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TDMS Study 05099-07 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                             SALICYLAZOSULFAPYRIDINE                                DATE: 04/03/96       
EXPERIMENT: 05099 TEST: 07                                                                                     TIME: 19:25:38       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85233                              ROUTE: GAVAGE                                                  NTP C#: 61552B       
PATHOLOGIST: DR J. HEATH                                                                                       CAS: 599-79-1        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                             SALICYLAZOSULFAPYRIDINE                                DATE: 04/03/96       
EXPERIMENT: 05099 TEST: 07                                                                                     TIME: 19:25:38       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85233                              ROUTE: GAVAGE                                                  NTP C#: 61552B       
PATHOLOGIST: DR J. HEATH                                                                                       CAS: 599-79-1        




                                                    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                             SALICYLAZOSULFAPYRIDINE                                DATE: 04/03/96       
EXPERIMENT: 05099 TEST: 07                                                                                     TIME: 19:25:38       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85233                              ROUTE: GAVAGE                                                  NTP C#: 61552B       
PATHOLOGIST: DR J. HEATH                                                                                       CAS: 599-79-1        




                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                    IN THE ANALYSIS OF THE STUDY OF SALICYLAZOSULFAPYRIDINE

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

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

              Adrenal Medulla               Pheochromocytoma Benign
                                            Pheochromocytoma: Benign, Complex, Malignant, NOS
              Clitoral/Preputial Gland      Adenoma
                                            Carcinoma or Adenoma
              Liver                         Hepatocellular Adenoma
                                            Hepatocellular Carcinoma or Hepatocellular Adenoma
                                            Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
              Mammary Gland                 Fibroma, Fibroadenoma, Carcinoma, or Adenoma
              Pancreas                      Carcinoma or Adenoma
              Skin                          Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign,
                                             malignant or NOS), or Trichoepithelioma
                                            Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal
                                             Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma
                                            Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma
              Testes                        Adenoma
              Thyroid Gland: C-Cell         Carcinoma or Adenoma
              Urinary Bladder               Papilloma
              Zymbal's Gland                Carcinoma
              All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
                                            Malignant Tumors
                                            Malignant and Benign Tumors

              ====================================================================================================
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                             SALICYLAZOSULFAPYRIDINE                                DATE: 04/03/96       
EXPERIMENT: 05099 TEST: 07                                                                                     TIME: 19:25:38       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85233                              ROUTE: GAVAGE                                                  NTP C#: 61552B       
PATHOLOGIST: DR J. HEATH                                                                                       CAS: 599-79-1        




                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                    IN THE ANALYSIS OF THE STUDY OF SALICYLAZOSULFAPYRIDINE

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

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

              Kidney: Pelvis and Transitional Epithelium
                                            Papilloma
              Mammary Gland                 Fibroadenoma
                                            Fibroma, Fibroadenoma or Adenoma
                                            Fibroma, Fibroadenoma, Carcinoma, or Adenoma
              Pituitary Gland: Pars Distalis or Unspecified Site
                                            Adenoma
                                            Carcinoma or Adenoma
              Skin                          Squamous Cell Papilloma
              All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
                                            Benign Tumors
                                            Malignant Tumors
                                            Malignant and Benign Tumors

              ====================================================================================================
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE   1
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/130 (0%)   0/60 (0%)    1/60 (2%)    2/130 (2%) |  1/60 (2%)    0/60 (0%)    1/60 (2%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         2.4%         3.8%      |   2.9%         0.0%         3.2%         3.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/66 (0%)    0/33 (0%)    0/31 (0%)    2/53 (4%)  |  1/35 (3%)    0/34 (0%)    1/31 (3%)    1/26 (4%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          578          729 (T)   |   737 (T)      ---          737 (T)      737 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.087        (e)        P=0.348      P=0.192    |  P=0.462      P=0.506N     P=0.735      P=0.694    |
|INCIDENTAL TUMOR       |  P=0.107        (e)        P=0.433      P=0.192    |  P=0.462      P=0.506N     P=0.735      P=0.694    |
|LOGISTIC REGRESSION    |  P=0.102        (e)        P=0.337      P=0.192    |  P=0.462      P=0.506N     P=0.735      P=0.694    |
|COCHRAN-ARMITAGE       |  P=0.118                                           |  P=0.539                                           |
|FISHER EXACT           |                 (e)        P=0.316      P=0.249    |               P=0.500N     P=0.752N     P=0.752N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 24/130 (18%)  7/59 (12%)   6/60 (10%)  13/129 (10%)|  1/60 (2%)    0/60 (0%)    3/60 (5%)    0/60 (0%)  |
|ADJUSTED (b)           |  32.4%        21.2%        18.7%        21.1%      |   2.6%         0.0%         9.7%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    1/20 (5%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 17/66 (26%)   7/33 (21%)   5/31 (16%)   8/53 (15%) |  0/35 (0%)    0/34 (0%)    3/31 (10%)   0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   591          729 (T)      704          456 (I)   |   691          ---          737 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.123N     P=0.118N     P=0.097N     P=0.130N   |  P=0.581N     P=0.505N     P=0.283      P=0.539N   |
