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TDMS Study 05075-02 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                     DIPHENYLHYDANTOIN                                   DATE: 09/09/94       
EXPERIMENT: 05075 TEST: 02                                                                                     TIME: 16:07:42       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-82151          ROUTE: DOSED FEED                                                                  NTP C#: 55765        
PATHOLOGIST: S. GRUMBEIN                     S. EUSTIS                                                         CAS: 57-41-0         
------------------------------------------------------------------------------------------------------------------------------------
               REASONS FOR REMOVAL:    ALL                                                                                          
               REMOVAL DATE RANGE:     ALL                                                                                          
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Battelle Columbus                                     DIPHENYLHYDANTOIN                                   DATE: 09/09/94      
EXPERIMENT: 05075 TEST: 02                                                                                     TIME: 16:07:42      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1-ES-82151          ROUTE: DOSED FEED                                                                  NTP C#: 55765       
PATHOLOGIST: S. GRUMBEIN                     S. EUSTIS                                                         CAS: 57-41-0        
                                                    MICE(B6C3F1)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
                                                    ----------------
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                     DIPHENYLHYDANTOIN                                   DATE: 09/09/94       
EXPERIMENT: 05075 TEST: 02                                                                                     TIME: 16:07:42       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-82151          ROUTE: DOSED FEED                                                                  NTP C#: 55765        
PATHOLOGIST: S. GRUMBEIN                     S. EUSTIS                                                         CAS: 57-41-0         
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                       IN THE ANALYSIS OF THE STUDY OF DIPHENYLHYDANTOIN
              ====================================================================================================
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
                             Liver                         Hemangiosarcoma
                                                           Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             All Organs                    Hemangiosarcoma
                                                           Hemangiosarcoma or Hemangioma
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
              ====================================================================================================
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
                             Adrenal Medulla               Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Harderian Gland               Carcinoma or Adenoma
                             Liver                         Hemangiosarcoma
                                                           Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma
                                                           Hepatocellular Carcinoma or Hepatoblastoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                                                           Carcinoma or Adenoma
                             Spleen                        Hemangiosarcoma
                             Stomach, Forestomach          Squamous Cell Papilloma
                             All Organs                    Hemangiosarcoma
                                                           Hemangiosarcoma or Hemangioma
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
              ====================================================================================================
         DATE: 09/09/94                     EXPERIMENT: 05075 TEST: 02                                                 PAGE   1
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O PPM        30 PPM       100 PPM      300 PPM   |   0 PPM        60 PPM       200 PPM      600 PPM   |
|                       |   10-0         1-1          0-3          0-10      |   10-0         1-1          0-3          0-10      |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/64 (2%)    0/11 (0%)    0/37 (0%)    1/94 (1%)  |  4/64 (6%)    1/14 (7%)    1/36 (3%)    2/98 (2%)  |
|ADJUSTED (b)           |   1.1%         0.0%         0.0%         1.4%      |   7.9%         0.0%         0.0%         2.6%      |
|TERMINAL (d)           |  0/40 (0%)    0/1 (0%)     0/2 (0%)     1/74 (1%)  |  2/36 (6%)    0/0          0/0          2/76 (3%)  |
|FIRST INCIDENCE (DAYS) |   609          ---          ---          734 (T)   |   607          682          675          736 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.694N     P=0.660N     P=0.428N     P=0.700N   |  P=0.095N     P=0.727      P=0.332N     P=0.139N   |
|INCIDENTAL TUMOR       |  P=0.687      P=0.617N     P=0.412N     P=0.767N   |  P=0.101N     P=0.696      P=0.354N     P=0.155N   |
|LOGISTIC REGRESSION    |  P=0.676N     P=0.703N     P=0.524N     P=0.671N   |  P=0.080N     P=0.601      P=0.461N     P=0.142N   |
|COCHRAN-ARMITAGE       |  P=0.676N                                          |  P=0.127N                                          |
|FISHER EXACT           |               P=0.853N     P=0.634N     P=0.648N   |               P=0.639      P=0.405N     P=0.168N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/64 (2%)    0/11 (0%)    0/37 (0%)    1/94 (1%)  |  6/64 (9%)    1/14 (7%)    1/36 (3%)    3/98 (3%)  |
|ADJUSTED (b)           |   1.1%         0.0%         0.0%         1.4%      |  11.7%         0.0%         0.0%         3.9%      |
|TERMINAL (d)           |  0/40 (0%)    0/1 (0%)     0/2 (0%)     1/74 (1%)  |  3/36 (8%)    0/0          0/0          3/76 (4%)  |
|FIRST INCIDENCE (DAYS) |   609          ---          ---          734 (T)   |   607          682          675          736 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.694N     P=0.660N     P=0.428N     P=0.700N   |  P=0.049N*    P=0.577N     P=0.155N     P=0.065N   |
|INCIDENTAL TUMOR       |  P=0.687      P=0.617N     P=0.412N     P=0.767N   |  P=0.051N     P=0.707N     P=0.161N     P=0.074N   |
|LOGISTIC REGRESSION    |  P=0.676N     P=0.703N     P=0.524N     P=0.671N   |  P=0.041N*    P=0.698      P=0.271N     P=0.063N   |
|COCHRAN-ARMITAGE       |  P=0.676N                                          |  P=0.085N                                          |
|FISHER EXACT           |               P=0.853N     P=0.634N     P=0.648N   |               P=0.632N     P=0.207N     P=0.088N   |
|=================================================================================================================================|
         DATE: 09/09/94                     EXPERIMENT: 05075 TEST: 02                                                 PAGE   2
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O PPM        30 PPM       100 PPM      300 PPM   |   0 PPM        60 PPM       200 PPM      600 PPM   |
