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TDMS Study 05128-06 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                D & C YELLOW NO. 11                                 DATE: 04/03/96       
EXPERIMENT: 05128 TEST: 06                                                                                     TIME: 23:51:52       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-95271                              ROUTE: DOSED FEED                                              NTP C#: 61789B       
PATHOLOGIST: J. E. HEATH                                                                                       CAS: 8003-22-3       
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                D & C YELLOW NO. 11                                 DATE: 04/03/96       
EXPERIMENT: 05128 TEST: 06                                                                                     TIME: 23:51:52       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-95271                              ROUTE: DOSED FEED                                              NTP C#: 61789B       
PATHOLOGIST: J. E. HEATH                                                                                       CAS: 8003-22-3       




                                                    RATS(FISCHER344)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
                                                                    

                                                    ----------------

                                                    Adrenal Cortex
                                                    Adrenal Medulla
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Clitoral/Preputial Gland
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                D & C YELLOW NO. 11                                 DATE: 04/03/96       
EXPERIMENT: 05128 TEST: 06                                                                                     TIME: 23:51:52       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-95271                              ROUTE: DOSED FEED                                              NTP C#: 61789B       
PATHOLOGIST: J. E. HEATH                                                                                       CAS: 8003-22-3       




                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                      IN THE ANALYSIS OF THE STUDY OF D & C YELLOW NO. 11

              ====================================================================================================

                                                           MALE RATS
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------

              Adrenal Medulla               Pheochromocytoma Benign
                                            Pheochromocytoma: Benign, Complex, Malignant, NOS
              Clitoral/Preputial Gland      Adenoma
                                            Carcinoma or Adenoma
              Intestine Small: Site Unspecified
                                            Carcinoma
              Islets, Pancreatic            Adenoma
                                            Carcinoma or Adenoma
              Kidney: Renal Tubule          Adenoma
                                            Carcinoma or Adenoma
              Liver                         Hepatocellular Adenoma
                                            Hepatocellular Carcinoma or Hepatocellular Adenoma
                                            Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
              Lung                          Alveolar/Bronchiolar Adenoma
                                            Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
              Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)
                                            Papilloma Squamous or Papilloma
                                            Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
              Pancreas                      Adenoma
              Pituitary Gland: Pars Distalis or Unspecified Site
                                            Adenoma
                                            Carcinoma or Adenoma
              Skin                          Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal
                                             Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma
                                            Keratoacanthoma
                                            Squamous Cell Papilloma
                                            Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma
                                            Squamous Cell Papilloma, Papilloma, or Keratoacanthoma
              Testes                        Adenoma
              Tongue                        Squamous Cell Papilloma
              All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
                                            Mesothelioma: Benign, Malignant, NOS
                                            Benign Tumors
                                            Malignant Tumors
                                            Malignant and Benign Tumors

              ====================================================================================================
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                D & C YELLOW NO. 11                                 DATE: 04/03/96       
EXPERIMENT: 05128 TEST: 06                                                                                     TIME: 23:51:52       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-95271                              ROUTE: DOSED FEED                                              NTP C#: 61789B       
PATHOLOGIST: J. E. HEATH                                                                                       CAS: 8003-22-3       




                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                      IN THE ANALYSIS OF THE STUDY OF D & C YELLOW NO. 11

              ====================================================================================================

                                                           FEMALE RATS
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------

              Clitoral/Preputial Gland      Adenoma
                                            Carcinoma or Adenoma
              Liver                         Hepatocellular Adenoma
                                            Hepatocellular Carcinoma or Hepatocellular Adenoma
                                            Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
              Lung                          Alveolar/Bronchiolar Carcinoma
              Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)
                                            Squamous Cell Carcinoma
              Pituitary Gland: Pars Distalis or Unspecified Site
                                            Adenoma
                                            Carcinoma
                                            Carcinoma or Adenoma
              Uterus                        Polyp Stromal
              All Organs                    Benign Tumors
                                            Malignant Tumors
                                            Malignant and Benign Tumors