|INCIDENTAL TUMOR       |  P=0.057N     P=0.118N     P=0.100N     P=0.050N*  |  P=0.575N     P=0.557N     P=0.321      P=0.557N   |
|LOGISTIC REGRESSION    |  P=0.074N     P=0.123N     P=0.091N     P=0.073N   |  P=0.568N     P=0.508N     P=0.318      P=0.535N   |
|COCHRAN-ARMITAGE       |  P=0.037N*                                         |  P=0.499N                                          |
|FISHER EXACT           |               P=0.179N     P=0.099N     P=0.039N*  |               P=0.500N     P=0.309      P=0.500N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE   2
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/130 (1%)   0/59 (0%)    1/60 (2%)    2/129 (2%) |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   1.5%         0.0%         3.2%         3.5%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/66 (2%)    0/33 (0%)    1/31 (3%)    1/53 (2%)  |  0/35 (0%)    0/34 (0%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          729 (T)      704       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.246      P=0.638N     P=0.584      P=0.431    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.285      P=0.638N     P=0.584      P=0.486    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.260      P=0.638N     P=0.584      P=0.447    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.313                                           |    (e)                                             |
|FISHER EXACT           |               P=0.688N     P=0.533      P=0.497    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 26/130 (20%)  7/59 (12%)   7/60 (12%)  15/129 (12%)|  1/60 (2%)    0/60 (0%)    3/60 (5%)    0/60 (0%)  |
|ADJUSTED (b)           |  34.7%        21.2%        21.8%        24.1%      |   2.6%         0.0%         9.7%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    1/20 (5%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 18/66 (27%)   7/33 (21%)   6/31 (19%)   9/53 (17%) |  0/35 (0%)    0/34 (0%)    3/31 (10%)   0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   591          729 (T)      704          456 (I)   |   691          ---          737 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.166N     P=0.078N     P=0.110N     P=0.158N   |  P=0.581N     P=0.505N     P=0.283      P=0.539N   |
|INCIDENTAL TUMOR       |  P=0.073N     P=0.075N     P=0.114N     P=0.054N   |  P=0.575N     P=0.557N     P=0.321      P=0.557N   |
|LOGISTIC REGRESSION    |  P=0.101N     P=0.078N     P=0.102N     P=0.088N   |  P=0.568N     P=0.508N     P=0.318      P=0.535N   |
|COCHRAN-ARMITAGE       |  P=0.050N*                                         |  P=0.499N                                          |
|FISHER EXACT           |               P=0.122N     P=0.113N     P=0.046N*  |               P=0.500N     P=0.309      P=0.500N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE   3
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone                                                                                                                             |
|     Osteosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/130 (0%)   0/60 (0%)    0/60 (0%)    2/130 (2%) |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         1.8%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/66 (0%)    0/33 (0%)    0/31 (0%)    0/53 (0%)  |  0/35 (0%)    0/34 (0%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          361       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.075        (e)          (e)        P=0.227    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.130        (e)          (e)        P=0.366    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.113        (e)          (e)        P=0.271    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.083                                           |    (e)                                             |
|FISHER EXACT           |                 (e)          (e)        P=0.249    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/130 (1%)   1/60 (2%)    3/60 (5%)    5/130 (4%) |  2/60 (3%)    3/60 (5%)    2/60 (3%)    2/60 (3%)  |
|ADJUSTED (b)           |   1.3%         3.0%         8.2%         9.4%      |   5.7%         7.6%         6.5%         7.7%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    1/10 (10%)   0/20 (0%)  |  0/10 (0%)    1/10 (10%)   0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/66 (0%)    1/33 (3%)    2/31 (6%)    5/53 (9%)  |  2/35 (6%)    2/34 (6%)    2/31 (6%)    2/26 (8%)  |
|FIRST INCIDENCE (DAYS) |   684          729 (T)      456 (I)      729 (T)   |   737 (T)      458 (I)      737 (T)      737 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.039 *    P=0.591      P=0.096      P=0.065    |  P=0.543      P=0.489      P=0.651      P=0.584    |
|INCIDENTAL TUMOR       |  P=0.046 *    P=0.599      P=0.087      P=0.079    |  P=0.543      P=0.489      P=0.651      P=0.584    |
|LOGISTIC REGRESSION    |  P=0.053      P=0.591      P=0.093      P=0.074    |  P=0.584      P=0.485      P=0.652      P=0.584    |
|COCHRAN-ARMITAGE       |  P=0.076                                           |  P=0.523N                                          |
|FISHER EXACT           |               P=0.533      P=0.094      P=0.107    |               P=0.500      P=0.691N     P=0.691N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE   4
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/130 (2%)   1/60 (2%)    3/60 (5%)    2/130 (2%) |  1/60 (2%)    2/60 (3%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   2.9%         1.8%         7.4%         2.8%      |   2.4%         5.9%         3.2%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/66 (2%)    0/33 (0%)    0/31 (0%)    1/53 (2%)  |  0/35 (0%)    2/34 (6%)    1/31 (3%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   708          424          502          383       |   663          737 (T)      737 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.493      P=0.724      P=0.189      P=0.627    |  P=0.312N     P=0.485      P=0.755      P=0.554N   |
|INCIDENTAL TUMOR       |  P=0.570N     P=0.721      P=0.227      P=0.682    |  P=0.299N     P=0.460      P=0.715N     P=0.557N   |
|LOGISTIC REGRESSION    |  P=0.567      P=0.714      P=0.191      P=0.680    |  P=0.290N     P=0.483      P=0.755N     P=0.521N   |
|COCHRAN-ARMITAGE       |  P=0.563                                           |  P=0.248N                                          |
|FISHER EXACT           |               P=0.682      P=0.182      P=0.689N   |               P=0.500      P=0.752N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/130 (2%)   2/60 (3%)    6/60 (10%)   7/130 (5%) |  3/60 (5%)    5/60 (8%)    3/60 (5%)    2/60 (3%)  |
|ADJUSTED (b)           |   4.1%         4.8%        14.9%        12.1%      |   8.0%        13.4%         9.7%         7.7%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    1/10 (10%)   0/20 (0%)  |  0/10 (0%)    1/10 (10%)   0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/66 (2%)    1/33 (3%)    2/31 (6%)    6/53 (11%) |  2/35 (6%)    4/34 (12%)   3/31 (10%)   2/26 (8%)  |
|FIRST INCIDENCE (DAYS) |   684          424          456 (I)      383       |   663          458 (I)      737 (T)      737 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.072      P=0.551      P=0.030 *    P=0.099    |  P=0.433N     P=0.341      P=0.621      P=0.631N   |
|INCIDENTAL TUMOR       |  P=0.109      P=0.554      P=0.033 *    P=0.131    |  P=0.427N     P=0.327      P=0.659      P=0.632N   |
|LOGISTIC REGRESSION    |  P=0.109      P=0.541      P=0.027 *    P=0.131    |  P=0.387N     P=0.334      P=0.645N     P=0.613N   |