|                       |   10-0         1-1          0-3          0-10      |   10-0         1-1          0-3          0-10      |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone Marrow                                                                                                                      |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/64 (3%)    0/11 (0%)    0/40 (0%)    0/100 (0%) |  3/64 (5%)    0/15 (0%)    0/36 (0%)    0/99 (0%)  |
|ADJUSTED (b)           |   3.6%         0.0%         0.0%         0.0%      |   3.7%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/40 (3%)    0/1 (0%)     0/3 (0%)     0/78 (0%)  |  0/36 (0%)    0/1 (0%)     0/0          0/76 (0%)  |
|FIRST INCIDENCE (DAYS) |   650          ---          ---          ---       |   607          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.123N     P=0.619N     P=0.387N     P=0.170N   |  P=0.093N     P=0.275N     P=0.053N     P=0.107N   |
|INCIDENTAL TUMOR       |  P=0.130N     P=0.740N     P=0.389N     P=0.205N   |  P=0.097N     P=0.320N     P=0.058N     P=0.121N   |
|LOGISTIC REGRESSION    |  P=0.122N     P=0.711N     P=0.406N     P=0.149N   |  P=0.060N     P=0.444N     P=0.230N     P=0.077N   |
|COCHRAN-ARMITAGE       |  P=0.124N                                          |  P=0.055N                                          |
|FISHER EXACT           |               P=0.726N     P=0.376N     P=0.151N   |               P=0.527N     P=0.258N     P=0.059N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/100 (7%)   1/50 (2%)    7/148 (5%)   6/100 (6%) |  4/100 (4%)   2/50 (4%)    6/150 (4%)   1/100 (1%) |
|ADJUSTED (b)           |   9.2%         2.6%         6.4%         7.7%      |   5.6%         5.7%         4.9%         1.3%      |
|TERMINAL (d)           |  7/76 (9%)    1/39 (3%)    7/109 (6%)   6/78 (8%)  |  3/70 (4%)    2/35 (6%)    4/113 (4%)   1/77 (1%)  |
|FIRST INCIDENCE (DAYS) |   734 (T)      734 (T)      734 (T)      734 (T)   |   726          736 (T)      625          736 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.529      P=0.175N     P=0.337N     P=0.481N   |  P=0.108N     P=0.669      P=0.581N     P=0.155N   |
|INCIDENTAL TUMOR       |  P=0.529      P=0.175N     P=0.337N     P=0.481N   |  P=0.122N     P=0.626      P=0.628N     P=0.161N   |
|LOGISTIC REGRESSION    |  P=0.529      P=0.175N     P=0.337N     P=0.481N   |  P=0.114N     P=0.670      P=0.610N     P=0.146N   |
|COCHRAN-ARMITAGE       |  P=0.510                                           |  P=0.131N                                          |
|FISHER EXACT           |               P=0.188N     P=0.312N     P=0.500N   |               P=0.683N     P=0.621N     P=0.184N   |
|=================================================================================================================================|
         DATE: 09/09/94                     EXPERIMENT: 05075 TEST: 02                                                 PAGE   3
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O PPM        30 PPM       100 PPM      300 PPM   |   0 PPM        60 PPM       200 PPM      600 PPM   |
|                       |   10-0         1-1          0-3          0-10      |   10-0         1-1          0-3          0-10      |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/100 (1%)   1/50 (2%)    1/148 (1%)   1/100 (1%) |  4/100 (4%)   0/50 (0%)    4/150 (3%)   0/100 (0%) |
|ADJUSTED (b)           |   1.3%         2.6%         0.8%         1.3%      |   5.3%         0.0%         3.4%         0.0%      |
|TERMINAL (d)           |  1/76 (1%)    1/39 (3%)    0/109 (0%)   0/78 (0%)  |  3/70 (4%)    0/35 (0%)    3/113 (3%)   0/77 (0%)  |
|FIRST INCIDENCE (DAYS) |   734 (T)      734 (T)      645          723       |   491          ---          662          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.606N     P=0.605      P=0.677N     P=0.753N   |  P=0.075N     P=0.188N     P=0.376N     P=0.056N   |
|INCIDENTAL TUMOR       |  P=0.653N     P=0.605      P=0.673N     P=0.719    |  P=0.094N     P=0.171N     P=0.432N     P=0.085N   |
|LOGISTIC REGRESSION    |  P=0.623N     P=0.605      P=0.665N     P=0.762    |  P=0.091N     P=0.186N     P=0.421N     P=0.074N   |
|COCHRAN-ARMITAGE       |  P=0.613N                                          |  P=0.088N                                          |
|FISHER EXACT           |               P=0.557      P=0.645N     P=0.751N   |               P=0.194N     P=0.405N     P=0.061N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  8/100 (8%)   2/50 (4%)    8/148 (5%)   7/100 (7%) |  8/100 (8%)   2/50 (4%)   10/150 (7%)   1/100 (1%) |
|ADJUSTED (b)           |  10.5%         5.1%         7.2%         8.9%      |  10.8%         5.7%         8.3%         1.3%      |
|TERMINAL (d)           |  8/76 (11%)   2/39 (5%)    7/109 (6%)   6/78 (8%)  |  6/70 (9%)    2/35 (6%)    7/113 (6%)   1/77 (1%)  |
|FIRST INCIDENCE (DAYS) |   734 (T)      734 (T)      645          723       |   491          736 (T)      625          736 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.554      P=0.268N     P=0.312N     P=0.478N   |  P=0.019N*    P=0.284N     P=0.379N     P=0.015N*  |
|INCIDENTAL TUMOR       |  P=0.537      P=0.268N     P=0.310N     P=0.502N   |  P=0.026N*    P=0.299N     P=0.453N     P=0.022N*  |
|LOGISTIC REGRESSION    |  P=0.548      P=0.268N     P=0.305N     P=0.473N   |  P=0.023N*    P=0.284N     P=0.432N     P=0.018N*  |
|COCHRAN-ARMITAGE       |  P=0.535                                           |  P=0.026N*                                         |
|FISHER EXACT           |               P=0.291N     P=0.287N     P=0.500N   |               P=0.291N     P=0.435N     P=0.017N*  |
|=================================================================================================================================|
         DATE: 09/09/94                     EXPERIMENT: 05075 TEST: 02                                                 PAGE   4
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O PPM        30 PPM       100 PPM      300 PPM   |   0 PPM        60 PPM       200 PPM      600 PPM   |
|                       |   10-0         1-1          0-3          0-10      |   10-0         1-1          0-3          0-10      |
|=================================================================================================================================|
|                                                                                                                                 |
|Heart                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/64 (2%)    0/12 (0%)    2/40 (5%)    0/99 (0%)  |  0/66 (0%)    0/15 (0%)    0/38 (0%)    0/100 (0%) |
|ADJUSTED (b)           |   2.5%         0.0%         1.6%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/40 (3%)    0/1 (0%)     0/2 (0%)     0/78 (0%)  |  0/36 (0%)    0/0          0/1 (0%)     0/77 (0%)  |
|FIRST INCIDENCE (DAYS) |   734 (T)      ---          633          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.276N     P=0.999N     P=0.354      P=0.367N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.323N     P=0.999N     P=0.369      P=0.367N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.224N     P=0.999N     P=0.281      P=0.367N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.225N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.842N     P=0.328      P=0.393N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  8/100 (8%)   0/50 (0%)    7/148 (5%)   4/99 (4%)  |  3/97 (3%)    2/50 (4%)    0/149 (0%)   0/100 (0%) |
|ADJUSTED (b)           |  10.0%         0.0%         5.8%         5.0%      |   4.2%         5.2%         0.0%         0.0%      |