              ====================================================================================================
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE   1
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/60 (12%)   8/59 (14%)  12/60 (20%)   8/60 (13%) |  2/58 (3%)    1/60 (2%)    2/59 (3%)    1/59 (2%)  |
|ADJUSTED (b)           |  25.9%        25.8%        49.3%        55.7%      |   7.7%         2.4%         4.9%         4.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/8 (0%)   |
|TERMINAL (d)           |  3/19 (16%)   1/19 (5%)    1/8 (13%)    0/2 (0%)   |  1/22 (5%)    0/26 (0%)    1/37 (3%)    1/23 (4%)  |
|FIRST INCIDENCE (DAYS) |   615          560          499          498       |   719          631          658          740 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.025 *    P=0.483      P=0.028 *    P=0.032 *  |  P=0.473N     P=0.486N     P=0.553N     P=0.479N   |
|INCIDENTAL TUMOR       |  P=0.503N     P=0.419      P=0.224      P=0.419    |  P=0.502N     P=0.480N     P=0.642      P=0.477N   |
|LOGISTIC REGRESSION    |  P=0.271      P=0.449      P=0.101      P=0.222    |  P=0.473N     P=0.486N     P=0.646N     P=0.472N   |
|COCHRAN-ARMITAGE       |  P=0.516                                           |  P=0.478N                                          |
|FISHER EXACT           |               P=0.486      P=0.159      P=0.500    |               P=0.487N     P=0.684N     P=0.494N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/60 (7%)    1/59 (2%)    2/60 (3%)    0/60 (0%)  |  0/58 (0%)    0/60 (0%)    1/59 (2%)    1/59 (2%)  |
|ADJUSTED (b)           |  18.5%         5.3%        19.8%         0.0%      |   0.0%         0.0%         2.4%         3.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/8 (0%)   |
|TERMINAL (d)           |  3/19 (16%)   1/19 (5%)    1/8 (13%)    0/2 (0%)   |  0/22 (0%)    0/26 (0%)    0/37 (0%)    0/23 (0%)  |
|FIRST INCIDENCE (DAYS) |   677          733 (T)      712          ---       |   ---          ---          671          723       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.454N     P=0.182N     P=0.663      P=0.404N   |  P=0.312        (e)        P=0.531      P=0.527    |
|INCIDENTAL TUMOR       |  P=0.294N     P=0.190N     P=0.522N     P=0.311N   |  P=0.380        (e)        P=0.323      P=0.522    |
|LOGISTIC REGRESSION    |  P=0.255N     P=0.186N     P=0.574N     P=0.211N   |  P=0.299        (e)        P=0.510      P=0.512    |
|COCHRAN-ARMITAGE       |  P=0.082N                                          |  P=0.299                                           |
|FISHER EXACT           |               P=0.187N     P=0.340N     P=0.059N   |                 (e)        P=0.504      P=0.504    |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE   2
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 10/60 (17%)   9/59 (15%)  14/60 (23%)   8/60 (13%) |  3/58 (5%)    1/60 (2%)    3/59 (5%)    2/59 (3%)  |
|ADJUSTED (b)           |  39.8%        29.9%        60.2%        55.7%      |  10.7%         2.4%         7.2%         7.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/8 (0%)   |
|TERMINAL (d)           |  6/19 (32%)   2/19 (11%)   2/8 (25%)    0/2 (0%)   |  1/22 (5%)    0/26 (0%)    1/37 (3%)    1/23 (4%)  |
|FIRST INCIDENCE (DAYS) |   615          560          499          498       |   712          631          658          723       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.033 *    P=0.516N     P=0.024 *    P=0.051    |  P=0.557N     P=0.300N     P=0.510N     P=0.463N   |
|INCIDENTAL TUMOR       |  P=0.442N     P=0.573N     P=0.214      P=0.489    |  P=0.538N     P=0.320N     P=0.471      P=0.462N   |
|LOGISTIC REGRESSION    |  P=0.433      P=0.567N     P=0.134      P=0.426    |  P=0.567N     P=0.291N     P=0.610N     P=0.470N   |
|COCHRAN-ARMITAGE       |  P=0.360N                                          |  P=0.571N                                          |
|FISHER EXACT           |               P=0.516N     P=0.247      P=0.399N   |               P=0.297N     P=0.652N     P=0.492N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/59 (8%)    2/59 (3%)    1/60 (2%)    0/60 (0%)  | 11/59 (19%)   4/59 (7%)    5/59 (8%)    4/60 (7%)  |
|ADJUSTED (b)           |  21.3%         9.3%         4.5%         0.0%      |  40.2%        16.0%        13.5%        13.7%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  3/19 (16%)   1/20 (5%)    0/8 (0%)     0/2 (0%)   |  7/22 (32%)   4/25 (16%)   5/37 (14%)   2/23 (9%)  |
|FIRST INCIDENCE (DAYS) |   638          726          686          ---       |   629          740 (T)      740 (T)      656       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.200N     P=0.203N     P=0.287N     P=0.302N   |  P=0.100N     P=0.029N*    P=0.009N**   P=0.043N*  |
|INCIDENTAL TUMOR       |  P=0.070N     P=0.234N     P=0.173N     P=0.145N   |  P=0.097N     P=0.036N*    P=0.034N*    P=0.045N*  |
|LOGISTIC REGRESSION    |  P=0.084N     P=0.228N     P=0.169N     P=0.108N   |  P=0.086N     P=0.043N*    P=0.035N*    P=0.036N*  |
|COCHRAN-ARMITAGE       |  P=0.031N*                                         |  P=0.105N                                          |
|FISHER EXACT           |               P=0.219N     P=0.100N     P=0.027N*  |               P=0.047N*    P=0.089N     P=0.044N*  |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE   3
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/59 (8%)    4/59 (7%)    1/60 (2%)    2/60 (3%)  |  6/59 (10%)   3/59 (5%)    6/59 (10%)   3/60 (5%)  |
|ADJUSTED (b)           |  23.7%        13.4%         3.3%        35.7%      |  23.3%         7.0%        15.2%         9.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    1/9 (11%)    0/10 (0%)    1/9 (11%)  |
|TERMINAL (d)           |  4/19 (21%)   1/20 (5%)    0/8 (0%)     0/2 (0%)   |  4/22 (18%)   0/25 (0%)    5/37 (14%)   1/23 (4%)  |
|FIRST INCIDENCE (DAYS) |   688          510          650          716       |   660          358 (I)      456          358 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.548      P=0.496N     P=0.318N     P=0.355    |  P=0.313N     P=0.231N     P=0.317N     P=0.241N   |
|INCIDENTAL TUMOR       |  P=0.283N     P=0.507N     P=0.195N     P=0.675N   |  P=0.269N     P=0.268N     P=0.442N     P=0.221N   |
|LOGISTIC REGRESSION    |  P=0.342N     P=0.528N     P=0.192N     P=0.645    |  P=0.297N     P=0.244N     P=0.552N     P=0.235N   |
|COCHRAN-ARMITAGE       |  P=0.165N                                          |  P=0.295N                                          |
|FISHER EXACT           |               P=0.500N     P=0.100N     P=0.213N   |               P=0.245N     P=0.619N     P=0.237N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 10/59 (17%)   6/59 (10%)   2/60 (3%)    2/60 (3%)  | 17/59 (29%)   7/59 (12%)  11/59 (19%)   7/60 (12%) |
|ADJUSTED (b)           |  42.9%        21.7%         7.7%        35.7%      |  58.9%        21.8%        28.5%        21.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    1/9 (11%)    0/10 (0%)    1/9 (11%)  |
|TERMINAL (d)           |  7/19 (37%)   2/20 (10%)   0/8 (0%)     0/2 (0%)   | 11/22 (50%)   4/25 (16%)  10/37 (27%)   3/23 (13%) |
|FIRST INCIDENCE (DAYS) |   638          510          650          716       |   629          358 (I)      456          358 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.365N     P=0.199N     P=0.138N     P=0.638N   |  P=0.069N     P=0.012N*    P=0.007N**   P=0.018N*  |
|INCIDENTAL TUMOR       |  P=0.049N*    P=0.220N     P=0.047N*    P=0.225N   |  P=0.054N     P=0.016N*    P=0.033N*    P=0.015N*  |
|LOGISTIC REGRESSION    |  P=0.071N     P=0.234N     P=0.045N*    P=0.184N   |  P=0.061N     P=0.017N*    P=0.059N     P=0.014N*  |
|COCHRAN-ARMITAGE       |  P=0.015N*                                         |  P=0.066N                                          |
|FISHER EXACT           |               P=0.210N     P=0.014N*    P=0.014N*  |               P=0.019N*    P=0.140N     P=0.017N*  |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE   4
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Site Unspecified                                                                                                |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    0/60 (0%)    2/60 (3%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   5.3%         0.0%         0.0%        39.4%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/19 (5%)    0/20 (0%)    0/8 (0%)     0/2 (0%)   |  0/22 (0%)    0/26 (0%)    0/37 (0%)    0/23 (0%)  |
|FIRST INCIDENCE (DAYS) |   733 (T)      ---          ---          700       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.007 **   P=0.490N     P=0.672N     P=0.065    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.102      P=0.490N     P=0.672N     P=0.348    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.038 *    P=0.490N     P=0.672N     P=0.189    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.189                                           |    (e)                                             |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.500    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/60 (7%)    3/60 (5%)    0/60 (0%)    0/60 (0%)  |  1/60 (2%)    1/60 (2%)    1/59 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |  19.6%         8.9%         0.0%         0.0%      |   3.0%         3.8%         2.7%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  3/19 (16%)   0/20 (0%)    0/8 (0%)     0/2 (0%)   |  0/22 (0%)    1/26 (4%)    1/37 (3%)    0/23 (0%)  |
|FIRST INCIDENCE (DAYS) |   716          586          ---          ---       |   700          740 (T)      740 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.146N     P=0.494N     P=0.215N     P=0.483N   |  P=0.314N     P=0.749N     P=0.677N     P=0.488N   |
|INCIDENTAL TUMOR       |  P=0.059N     P=0.520N     P=0.129N     P=0.311N   |  P=0.306N     P=0.736      P=0.731      P=0.489N   |
|LOGISTIC REGRESSION    |  P=0.055N     P=0.521N     P=0.167N     P=0.320N   |  P=0.314N     P=0.762N     P=0.737N     P=0.500N   |
|COCHRAN-ARMITAGE       |  P=0.031N*                                         |  P=0.322N                                          |
|FISHER EXACT           |               P=0.500N     P=0.059N     P=0.059N   |               P=0.752N     P=0.748      P=0.500N   |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE   5
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    2/60 (3%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    0/59 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   5.3%         0.0%        16.5%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/19 (5%)    0/20 (0%)    1/8 (13%)    0/2 (0%)   |  0/22 (0%)    0/26 (0%)    0/37 (0%)    0/23 (0%)  |