|COCHRAN-ARMITAGE       |  P=0.132                                           |  P=0.298N                                          |
|FISHER EXACT           |               P=0.505      P=0.029 *    P=0.167    |               P=0.359      P=0.660N     P=0.500N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE   5
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Heart                                                                                                                            |
|     Schwannoma Benign                                                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/130 (1%)   0/60 (0%)    0/60 (0%)    3/130 (2%) |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   1.5%         0.0%         0.0%         5.5%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/66 (2%)    0/33 (0%)    0/31 (0%)    2/53 (4%)  |  0/35 (0%)    0/34 (0%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          718       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.095      P=0.638N     P=0.651N     P=0.235    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.120      P=0.638N     P=0.651N     P=0.277    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.100      P=0.638N     P=0.651N     P=0.242    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.140                                           |    (e)                                             |
|FISHER EXACT           |               P=0.684N     P=0.684N     P=0.311    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Heart                                                                                                                            |
|     Schwannoma Malignant                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/130 (0%)   1/60 (2%)    1/60 (2%)    0/130 (0%) |  3/60 (5%)    0/60 (0%)    0/60 (0%)    3/60 (5%)  |
|ADJUSTED (b)           |   0.0%         3.0%         3.2%         0.0%      |   8.6%         0.0%         0.0%        11.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/66 (0%)    1/33 (3%)    1/31 (3%)    0/53 (0%)  |  3/35 (9%)    0/34 (0%)    0/31 (0%)    2/26 (8%)  |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      729 (T)      ---       |   737 (T)      ---          ---          733       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.610N     P=0.362      P=0.349        (e)      |  P=0.336      P=0.126N     P=0.143N     P=0.523    |
|INCIDENTAL TUMOR       |  P=0.610N     P=0.362      P=0.349        (e)      |  P=0.344      P=0.126N     P=0.143N     P=0.520    |
|LOGISTIC REGRESSION    |  P=0.610N     P=0.362      P=0.349        (e)      |  P=0.347      P=0.126N     P=0.143N     P=0.539    |
|COCHRAN-ARMITAGE       |  P=0.552N                                          |  P=0.443                                           |
|FISHER EXACT           |               P=0.316      P=0.316        (e)      |               P=0.122N     P=0.122N     P=0.660N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE   6
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Large: Colon/Rectum                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/130 (2%)   0/60 (0%)    0/60 (0%)    0/130 (0%) |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   1.9%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  1/20 (5%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/66 (0%)    0/33 (0%)    0/31 (0%)    0/53 (0%)  |  0/35 (0%)    0/34 (0%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   456 (I)      ---          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.137N     P=0.411N     P=0.411N     P=0.252N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.124N     P=0.415N     P=0.346N     P=0.240N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.118N     P=0.455N     P=0.484N     P=0.214N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.131N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.467N     P=0.467N     P=0.249N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/130 (3%)   3/60 (5%)    6/60 (10%)   6/129 (5%) |  1/60 (2%)    0/60 (0%)    1/60 (2%)    1/60 (2%)  |
|ADJUSTED (b)           |   4.9%         9.1%        17.1%         9.4%      |   2.9%         0.0%         3.2%         3.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  1/20 (5%)    0/10 (0%)    0/10 (0%)    1/20 (5%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/66 (2%)    3/33 (9%)    4/31 (13%)   3/53 (6%)  |  1/35 (3%)    0/34 (0%)    1/31 (3%)    1/26 (4%)  |
|FIRST INCIDENCE (DAYS) |   456 (I)      729 (T)      502          456 (I)   |   737 (T)      ---          737 (T)      737 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.218      P=0.438      P=0.057      P=0.286    |  P=0.462      P=0.506N     P=0.735      P=0.694    |
|INCIDENTAL TUMOR       |  P=0.306      P=0.446      P=0.053      P=0.393    |  P=0.462      P=0.506N     P=0.735      P=0.694    |
|LOGISTIC REGRESSION    |  P=0.282      P=0.424      P=0.055      P=0.339    |  P=0.462      P=0.506N     P=0.735      P=0.694    |
|COCHRAN-ARMITAGE       |  P=0.334                                           |  P=0.539                                           |
|FISHER EXACT           |               P=0.388      P=0.055      P=0.370    |               P=0.500N     P=0.752N     P=0.752N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE   7
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/130 (2%)   1/60 (2%)    0/60 (0%)    0/129 (0%) |  0/60 (0%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   3.0%         3.0%         0.0%         0.0%      |   0.0%         2.9%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/66 (3%)    1/33 (3%)    0/31 (0%)    0/53 (0%)  |  0/35 (0%)    1/34 (3%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      ---          ---       |   ---          737 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.141N     P=0.732      P=0.416N     P=0.288N   |  P=0.614N     P=0.494        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.141N     P=0.732      P=0.416N     P=0.288N   |  P=0.614N     P=0.494        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.141N     P=0.732      P=0.416N     P=0.288N   |  P=0.614N     P=0.494        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.115N                                          |  P=0.568N                                          |
|FISHER EXACT           |               P=0.682      P=0.467N     P=0.251N   |               P=0.500        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/130 (5%)   4/60 (7%)    6/60 (10%)   6/129 (5%) |  1/60 (2%)    1/60 (2%)    1/60 (2%)    1/60 (2%)  |
|ADJUSTED (b)           |   7.8%        12.1%        17.1%         9.4%      |   2.9%         2.9%         3.2%         3.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  1/20 (5%)    0/10 (0%)    0/10 (0%)    1/20 (5%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/66 (5%)    4/33 (12%)   4/31 (13%)   3/53 (6%)  |  1/35 (3%)    1/34 (3%)    1/31 (3%)    1/26 (4%)  |
|FIRST INCIDENCE (DAYS) |   456 (I)      729 (T)      502          456 (I)   |   737 (T)      737 (T)      737 (T)      737 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.423      P=0.447      P=0.147      P=0.502    |  P=0.550      P=0.755      P=0.735      P=0.694    |
|INCIDENTAL TUMOR       |  P=0.522      P=0.454      P=0.142      P=0.610    |  P=0.550      P=0.755      P=0.735      P=0.694    |
|LOGISTIC REGRESSION    |  P=0.507      P=0.431      P=0.144      P=0.570    |  P=0.550      P=0.755      P=0.735      P=0.694    |