|TERMINAL (d)           |  6/76 (8%)    0/39 (0%)    3/109 (3%)   3/78 (4%)  |  2/69 (3%)    1/35 (3%)    0/113 (0%)   0/77 (0%)  |
|FIRST INCIDENCE (DAYS) |   642          ---          633          710       |   682          633          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.323N     P=0.048N*    P=0.237N     P=0.179N   |  P=0.040N*    P=0.568      P=0.051N     P=0.103N   |
|INCIDENTAL TUMOR       |  P=0.411N     P=0.053N     P=0.211N     P=0.234N   |  P=0.045N*    P=0.576      P=0.051N     P=0.111N   |
|LOGISTIC REGRESSION    |  P=0.352N     P=0.048N*    P=0.211N     P=0.207N   |  P=0.045N*    P=0.574      P=0.054N     P=0.108N   |
|COCHRAN-ARMITAGE       |  P=0.338N                                          |  P=0.046N*                                         |
|FISHER EXACT           |               P=0.035N*    P=0.214N     P=0.191N   |               P=0.555      P=0.060N     P=0.117N   |
|=================================================================================================================================|
         DATE: 09/09/94                     EXPERIMENT: 05075 TEST: 02                                                 PAGE   5
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O PPM        30 PPM       100 PPM      300 PPM   |   0 PPM        60 PPM       200 PPM      600 PPM   |
|                       |   10-0         1-1          0-3          0-10      |   10-0         1-1          0-3          0-10      |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatoblastoma                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/100 (0%)   1/50 (2%)    2/148 (1%)   0/99 (0%)  |  0/97 (0%)    0/50 (0%)    0/149 (0%)   1/100 (1%) |
|ADJUSTED (b)           |   0.0%         2.6%         1.8%         0.0%      |   0.0%         0.0%         0.0%         1.3%      |
|TERMINAL (d)           |  0/76 (0%)    1/39 (3%)    1/109 (1%)   0/78 (0%)  |  0/69 (0%)    0/35 (0%)    0/113 (0%)   1/77 (1%)  |
|FIRST INCIDENCE (DAYS) |   ---          734 (T)      697          ---       |   ---          ---          ---          736 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.453N     P=0.367      P=0.325        (e)      |  P=0.243        (e)          (e)        P=0.522    |
|INCIDENTAL TUMOR       |  P=0.480N     P=0.367      P=0.327        (e)      |  P=0.243        (e)          (e)        P=0.522    |
|LOGISTIC REGRESSION    |  P=0.468N     P=0.367      P=0.325        (e)      |  P=0.243        (e)          (e)        P=0.522    |
|COCHRAN-ARMITAGE       |  P=0.464N                                          |  P=0.232                                           |
|FISHER EXACT           |               P=0.333      P=0.355        (e)      |                 (e)          (e)        P=0.508    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 42/100 (42%) 16/50 (32%)  62/148 (42%) 53/99 (54%) | 16/97 (16%)  11/50 (22%)  50/149 (34%) 48/100 (48%)|
|ADJUSTED (b)           |  49.6%        38.0%        51.1%        63.0%      |  21.4%        30.2%        41.9%        52.5%      |
|TERMINAL (d)           | 34/76 (45%)  13/39 (33%)  51/109 (47%) 47/78 (60%) | 12/69 (17%)  10/35 (29%)  44/113 (39%) 34/77 (44%) |
|FIRST INCIDENCE (DAYS) |   540          584          535          612       |   607          587          660          503       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.030 *    P=0.151N     P=0.482      P=0.109    |  P<0.001 **   P=0.257      P=0.006 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.006 **   P=0.180N     P=0.513      P=0.035 *  |  P<0.001 **   P=0.241      P=0.005 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P=0.008 **   P=0.173N     P=0.517      P=0.040 *  |  P<0.001 **   P=0.255      P=0.005 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.015 *                                         |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.157N     P=0.545N     P=0.068    |               P=0.274      P=0.002 **   P<0.001 ** |
|=================================================================================================================================|
         DATE: 09/09/94                     EXPERIMENT: 05075 TEST: 02                                                 PAGE   6
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O PPM        30 PPM       100 PPM      300 PPM   |   0 PPM        60 PPM       200 PPM      600 PPM   |
|                       |   10-0         1-1          0-3          0-10      |   10-0         1-1          0-3          0-10      |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 27/100 (27%) 13/50 (26%)  50/148 (34%) 27/99 (27%) |  1/97 (1%)    4/50 (8%)    8/149 (5%)  21/100 (21%)|
|ADJUSTED (b)           |  30.7%        28.4%        38.7%        31.9%      |   1.0%         9.6%         6.8%        25.4%      |
|TERMINAL (d)           | 17/76 (22%)   7/39 (18%)  32/109 (29%) 21/78 (27%) |  0/69 (0%)    1/35 (3%)    6/113 (5%)  17/77 (22%) |
|FIRST INCIDENCE (DAYS) |   463          495          481          564       |   486          587          675          570       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.467N     P=0.517N     P=0.151      P=0.537N   |  P<0.001 **   P=0.040 *    P=0.092      P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.308      P=0.551N     P=0.155      P=0.336    |  P<0.001 **   P=0.125      P=0.068      P<0.001 ** |
|LOGISTIC REGRESSION    |  P=0.260      P=0.467N     P=0.139      P=0.504    |  P<0.001 **   P=0.036 *    P=0.074      P<0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.513N                                          |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.530N     P=0.160      P=0.546    |               P=0.046 *    P=0.072      P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatoblastoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 27/100 (27%) 13/50 (26%)  51/148 (34%) 27/99 (27%) |  1/97 (1%)    4/50 (8%)    8/149 (5%)  22/100 (22%)|
|ADJUSTED (b)           |  30.7%        28.4%        39.5%        31.9%      |   1.0%         9.6%         6.8%        26.6%      |
|TERMINAL (d)           | 17/76 (22%)   7/39 (18%)  33/109 (30%) 21/78 (27%) |  0/69 (0%)    1/35 (3%)    6/113 (5%)  18/77 (23%) |
|FIRST INCIDENCE (DAYS) |   463          495          481          564       |   486          587          675          570       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.461N     P=0.517N     P=0.129      P=0.537N   |  P<0.001 **   P=0.040 *    P=0.092      P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.314      P=0.551N     P=0.130      P=0.336    |  P<0.001 **   P=0.125      P=0.068      P<0.001 ** |
|LOGISTIC REGRESSION    |  P=0.267      P=0.467N     P=0.149      P=0.504    |  P<0.001 **   P=0.036 *    P=0.074      P<0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.507N                                          |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.530N     P=0.135      P=0.546    |               P=0.046 *    P=0.072      P<0.001 ** |
|=================================================================================================================================|
         DATE: 09/09/94                     EXPERIMENT: 05075 TEST: 02                                                 PAGE   7
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O PPM        30 PPM       100 PPM      300 PPM   |   0 PPM        60 PPM       200 PPM      600 PPM   |
|                       |   10-0         1-1          0-3          0-10      |   10-0         1-1          0-3          0-10      |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 62/100 (62%) 25/50 (50%)  95/148 (64%) 67/99 (68%) | 17/97 (18%)  13/50 (26%)  56/149 (38%) 64/100 (64%)|