|FIRST INCIDENCE (DAYS) |   733 (T)      ---          686          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.672      P=0.490N     P=0.273      P=0.916N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.750      P=0.490N     P=0.363      P=0.916N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.687N     P=0.490N     P=0.345      P=0.916N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.458N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.500N     P=0.500      P=0.500N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/60 (8%)    3/60 (5%)    2/60 (3%)    0/60 (0%)  |  1/60 (2%)    1/60 (2%)    1/59 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |  24.6%         8.9%        16.5%         0.0%      |   3.0%         3.8%         2.7%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  4/19 (21%)   0/20 (0%)    1/8 (13%)    0/2 (0%)   |  0/22 (0%)    1/26 (4%)    1/37 (3%)    0/23 (0%)  |
|FIRST INCIDENCE (DAYS) |   716          586          686          ---       |   700          740 (T)      740 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.222N     P=0.350N     P=0.597N     P=0.430N   |  P=0.314N     P=0.749N     P=0.677N     P=0.488N   |
|INCIDENTAL TUMOR       |  P=0.084N     P=0.372N     P=0.419N     P=0.276N   |  P=0.306N     P=0.736      P=0.731      P=0.489N   |
|LOGISTIC REGRESSION    |  P=0.070N     P=0.378N     P=0.479N     P=0.265N   |  P=0.314N     P=0.762N     P=0.737N     P=0.500N   |
|COCHRAN-ARMITAGE       |  P=0.029N*                                         |  P=0.322N                                          |
|FISHER EXACT           |               P=0.359N     P=0.219N     P=0.029N*  |               P=0.752N     P=0.748      P=0.500N   |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE   6
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    2/60 (3%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%        24.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/19 (0%)    0/20 (0%)    0/8 (0%)     0/2 (0%)   |  0/22 (0%)    0/26 (0%)    0/37 (0%)    0/23 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          658       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.004 **     (e)          (e)        P=0.073    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.052        (e)          (e)        P=0.287    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.015 *      (e)          (e)        P=0.132    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.042 *                                         |    (e)                                             |
|FISHER EXACT           |                 (e)          (e)        P=0.248    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    1/60 (2%)    2/60 (3%)  |  0/60 (0%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         4.5%        24.0%      |   0.0%         0.0%         2.7%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/19 (0%)    0/20 (0%)    0/8 (0%)     0/2 (0%)   |  0/22 (0%)    0/26 (0%)    1/37 (3%)    0/23 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          686          658       |   ---          ---          740 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.015 *      (e)        P=0.438      P=0.073    |  P=0.810N       (e)        P=0.604        (e)      |
|INCIDENTAL TUMOR       |  P=0.108        (e)        P=0.604      P=0.287    |  P=0.810N       (e)        P=0.604        (e)      |
|LOGISTIC REGRESSION    |  P=0.033 *      (e)        P=0.463      P=0.132    |  P=0.810N       (e)        P=0.605        (e)      |
|COCHRAN-ARMITAGE       |  P=0.083                                           |  P=0.787N                                          |
|FISHER EXACT           |                 (e)        P=0.500      P=0.248    |                 (e)        P=0.500        (e)      |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE   7
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    2/60 (3%)    1/60 (2%)    7/60 (12%) |  0/60 (0%)    2/60 (3%)    5/60 (8%)    4/60 (7%)  |
|ADJUSTED (b)           |   5.3%         7.9%         2.6%        75.0%      |   0.0%         6.4%        13.5%        15.7%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/19 (5%)    1/20 (5%)    0/8 (0%)     1/2 (50%)  |  0/22 (0%)    1/26 (4%)    5/37 (14%)   3/23 (13%) |
|FIRST INCIDENCE (DAYS) |   733 (T)      656          607          498       |   ---          645          740 (T)      720       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.508      P=0.650      P<0.001 ** |  P=0.082      P=0.252      P=0.095      P=0.072    |
|INCIDENTAL TUMOR       |  P=0.001 **   P=0.488      P=0.615      P=0.012 *  |  P=0.095      P=0.212      P=0.095      P=0.070    |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.488      P=0.736      P=0.007 ** |  P=0.101      P=0.239      P=0.095      P=0.068    |
|COCHRAN-ARMITAGE       |  P=0.005 **                                        |  P=0.101                                           |
|FISHER EXACT           |               P=0.500      P=0.752N     P=0.031 *  |               P=0.248      P=0.029 *    P=0.059    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    2/60 (3%)    1/60 (2%)    7/60 (12%) |  0/60 (0%)    2/60 (3%)    5/60 (8%)    5/60 (8%)  |
|ADJUSTED (b)           |   5.3%         7.9%         2.6%        75.0%      |   0.0%         6.4%        13.5%        18.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/19 (5%)    1/20 (5%)    0/8 (0%)     1/2 (50%)  |  0/22 (0%)    1/26 (4%)    5/37 (14%)   3/23 (13%) |
|FIRST INCIDENCE (DAYS) |   733 (T)      656          607          498       |   ---          645          740 (T)      720       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.508      P=0.650      P<0.001 ** |  P=0.033 *    P=0.252      P=0.095      P=0.041 *  |
|INCIDENTAL TUMOR       |  P=0.001 **   P=0.488      P=0.615      P=0.012 *  |  P=0.045 *    P=0.212      P=0.095      P=0.038 *  |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.488      P=0.736      P=0.007 ** |  P=0.042 *    P=0.239      P=0.095      P=0.036 *  |
|COCHRAN-ARMITAGE       |  P=0.005 **                                        |  P=0.044 *                                         |
|FISHER EXACT           |               P=0.500      P=0.752N     P=0.031 *  |               P=0.248      P=0.029 *    P=0.029 *  |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE   8
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    2/60 (3%)    1/60 (2%)    7/60 (12%) |  0/60 (0%)    2/60 (3%)    5/60 (8%)    5/60 (8%)  |
|ADJUSTED (b)           |   5.3%         7.9%         2.6%        75.0%      |   0.0%         6.4%        13.5%        18.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/19 (5%)    1/20 (5%)    0/8 (0%)     1/2 (50%)  |  0/22 (0%)    1/26 (4%)    5/37 (14%)   3/23 (13%) |
|FIRST INCIDENCE (DAYS) |   733 (T)      656          607          498       |   ---          645          740 (T)      720       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.508      P=0.650      P<0.001 ** |  P=0.033 *    P=0.252      P=0.095      P=0.041 *  |
|INCIDENTAL TUMOR       |  P=0.001 **   P=0.488      P=0.615      P=0.012 *  |  P=0.045 *    P=0.212      P=0.095      P=0.038 *  |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.488      P=0.736      P=0.007 ** |  P=0.042 *    P=0.239      P=0.095      P=0.036 *  |
|COCHRAN-ARMITAGE       |  P=0.005 **                                        |  P=0.044 *                                         |
|FISHER EXACT           |               P=0.500      P=0.752N     P=0.031 *  |               P=0.248      P=0.029 *    P=0.029 *  |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/60 (12%)   2/60 (3%)    2/60 (3%)    1/60 (2%)  |  1/60 (2%)    1/60 (2%)    2/60 (3%)    1/60 (2%)  |
|ADJUSTED (b)           |  28.9%        10.0%         9.6%         7.1%      |   4.5%         3.8%         5.4%         4.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  4/19 (21%)   2/20 (10%)   0/8 (0%)     0/2 (0%)   |  1/22 (5%)    1/26 (4%)    2/37 (5%)    1/23 (4%)  |
|FIRST INCIDENCE (DAYS) |   650          733 (T)      453          695       |   740 (T)      740 (T)      740 (T)      740 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.405N     P=0.073N     P=0.294N     P=0.414N   |  P=0.656      P=0.725N     P=0.678      P=0.753N   |
|INCIDENTAL TUMOR       |  P=0.126N     P=0.087N     P=0.080N     P=0.157N   |  P=0.656      P=0.725N     P=0.678      P=0.753N   |
|LOGISTIC REGRESSION    |  P=0.123N     P=0.084N     P=0.120N     P=0.149N   |  P=0.656      P=0.725N     P=0.678      P=0.753N   |
|COCHRAN-ARMITAGE       |  P=0.054N                                          |  P=0.640N                                          |
|FISHER EXACT           |               P=0.081N     P=0.081N     P=0.031N*  |               P=0.752N     P=0.500      P=0.752N   |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE   9
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    1/60 (2%)    0/60 (0%)    1/60 (2%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    2/60 (3%)  |
|ADJUSTED (b)           |   5.3%         2.2%         0.0%        14.3%      |   0.0%         0.0%         0.0%         5.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/19 (5%)    0/20 (0%)    0/8 (0%)     0/2 (0%)   |  0/22 (0%)    0/26 (0%)    0/37 (0%)    0/23 (0%)  |
|FIRST INCIDENCE (DAYS) |   733 (T)      558          ---          716       |   ---          ---          ---          590       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.418      P=0.759N     P=0.672N     P=0.376    |  P=0.037 *      (e)          (e)        P=0.238    |
|INCIDENTAL TUMOR       |  P=0.603      P=0.755N     P=0.672N     P=0.603    |  P=0.025 *      (e)          (e)        P=0.143    |
|LOGISTIC REGRESSION    |  P=0.616      P=0.759      P=0.672N     P=0.506    |  P=0.041 *      (e)          (e)        P=0.237    |
|COCHRAN-ARMITAGE       |  P=0.678                                           |  P=0.042 *                                         |
|FISHER EXACT           |               P=0.752N     P=0.500N     P=0.752N   |                 (e)          (e)        P=0.248    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  8/60 (13%)   3/60 (5%)    2/60 (3%)    2/60 (3%)  |  1/60 (2%)    1/60 (2%)    2/60 (3%)    3/60 (5%)  |
|ADJUSTED (b)           |  33.7%        12.0%         9.6%        20.4%      |   4.5%         3.8%         5.4%        10.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  5/19 (26%)   2/20 (10%)   0/8 (0%)     0/2 (0%)   |  1/22 (5%)    1/26 (4%)    2/37 (5%)    1/23 (4%)  |
|FIRST INCIDENCE (DAYS) |   650          558          453          695       |   740 (T)      740 (T)      740 (T)      590       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.574N     P=0.092N     P=0.233N     P=0.642N   |  P=0.155      P=0.725N     P=0.678      P=0.314    |
|INCIDENTAL TUMOR       |  P=0.196N     P=0.106N     P=0.059N     P=0.265N   |  P=0.133      P=0.725N     P=0.678      P=0.237    |
|LOGISTIC REGRESSION    |  P=0.175N     P=0.111N     P=0.080N     P=0.261N   |  P=0.177      P=0.725N     P=0.678      P=0.306    |
|COCHRAN-ARMITAGE       |  P=0.076N                                          |  P=0.180                                           |
