           |               P=0.742N     P=0.312      P=0.050    |               P=0.667N     P=0.475      P=0.059    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/100 (2%)   0/50 (0%)    0/150 (0%)   1/100 (1%) |  0/100 (0%)   0/50 (0%)    1/150 (1%)   0/100 (0%) |
|ADJUSTED (b)           |   4.7%         0.0%         0.0%         5.0%      |   0.0%         0.0%         0.8%         0.0%      |
|TERMINAL (d)           |  0/37 (0%)    0/22 (0%)    0/52 (0%)    1/20 (5%)  |  0/54 (0%)    0/34 (0%)    0/93 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   712          ---          ---          733 (T)   |   ---          ---          665          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.692      P=0.371N     P=0.174N     P=0.652N   |  P=0.807N       (e)        P=0.599        (e)      |
|INCIDENTAL TUMOR       |  P=0.645N     P=0.383N     P=0.146N     P=0.546N   |  P=0.704N       (e)        P=0.555        (e)      |
|LOGISTIC REGRESSION    |  P=0.709      P=0.378N     P=0.166N     P=0.631N   |  P=0.764N       (e)        P=0.571        (e)      |
|COCHRAN-ARMITAGE       |  P=0.605N                                          |  P=0.770N                                          |
|FISHER EXACT           |               P=0.443N     P=0.159N     P=0.500N   |                 (e)        P=0.600        (e)      |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE  30
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/100 (2%)   0/50 (0%)    0/150 (0%)   1/100 (1%) |  1/100 (1%)   0/50 (0%)    1/150 (1%)   0/100 (0%) |
|ADJUSTED (b)           |   4.7%         0.0%         0.0%         5.0%      |   1.9%         0.0%         0.8%         0.0%      |
|TERMINAL (d)           |  0/37 (0%)    0/22 (0%)    0/52 (0%)    1/20 (5%)  |  1/54 (2%)    0/34 (0%)    0/93 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   712          ---          ---          733 (T)   |   740 (T)      ---          665          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.692      P=0.371N     P=0.174N     P=0.652N   |  P=0.493N     P=0.592N     P=0.641N     P=0.592N   |
|INCIDENTAL TUMOR       |  P=0.645N     P=0.383N     P=0.146N     P=0.546N   |  P=0.424N     P=0.592N     P=0.667N     P=0.592N   |
|LOGISTIC REGRESSION    |  P=0.709      P=0.378N     P=0.166N     P=0.631N   |  P=0.430N     P=0.592N     P=0.661N     P=0.592N   |
|COCHRAN-ARMITAGE       |  P=0.605N                                          |  P=0.420N                                          |
|FISHER EXACT           |               P=0.443N     P=0.159N     P=0.500N   |               P=0.667N     P=0.641N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 54/100 (54%) 29/50 (58%)  91/150 (61%) 55/100 (55%)| 36/100 (36%) 19/50 (38%)  74/150 (49%) 52/100 (52%)|
|ADJUSTED (b)           |  71.5%        70.9%        80.7%        84.2%      |  46.7%        45.0%        55.9%        69.9%      |
|TERMINAL (d)           | 18/37 (49%)  11/22 (50%)  33/52 (63%)  12/20 (60%) | 15/54 (28%)  12/34 (35%)  36/93 (39%)  15/34 (44%) |
|FIRST INCIDENCE (DAYS) |   372          444          371          486       |   523          523          312          469       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.009 **   P=0.480N     P=0.163      P=0.026 *  |  P<0.001 **   P=0.369N     P=0.168      P=0.001 ** |
|INCIDENTAL TUMOR       |  P=0.536N     P=0.345      P=0.182      P=0.452    |  P=0.146      P=0.455      P=0.026 *    P=0.104    |
|LOGISTIC REGRESSION    |  P=0.487N     P=0.262      P=0.175      P=0.456    |  P=0.086      P=0.475      P=0.023 *    P=0.111    |
|COCHRAN-ARMITAGE       |  P=0.481N                                          |  P=0.016 *                                         |
|FISHER EXACT           |               P=0.387      P=0.180      P=0.500    |               P=0.474      P=0.025 *    P=0.016 *  |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE  31
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma Benign, Malignant, NOS                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/100 (2%)   2/50 (4%)    4/150 (3%)   3/100 (3%) |  1/100 (1%)   0/50 (0%)    0/150 (0%)   0/100 (0%) |
|ADJUSTED (b)           |   3.7%         7.1%         5.3%         4.1%      |   1.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/37 (0%)    1/22 (5%)    1/52 (2%)    0/20 (0%)  |  0/54 (0%)    0/34 (0%)    0/93 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   650          646          605          506       |   424          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.355      P=0.476      P=0.500      P=0.419    |  P=0.443N     P=0.636N     P=0.420N     P=0.498N   |
|INCIDENTAL TUMOR       |  P=0.564      P=0.466      P=0.547      P=0.595    |  P=0.566N     P=0.788N     P=0.597N     P=0.690N   |
|LOGISTIC REGRESSION    |  P=0.507      P=0.437      P=0.527      P=0.518    |  P=0.603N     P=0.863N     P=0.544N     P=0.742N   |
|COCHRAN-ARMITAGE       |  P=0.520                                           |  P=0.444N                                          |
|FISHER EXACT           |               P=0.407      P=0.544      P=0.500    |               P=0.667N     P=0.400N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Osteosarcoma or Osteoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/100 (1%)   0/50 (0%)    2/150 (1%)   0/100 (0%) |  1/100 (1%)   0/50 (0%)    0/150 (0%)   0/100 (0%) |