|ADJUSTED (b)           |  65.8%        53.0%        71.1%        76.1%      |  22.2%        33.5%        46.1%        67.9%      |
|TERMINAL (d)           | 44/76 (58%)  17/39 (44%)  71/109 (65%) 57/78 (73%) | 12/69 (17%)  10/35 (29%)  48/113 (42%) 47/77 (61%) |
|FIRST INCIDENCE (DAYS) |   463          495          481          564       |   486          587          660          503       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.203      P=0.145N     P=0.338      P=0.362    |  P<0.001 **   P=0.150      P=0.002 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.016 *    P=0.132N     P=0.373      P=0.065    |  P<0.001 **   P=0.183      P=0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P=0.011 *    P=0.096N     P=0.344      P=0.127    |  P<0.001 **   P=0.155      P=0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.100                                           |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.110N     P=0.413      P=0.245    |               P=0.161      P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 62/100 (62%) 25/50 (50%)  95/148 (64%) 67/99 (68%) | 17/97 (18%)  13/50 (26%)  56/149 (38%) 64/100 (64%)|
|ADJUSTED (b)           |  65.8%        53.0%        71.1%        76.1%      |  22.2%        33.5%        46.1%        67.9%      |
|TERMINAL (d)           | 44/76 (58%)  17/39 (44%)  71/109 (65%) 57/78 (73%) | 12/69 (17%)  10/35 (29%)  48/113 (42%) 47/77 (61%) |
|FIRST INCIDENCE (DAYS) |   463          495          481          564       |   486          587          660          503       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.203      P=0.145N     P=0.338      P=0.362    |  P<0.001 **   P=0.150      P=0.002 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.016 *    P=0.132N     P=0.373      P=0.065    |  P<0.001 **   P=0.183      P=0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P=0.011 *    P=0.096N     P=0.344      P=0.127    |  P<0.001 **   P=0.155      P=0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.100                                           |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.110N     P=0.413      P=0.245    |               P=0.161      P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
         DATE: 09/09/94                     EXPERIMENT: 05075 TEST: 02                                                 PAGE   8
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O PPM        30 PPM       100 PPM      300 PPM   |   0 PPM        60 PPM       200 PPM      600 PPM   |
|                       |   10-0         1-1          0-3          0-10      |   10-0         1-1          0-3          0-10      |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 14/69 (20%)   5/19 (26%)  10/63 (16%)  11/99 (11%) |  7/70 (10%)   1/20 (5%)    4/41 (10%)   3/100 (3%) |
|ADJUSTED (b)           |  23.4%        40.4%        29.8%        14.1%      |  17.5%         2.7%        75.2%         3.9%      |
|TERMINAL (d)           |  8/45 (18%)   3/8 (38%)    7/25 (28%)  11/78 (14%) |  7/40 (18%)   0/5 (0%)     3/4 (75%)    3/77 (4%)  |
|FIRST INCIDENCE (DAYS) |   491          574          649          734 (T)   |   736 (T)      690          636          736 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.019N*    P=0.455      P=0.467N     P=0.062N   |  P=0.007N**   P=0.665N     P=0.018 *    P=0.016N*  |
|INCIDENTAL TUMOR       |  P=0.029N*    P=0.383      P=0.464N     P=0.113N   |  P=0.008N**   P=0.705      P=0.015 *    P=0.016N*  |
|LOGISTIC REGRESSION    |  P=0.025N*    P=0.352      P=0.475N     P=0.081N   |  P=0.008N**   P=0.692N     P=0.225      P=0.016N*  |
|COCHRAN-ARMITAGE       |  P=0.042N*                                         |  P=0.052N                                          |
|FISHER EXACT           |               P=0.389      P=0.334N     P=0.078N   |               P=0.431N     P=0.621N     P=0.058N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  9/69 (13%)   4/19 (21%)  15/63 (24%)   6/99 (6%)  |  1/70 (1%)    1/20 (5%)    3/41 (7%)    0/100 (0%) |
|ADJUSTED (b)           |  17.4%        39.1%        60.0%         7.7%      |   2.5%        20.0%        26.1%         0.0%      |
|TERMINAL (d)           |  7/45 (16%)   3/8 (38%)   15/25 (60%)   6/78 (8%)  |  1/40 (3%)    1/5 (20%)    1/4 (25%)    0/77 (0%)  |
|FIRST INCIDENCE (DAYS) |   633          713          734 (T)      734 (T)   |   736 (T)      736 (T)      565          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.002N**   P=0.216      P=0.003 **   P=0.065N   |  P=0.101N     P=0.264      P=0.086      P=0.369N   |
|INCIDENTAL TUMOR       |  P=0.003N**   P=0.201      P=0.003 **   P=0.083N   |  P=0.120N     P=0.264      P=0.056      P=0.369N   |
|LOGISTIC REGRESSION    |  P=0.003N**   P=0.158      P=0.007 **   P=0.088N   |  P=0.129N     P=0.264      P=0.129      P=0.369N   |
|COCHRAN-ARMITAGE       |  P=0.019N*                                         |  P=0.141N                                          |
|FISHER EXACT           |               P=0.294      P=0.084      P=0.100N   |               P=0.397      P=0.142      P=0.412N   |
|=================================================================================================================================|
         DATE: 09/09/94                     EXPERIMENT: 05075 TEST: 02                                                 PAGE   9
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O PPM        30 PPM       100 PPM      300 PPM   |   0 PPM        60 PPM       200 PPM      600 PPM   |
|                       |   10-0         1-1          0-3          0-10      |   10-0         1-1          0-3          0-10      |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 22/69 (32%)   8/19 (42%)  23/63 (37%)  17/99 (17%) |  8/70 (11%)   2/20 (10%)   7/41 (17%)   3/100 (3%) |
|ADJUSTED (b)           |  37.2%        76.2%        80.5%        21.8%      |  20.0%        22.2%       100.0%         3.9%      |
|TERMINAL (d)           | 14/45 (31%)   6/8 (75%)   20/25 (80%)  17/78 (22%) |  8/40 (20%)   1/5 (20%)    4/4 (100%)   3/77 (4%)  |
|FIRST INCIDENCE (DAYS) |   491          574          649          734 (T)   |   736 (T)      690          565          736 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001N**   P=0.267      P=0.068      P=0.012N*  |  P=0.001N**   P=0.433      P=0.002 **   P=0.006N** |
|INCIDENTAL TUMOR       |  P<0.001N**   P=0.217      P=0.067      P=0.028N*  |  P=0.002N**   P=0.369      P<0.001 **   P=0.006N** |
|LOGISTIC REGRESSION    |  P<0.001N**   P=0.166      P=0.094      P=0.021N*  |  P=0.003N**   P=0.416      P=0.092      P=0.006N** |
|COCHRAN-ARMITAGE       |  P=0.003N**                                        |  P=0.016N*                                         |
|FISHER EXACT           |               P=0.285      P=0.353      P=0.021N*  |               P=0.610N     P=0.287      P=0.031N*  |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/100 (0%)   0/50 (0%)    0/148 (0%)   0/100 (0%) |  2/100 (2%)   2/50 (4%)    2/150 (1%)   0/100 (0%) |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   2.2%         5.7%         1.7%         0.0%      |
|TERMINAL (d)           |  0/76 (0%)    0/39 (0%)    0/109 (0%)   0/78 (0%)  |  0/70 (0%)    2/35 (6%)    1/113 (1%)   0/77 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   528          736 (T)      690          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.098N     P=0.426      P=0.512N     P=0.226N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.137N     P=0.515      P=0.631N     P=0.369N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.124N     P=0.423      P=0.587N     P=0.331N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.110N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.407      P=0.525N     P=0.249N   |