|FISHER EXACT           |               P=0.102N     P=0.047N*    P=0.047N*  |               P=0.752N     P=0.500      P=0.309    |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE  10
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |  2/60 (3%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   6.2%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/19 (0%)    0/20 (0%)    0/8 (0%)     0/2 (0%)   |  0/22 (0%)    0/26 (0%)    0/37 (0%)    0/23 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   700          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.222N     P=0.250N     P=0.190N     P=0.223N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.220N     P=0.330N     P=0.462N     P=0.225N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.236N     P=0.236N     P=0.218N     P=0.236N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.239N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.248N     P=0.248N     P=0.248N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |  5/60 (8%)    5/60 (8%)    3/60 (5%)    4/60 (7%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |  12.1%        15.7%         7.8%         9.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  1/10 (10%)   0/9 (0%)     0/10 (0%)    1/9 (11%)  |
|TERMINAL (d)           |  0/19 (0%)    0/20 (0%)    0/8 (0%)     0/2 (0%)   |  0/22 (0%)    3/26 (12%)   2/37 (5%)    0/23 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   358 (I)      628          722          358 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.440N     P=0.604N     P=0.244N     P=0.519N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.412N     P=0.612N     P=0.522N     P=0.442N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.430N     P=0.629      P=0.363N     P=0.481N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.431N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.628N     P=0.359N     P=0.500N   |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE  11
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |  7/60 (12%)   5/60 (8%)    3/60 (5%)    4/60 (7%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |  17.5%        15.7%         7.8%         9.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  1/10 (10%)   0/9 (0%)     0/10 (0%)    1/9 (11%)  |
|TERMINAL (d)           |  0/19 (0%)    0/20 (0%)    0/8 (0%)     0/2 (0%)   |  0/22 (0%)    3/26 (12%)   2/37 (5%)    0/23 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   358 (I)      628          722          358 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.274N     P=0.372N     P=0.091N     P=0.278N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.243N     P=0.412N     P=0.366N     P=0.209N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.272N     P=0.380N     P=0.160N     P=0.253N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.272N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.381N     P=0.161N     P=0.264N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    2/60 (3%)    3/60 (5%)    1/60 (2%)  | 21/60 (35%)  22/60 (37%)  23/60 (38%)  26/60 (43%) |
|ADJUSTED (b)           |  14.6%        10.0%        29.2%        20.0%      |  62.0%        55.8%        51.9%        69.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  2/19 (11%)   2/20 (10%)   2/8 (25%)    0/2 (0%)   | 10/22 (45%)  10/26 (38%)  16/37 (43%)  12/23 (52%) |
|FIRST INCIDENCE (DAYS) |   716          733 (T)      692          722       |   589          548          456          568       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.285      P=0.469N     P=0.285      P=0.573    |  P=0.189      P=0.510N     P=0.162N     P=0.292    |
|INCIDENTAL TUMOR       |  P=0.566      P=0.500N     P=0.478      P=0.598N   |  P=0.166      P=0.438      P=0.360      P=0.208    |
|LOGISTIC REGRESSION    |  P=0.532      P=0.470N     P=0.394      P=0.729    |  P=0.162      P=0.510      P=0.578N     P=0.211    |
|COCHRAN-ARMITAGE       |  P=0.274N                                          |  P=0.191                                           |
|FISHER EXACT           |               P=0.500N     P=0.660N     P=0.309N   |               P=0.500      P=0.425      P=0.227    |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE  12
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    2/60 (3%)    3/60 (5%)    1/60 (2%)  | 22/60 (37%)  22/60 (37%)  23/60 (38%)  26/60 (43%) |
|ADJUSTED (b)           |  14.6%        10.0%        29.2%        20.0%      |  63.3%        55.8%        51.9%        69.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  2/19 (11%)   2/20 (10%)   2/8 (25%)    0/2 (0%)   | 10/22 (45%)  10/26 (38%)  16/37 (43%)  12/23 (52%) |
|FIRST INCIDENCE (DAYS) |   716          733 (T)      692          722       |   589          548          456          568       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.285      P=0.469N     P=0.285      P=0.573    |  P=0.224      P=0.444N     P=0.121N     P=0.356    |
|INCIDENTAL TUMOR       |  P=0.566      P=0.500N     P=0.478      P=0.598N   |  P=0.206      P=0.504      P=0.406      P=0.275    |
|LOGISTIC REGRESSION    |  P=0.532      P=0.470N     P=0.394      P=0.729    |  P=0.197      P=0.571N     P=0.494N     P=0.277    |
|COCHRAN-ARMITAGE       |  P=0.274N                                          |  P=0.226                                           |
|FISHER EXACT           |               P=0.500N     P=0.660N     P=0.309N   |               P=0.575N     P=0.500      P=0.288    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    2/60 (3%)    3/60 (5%)    1/60 (2%)  | 26/60 (43%)  27/60 (45%)  25/60 (42%)  29/60 (48%) |
|ADJUSTED (b)           |  14.6%        10.0%        29.2%        20.0%      |  66.5%        65.7%        55.4%        71.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  1/10 (10%)   0/9 (0%)     0/10 (0%)    1/9 (11%)  |
|TERMINAL (d)           |  2/19 (11%)   2/20 (10%)   2/8 (25%)    0/2 (0%)   | 10/22 (45%)  13/26 (50%)  17/37 (46%)  12/23 (52%) |
|FIRST INCIDENCE (DAYS) |   716          733 (T)      692          722       |   358 (I)      548          456          358 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.285      P=0.469N     P=0.285      P=0.573    |  P=0.323      P=0.499N     P=0.066N     P=0.419    |
|INCIDENTAL TUMOR       |  P=0.566      P=0.500N     P=0.478      P=0.598N   |  P=0.317      P=0.451      P=0.495      P=0.387    |
|LOGISTIC REGRESSION    |  P=0.532      P=0.470N     P=0.394      P=0.729    |  P=0.248      P=0.508      P=0.382N     P=0.333    |
|COCHRAN-ARMITAGE       |  P=0.274N                                          |  P=0.326                                           |
|FISHER EXACT           |               P=0.500N     P=0.660N     P=0.309N   |               P=0.500      P=0.500N     P=0.357    |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE  13
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Papilloma Squamous or Papilloma                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    1/60 (2%)    2/60 (3%)    4/60 (7%)  |  1/60 (2%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   5.3%         3.2%         6.5%        28.1%      |   4.5%         2.3%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/19 (5%)    0/20 (0%)    0/8 (0%)     0/2 (0%)   |  1/22 (5%)    0/26 (0%)    0/37 (0%)    0/23 (0%)  |
|FIRST INCIDENCE (DAYS) |   733 (T)      658          406          481       |   740 (T)      628          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.008 **   P=0.758N     P=0.367      P=0.020 *  |  P=0.295N     P=0.736N     P=0.396N     P=0.491N   |
|INCIDENTAL TUMOR       |  P=0.134      P=0.743      P=0.561      P=0.171    |  P=0.386N     P=0.716N     P=0.396N     P=0.491N   |
|LOGISTIC REGRESSION    |  P=0.052      P=0.754      P=0.501      P=0.097    |  P=0.299N     P=0.762N     P=0.396N     P=0.491N   |
|COCHRAN-ARMITAGE       |  P=0.074                                           |  P=0.299N                                          |
|FISHER EXACT           |               P=0.752N     P=0.500      P=0.182    |               P=0.752N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    2/60 (3%)    1/60 (2%)    1/60 (2%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    2/60 (3%)  |
|ADJUSTED (b)           |   0.0%         5.5%         4.3%         3.2%      |   0.0%         0.0%         0.0%         8.2%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    1/9 (11%)    0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/19 (0%)    0/20 (0%)    0/8 (0%)     0/2 (0%)   |  0/22 (0%)    0/26 (0%)    0/37 (0%)    1/23 (4%)  |
|FIRST INCIDENCE (DAYS) |   ---          357 (I)      680          590       |   ---          ---          ---          733       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.429      P=0.246      P=0.447      P=0.417    |  P=0.031 *      (e)          (e)        P=0.245    |
|INCIDENTAL TUMOR       |  P=0.640      P=0.206      P=0.604      P=0.531    |  P=0.054        (e)          (e)        P=0.251    |
|LOGISTIC REGRESSION    |  P=0.631      P=0.249      P=0.468      P=0.504    |  P=0.039 *      (e)          (e)        P=0.248    |
|COCHRAN-ARMITAGE       |  P=0.617                                           |  P=0.042 *                                         |
|FISHER EXACT           |               P=0.248      P=0.500      P=0.500    |                 (e)          (e)        P=0.248    |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE  14
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    3/60 (5%)    3/60 (5%)    5/60 (8%)  |  1/60 (2%)    1/60 (2%)    0/60 (0%)    2/60 (3%)  |
|ADJUSTED (b)           |   5.3%         8.5%        10.6%        30.4%      |   4.5%         2.3%         0.0%         8.2%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    1/9 (11%)    0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/19 (5%)    0/20 (0%)    0/8 (0%)     0/2 (0%)   |  1/22 (5%)    0/26 (0%)    0/37 (0%)    1/23 (4%)  |
|FIRST INCIDENCE (DAYS) |   733 (T)      357 (I)      406          481       |   740 (T)      628          ---          733       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.010 **   P=0.315      P=0.191      P=0.008 ** |  P=0.317      P=0.736N     P=0.396N     P=0.510    |
|INCIDENTAL TUMOR       |  P=0.173      P=0.266      P=0.395      P=0.102    |  P=0.274      P=0.716N     P=0.396N     P=0.517    |
|LOGISTIC REGRESSION    |  P=0.085      P=0.306      P=0.294      P=0.055    |  P=0.333      P=0.762N     P=0.396N     P=0.518    |
|COCHRAN-ARMITAGE       |  P=0.102                                           |  P=0.335                                           |