|COCHRAN-ARMITAGE       |  P=0.530N                                          |  P=0.634                                           |
|FISHER EXACT           |               P=0.392      P=0.137      P=0.610    |               P=0.752N     P=0.752N     P=0.752N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE   8
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Pelvis and Transitional Epithelium                                                                                       |
|     Papilloma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/130 (0%)   0/60 (0%)    0/60 (0%)    0/130 (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%         7.7%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/66 (0%)    0/33 (0%)    0/31 (0%)    0/53 (0%)  |  0/35 (0%)    0/34 (0%)    0/31 (0%)    2/26 (8%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          ---          ---          737 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.028 *      (e)          (e)        P=0.175    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.028 *      (e)          (e)        P=0.175    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.028 *      (e)          (e)        P=0.175    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.046 *                                         |
|FISHER EXACT           |                 (e)          (e)          (e)      |                 (e)          (e)        P=0.248    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/130 (3%)   1/60 (2%)    0/60 (0%)    0/130 (0%) |  0/60 (0%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   5.9%         1.8%         0.0%         0.0%      |   0.0%         0.0%         3.2%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    1/10 (10%)   0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/66 (5%)    0/33 (0%)    0/31 (0%)    0/53 (0%)  |  0/35 (0%)    0/34 (0%)    1/31 (3%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   726          456 (I)      ---          ---       |   ---          ---          737 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.037N*    P=0.437N     P=0.202N     P=0.098N   |  P=0.661        (e)        P=0.476        (e)      |
|INCIDENTAL TUMOR       |  P=0.031N*    P=0.437N     P=0.212N     P=0.076N   |  P=0.661        (e)        P=0.476        (e)      |
|LOGISTIC REGRESSION    |  P=0.031N*    P=0.455N     P=0.204N     P=0.094N   |  P=0.661        (e)        P=0.476        (e)      |
|COCHRAN-ARMITAGE       |  P=0.028N*                                         |  P=0.696                                           |
|FISHER EXACT           |               P=0.495N     P=0.216N     P=0.061N   |                 (e)        P=0.500        (e)      |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE   9
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/130 (3%)   2/60 (3%)    1/60 (2%)    0/130 (0%) |  0/60 (0%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   5.9%         4.8%         3.2%         0.0%      |   0.0%         0.0%         3.2%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    1/10 (10%)   0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/66 (5%)    1/33 (3%)    1/31 (3%)    0/53 (0%)  |  0/35 (0%)    0/34 (0%)    1/31 (3%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   726          456 (I)      729 (T)      ---       |   ---          ---          737 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.055N     P=0.669N     P=0.465N     P=0.098N   |  P=0.661        (e)        P=0.476        (e)      |
|INCIDENTAL TUMOR       |  P=0.047N*    P=0.669N     P=0.480N     P=0.076N   |  P=0.661        (e)        P=0.476        (e)      |
|LOGISTIC REGRESSION    |  P=0.045N*    P=0.654      P=0.475N     P=0.094N   |  P=0.661        (e)        P=0.476        (e)      |
|COCHRAN-ARMITAGE       |  P=0.038N*                                         |  P=0.696                                           |
|FISHER EXACT           |               P=0.617      P=0.495N     P=0.061N   |                 (e)        P=0.500        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/130 (3%)   2/60 (3%)    1/60 (2%)    0/130 (0%) |  0/60 (0%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   5.9%         4.8%         3.2%         0.0%      |   0.0%         0.0%         3.2%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    1/10 (10%)   0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/66 (5%)    1/33 (3%)    1/31 (3%)    0/53 (0%)  |  0/35 (0%)    0/34 (0%)    1/31 (3%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   726          456 (I)      729 (T)      ---       |   ---          ---          737 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.055N     P=0.669N     P=0.465N     P=0.098N   |  P=0.661        (e)        P=0.476        (e)      |
|INCIDENTAL TUMOR       |  P=0.047N*    P=0.669N     P=0.480N     P=0.076N   |  P=0.661        (e)        P=0.476        (e)      |
|LOGISTIC REGRESSION    |  P=0.045N*    P=0.654      P=0.475N     P=0.094N   |  P=0.661        (e)        P=0.476        (e)      |
|COCHRAN-ARMITAGE       |  P=0.038N*                                         |  P=0.696                                           |
|FISHER EXACT           |               P=0.617      P=0.495N     P=0.061N   |                 (e)        P=0.500        (e)      |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE  10
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/130 (2%)   0/60 (0%)    0/60 (0%)    0/130 (0%) |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   4.5%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/66 (5%)    0/33 (0%)    0/31 (0%)    0/53 (0%)  |  0/35 (0%)    0/34 (0%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.077N     P=0.268N     P=0.283N     P=0.164N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.077N     P=0.268N     P=0.283N     P=0.164N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.077N     P=0.268N     P=0.283N     P=0.164N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.061N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.318N     P=0.318N     P=0.124N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/130 (1%)   0/60 (0%)    0/60 (0%)    2/130 (2%) |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.8%         0.0%         0.0%         3.8%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  1/20 (5%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/66 (0%)    0/33 (0%)    0/31 (0%)    2/53 (4%)  |  0/35 (0%)    0/34 (0%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   456 (I)      ---          ---          729 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.262      P=0.638N     P=0.638N     P=0.449    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.262      P=0.638N     P=0.638N     P=0.449    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.296      P=0.684N     P=0.713N     P=0.486    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.307                                           |    (e)                                             |
|FISHER EXACT           |               P=0.684N     P=0.684N     P=0.500    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE  11