|=================================================================================================================================|
         DATE: 09/09/94                     EXPERIMENT: 05075 TEST: 02                                                 PAGE  10
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O PPM        30 PPM       100 PPM      300 PPM   |   0 PPM        60 PPM       200 PPM      600 PPM   |
|                       |   10-0         1-1          0-3          0-10      |   10-0         1-1          0-3          0-10      |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Cystadenoma                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  1/77 (1%)    1/36 (3%)    5/83 (6%)    3/99 (3%)  |
|ADJUSTED (b)           |                                                    |   2.1%         4.3%         9.3%         3.9%      |
|TERMINAL (d)           |                                                    |  1/48 (2%)    1/23 (4%)    4/47 (9%)    3/76 (4%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   736 (T)      736 (T)      735          736 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.598      P=0.589      P=0.120      P=0.480    |
|INCIDENTAL TUMOR       |                                                    |  P=0.599      P=0.589      P=0.121      P=0.480    |
|LOGISTIC REGRESSION    |                                                    |  P=0.577N     P=0.589      P=0.111      P=0.480    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.495                                           |
|FISHER EXACT           |                                                    |               P=0.538      P=0.123      P=0.410    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/56 (0%)    0/4 (0%)     0/31 (0%)    0/76 (0%)  | 14/63 (22%)   3/17 (18%)  13/46 (28%)   6/85 (7%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |  31.6%       100.0%        84.9%         9.1%      |
|TERMINAL (d)           |  0/35 (0%)    0/1 (0%)     0/2 (0%)     0/64 (0%)  | 11/38 (29%)   3/3 (100%)  11/13 (85%)   6/66 (9%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   530          736 (T)      689          736 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P<0.001N**   P=0.338      P=0.023 *    P=0.002N** |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P<0.001N**   P=0.259      P=0.015 *    P=0.003N** |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P<0.001N**   P=0.419      P=0.070      P=0.003N** |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.004N**                                        |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.486N     P=0.308      P=0.008N** |
|=================================================================================================================================|
         DATE: 09/09/94                     EXPERIMENT: 05075 TEST: 02                                                 PAGE  11
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O PPM        30 PPM       100 PPM      300 PPM   |   0 PPM        60 PPM       200 PPM      600 PPM   |
|                       |   10-0         1-1          0-3          0-10      |   10-0         1-1          0-3          0-10      |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/56 (0%)    1/4 (25%)    0/31 (0%)    0/76 (0%)  | 15/63 (24%)   3/17 (18%)  13/46 (28%)   6/85 (7%)  |
|ADJUSTED (b)           |   0.0%         2.4%         0.0%         0.0%      |  32.4%       100.0%        84.9%         9.1%      |
|TERMINAL (d)           |  0/35 (0%)    0/1 (0%)     0/2 (0%)     0/64 (0%)  | 11/38 (29%)   3/3 (100%)  11/13 (85%)   6/66 (9%)  |
|FIRST INCIDENCE (DAYS) |   ---          669          ---          ---       |   530          736 (T)      689          736 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.545N     P=0.362        (e)          (e)      |  P<0.001N**   P=0.449      P=0.053      P=0.001N** |
|INCIDENTAL TUMOR       |  P=0.725N     P=0.056        (e)          (e)      |  P<0.001N**   P=0.329      P=0.036 *    P=0.002N** |
|LOGISTIC REGRESSION    |  P=0.424N     P=0.061        (e)          (e)      |  P<0.001N**   P=0.513      P=0.149      P=0.002N** |
|COCHRAN-ARMITAGE       |  P=0.425N                                          |  P=0.002N**                                        |
|FISHER EXACT           |               P=0.067        (e)          (e)      |               P=0.430N     P=0.379      P=0.004N** |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/100 (2%)   0/50 (0%)    0/148 (0%)   0/100 (0%) |  0/100 (0%)   0/50 (0%)    0/150 (0%)   0/100 (0%) |
|ADJUSTED (b)           |   2.6%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/76 (1%)    0/39 (0%)    0/109 (0%)   0/78 (0%)  |  0/70 (0%)    0/35 (0%)    0/113 (0%)   0/77 (0%)  |
|FIRST INCIDENCE (DAYS) |   696          ---          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.202N     P=0.394N     P=0.163N     P=0.232N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.217N     P=0.475N     P=0.160N     P=0.281N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.209N     P=0.404N     P=0.160N     P=0.248N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.204N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.443N     P=0.162N     P=0.249N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 09/09/94                     EXPERIMENT: 05075 TEST: 02                                                 PAGE  12
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O PPM        30 PPM       100 PPM      300 PPM   |   0 PPM        60 PPM       200 PPM      600 PPM   |
|                       |   10-0         1-1          0-3          0-10      |   10-0         1-1          0-3          0-10      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/100 (2%)   0/50 (0%)    3/148 (2%)   0/100 (0%) |  2/100 (2%)   1/50 (2%)    2/150 (1%)   1/100 (1%) |
|ADJUSTED (b)           |   2.5%         0.0%         2.7%         0.0%      |   2.4%         2.9%         1.5%         1.0%      |
|TERMINAL (d)           |  1/76 (1%)    0/39 (0%)    2/109 (2%)   0/78 (0%)  |  0/70 (0%)    1/35 (3%)    0/113 (0%)   0/77 (0%)  |
|FIRST INCIDENCE (DAYS) |   673          ---          678          ---       |   544          736 (T)      625          423       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.232N     P=0.401N     P=0.659      P=0.236N   |  P=0.373N     P=0.730      P=0.509N     P=0.474N   |
|INCIDENTAL TUMOR       |  P=0.256N     P=0.475N     P=0.666      P=0.281N   |  P=0.535N     P=0.704      P=0.628N     P=0.746    |
|LOGISTIC REGRESSION    |  P=0.244N     P=0.399N     P=0.668      P=0.244N   |  P=0.514N     P=0.729      P=0.591N     P=0.701N   |
|COCHRAN-ARMITAGE       |  P=0.236N                                          |  P=0.403N                                          |
|FISHER EXACT           |               P=0.443N     P=0.678      P=0.249N   |               P=0.742N     P=0.525N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/100 (0%)   0/50 (0%)    0/148 (0%)   1/100 (1%) |  3/100 (3%)   0/50 (0%)    0/150 (0%)   0/100 (0%) |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         1.2%      |   3.5%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/76 (0%)    0/39 (0%)    0/109 (0%)   0/78 (0%)  |  0/70 (0%)    0/35 (0%)    0/113 (0%)   0/77 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          710       |   579          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.240        (e)          (e)        P=0.510    |  P=0.095N     P=0.275N     P=0.056N     P=0.111N   |