|FISHER EXACT           |               P=0.309      P=0.309      P=0.103    |               P=0.752N     P=0.500N     P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Mucosa                                                                                                                      |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    1/60 (2%)    1/60 (2%)    2/60 (3%)  |  1/60 (2%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         3.2%         2.0%         9.1%      |   4.5%         2.3%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/19 (0%)    0/20 (0%)    0/8 (0%)     0/2 (0%)   |  1/22 (5%)    0/26 (0%)    0/37 (0%)    0/23 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          658          406          481       |   740 (T)      628          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.127      P=0.494      P=0.496      P=0.162    |  P=0.295N     P=0.736N     P=0.396N     P=0.491N   |
|INCIDENTAL TUMOR       |  P=0.428      P=0.459      P=0.669      P=0.423    |  P=0.386N     P=0.716N     P=0.396N     P=0.491N   |
|LOGISTIC REGRESSION    |  P=0.217      P=0.496      P=0.555      P=0.239    |  P=0.299N     P=0.762N     P=0.396N     P=0.491N   |
|COCHRAN-ARMITAGE       |  P=0.193                                           |  P=0.299N                                          |
|FISHER EXACT           |               P=0.500      P=0.500      P=0.248    |               P=0.752N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE  15
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Granulosa Cell Tumor: Benign, Malignant, NOS                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/60 (0%)    0/60 (0%)    2/60 (3%)    0/60 (0%)  |
|ADJUSTED (b)           |                                                    |   0.0%         0.0%         5.4%         0.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |                                                    |  0/22 (0%)    0/26 (0%)    2/37 (5%)    0/23 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          ---          740 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.725N       (e)        P=0.358        (e)      |
|INCIDENTAL TUMOR       |                                                    |  P=0.725N       (e)        P=0.358        (e)      |
|LOGISTIC REGRESSION    |                                                    |  P=0.725N       (e)        P=0.358        (e)      |
|COCHRAN-ARMITAGE       |                                                    |  P=0.701N                                          |
|FISHER EXACT           |                                                    |                 (e)        P=0.248        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    1/60 (2%)    4/60 (7%)    2/60 (3%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         5.0%        18.0%         7.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     1/6 (17%)  |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/19 (0%)    1/20 (5%)    0/8 (0%)     0/2 (0%)   |  0/22 (0%)    0/26 (0%)    0/37 (0%)    0/23 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          733 (T)      649          357 (I)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.073      P=0.510      P=0.031 *    P=0.142    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.226      P=0.510      P=0.144      P=0.206    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.220      P=0.510      P=0.044 *    P=0.280    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.274                                           |    (e)                                             |
|FISHER EXACT           |               P=0.500      P=0.059      P=0.248    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE  16
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 21/60 (35%)   8/59 (14%)  14/58 (24%)  10/58 (17%) | 24/60 (40%)  23/60 (38%)  18/60 (30%)  22/60 (37%) |
|ADJUSTED (b)           |  64.5%        27.7%        58.0%        36.1%      |  62.3%        64.9%        42.3%        56.5%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   0/9 (0%)     0/8 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    2/9 (22%)  |
|TERMINAL (d)           | 10/19 (53%)   3/20 (15%)   3/8 (38%)    0/2 (0%)   |  9/22 (41%)  14/26 (54%)  13/37 (35%)   8/23 (35%) |
|FIRST INCIDENCE (DAYS) |   357 (I)      586          502          509       |   537          601          610          358 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.161      P=0.009N**   P=0.559      P=0.407    |  P=0.446N     P=0.374N     P=0.015N*    P=0.402N   |
|INCIDENTAL TUMOR       |  P=0.263N     P=0.005N**   P=0.247N     P=0.126N   |  P=0.385N     P=0.565N     P=0.271N     P=0.431N   |
|LOGISTIC REGRESSION    |  P=0.118N     P=0.006N**   P=0.205N     P=0.021N*  |  P=0.433N     P=0.488N     P=0.096N     P=0.434N   |
|COCHRAN-ARMITAGE       |  P=0.117N                                          |  P=0.422N                                          |
|FISHER EXACT           |               P=0.006N**   P=0.138N     P=0.023N*  |               P=0.500N     P=0.169N     P=0.426N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/59 (0%)    0/58 (0%)    0/58 (0%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    2/60 (3%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         7.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/8 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/19 (0%)    0/20 (0%)    0/8 (0%)     0/2 (0%)   |  0/22 (0%)    0/26 (0%)    0/37 (0%)    1/23 (4%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          ---          ---          723       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.038 *      (e)          (e)        P=0.259    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.054        (e)          (e)        P=0.251    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.040 *      (e)          (e)        P=0.247    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.042 *                                         |
|FISHER EXACT           |                 (e)          (e)          (e)      |                 (e)          (e)        P=0.248    |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE  17
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 21/60 (35%)   8/59 (14%)  14/58 (24%)  10/58 (17%) | 24/60 (40%)  23/60 (38%)  18/60 (30%)  24/60 (40%) |
|ADJUSTED (b)           |  64.5%        27.7%        58.0%        36.1%      |  62.3%        64.9%        42.3%        60.7%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   0/9 (0%)     0/8 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    2/9 (22%)  |
|TERMINAL (d)           | 10/19 (53%)   3/20 (15%)   3/8 (38%)    0/2 (0%)   |  9/22 (41%)  14/26 (54%)  13/37 (35%)   9/23 (39%) |
|FIRST INCIDENCE (DAYS) |   357 (I)      586          502          509       |   537          601          610          358 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.161      P=0.009N**   P=0.559      P=0.407    |  P=0.477      P=0.374N     P=0.015N*    P=0.522N   |
|INCIDENTAL TUMOR       |  P=0.263N     P=0.005N**   P=0.247N     P=0.126N   |  P=0.530      P=0.565N     P=0.271N     P=0.573    |
|LOGISTIC REGRESSION    |  P=0.118N     P=0.006N**   P=0.205N     P=0.021N*  |  P=0.477      P=0.488N     P=0.096N     P=0.565    |
|COCHRAN-ARMITAGE       |  P=0.117N                                          |  P=0.493                                           |
|FISHER EXACT           |               P=0.006N**   P=0.138N     P=0.023N*  |               P=0.500N     P=0.169N     P=0.574N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Adenoma                                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    1/60 (2%)    2/60 (3%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   3.6%         3.3%         8.1%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/19 (0%)    0/20 (0%)    0/8 (0%)     0/2 (0%)   |  0/22 (0%)    0/26 (0%)    0/37 (0%)    0/23 (0%)  |
|FIRST INCIDENCE (DAYS) |   695          672          590          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.493N     P=0.753      P=0.373      P=0.638N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.266N     P=0.717      P=0.574      P=0.455N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.401N     P=0.755      P=0.465      P=0.608N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.335N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.752N     P=0.500      P=0.500N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE  18
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Adenoma, Basosquamous Tumor Benign, or Trichoepithelioma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    1/60 (2%)    2/60 (3%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   8.6%         3.3%         8.1%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/19 (5%)    0/20 (0%)    0/8 (0%)     0/2 (0%)   |  0/22 (0%)    0/26 (0%)    0/37 (0%)    0/23 (0%)  |
|FIRST INCIDENCE (DAYS) |   695          672          590          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.420N     P=0.502N     P=0.510      P=0.551N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.220N     P=0.542N     P=0.683      P=0.397N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.288N     P=0.514N     P=0.641      P=0.416N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.212N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.500N     P=0.691N     P=0.248N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Carcinoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    2/60 (3%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%        15.0%         0.0%      |   0.0%         0.0%         0.0%         4.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/19 (0%)    0/20 (0%)    1/8 (13%)    0/2 (0%)   |  0/22 (0%)    0/26 (0%)    0/37 (0%)    1/23 (4%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          646          ---       |   ---          ---          ---          740 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.582        (e)        P=0.149        (e)      |  P=0.190        (e)          (e)        P=0.509    |
|INCIDENTAL TUMOR       |  P=0.667        (e)        P=0.193        (e)      |  P=0.190        (e)          (e)        P=0.509    |
|LOGISTIC REGRESSION    |  P=0.689        (e)        P=0.192        (e)      |  P=0.190        (e)          (e)        P=0.509    |
|COCHRAN-ARMITAGE       |  P=0.701N                                          |  P=0.213                                           |
|FISHER EXACT           |                 (e)        P=0.248        (e)      |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE  19
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign,                                                       |
|     malignant or NOS), or Trichoepithelioma                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    1/60 (2%)    4/60 (7%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   8.6%         3.3%        21.9%         0.0%      |   0.0%         0.0%         0.0%         4.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/19 (5%)    0/20 (0%)    1/8 (13%)    0/2 (0%)   |  0/22 (0%)    0/26 (0%)    0/37 (0%)    1/23 (4%)  |
|FIRST INCIDENCE (DAYS) |   695          672          590          ---       |   ---          ---          ---          740 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.545N     P=0.502N     P=0.156      P=0.551N   |  P=0.190        (e)          (e)        P=0.509    |