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/130 (3%)   0/60 (0%)    0/60 (0%)    2/130 (2%) |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   5.4%         0.0%         0.0%         3.8%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  1/20 (5%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/66 (5%)    0/33 (0%)    0/31 (0%)    2/53 (4%)  |  0/35 (0%)    0/34 (0%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   456 (I)      ---          ---          729 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.381N     P=0.187N     P=0.197N     P=0.425N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.381N     P=0.187N     P=0.197N     P=0.425N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.342N     P=0.197N     P=0.198N     P=0.379N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.310N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.216N     P=0.216N     P=0.342N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/130 (0%)   0/60 (0%)    0/60 (0%)    0/130 (0%) |  0/60 (0%)    1/60 (2%)    2/60 (3%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         2.9%         5.4%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/66 (0%)    0/33 (0%)    0/31 (0%)    0/53 (0%)  |  0/35 (0%)    1/34 (3%)    1/31 (3%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          737 (T)      687          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.635      P=0.494      P=0.239        (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.644      P=0.494      P=0.285        (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.647      P=0.494      P=0.246        (e)      |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.615N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.500      P=0.248        (e)      |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE  12
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/130 (0%)   0/60 (0%)    1/60 (2%)    0/130 (0%) |  2/60 (3%)    0/60 (0%)    3/60 (5%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         3.0%         0.0%      |   5.6%         0.0%         7.9%         2.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/66 (0%)    0/33 (0%)    0/31 (0%)    0/53 (0%)  |  1/35 (3%)    0/34 (0%)    1/31 (3%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          704          ---       |   709          ---          544          568       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.669        (e)        P=0.342        (e)      |  P=0.574      P=0.243N     P=0.481      P=0.596N   |
|INCIDENTAL TUMOR       |  P=0.700N       (e)        P=0.305        (e)      |  P=0.498N     P=0.275N     P=0.577      P=0.600N   |
|LOGISTIC REGRESSION    |  P=0.677        (e)        P=0.348        (e)      |  P=0.587N     P=0.248N     P=0.512      P=0.544N   |
|COCHRAN-ARMITAGE       |  P=0.692                                           |  P=0.555N                                          |
|FISHER EXACT           |                 (e)        P=0.316        (e)      |               P=0.248N     P=0.500      P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/130 (0%)   0/60 (0%)    1/60 (2%)    0/130 (0%) |  2/60 (3%)    1/60 (2%)    5/60 (8%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         3.0%         0.0%      |   5.6%         2.9%        13.0%         2.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/66 (0%)    0/33 (0%)    0/31 (0%)    0/53 (0%)  |  1/35 (3%)    1/34 (3%)    2/31 (6%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          704          ---       |   709          737 (T)      544          568       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.669        (e)        P=0.342        (e)      |  P=0.546      P=0.507N     P=0.211      P=0.596N   |
|INCIDENTAL TUMOR       |  P=0.700N       (e)        P=0.305        (e)      |  P=0.509N     P=0.540N     P=0.295      P=0.600N   |
|LOGISTIC REGRESSION    |  P=0.677        (e)        P=0.348        (e)      |  P=0.582N     P=0.515N     P=0.230      P=0.544N   |
|COCHRAN-ARMITAGE       |  P=0.692                                           |  P=0.522N                                          |
|FISHER EXACT           |                 (e)        P=0.316        (e)      |               P=0.500N     P=0.219      P=0.500N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE  13
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/130 (3%)   4/60 (7%)    5/60 (8%)    7/130 (5%) | 22/60 (37%)   9/60 (15%)  20/60 (33%)   5/60 (8%)  |
|ADJUSTED (b)           |   6.1%        11.5%        15.4%        11.5%      |  54.3%        25.7%        48.4%        15.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  4/66 (6%)    3/33 (9%)    4/31 (13%)   4/53 (8%)  | 17/35 (49%)   8/34 (24%)  11/31 (35%)   0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      691          696          644       |   507          724          619          603       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.158      P=0.259      P=0.115      P=0.171    |  P=0.020N*    P=0.008N**   P=0.526N     P=0.004N** |
|INCIDENTAL TUMOR       |  P=0.225      P=0.260      P=0.107      P=0.224    |  P=0.006N**   P=0.006N**   P=0.362N     P=0.001N** |
|LOGISTIC REGRESSION    |  P=0.189      P=0.246      P=0.105      P=0.197    |  P=0.009N**   P=0.007N**   P=0.352N     P=0.002N** |
|COCHRAN-ARMITAGE       |  P=0.287                                           |  P=0.002N**                                        |
|FISHER EXACT           |               P=0.220      P=0.114      P=0.270    |               P=0.006N**   P=0.424N     P<0.001N** |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/130 (3%)   4/60 (7%)    5/60 (8%)    7/130 (5%) | 22/60 (37%)  10/60 (17%)  21/60 (35%)   5/60 (8%)  |
|ADJUSTED (b)           |   6.1%        11.5%        15.4%        11.5%      |  54.3%        28.6%        49.6%        15.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  4/66 (6%)    3/33 (9%)    4/31 (13%)   4/53 (8%)  | 17/35 (49%)   9/34 (26%)  11/31 (35%)   0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      691          696          644       |   507          724          619          603       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.158      P=0.259      P=0.115      P=0.171    |  P=0.020N*    P=0.014N*    P=0.550      P=0.004N** |
|INCIDENTAL TUMOR       |  P=0.225      P=0.260      P=0.107      P=0.224    |  P=0.005N**   P=0.011N*    P=0.418N     P=0.001N** |
|LOGISTIC REGRESSION    |  P=0.189      P=0.246      P=0.105      P=0.197    |  P=0.009N**   P=0.013N*    P=0.397N     P=0.002N** |
|COCHRAN-ARMITAGE       |  P=0.287                                           |  P=0.002N**                                        |
|FISHER EXACT           |               P=0.220      P=0.114      P=0.270    |               P=0.011N*    P=0.500N     P<0.001N** |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE  14
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/130 (3%)   4/60 (7%)    6/60 (10%)   7/130 (5%) | 24/60 (40%)  10/60 (17%)  23/60 (38%)   6/60 (10%) |
|ADJUSTED (b)           |   6.1%        11.5%        18.0%        11.5%      |  58.0%        28.6%        53.0%        18.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  4/66 (6%)    3/33 (9%)    4/31 (13%)   4/53 (8%)  | 18/35 (51%)   9/34 (26%)  12/31 (39%)   0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      691          696          644       |   507          724          544          568       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.155      P=0.259      P=0.053      P=0.171    |  P=0.024N*    P=0.005N**   P=0.541      P=0.005N** |
|INCIDENTAL TUMOR       |  P=0.234      P=0.260      P=0.045 *    P=0.224    |  P=0.004N**   P=0.004N**   P=0.405N     P<0.001N** |
|LOGISTIC REGRESSION    |  P=0.186      P=0.246      P=0.047 *    P=0.197    |  P=0.009N**   P=0.005N**   P=0.391N     P=0.002N** |
|COCHRAN-ARMITAGE       |  P=0.285                                           |  P=0.002N**                                        |