|INCIDENTAL TUMOR       |  P=0.182        (e)          (e)        P=0.419    |  P=0.118N     P=0.212N     P=0.080N     P=0.133N   |
|LOGISTIC REGRESSION    |  P=0.225        (e)          (e)        P=0.493    |  P=0.125N     P=0.279N     P=0.079N     P=0.166N   |
|COCHRAN-ARMITAGE       |  P=0.230                                           |  P=0.102N                                          |
|FISHER EXACT           |                 (e)          (e)        P=0.500    |               P=0.293N     P=0.063N     P=0.123N   |
|=================================================================================================================================|
         DATE: 09/09/94                     EXPERIMENT: 05075 TEST: 02                                                 PAGE  13
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O PPM        30 PPM       100 PPM      300 PPM   |   0 PPM        60 PPM       200 PPM      600 PPM   |
|                       |   10-0         1-1          0-3          0-10      |   10-0         1-1          0-3          0-10      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/100 (4%)   0/50 (0%)    3/148 (2%)   1/100 (1%) |  3/100 (3%)   1/50 (2%)    2/150 (1%)   1/100 (1%) |
|ADJUSTED (b)           |   5.0%         0.0%         2.7%         1.3%      |   3.5%         2.9%         1.5%         1.0%      |
|TERMINAL (d)           |  2/76 (3%)    0/39 (0%)    2/109 (2%)   1/78 (1%)  |  0/70 (0%)    1/35 (3%)    0/113 (0%)   0/77 (0%)  |
|FIRST INCIDENCE (DAYS) |   673          ---          678          734 (T)   |   544          736 (T)      625          423       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.228N     P=0.184N     P=0.313N     P=0.176N   |  P=0.245N     P=0.575N     P=0.294N     P=0.286N   |
|INCIDENTAL TUMOR       |  P=0.259N     P=0.251N     P=0.303N     P=0.227N   |  P=0.387N     P=0.547N     P=0.423N     P=0.513N   |
|LOGISTIC REGRESSION    |  P=0.246N     P=0.186N     P=0.303N     P=0.195N   |  P=0.370N     P=0.581N     P=0.379N     P=0.494N   |
|COCHRAN-ARMITAGE       |  P=0.234N                                          |  P=0.268N                                          |
|FISHER EXACT           |               P=0.194N     P=0.294N     P=0.184N   |               P=0.593N     P=0.316N     P=0.311N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/100 (2%)   0/50 (0%)    3/148 (2%)   1/100 (1%) |  3/100 (3%)   1/50 (2%)    2/150 (1%)   1/100 (1%) |
|ADJUSTED (b)           |   2.5%         0.0%         2.7%         1.3%      |   3.5%         2.9%         1.5%         1.0%      |
|TERMINAL (d)           |  1/76 (1%)    0/39 (0%)    2/109 (2%)   1/78 (1%)  |  0/70 (0%)    1/35 (3%)    0/113 (0%)   0/77 (0%)  |
|FIRST INCIDENCE (DAYS) |   673          ---          678          734 (T)   |   544          736 (T)      625          423       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.493N     P=0.401N     P=0.659      P=0.493N   |  P=0.245N     P=0.575N     P=0.294N     P=0.286N   |
|INCIDENTAL TUMOR       |  P=0.531N     P=0.475N     P=0.666      P=0.540N   |  P=0.387N     P=0.547N     P=0.423N     P=0.513N   |
|LOGISTIC REGRESSION    |  P=0.518N     P=0.399N     P=0.668      P=0.514N   |  P=0.370N     P=0.581N     P=0.379N     P=0.494N   |
|COCHRAN-ARMITAGE       |  P=0.503N                                          |  P=0.268N                                          |
|FISHER EXACT           |               P=0.443N     P=0.678      P=0.500N   |               P=0.593N     P=0.316N     P=0.311N   |
|=================================================================================================================================|
         DATE: 09/09/94                     EXPERIMENT: 05075 TEST: 02                                                 PAGE  14
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O PPM        30 PPM       100 PPM      300 PPM   |   0 PPM        60 PPM       200 PPM      600 PPM   |
|                       |   10-0         1-1          0-3          0-10      |   10-0         1-1          0-3          0-10      |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/70 (9%)    0/18 (0%)    3/62 (5%)    2/96 (2%)  |  7/71 (10%)   0/27 (0%)    0/73 (0%)    0/98 (0%)  |
|ADJUSTED (b)           |   9.5%         0.0%         5.3%         2.6%      |  11.4%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  3/47 (6%)    0/9 (0%)     1/27 (4%)    2/77 (3%)  |  3/43 (7%)    0/13 (0%)    0/37 (0%)    0/77 (0%)  |
|FIRST INCIDENCE (DAYS) |   633          ---          633          734 (T)   |   579          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.089N     P=0.179N     P=0.266N     P=0.065N   |  P=0.004N**   P=0.101N     P=0.005N**   P=0.003N** |
|INCIDENTAL TUMOR       |  P=0.119N     P=0.202N     P=0.246N     P=0.102N   |  P=0.005N**   P=0.090N     P=0.006N**   P=0.005N** |
|LOGISTIC REGRESSION    |  P=0.081N     P=0.209N     P=0.314N     P=0.061N   |  P=0.004N**   P=0.105N     P=0.009N**   P=0.003N** |
|COCHRAN-ARMITAGE       |  P=0.081N                                          |  P=0.004N**                                        |
|FISHER EXACT           |               P=0.242N     P=0.310N     P=0.060N   |               P=0.096N     P=0.006N**   P=0.002N** |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/100 (2%)   0/50 (0%)    2/148 (1%)   0/100 (0%) |  5/100 (5%)   3/50 (6%)    3/150 (2%)   0/100 (0%) |
|ADJUSTED (b)           |   2.6%         0.0%         1.8%         0.0%      |   7.1%         8.0%         2.7%         0.0%      |
|TERMINAL (d)           |  2/76 (3%)    0/39 (0%)    2/109 (2%)   0/78 (0%)  |  5/70 (7%)    2/35 (6%)    3/113 (3%)   0/77 (0%)  |
|FIRST INCIDENCE (DAYS) |   734 (T)      ---          734 (T)      ---       |   736 (T)      628          736 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.229N     P=0.395N     P=0.558N     P=0.233N   |  P=0.013N*    P=0.550      P=0.143N     P=0.027N*  |
|INCIDENTAL TUMOR       |  P=0.229N     P=0.395N     P=0.558N     P=0.233N   |  P=0.014N*    P=0.592      P=0.143N     P=0.027N*  |
|LOGISTIC REGRESSION    |  P=0.229N     P=0.395N     P=0.558N     P=0.233N   |  P=0.013N*    P=0.545      P=0.143N     P=0.027N*  |
|COCHRAN-ARMITAGE       |  P=0.232N                                          |  P=0.017N*                                         |
|FISHER EXACT           |               P=0.443N     P=0.531N     P=0.249N   |               P=0.535      P=0.170N     P=0.030N*  |
|=================================================================================================================================|
         DATE: 09/09/94                     EXPERIMENT: 05075 TEST: 02                                                 PAGE  15
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O PPM        30 PPM       100 PPM      300 PPM   |   0 PPM        60 PPM       200 PPM      600 PPM   |
|                       |   10-0         1-1          0-3          0-10      |   10-0         1-1          0-3          0-10      |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/64 (0%)    0/12 (0%)    0/39 (0%)    2/100 (2%) |                                                    |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         2.6%      |                                                    |
|TERMINAL (d)           |  0/40 (0%)    0/1 (0%)     0/2 (0%)     2/78 (3%)  |                                                    |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          734 (T)   |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.292        (e)          (e)        P=0.395    |                                                    |