|ADJUSTED (b)           |   1.0%         0.0%         1.4%         0.0%      |   1.4%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/37 (0%)    0/22 (0%)    0/52 (0%)    0/20 (0%)  |  0/54 (0%)    0/34 (0%)    0/93 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   416          ---          381          ---       |   658          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.408N     P=0.649N     P=0.635      P=0.506N   |  P=0.475N     P=0.618N     P=0.405N     P=0.535N   |
|INCIDENTAL TUMOR       |  P=0.360N     P=0.638N     P=0.643      P=0.469N   |  P=0.390N     P=0.701N     P=0.445N     P=0.445N   |
|LOGISTIC REGRESSION    |  P=0.217N     P=0.632N     P=0.700      P=0.381N   |  P=0.440N     P=0.660N     P=0.432N     P=0.499N   |
|COCHRAN-ARMITAGE       |  P=0.401N                                          |  P=0.444N                                          |
|FISHER EXACT           |               P=0.667N     P=0.649      P=0.500N   |               P=0.667N     P=0.400N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE  32
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 98/100 (98%) 46/50 (92%) 146/150 (97%) 94/100 (94%)| 78/100 (78%) 39/50 (78%) 117/150 (78%) 86/100 (86%)|
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  91.5%        88.6%        88.4%        96.5%      |
|TERMINAL (d)           | 37/37 (100%) 22/22 (100%) 52/52 (100%) 20/20 (100%)| 47/54 (87%)  29/34 (85%)  78/93 (84%)  31/34 (91%) |
|FIRST INCIDENCE (DAYS) |   372          382          276          391       |   424          581          312          462       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.120N     P=0.370      P=0.009 ** |  P<0.001 **   P=0.087N     P=0.137N     P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.520      P=0.025N*    P=0.547N     P=0.531N   |  P=0.018 *    P=0.409N     P=0.482N     P=0.027 *  |
|LOGISTIC REGRESSION    |  P=0.597      P=0.115N     P=0.678N     P=0.483N   |  P=0.043 *    P=0.414N     P=0.456N     P=0.093    |
|COCHRAN-ARMITAGE       |  P=0.209N                                          |  P=0.065                                           |
|FISHER EXACT           |               P=0.096N     P=0.544N     P=0.140N   |               P=0.578N     P=0.564N     P=0.099    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 66/100 (66%) 36/50 (72%) 116/150 (77%) 91/100 (91%)| 49/100 (49%) 24/50 (48%)  93/150 (62%) 76/100 (76%)|
|ADJUSTED (b)           |  80.3%        79.2%        89.1%        98.9%      |  58.9%        53.7%        67.5%        88.6%      |
|TERMINAL (d)           | 22/37 (59%)  13/22 (59%)  39/52 (75%)  19/20 (95%) | 21/54 (39%)  14/34 (41%)  49/93 (53%)  25/34 (74%) |
|FIRST INCIDENCE (DAYS) |   372          368          371          391       |   424          447          312          462       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.507N     P=0.075      P<0.001 ** |  P<0.001 **   P=0.227N     P=0.247      P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.260      P=0.033 *    P<0.001 ** |  P<0.001 **   P=0.541      P=0.025 *    P=0.002 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.193      P=0.031 *    P<0.001 ** |  P<0.001 **   P=0.545N     P=0.022 *    P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.291      P=0.034 *    P<0.001 ** |               P=0.523N     P=0.029 *    P<0.001 ** |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05076 TEST: 01                                                 PAGE  33
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        25 PPM       83 PPM       250 PPM   |   0 PPM        25 PPM       83 PPM       250 PPM   |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 98/100 (98%) 49/50 (98%) 148/150 (99%) 95/100 (95%)| 94/100 (94%) 46/50 (92%) 139/150 (93%) 99/100 (99%)|
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  94.9%        95.8%        93.9%       100.0%      |
|TERMINAL (d)           | 37/37 (100%) 22/22 (100%) 52/52 (100%) 20/20 (100%)| 49/54 (91%)  32/34 (94%)  84/93 (90%)  34/34 (100%)|
|FIRST INCIDENCE (DAYS) |   372          368          276          391       |   424          447          312          462       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.241N     P=0.322      P=0.008 ** |  P<0.001 **   P=0.060N     P=0.098N     P=0.003 ** |
|INCIDENTAL TUMOR       |  P=0.604N       (e)        P=0.581        (e)      |  P=0.093      P=0.421N     P=0.460N     P=0.149    |
|LOGISTIC REGRESSION    |  P=0.723        (e)        P=0.349        (e)      |  P=0.072      P=0.385N     P=0.430N     P=0.062    |
|COCHRAN-ARMITAGE       |  P=0.093N                                          |  P=0.035 *                                         |
|FISHER EXACT           |               P=0.707N     P=0.525      P=0.222N   |               P=0.441N     P=0.445N     P=0.059    |
|=================================================================================================================================|
 
 (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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