|INCIDENTAL TUMOR       |  P=0.299N     P=0.542N     P=0.293      P=0.397N   |  P=0.190        (e)          (e)        P=0.509    |
|LOGISTIC REGRESSION    |  P=0.348N     P=0.514N     P=0.262      P=0.416N   |  P=0.190        (e)          (e)        P=0.509    |
|COCHRAN-ARMITAGE       |  P=0.236N                                          |  P=0.213                                           |
|FISHER EXACT           |               P=0.500N     P=0.340      P=0.248N   |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal                                                       |
|     Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 12/60 (20%)   8/60 (13%)   8/60 (13%)   4/60 (7%)  |  0/60 (0%)    1/60 (2%)    2/60 (3%)    2/60 (3%)  |
|ADJUSTED (b)           |  40.5%        34.5%        40.6%        59.4%      |   0.0%         3.8%         4.9%         8.7%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  4/19 (21%)   6/20 (30%)   1/8 (13%)    1/2 (50%)  |  0/22 (0%)    1/26 (4%)    1/37 (3%)    2/23 (9%)  |
|FIRST INCIDENCE (DAYS) |   628          658          590          596       |   ---          740 (T)      638          740 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.441      P=0.229N     P=0.516      P=0.595N   |  P=0.205      P=0.533      P=0.311      P=0.247    |
|INCIDENTAL TUMOR       |  P=0.154N     P=0.268N     P=0.183N     P=0.108N   |  P=0.145      P=0.533      P=0.212      P=0.247    |
|LOGISTIC REGRESSION    |  P=0.187N     P=0.254N     P=0.384N     P=0.150N   |  P=0.224      P=0.533      P=0.248      P=0.247    |
|COCHRAN-ARMITAGE       |  P=0.037N*                                         |  P=0.225                                           |
|FISHER EXACT           |               P=0.232N     P=0.232N     P=0.029N*  |               P=0.500      P=0.248      P=0.248    |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE  20
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    2/60 (3%)    3/60 (5%)    0/60 (0%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  10.1%         6.0%        23.4%         0.0%      |   2.9%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/19 (5%)    0/20 (0%)    1/8 (13%)    0/2 (0%)   |  0/22 (0%)    0/26 (0%)    0/37 (0%)    0/23 (0%)  |
|FIRST INCIDENCE (DAYS) |   632          558          663          ---       |   699          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.359N     P=0.509N     P=0.442      P=0.333N   |  P=0.460N     P=0.518N     P=0.463N     P=0.494N   |
|INCIDENTAL TUMOR       |  P=0.138N     P=0.514N     P=0.552      P=0.185N   |  P=0.434N     P=0.581N     P=0.688N     P=0.489N   |
|LOGISTIC REGRESSION    |  P=0.166N     P=0.509N     P=0.581      P=0.169N   |  P=0.470N     P=0.499N     P=0.486N     P=0.500N   |
|COCHRAN-ARMITAGE       |  P=0.110N                                          |  P=0.469N                                          |
|FISHER EXACT           |               P=0.500N     P=0.660N     P=0.122N   |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/60 (12%)   4/60 (7%)    2/60 (3%)    1/60 (2%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  23.1%        17.7%        11.4%         3.3%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  2/19 (11%)   3/20 (15%)   0/8 (0%)     0/2 (0%)   |  0/22 (0%)    0/26 (0%)    0/37 (0%)    0/23 (0%)  |
|FIRST INCIDENCE (DAYS) |   628          658          650          596       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.244N     P=0.276N     P=0.232N     P=0.236N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.067N     P=0.293N     P=0.071N     P=0.056N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.075N     P=0.283N     P=0.122N     P=0.074N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.032N*                                         |    (e)                                             |
|FISHER EXACT           |               P=0.264N     P=0.081N     P=0.031N*  |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE  21
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    2/60 (3%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         4.9%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/19 (0%)    0/20 (0%)    0/8 (0%)     0/2 (0%)   |  0/22 (0%)    0/26 (0%)    1/37 (3%)    0/23 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          ---          638          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.707N       (e)        P=0.311        (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.676        (e)        P=0.212        (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.704N       (e)        P=0.248        (e)      |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.701N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |                 (e)        P=0.248        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma, Basal Cell Carcinoma, Basosquamous Tumor                                                           |
|     (malignant or NOS), or Carcinoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    2/60 (3%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    2/60 (3%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%        15.0%         0.0%      |   0.0%         0.0%         4.9%         4.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/19 (0%)    0/20 (0%)    1/8 (13%)    0/2 (0%)   |  0/22 (0%)    0/26 (0%)    1/37 (3%)    1/23 (4%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          646          ---       |   ---          ---          638          740 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.582        (e)        P=0.149        (e)      |  P=0.334        (e)        P=0.311      P=0.509    |
|INCIDENTAL TUMOR       |  P=0.667        (e)        P=0.193        (e)      |  P=0.236        (e)        P=0.212      P=0.509    |
|LOGISTIC REGRESSION    |  P=0.689        (e)        P=0.192        (e)      |  P=0.341        (e)        P=0.248      P=0.509    |
|COCHRAN-ARMITAGE       |  P=0.701N                                          |  P=0.344                                           |
|FISHER EXACT           |                 (e)        P=0.248        (e)      |                 (e)        P=0.248      P=0.500    |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE  22
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    3/60 (5%)    2/60 (3%)    3/60 (5%)  |  0/60 (0%)    1/60 (2%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |  13.7%        15.0%        14.1%        58.0%      |   0.0%         3.8%         0.0%         4.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/19 (5%)    3/20 (15%)   0/8 (0%)     1/2 (50%)  |  0/22 (0%)    1/26 (4%)    0/37 (0%)    1/23 (4%)  |
|FIRST INCIDENCE (DAYS) |   706          733 (T)      686          624       |   ---          740 (T)      ---          740 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.036 *    P=0.633N     P=0.577      P=0.101    |  P=0.451      P=0.533        (e)        P=0.509    |
|INCIDENTAL TUMOR       |  P=0.291      P=0.648      P=0.383N     P=0.461    |  P=0.451      P=0.533        (e)        P=0.509    |
|LOGISTIC REGRESSION    |  P=0.235      P=0.652N     P=0.674N     P=0.357    |  P=0.451      P=0.533        (e)        P=0.509    |
|COCHRAN-ARMITAGE       |  P=0.597                                           |  P=0.464                                           |
|FISHER EXACT           |               P=0.660N     P=0.500N     P=0.660N   |               P=0.500        (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 10/60 (17%)   7/60 (12%)   4/60 (7%)    4/60 (7%)  |  0/60 (0%)    1/60 (2%)    2/60 (3%)    1/60 (2%)  |
|ADJUSTED (b)           |  34.1%        32.3%        23.9%        59.4%      |   0.0%         3.8%         4.9%         4.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  3/19 (16%)   6/20 (30%)   0/8 (0%)     1/2 (50%)  |  0/22 (0%)    1/26 (4%)    1/37 (3%)    1/23 (4%)  |
|FIRST INCIDENCE (DAYS) |   628          658          650          596       |   ---          740 (T)      638          740 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.369      P=0.293N     P=0.335N     P=0.544    |  P=0.489      P=0.533      P=0.311      P=0.509    |
|INCIDENTAL TUMOR       |  P=0.270N     P=0.333N     P=0.043N*    P=0.190N   |  P=0.400      P=0.533      P=0.212      P=0.509    |
|LOGISTIC REGRESSION    |  P=0.295N     P=0.327N     P=0.144N     P=0.255N   |  P=0.496      P=0.533      P=0.248      P=0.509    |
|COCHRAN-ARMITAGE       |  P=0.078N                                          |  P=0.495                                           |
|FISHER EXACT           |               P=0.301N     P=0.077N     P=0.077N   |               P=0.500      P=0.248      P=0.500    |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE  23
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, or Keratoacanthoma                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 10/60 (17%)   7/60 (12%)   4/60 (7%)    4/60 (7%)  |  0/60 (0%)    1/60 (2%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |  34.1%        32.3%        23.9%        59.4%      |   0.0%         3.8%         0.0%         4.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  3/19 (16%)   6/20 (30%)   0/8 (0%)     1/2 (50%)  |  0/22 (0%)    1/26 (4%)    0/37 (0%)    1/23 (4%)  |
|FIRST INCIDENCE (DAYS) |   628          658          650          596       |   ---          740 (T)      ---          740 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.369      P=0.293N     P=0.335N     P=0.544    |  P=0.451      P=0.533        (e)        P=0.509    |
|INCIDENTAL TUMOR       |  P=0.270N     P=0.333N     P=0.043N*    P=0.190N   |  P=0.451      P=0.533        (e)        P=0.509    |
|LOGISTIC REGRESSION    |  P=0.295N     P=0.327N     P=0.144N     P=0.255N   |  P=0.451      P=0.533        (e)        P=0.509    |
|COCHRAN-ARMITAGE       |  P=0.078N                                          |  P=0.464                                           |
|FISHER EXACT           |               P=0.301N     P=0.077N     P=0.077N   |               P=0.500        (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Sebaceous Gland                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   8.9%         0.0%         0.0%         6.7%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/19 (5%)    0/20 (0%)    0/8 (0%)     0/2 (0%)   |  0/22 (0%)    0/26 (0%)    0/37 (0%)    0/23 (0%)  |
|FIRST INCIDENCE (DAYS) |   701          ---          ---          693       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.462      P=0.234N     P=0.422N     P=0.607    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.680      P=0.257N     P=0.262N     P=0.652N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.591      P=0.240N     P=0.333N     P=0.741N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.645N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.248N     P=0.248N     P=0.500N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE  24