|INCIDENTAL TUMOR       |  P=0.292        (e)          (e)        P=0.395    |                                                    |
|LOGISTIC REGRESSION    |  P=0.292        (e)          (e)        P=0.395    |                                                    |
|COCHRAN-ARMITAGE       |  P=0.171                                           |                                                    |
|FISHER EXACT           |                 (e)          (e)        P=0.370    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/63 (2%)    1/11 (9%)    1/39 (3%)    0/99 (0%)  |  4/63 (6%)    0/15 (0%)    0/37 (0%)    8/99 (8%)  |
|ADJUSTED (b)           |   1.1%         2.2%         0.8%         0.0%      |  11.1%         0.0%         0.0%        10.4%      |
|TERMINAL (d)           |  0/40 (0%)    0/1 (0%)     0/2 (0%)     0/78 (0%)  |  4/36 (11%)   0/0          0/1 (0%)     7/76 (9%)  |
|FIRST INCIDENCE (DAYS) |   646          584          639          ---       |   736 (T)      ---          ---          730       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.277N     P=0.587      P=0.678N     P=0.505N   |  P=0.543        (e)        P=0.897N     P=0.624    |
|INCIDENTAL TUMOR       |  P=0.357N     P=0.545      P=0.659N     P=0.564N   |  P=0.546        (e)        P=0.897N     P=0.622    |
|LOGISTIC REGRESSION    |  P=0.129N     P=0.528      P=0.717      P=0.397N   |  P=0.586N       (e)        P=0.897N     P=0.582N   |
|COCHRAN-ARMITAGE       |  P=0.141N                                          |  P=0.189                                           |
|FISHER EXACT           |               P=0.277      P=0.621      P=0.389N   |               P=0.418N     P=0.152N     P=0.467    |
|=================================================================================================================================|
         DATE: 09/09/94                     EXPERIMENT: 05075 TEST: 02                                                 PAGE  16
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O PPM        30 PPM       100 PPM      300 PPM   |   0 PPM        60 PPM       200 PPM      600 PPM   |
|                       |   10-0         1-1          0-3          0-10      |   10-0         1-1          0-3          0-10      |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  2/100 (2%)   0/50 (0%)    2/150 (1%)   0/100 (0%) |
|ADJUSTED (b)           |                                                    |   2.9%         0.0%         1.6%         0.0%      |
|TERMINAL (d)           |                                                    |  2/70 (3%)    0/35 (0%)    1/113 (1%)   0/77 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   736 (T)      ---          465          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.217N     P=0.401N     P=0.519N     P=0.218N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.275N     P=0.401N     P=0.601N     P=0.218N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.258N     P=0.401N     P=0.570N     P=0.218N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.232N                                          |
|FISHER EXACT           |                                                    |               P=0.443N     P=0.525N     P=0.249N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  3/100 (3%)   0/50 (0%)    3/150 (2%)   1/100 (1%) |
|ADJUSTED (b)           |                                                    |   4.3%         0.0%         2.4%         1.3%      |
|TERMINAL (d)           |                                                    |  3/70 (4%)    0/35 (0%)    2/113 (2%)   1/77 (1%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   736 (T)      ---          465          736 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.322N     P=0.268N     P=0.436N     P=0.274N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.378N     P=0.268N     P=0.504N     P=0.274N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.360N     P=0.268N     P=0.479N     P=0.274N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.351N                                          |
|FISHER EXACT           |                                                    |               P=0.293N     P=0.456N     P=0.311N   |
|=================================================================================================================================|
         DATE: 09/09/94                     EXPERIMENT: 05075 TEST: 02                                                 PAGE  17
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O PPM        30 PPM       100 PPM      300 PPM   |   0 PPM        60 PPM       200 PPM      600 PPM   |
|                       |   10-0         1-1          0-3          0-10      |   10-0         1-1          0-3          0-10      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 12/100 (12%)  1/50 (2%)    9/148 (6%)   4/100 (4%) | 10/100 (10%)  2/50 (4%)    0/150 (0%)   0/100 (0%) |
|ADJUSTED (b)           |  14.8%         2.6%         7.6%         5.0%      |  12.9%         5.2%         0.0%         0.0%      |
|TERMINAL (d)           |  9/76 (12%)   1/39 (3%)    5/109 (5%)   3/78 (4%)  |  6/70 (9%)    1/35 (3%)    0/113 (0%)   0/77 (0%)  |
|FIRST INCIDENCE (DAYS) |   633          734 (T)      633          710       |   579          633          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.077N     P=0.042N*    P=0.095N     P=0.033N*  |  P<0.001N**   P=0.179N     P<0.001N**   P=0.001N** |
|INCIDENTAL TUMOR       |  P=0.109N     P=0.042N*    P=0.078N     P=0.053N   |  P<0.001N**   P=0.148N     P<0.001N**   P=0.002N** |
|LOGISTIC REGRESSION    |  P=0.088N     P=0.042N*    P=0.080N     P=0.041N*  |  P<0.001N**   P=0.169N     P<0.001N**   P=0.002N** |
|COCHRAN-ARMITAGE       |  P=0.078N                                          |  P<0.001N**                                        |
|FISHER EXACT           |               P=0.033N*    P=0.080N     P=0.033N*  |               P=0.170N     P<0.001N**   P<0.001N** |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 12/100 (12%)  1/50 (2%)    9/148 (6%)   4/100 (4%) | 10/100 (10%)  2/50 (4%)    1/150 (1%)   0/100 (0%) |
|ADJUSTED (b)           |  14.8%         2.6%         7.6%         5.0%      |  12.9%         5.2%         0.7%         0.0%      |
|TERMINAL (d)           |  9/76 (12%)   1/39 (3%)    5/109 (5%)   3/78 (4%)  |  6/70 (9%)    1/35 (3%)    0/113 (0%)   0/77 (0%)  |
|FIRST INCIDENCE (DAYS) |   633          734 (T)      633          710       |   579          633          525          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.077N     P=0.042N*    P=0.095N     P=0.033N*  |  P<0.001N**   P=0.179N     P<0.001N**   P=0.001N** |
|INCIDENTAL TUMOR       |  P=0.109N     P=0.042N*    P=0.078N     P=0.053N   |  P=0.001N**   P=0.148N     P=0.001N**   P=0.002N** |
|LOGISTIC REGRESSION    |  P=0.088N     P=0.042N*    P=0.080N     P=0.041N*  |  P=0.001N**   P=0.169N     P<0.001N**   P=0.002N** |
|COCHRAN-ARMITAGE       |  P=0.078N                                          |  P<0.001N**                                        |
|FISHER EXACT           |               P=0.033N*    P=0.080N     P=0.033N*  |               P=0.170N     P<0.001N**   P<0.001N** |
|=================================================================================================================================|
         DATE: 09/09/94                     EXPERIMENT: 05075 TEST: 02                                                 PAGE  18