|FISHER EXACT           |               P=0.220      P=0.055      P=0.270    |               P=0.004N**   P=0.500N     P<0.001N** |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/130 (0%)   0/60 (0%)    2/60 (3%)    2/130 (2%) |  1/60 (2%)    1/60 (2%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         4.8%         3.3%      |   2.9%         2.9%         2.2%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/66 (0%)    0/33 (0%)    0/31 (0%)    0/53 (0%)  |  1/35 (3%)    1/34 (3%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          515          684       |   737 (T)      737 (T)      625          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.112        (e)        P=0.095      P=0.199    |  P=0.376N     P=0.755      P=0.752      P=0.559N   |
|INCIDENTAL TUMOR       |  P=0.197        (e)        P=0.178      P=0.310    |  P=0.365N     P=0.755      P=0.747      P=0.559N   |
|LOGISTIC REGRESSION    |  P=0.132        (e)        P=0.085      P=0.214    |  P=0.344N     P=0.755      P=0.758N     P=0.559N   |
|COCHRAN-ARMITAGE       |  P=0.141                                           |  P=0.312N                                          |
|FISHER EXACT           |                 (e)        P=0.099      P=0.249    |               P=0.752N     P=0.752N     P=0.500N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE  15
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 24/130 (18%)  6/60 (10%)   7/60 (12%)  14/128 (11%)|  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  32.3%        17.3%        20.7%        23.7%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 17/66 (26%)   5/33 (15%)   5/31 (16%)   9/53 (17%) |  0/35 (0%)    0/34 (0%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   591          659          611          696       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.201N     P=0.072N     P=0.163N     P=0.183N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.091N     P=0.075N     P=0.146N     P=0.074N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.134N     P=0.072N     P=0.153N     P=0.116N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.073N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.099N     P=0.167N     P=0.063N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 25/130 (19%)  6/60 (10%)   7/60 (12%)  14/128 (11%)|  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  33.7%        17.3%        20.7%        23.7%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 18/66 (27%)   5/33 (15%)   5/31 (16%)   9/53 (17%) |  0/35 (0%)    0/34 (0%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   591          659          611          696       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.162N     P=0.057N     P=0.134N     P=0.147N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.069N     P=0.059N     P=0.119N     P=0.055N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.104N     P=0.056N     P=0.125N     P=0.088N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.054N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.079N     P=0.138N     P=0.045N*  |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE  16
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 38/128 (30%) 19/60 (32%)  18/59 (31%)  38/127 (30%)| 27/60 (45%)  20/59 (34%)  24/60 (40%)  13/60 (22%) |
|ADJUSTED (b)           |  44.9%        46.2%        45.2%        49.1%      |  58.4%        47.8%        57.6%        44.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  5/20 (25%)   3/10 (30%)   0/10 (0%)    2/19 (11%) |  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 21/64 (33%)  12/33 (36%)  10/31 (32%)  17/52 (33%) | 16/35 (46%)  12/33 (36%)  14/31 (45%)  10/26 (38%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      456 (I)      396          423       |   458 (I)      432          619          693       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.220      P=0.553N     P=0.551N     P=0.258    |  P=0.107N     P=0.216N     P=0.458N     P=0.078N   |
|INCIDENTAL TUMOR       |  P=0.519      P=0.562      P=0.544N     P=0.525    |  P=0.027N*    P=0.236N     P=0.193N     P=0.055N   |
|LOGISTIC REGRESSION    |  P=0.410      P=0.524      P=0.562N     P=0.438    |  P=0.041N*    P=0.303N     P=0.237N     P=0.055N   |
|COCHRAN-ARMITAGE       |  P=0.519N                                          |  P=0.008N**                                        |
|FISHER EXACT           |               P=0.455      P=0.520      P=0.538    |               P=0.147N     P=0.356N     P=0.006N** |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/128 (0%)   0/60 (0%)    0/59 (0%)    0/127 (0%) |  0/60 (0%)    2/59 (3%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         6.1%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/19 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/64 (0%)    0/33 (0%)    0/31 (0%)    0/52 (0%)  |  0/35 (0%)    2/33 (6%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          737 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.464N     P=0.225        (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.464N     P=0.225        (e)          (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.464N     P=0.225        (e)          (e)      |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.404N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.244        (e)          (e)      |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE  17
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 38/128 (30%) 19/60 (32%)  18/59 (31%)  38/127 (30%)| 27/60 (45%)  22/59 (37%)  24/60 (40%)  13/60 (22%) |
|ADJUSTED (b)           |  44.9%        46.2%        45.2%        49.1%      |  58.4%        52.8%        57.6%        44.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  5/20 (25%)   3/10 (30%)   0/10 (0%)    2/19 (11%) |  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 21/64 (33%)  12/33 (36%)  10/31 (32%)  17/52 (33%) | 16/35 (46%)  14/33 (42%)  14/31 (45%)  10/26 (38%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      456 (I)      396          423       |   458 (I)      432          619          693       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.220      P=0.553N     P=0.551N     P=0.258    |  P=0.089N     P=0.330N     P=0.458N     P=0.078N   |
|INCIDENTAL TUMOR       |  P=0.519      P=0.562      P=0.544N     P=0.525    |  P=0.020N*    P=0.391N     P=0.193N     P=0.055N   |
|LOGISTIC REGRESSION    |  P=0.410      P=0.524      P=0.562N     P=0.438    |  P=0.031N*    P=0.466N     P=0.237N     P=0.055N   |
|COCHRAN-ARMITAGE       |  P=0.519N                                          |  P=0.006N**                                        |
|FISHER EXACT           |               P=0.455      P=0.520      P=0.538    |               P=0.252N     P=0.356N     P=0.006N** |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Adenoma                                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/130 (2%)   3/60 (5%)    0/60 (0%)    0/130 (0%) |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   2.9%         8.7%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/66 (2%)    2/33 (6%)    0/31 (0%)    0/53 (0%)  |  0/35 (0%)    0/34 (0%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   717          709          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.116N     P=0.210      P=0.424N     P=0.290N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.083N     P=0.211      P=0.443N     P=0.227N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.104N     P=0.200      P=0.422N     P=0.274N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.083N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.182      P=0.467N     P=0.249N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE  18