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    2/60 (3%)    0/60 (0%)    0/60 (0%)  |  0/60 (0%)    3/60 (5%)    0/60 (0%)    2/60 (3%)  |
|ADJUSTED (b)           |   0.0%         8.7%         0.0%         0.0%      |   0.0%        11.5%         0.0%         6.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/19 (0%)    1/20 (5%)    0/8 (0%)     0/2 (0%)   |  0/22 (0%)    3/26 (12%)   0/37 (0%)    1/23 (4%)  |
|FIRST INCIDENCE (DAYS) |   ---          712          ---          ---       |   ---          740 (T)      ---          590       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.698N     P=0.264        (e)          (e)      |  P=0.403      P=0.150        (e)        P=0.247    |
|INCIDENTAL TUMOR       |  P=0.493N     P=0.222        (e)          (e)      |  P=0.330      P=0.150        (e)        P=0.142    |
|LOGISTIC REGRESSION    |  P=0.565N     P=0.237        (e)          (e)      |  P=0.421      P=0.150        (e)        P=0.237    |
|COCHRAN-ARMITAGE       |  P=0.365N                                          |  P=0.422                                           |
|FISHER EXACT           |               P=0.248        (e)          (e)      |               P=0.122        (e)        P=0.248    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    2/60 (3%)    0/60 (0%)    0/60 (0%)  |  0/60 (0%)    2/60 (3%)    0/60 (0%)    2/60 (3%)  |
|ADJUSTED (b)           |   0.0%         8.7%         0.0%         0.0%      |   0.0%         7.7%         0.0%         6.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/19 (0%)    1/20 (5%)    0/8 (0%)     0/2 (0%)   |  0/22 (0%)    2/26 (8%)    0/37 (0%)    1/23 (4%)  |
|FIRST INCIDENCE (DAYS) |   ---          712          ---          ---       |   ---          740 (T)      ---          590       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.698N     P=0.264        (e)          (e)      |  P=0.267      P=0.275        (e)        P=0.247    |
|INCIDENTAL TUMOR       |  P=0.493N     P=0.222        (e)          (e)      |  P=0.195      P=0.275        (e)        P=0.142    |
|LOGISTIC REGRESSION    |  P=0.565N     P=0.237        (e)          (e)      |  P=0.286      P=0.275        (e)        P=0.237    |
|COCHRAN-ARMITAGE       |  P=0.365N                                          |  P=0.289                                           |
|FISHER EXACT           |               P=0.248        (e)          (e)      |               P=0.248        (e)        P=0.248    |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE  25
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 39/59 (66%)  49/60 (82%)  49/60 (82%)  46/60 (77%) |                                                    |
|ADJUSTED (b)           |  95.0%       100.0%       100.0%       100.0%      |                                                    |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    3/9 (33%)    1/9 (11%)    0/6 (0%)   |                                                    |
|TERMINAL (d)           | 17/19 (89%)  20/20 (100%)  8/8 (100%)   2/2 (100%) |                                                    |
|FIRST INCIDENCE (DAYS) |   481          357 (I)      357 (I)      370       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.112      P<0.001 **   P<0.001 ** |                                                    |
|INCIDENTAL TUMOR       |  P=0.083      P=0.009 **   P=0.005 **   P=0.018 *  |                                                    |
|LOGISTIC REGRESSION    |  P=0.017 *    P=0.006 **   P<0.001 **   P<0.001 ** |                                                    |
|COCHRAN-ARMITAGE       |  P=0.337                                           |                                                    |
|FISHER EXACT           |               P=0.042 *    P=0.042 *    P=0.142    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/60 (10%)   3/60 (5%)    3/59 (5%)    3/60 (5%)  |  2/60 (3%)    2/60 (3%)    4/60 (7%)    6/60 (10%) |
|ADJUSTED (b)           |  20.7%        12.2%        11.5%        23.8%      |   9.1%         7.7%        10.5%        20.2%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  2/19 (11%)   2/20 (10%)   0/8 (0%)     0/2 (0%)   |  2/22 (9%)    2/26 (8%)    3/37 (8%)    3/23 (13%) |
|FIRST INCIDENCE (DAYS) |   590          575          610          498       |   740 (T)      740 (T)      722          656       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.373      P=0.265N     P=0.484N     P=0.525    |  P=0.050      P=0.635N     P=0.572      P=0.159    |
|INCIDENTAL TUMOR       |  P=0.369N     P=0.256N     P=0.289N     P=0.266N   |  P=0.067      P=0.635N     P=0.470      P=0.151    |
|LOGISTIC REGRESSION    |  P=0.451N     P=0.259N     P=0.316N     P=0.391N   |  P=0.059      P=0.635N     P=0.475      P=0.141    |
|COCHRAN-ARMITAGE       |  P=0.304N                                          |  P=0.061                                           |
|FISHER EXACT           |               P=0.245N     P=0.254N     P=0.245N   |               P=0.691N     P=0.340      P=0.136    |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE  26
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/60 (10%)   3/60 (5%)    4/59 (7%)    4/60 (7%)  |  2/60 (3%)    3/60 (5%)    5/60 (8%)    6/60 (10%) |
|ADJUSTED (b)           |  20.7%        12.2%        22.5%        26.5%      |   9.1%        11.5%        12.5%        20.2%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  2/19 (11%)   2/20 (10%)   1/8 (13%)    0/2 (0%)   |  2/22 (9%)    3/26 (12%)   3/37 (8%)    3/23 (13%) |
|FIRST INCIDENCE (DAYS) |   590          575          610          498       |   740 (T)      740 (T)      638          656       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.157      P=0.265N     P=0.594      P=0.350    |  P=0.091      P=0.577      P=0.418      P=0.159    |
|INCIDENTAL TUMOR       |  P=0.583      P=0.256N     P=0.482N     P=0.399N   |  P=0.090      P=0.577      P=0.271      P=0.151    |
|LOGISTIC REGRESSION    |  P=0.535      P=0.259N     P=0.474N     P=0.529N   |  P=0.100      P=0.577      P=0.274      P=0.141    |
|COCHRAN-ARMITAGE       |  P=0.466N                                          |  P=0.102                                           |
|FISHER EXACT           |               P=0.245N     P=0.382N     P=0.372N   |               P=0.500      P=0.219      P=0.136    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    1/59 (2%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    1/60 (2%)    2/60 (3%)  |
|ADJUSTED (b)           |   0.0%         0.0%         3.6%         0.0%      |   0.0%         0.0%         2.7%         6.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/19 (0%)    0/20 (0%)    0/8 (0%)     0/2 (0%)   |  0/22 (0%)    0/26 (0%)    1/37 (3%)    0/23 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          659          ---       |   ---          ---          740 (T)      720       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.787        (e)        P=0.473        (e)      |  P=0.085        (e)        P=0.604      P=0.269    |
|INCIDENTAL TUMOR       |  P=0.758N       (e)        P=0.597        (e)      |  P=0.117        (e)        P=0.604      P=0.249    |
|LOGISTIC REGRESSION    |  P=0.805        (e)        P=0.477        (e)      |  P=0.081        (e)        P=0.605      P=0.242    |
|COCHRAN-ARMITAGE       |  P=0.787N                                          |  P=0.083                                           |
|FISHER EXACT           |                 (e)        P=0.496        (e)      |                 (e)        P=0.500      P=0.248    |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE  27
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    1/60 (2%)    1/59 (2%)    3/60 (5%)  |  0/60 (0%)    1/60 (2%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |  13.7%         2.2%        12.5%        37.8%      |   0.0%         3.8%         0.0%         4.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  2/19 (11%)   0/20 (0%)    1/8 (13%)    0/2 (0%)   |  0/22 (0%)    1/26 (4%)    0/37 (0%)    1/23 (4%)  |
|FIRST INCIDENCE (DAYS) |   695          558          733 (T)      596       |   ---          740 (T)      ---          740 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.055      P=0.305N     P=0.602N     P=0.144    |  P=0.451      P=0.533        (e)        P=0.509    |
|INCIDENTAL TUMOR       |  P=0.225      P=0.316N     P=0.496N     P=0.454    |  P=0.451      P=0.533        (e)        P=0.509    |
|LOGISTIC REGRESSION    |  P=0.283      P=0.317N     P=0.514N     P=0.474    |  P=0.451      P=0.533        (e)        P=0.509    |
|COCHRAN-ARMITAGE       |  P=0.416                                           |  P=0.464                                           |
|FISHER EXACT           |               P=0.309N     P=0.316N     P=0.660N   |               P=0.500        (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    1/60 (2%)    2/59 (3%)    3/60 (5%)  |  0/60 (0%)    1/60 (2%)    1/60 (2%)    3/60 (5%)  |
|ADJUSTED (b)           |  13.7%         2.2%        15.6%        37.8%      |   0.0%         3.8%         2.7%        10.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  2/19 (11%)   0/20 (0%)    1/8 (13%)    0/2 (0%)   |  0/22 (0%)    1/26 (4%)    1/37 (3%)    1/23 (4%)  |
|FIRST INCIDENCE (DAYS) |   695          558          659          596       |   ---          740 (T)      740 (T)      720       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.063      P=0.305N     P=0.590      P=0.144    |  P=0.059      P=0.533      P=0.604      P=0.143    |
|INCIDENTAL TUMOR       |  P=0.259      P=0.316N     P=0.643N     P=0.454    |  P=0.077      P=0.533      P=0.604      P=0.131    |
|LOGISTIC REGRESSION    |  P=0.290      P=0.317N     P=0.663N     P=0.474    |  P=0.063      P=0.533      P=0.605      P=0.126    |
|COCHRAN-ARMITAGE       |  P=0.428                                           |  P=0.064                                           |
|FISHER EXACT           |               P=0.309N     P=0.508N     P=0.660N   |               P=0.500      P=0.500      P=0.122    |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE  28
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Tongue                                                                                                                           |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    1/60 (2%)    1/60 (2%)    2/60 (3%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   5.3%         1.7%         4.5%        20.4%      |   0.0%         0.0%         0.0%         4.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    1/9 (11%)    0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/19 (5%)    0/20 (0%)    0/8 (0%)     0/2 (0%)   |  0/22 (0%)    0/26 (0%)    0/37 (0%)    0/23 (0%)  |
|FIRST INCIDENCE (DAYS) |   733 (T)      357 (I)      686          695       |   ---          ---          ---          733       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.094      P=0.754      P=0.628      P=0.118    |  P=0.194        (e)          (e)        P=0.500    |