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O PPM        30 PPM       100 PPM      300 PPM   |   0 PPM        60 PPM       200 PPM      600 PPM   |
|                       |   10-0         1-1          0-3          0-10      |   10-0         1-1          0-3          0-10      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 23/100 (23%)  6/50 (12%)  25/148 (17%) 14/100 (14%)| 34/100 (34%) 11/50 (22%)  42/150 (28%) 28/100 (28%)|
|ADJUSTED (b)           |  26.1%        14.9%        20.6%        16.6%      |  39.5%        27.8%        32.8%        32.1%      |
|TERMINAL (d)           | 13/76 (17%)   5/39 (13%)  16/109 (15%)  9/78 (12%) | 20/70 (29%)   7/35 (20%)  29/113 (26%) 19/77 (25%) |
|FIRST INCIDENCE (DAYS) |   576          669          412          408       |   128          544          185          568       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.138N     P=0.095N     P=0.193N     P=0.079N   |  P=0.238N     P=0.121N     P=0.124N     P=0.135N   |
|INCIDENTAL TUMOR       |  P=0.260N     P=0.133N     P=0.150N     P=0.194N   |  P=0.377N     P=0.115N     P=0.197N     P=0.227N   |
|LOGISTIC REGRESSION    |  P=0.147N     P=0.202N     P=0.139N     P=0.079N   |  P=0.407N     P=0.093N     P=0.226N     P=0.267N   |
|COCHRAN-ARMITAGE       |  P=0.138N                                          |  P=0.371N                                          |
|FISHER EXACT           |               P=0.080N     P=0.151N     P=0.072N   |               P=0.092N     P=0.192N     P=0.222N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 23/100 (23%)  6/50 (12%)  25/148 (17%) 14/100 (14%)| 34/100 (34%) 11/50 (22%)  42/150 (28%) 28/100 (28%)|
|ADJUSTED (b)           |  26.1%        14.9%        20.6%        16.6%      |  39.5%        27.8%        32.8%        32.1%      |
|TERMINAL (d)           | 13/76 (17%)   5/39 (13%)  16/109 (15%)  9/78 (12%) | 20/70 (29%)   7/35 (20%)  29/113 (26%) 19/77 (25%) |
|FIRST INCIDENCE (DAYS) |   576          669          412          408       |   128          544          185          568       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.138N     P=0.095N     P=0.193N     P=0.079N   |  P=0.238N     P=0.121N     P=0.124N     P=0.135N   |
|INCIDENTAL TUMOR       |  P=0.260N     P=0.133N     P=0.150N     P=0.194N   |  P=0.377N     P=0.115N     P=0.197N     P=0.227N   |
|LOGISTIC REGRESSION    |  P=0.147N     P=0.202N     P=0.139N     P=0.079N   |  P=0.407N     P=0.093N     P=0.226N     P=0.267N   |
|COCHRAN-ARMITAGE       |  P=0.138N                                          |  P=0.371N                                          |
|FISHER EXACT           |               P=0.080N     P=0.151N     P=0.072N   |               P=0.092N     P=0.192N     P=0.222N   |
|=================================================================================================================================|
         DATE: 09/09/94                     EXPERIMENT: 05075 TEST: 02                                                 PAGE  19
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O PPM        30 PPM       100 PPM      300 PPM   |   0 PPM        60 PPM       200 PPM      600 PPM   |
|                       |   10-0         1-1          0-3          0-10      |   10-0         1-1          0-3          0-10      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 57/100 (57%) 20/50 (40%)  72/148 (49%) 62/100 (62%)| 45/100 (45%) 18/50 (36%)  75/150 (50%) 61/100 (61%)|
|ADJUSTED (b)           |  62.3%        46.3%        58.1%        73.8%      |  56.6%        45.8%        59.3%        66.9%      |
|TERMINAL (d)           | 42/76 (55%)  16/39 (41%)  58/109 (53%) 56/78 (72%) | 36/70 (51%)  14/35 (40%)  62/113 (55%) 47/77 (61%) |
|FIRST INCIDENCE (DAYS) |   491          574          535          612       |   530          587          525          503       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.100      P=0.050N     P=0.201N     P=0.354    |  P=0.029 *    P=0.203N     P=0.469      P=0.101    |
|INCIDENTAL TUMOR       |  P=0.018 *    P=0.048N*    P=0.150N     P=0.111    |  P=0.010 **   P=0.239N     P=0.383      P=0.037 *  |
|LOGISTIC REGRESSION    |  P=0.023 *    P=0.039N*    P=0.142N     P=0.145    |  P=0.011 *    P=0.198N     P=0.412      P=0.043 *  |
|COCHRAN-ARMITAGE       |  P=0.061                                           |  P=0.003 **                                        |
|FISHER EXACT           |               P=0.037N*    P=0.123N     P=0.282    |               P=0.190N     P=0.259      P=0.017 *  |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 60/100 (60%) 24/50 (48%)  95/148 (64%) 43/100 (43%)| 56/100 (56%) 22/50 (44%)  65/150 (43%) 48/100 (48%)|
|ADJUSTED (b)           |  61.7%        50.8%        66.4%        47.7%      |  58.0%        48.5%        47.7%        51.8%      |
|TERMINAL (d)           | 39/76 (51%)  16/39 (41%)  61/109 (56%) 31/78 (40%) | 30/70 (43%)  12/35 (34%)  43/113 (38%) 33/77 (43%) |
|FIRST INCIDENCE (DAYS) |   463          495          412          408       |   128          461          185          423       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.025N*    P=0.156N     P=0.267      P=0.024N*  |  P=0.173N     P=0.184N     P=0.024N*    P=0.090N   |
|INCIDENTAL TUMOR       |  P=0.105N     P=0.149N     P=0.273      P=0.100N   |  P=0.414N     P=0.124N     P=0.049N*    P=0.246N   |
|LOGISTIC REGRESSION    |  P=0.151N     P=0.086N     P=0.222      P=0.119N   |  P=0.470N     P=0.082N     P=0.061N     P=0.309N   |
|COCHRAN-ARMITAGE       |  P=0.010N*                                         |  P=0.316N                                          |
|FISHER EXACT           |               P=0.111N     P=0.296      P=0.012N*  |               P=0.112N     P=0.033N*    P=0.161N   |
|=================================================================================================================================|
         DATE: 09/09/94                     EXPERIMENT: 05075 TEST: 02                                                 PAGE  20
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   O PPM        30 PPM       100 PPM      300 PPM   |   0 PPM        60 PPM       200 PPM      600 PPM   |
|                       |   10-0         1-1          0-3          0-10      |   10-0         1-1          0-3          0-10      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 86/100 (86%) 33/50 (66%) 126/148 (85%) 81/100 (81%)| 76/100 (76%) 28/50 (56%) 111/150 (74%) 88/100 (88%)|
|ADJUSTED (b)           |  86.8%        68.6%        86.9%        89.0%      |  78.2%        62.0%        78.1%        88.0%      |
|TERMINAL (d)           | 63/76 (83%)  24/39 (62%)  90/109 (83%) 68/78 (87%) | 49/70 (70%)  18/35 (51%)  82/113 (73%) 65/77 (84%) |
|FIRST INCIDENCE (DAYS) |   463          495          412          408       |   128          461          185          423       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.443N     P=0.030N*    P=0.459      P=0.232N   |  P=0.094      P=0.052N     P=0.197N     P=0.349    |
|INCIDENTAL TUMOR       |  P=0.064      P=0.005N**   P=0.572      P=0.341    |  P<0.001 **   P=0.013N*    P=0.456N     P=0.012 *  |
|LOGISTIC REGRESSION    |  P=0.049 *    P=0.003N**   P=0.513      P=0.571N   |  P<0.001 **   P=0.010N**   P=0.449N     P=0.010 *  |
|COCHRAN-ARMITAGE       |  P=0.530N                                          |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.005N**   P=0.501N     P=0.223N   |               P=0.011N*    P=0.419N     P=0.021 *  |
|=================================================================================================================================|
 (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).