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Adenoma, Basosquamous Tumor Benign, or Trichoepithelioma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/130 (2%)   3/60 (5%)    1/60 (2%)    0/130 (0%) |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   4.4%         8.7%         2.6%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/66 (3%)    2/33 (6%)    0/31 (0%)    0/53 (0%)  |  0/35 (0%)    0/34 (0%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   717          709          639          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.089N     P=0.328      P=0.601N     P=0.165N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.057N     P=0.330      P=0.573N     P=0.129N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.076N     P=0.316      P=0.598N     P=0.154N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.060N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.283      P=0.624N     P=0.124N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign,                                                       |
|     malignant or NOS), or Trichoepithelioma                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/130 (2%)   4/60 (7%)    1/60 (2%)    0/130 (0%) |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   4.4%        11.2%         2.6%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/66 (3%)    2/33 (6%)    0/31 (0%)    0/53 (0%)  |  0/35 (0%)    0/34 (0%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   717          691          639          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.079N     P=0.169      P=0.601N     P=0.165N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.044N*    P=0.168      P=0.573N     P=0.129N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.065N     P=0.158      P=0.598N     P=0.154N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.051N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.143      P=0.624N     P=0.124N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE  19
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|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)            |  9/130 (7%)   9/60 (15%)   6/60 (10%)   7/130 (5%) |  3/60 (5%)    0/60 (0%)    1/60 (2%)    1/60 (2%)  |
|ADJUSTED (b)           |  13.1%        24.9%        16.9%        12.0%      |   8.6%         0.0%         2.9%         2.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |
|TERMINAL (d)           |  7/66 (11%)   6/33 (18%)   3/31 (10%)   4/53 (8%)  |  3/35 (9%)    0/34 (0%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   709          691          639          687       |   737 (T)      ---          733          458 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.397N     P=0.093      P=0.337      P=0.572N   |  P=0.363N     P=0.126N     P=0.342N     P=0.388N   |
|INCIDENTAL TUMOR       |  P=0.231N     P=0.089      P=0.320      P=0.438N   |  P=0.351N     P=0.126N     P=0.288N     P=0.388N   |
|LOGISTIC REGRESSION    |  P=0.330N     P=0.039 *    P=0.326      P=0.524N   |  P=0.325N     P=0.126N     P=0.311N     P=0.344N   |
|COCHRAN-ARMITAGE       |  P=0.215N                                          |  P=0.297N                                          |
|FISHER EXACT           |               P=0.070      P=0.321      P=0.399N   |               P=0.122N     P=0.309N     P=0.309N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/130 (4%)   5/60 (8%)    1/60 (2%)    9/130 (7%) |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   6.9%        13.2%         2.5%        16.1%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/66 (5%)    2/33 (6%)    0/31 (0%)    7/53 (13%) |  0/35 (0%)    0/34 (0%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   620          654          611          696       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.131      P=0.212      P=0.361N     P=0.110    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.234      P=0.184      P=0.309N     P=0.165    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.167      P=0.192      P=0.353N     P=0.135    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.242                                           |    (e)                                             |
|FISHER EXACT           |               P=0.173      P=0.383N     P=0.205    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE  20
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/130 (4%)   5/60 (8%)    1/60 (2%)   11/130 (8%) |  0/60 (0%)    1/60 (2%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   6.9%        13.2%         2.5%        18.6%      |   0.0%         2.9%         0.0%         3.2%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/66 (5%)    2/33 (6%)    0/31 (0%)    7/53 (13%) |  0/35 (0%)    1/34 (3%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   620          654          611          645       |   ---          737 (T)      ---          696       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.048 *    P=0.212      P=0.361N     P=0.046 *  |  P=0.354      P=0.494        (e)        P=0.465    |
|INCIDENTAL TUMOR       |  P=0.114      P=0.184      P=0.309N     P=0.087    |  P=0.358      P=0.494        (e)        P=0.443    |
|LOGISTIC REGRESSION    |  P=0.065      P=0.192      P=0.353N     P=0.058    |  P=0.359      P=0.494        (e)        P=0.462    |
|COCHRAN-ARMITAGE       |  P=0.110                                           |  P=0.405                                           |
|FISHER EXACT           |               P=0.173      P=0.383N     P=0.098    |               P=0.500        (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/130 (0%)   0/60 (0%)    0/60 (0%)    2/130 (2%) |  0/60 (0%)    1/60 (2%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         2.9%      |   0.0%         2.9%         0.0%         3.2%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/66 (0%)    0/33 (0%)    0/31 (0%)    0/53 (0%)  |  0/35 (0%)    1/34 (3%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          645       |   ---          737 (T)      ---          696       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.068        (e)          (e)        P=0.212    |  P=0.354      P=0.494        (e)        P=0.465    |
|INCIDENTAL TUMOR       |  P=0.123        (e)          (e)        P=0.310    |  P=0.358      P=0.494        (e)        P=0.443    |
|LOGISTIC REGRESSION    |  P=0.073        (e)          (e)        P=0.222    |  P=0.359      P=0.494        (e)        P=0.462    |
|COCHRAN-ARMITAGE       |  P=0.083                                           |  P=0.405                                           |
|FISHER EXACT           |                 (e)          (e)        P=0.249    |               P=0.500        (e)        P=0.500    |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE  21
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/130 (4%)   3/60 (5%)    3/60 (5%)    5/130 (4%) |  1/60 (2%)    0/60 (0%)    1/60 (2%)    1/60 (2%)  |
|ADJUSTED (b)           |   7.4%         8.8%         8.0%         8.8%      |   2.9%         0.0%         2.9%         2.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |
|TERMINAL (d)           |  4/66 (6%)    2/33 (6%)    0/31 (0%)    3/53 (6%)  |  1/35 (3%)    0/34 (0%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   709          726          639          687       |   737 (T)      ---          733          458 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.443      P=0.550      P=0.513      P=0.491    |  P=0.493      P=0.506N     P=0.744      P=0.728    |
|INCIDENTAL TUMOR       |  P=0.522N     P=0.551      P=0.504      P=0.592    |  P=0.507      P=0.506N     P=0.715N     P=0.728    |
|LOGISTIC REGRESSION    |  P=0.492      P=0.537      P=0.513      P=0.530    |  P=0.538      P=0.506N     P=0.763      P=0.750N   |