|INCIDENTAL TUMOR       |  P=0.268      P=0.754      P=0.738      P=0.348    |  P=0.272        (e)          (e)        P=0.511    |
|LOGISTIC REGRESSION    |  P=0.313      P=0.752N     P=0.689      P=0.228    |  P=0.211        (e)          (e)        P=0.510    |
|COCHRAN-ARMITAGE       |  P=0.360                                           |  P=0.213                                           |
|FISHER EXACT           |               P=0.752N     P=0.752N     P=0.500    |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Tongue                                                                                                                           |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    1/60 (2%)    2/60 (3%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   5.3%         0.0%         4.5%        20.4%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/19 (5%)    0/20 (0%)    0/8 (0%)     0/2 (0%)   |  0/22 (0%)    0/26 (0%)    0/37 (0%)    0/23 (0%)  |
|FIRST INCIDENCE (DAYS) |   733 (T)      ---          686          695       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.034 *    P=0.490N     P=0.628      P=0.118    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.164      P=0.490N     P=0.738      P=0.348    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.081      P=0.490N     P=0.689      P=0.228    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.230                                           |    (e)                                             |
|FISHER EXACT           |               P=0.500N     P=0.752N     P=0.500    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE  29
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    | 14/60 (23%)  13/60 (22%)  10/60 (17%)   6/60 (10%) |
|ADJUSTED (b)           |                                                    |  35.5%        33.6%        21.5%        18.9%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  2/10 (20%)   2/9 (22%)    3/10 (30%)   0/9 (0%)   |
|TERMINAL (d)           |                                                    |  2/22 (9%)    4/26 (15%)   5/37 (14%)   1/23 (4%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   358 (I)      358 (I)      358 (I)      648       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.034N*    P=0.474N     P=0.101N     P=0.056N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.038N*    P=0.568      P=0.507N     P=0.063N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.027N*    P=0.500N     P=0.259N     P=0.044N*  |
|COCHRAN-ARMITAGE       |                                                    |  P=0.027N*                                         |
|FISHER EXACT           |                                                    |               P=0.500N     P=0.247N     P=0.042N*  |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 37/60 (62%)  36/60 (60%)  20/60 (33%)  22/60 (37%) | 16/60 (27%)  21/60 (35%)  19/60 (32%)  16/60 (27%) |
|ADJUSTED (b)           |  80.0%        77.1%        61.7%        81.6%      |  47.3%        49.7%        41.9%        40.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           | 10/19 (53%)  10/20 (50%)   2/8 (25%)    0/2 (0%)   |  6/22 (27%)   7/26 (27%)  11/37 (30%)   4/23 (17%) |
|FIRST INCIDENCE (DAYS) |   481          222          453          481       |   589          308          532          441       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.190      P=0.524N     P=0.241N     P=0.151    |  P=0.365N     P=0.308      P=0.345N     P=0.533N   |
|INCIDENTAL TUMOR       |  P<0.001N**   P=0.446N     P<0.001N**   P<0.001N** |  P=0.278N     P=0.192      P=0.147      P=0.572N   |
|LOGISTIC REGRESSION    |  P=0.001N**   P=0.521N     P<0.001N**   P=0.007N** |  P=0.443N     P=0.212      P=0.442      P=0.509    |
|COCHRAN-ARMITAGE       |  P=0.002N**                                        |  P=0.355N                                          |
|FISHER EXACT           |               P=0.500N     P=0.002N**   P=0.005N** |               P=0.215      P=0.344      P=0.582N   |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE  30
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma: Benign, Malignant, NOS                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    2/60 (3%)    3/60 (5%)    4/60 (7%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   6.7%         9.5%         8.7%        22.7%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/9 (0%)     0/9 (0%)     0/6 (0%)   |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/19 (0%)    1/20 (5%)    0/8 (0%)     0/2 (0%)   |  0/22 (0%)    0/26 (0%)    0/37 (0%)    0/23 (0%)  |
|FIRST INCIDENCE (DAYS) |   656          727          491          496       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.037 *    P=0.681N     P=0.384      P=0.127    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.372      P=0.644      P=0.676      P=0.529    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.172      P=0.682      P=0.488      P=0.273    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.231                                           |    (e)                                             |
|FISHER EXACT           |               P=0.691N     P=0.500      P=0.340    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 50/60 (83%)  53/60 (88%)  50/60 (83%)  50/60 (83%) | 44/60 (73%)  46/60 (77%)  44/60 (73%)  43/60 (72%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  93.4%        93.8%        87.9%        91.4%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   3/9 (33%)    1/9 (11%)    1/6 (17%)  |  2/10 (20%)   2/9 (22%)    3/10 (30%)   2/9 (22%)  |
|TERMINAL (d)           | 19/19 (100%) 20/20 (100%)  8/8 (100%)   2/2 (100%) | 19/22 (86%)  23/26 (88%)  31/37 (84%)  19/23 (83%) |
|FIRST INCIDENCE (DAYS) |   357 (I)      357 (I)      357 (I)      357 (I)   |   358 (I)      358 (I)      358 (I)      358 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.382      P=0.008 **   P<0.001 ** |  P=0.456N     P=0.475N     P=0.013N*    P=0.441N   |
|INCIDENTAL TUMOR       |  P=0.587      P=0.144      P=0.641      P=0.451    |  P=0.491N     P=0.362      P=0.590      P=0.583    |
|LOGISTIC REGRESSION    |  P=0.476      P=0.129      P=0.284      P=0.229    |  P=0.439N     P=0.407      P=0.479N     P=0.572N   |
|COCHRAN-ARMITAGE       |  P=0.418N                                          |  P=0.377N                                          |
|FISHER EXACT           |               P=0.301      P=0.596N     P=0.596N   |               P=0.417      P=0.582N     P=0.500N   |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE  31
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.05%        0.17%        0.5%      |   UNTREATD     0.05%        0.17%        0.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 42/60 (70%)  40/60 (67%)  30/60 (50%)  26/60 (43%) | 32/60 (53%)  30/60 (50%)  30/60 (50%)  30/60 (50%) |
|ADJUSTED (b)           |  87.3%        82.4%        89.6%        88.8%      |  72.5%        64.6%        63.6%        65.7%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    1/9 (11%)    0/9 (0%)     0/6 (0%)   |  2/10 (20%)   1/9 (11%)    0/10 (0%)    2/9 (22%)  |
|TERMINAL (d)           | 13/19 (68%)  12/20 (60%)   6/8 (75%)    0/2 (0%)   | 11/22 (50%)  11/26 (42%)  20/37 (54%)   9/23 (39%) |
|FIRST INCIDENCE (DAYS) |   481          222          384          481       |   358 (I)      308          456          358 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.072      P=0.476N     P=0.417      P=0.080    |  P=0.478N     P=0.357N     P=0.044N*    P=0.413N   |
|INCIDENTAL TUMOR       |  P<0.001N**   P=0.325N     P=0.009N**   P<0.001N** |  P=0.361N     P=0.437N     P=0.524      P=0.430N   |
|LOGISTIC REGRESSION    |  P<0.001N**   P=0.435N     P=0.009N**   P=0.003N** |  P=0.538N     P=0.437N     P=0.527N     P=0.508N   |
|COCHRAN-ARMITAGE       |  P=0.001N**                                        |  P=0.449N                                          |
|FISHER EXACT           |               P=0.422N     P=0.020N*    P=0.003N** |               P=0.428N     P=0.428N     P=0.428N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 51/60 (85%)  55/60 (92%)  51/60 (85%)  50/60 (83%) | 52/60 (87%)  53/60 (88%)  53/60 (88%)  53/60 (88%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  96.3%        98.1%       100.0%        98.1%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   4/9 (44%)    1/9 (11%)    1/6 (17%)  |  4/10 (40%)   3/9 (33%)    3/10 (30%)   4/9 (44%)  |
|TERMINAL (d)           | 19/19 (100%) 20/20 (100%)  8/8 (100%)   2/2 (100%) | 20/22 (91%)  25/26 (96%)  37/37 (100%) 22/23 (96%) |
|FIRST INCIDENCE (DAYS) |   357 (I)      222          357 (I)      357 (I)   |   358 (I)      308          358 (I)      358 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.331      P=0.009 **   P<0.001 ** |  P=0.435      P=0.423N     P=0.010N*    P=0.545    |
|INCIDENTAL TUMOR       |  P=0.152N     P=0.125      P=0.743      P=0.712    |  P=0.513      P=0.555      P=0.422      P=0.430    |
|LOGISTIC REGRESSION    |  P=0.295N     P=0.063      P=0.743      P=0.621    |  P=0.420      P=0.491      P=0.548      P=0.390    |
|COCHRAN-ARMITAGE       |  P=0.258N                                          |  P=0.494                                           |
|FISHER EXACT           |               P=0.197      P=0.601N     P=0.500N   |               P=0.500      P=0.500      P=0.500    |
|=================================================================================================================================|
         DATE: 04/04/96                     EXPERIMENT: 05128 TEST: 06                                                 PAGE  32
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11

                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
                                                                           

 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (c)  Observed incidence at interim kill.
          Male interim sacrifices(days):   357
          Female interim sacrifices(days): 358
 (d)  Observed incidence at terminal kill.
 (f)  Beneath the control incidence are the P-values associated with the trend 
      test.  Beneath the dosed group incidence are the P-values corresponding to 
      pairwise comparisons between the controls and that dosed group.  The life
      table analysis regards tumors in animals dying  prior to terminal kill as
      being (directly or indirectly) the cause of death.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's exact tests compare directly the overall incidence rates.  
      For all tests, a negative trend is indicated by "N".
 (e)  Value of Statistic cannot be computed. 
 (I)  Interim sacrifice
 (T)  Terminal sacrifice
  #   Tumor rates based on number of animals necropsied.

  *   To the right of any statistical result, indicates significance at (P<=0.05).
  **  To the right of any statistical result, indicates significance at (P<=0.01).
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.