|COCHRAN-ARMITAGE       |  P=0.532N                                          |  P=0.539                                           |
|FISHER EXACT           |               P=0.490      P=0.490      P=0.625N   |               P=0.500N     P=0.752N     P=0.752N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Neurofibrosarcoma, Neurofibroma, or Schwannoma (benign, malignant or NOS)                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/130 (1%)   0/60 (0%)    1/60 (2%)    3/130 (2%) |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   1.1%         0.0%         3.2%         3.9%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/66 (0%)    0/33 (0%)    1/31 (3%)    1/53 (2%)  |  0/35 (0%)    0/34 (0%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   542          ---          729 (T)      423       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.126      P=0.647N     P=0.583      P=0.275    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.126      P=0.662N     P=0.647      P=0.280    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.160      P=0.667N     P=0.583      P=0.317    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.157                                           |    (e)                                             |
|FISHER EXACT           |               P=0.684N     P=0.533      P=0.311    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE  22
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Schwannoma Malignant                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/130 (1%)   0/60 (0%)    1/60 (2%)    2/130 (2%) |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   1.1%         0.0%         3.2%         3.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/66 (0%)    0/33 (0%)    1/31 (3%)    1/53 (2%)  |  0/35 (0%)    0/34 (0%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   542          ---          729 (T)      542       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.268      P=0.647N     P=0.583      P=0.462    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.275      P=0.662N     P=0.647      P=0.474    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.303      P=0.667N     P=0.583      P=0.497    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.314                                           |    (e)                                             |
|FISHER EXACT           |               P=0.684N     P=0.533      P=0.500    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/130 (2%)   2/60 (3%)    3/60 (5%)    2/130 (2%) |  3/60 (5%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   4.5%         6.1%         9.7%         3.4%      |   8.6%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/66 (5%)    2/33 (6%)    3/31 (10%)   1/53 (2%)  |  3/35 (9%)    0/34 (0%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      729 (T)      696       |   737 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.513N     P=0.564      P=0.300      P=0.593N   |  P=0.063N     P=0.126N     P=0.143N     P=0.178N   |
|INCIDENTAL TUMOR       |  P=0.486N     P=0.564      P=0.300      P=0.551N   |  P=0.063N     P=0.126N     P=0.143N     P=0.178N   |
|LOGISTIC REGRESSION    |  P=0.494N     P=0.564      P=0.300      P=0.572N   |  P=0.063N     P=0.126N     P=0.143N     P=0.178N   |
|COCHRAN-ARMITAGE       |  P=0.394N                                          |  P=0.048N*                                         |
|FISHER EXACT           |               P=0.505      P=0.283      P=0.500N   |               P=0.122N     P=0.122N     P=0.122N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE  23
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/130 (5%)   5/60 (8%)    6/60 (10%)   7/130 (5%) |  3/60 (5%)    0/60 (0%)    1/60 (2%)    1/60 (2%)  |
|ADJUSTED (b)           |  10.4%        14.7%        16.9%        12.0%      |   8.6%         0.0%         2.9%         2.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |
|TERMINAL (d)           |  6/66 (9%)    4/33 (12%)   3/31 (10%)   4/53 (8%)  |  3/35 (9%)    0/34 (0%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   709          726          639          687       |   737 (T)      ---          733          458 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.412      P=0.374      P=0.202      P=0.448    |  P=0.363N     P=0.126N     P=0.342N     P=0.388N   |
|INCIDENTAL TUMOR       |  P=0.542N     P=0.375      P=0.193      P=0.560    |  P=0.351N     P=0.126N     P=0.288N     P=0.388N   |
|LOGISTIC REGRESSION    |  P=0.468      P=0.356      P=0.191      P=0.492    |  P=0.325N     P=0.126N     P=0.311N     P=0.344N   |
|COCHRAN-ARMITAGE       |  P=0.497N                                          |  P=0.297N                                          |
|FISHER EXACT           |               P=0.315      P=0.192      P=0.608N   |               P=0.122N     P=0.309N     P=0.309N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, or Keratoacanthoma                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/130 (5%)   5/60 (8%)    6/60 (10%)   7/130 (5%) |  3/60 (5%)    0/60 (0%)    1/60 (2%)    1/60 (2%)  |
|ADJUSTED (b)           |  10.4%        14.7%        16.9%        12.0%      |   8.6%         0.0%         2.9%         2.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |
|TERMINAL (d)           |  6/66 (9%)    4/33 (12%)   3/31 (10%)   4/53 (8%)  |  3/35 (9%)    0/34 (0%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   709          726          639          687       |   737 (T)      ---          733          458 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.412      P=0.374      P=0.202      P=0.448    |  P=0.363N     P=0.126N     P=0.342N     P=0.388N   |
|INCIDENTAL TUMOR       |  P=0.542N     P=0.375      P=0.193      P=0.560    |  P=0.351N     P=0.126N     P=0.288N     P=0.388N   |
|LOGISTIC REGRESSION    |  P=0.468      P=0.356      P=0.191      P=0.492    |  P=0.325N     P=0.126N     P=0.311N     P=0.344N   |
|COCHRAN-ARMITAGE       |  P=0.497N                                          |  P=0.297N                                          |
|FISHER EXACT           |               P=0.315      P=0.192      P=0.608N   |               P=0.122N     P=0.309N     P=0.309N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE  24
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |107/130 (82%) 48/59 (81%)  56/60 (93%) 101/130 (78%)|                                                    |
|ADJUSTED (b)           |  98.1%        94.0%       100.0%        99.0%      |                                                    |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)| 17/20 (85%)   7/10 (70%)  10/10 (100%) 19/20 (95%) |                                                    |
|TERMINAL (d)           | 64/66 (97%)  30/33 (91%)  31/31 (100%) 52/53 (98%) |                                                    |
|FIRST INCIDENCE (DAYS) |   456 (I)      456 (I)      414          423       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.051      P=0.182N     P=0.157      P=0.112    |                                                    |
|INCIDENTAL TUMOR       |  P=0.439      P=0.177N     P=0.179      P=0.575N   |                                                    |
|LOGISTIC REGRESSION    |  P=0.467      P=0.267N     P=0.101      P=0.536N   |                                                    |
|COCHRAN-ARMITAGE       |  P=0.203N                                          |                                                    |
|FISHER EXACT           |               P=0.512N     P=0.031 *    P=0.219N   |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  9/130 (7%)   9/60 (15%)   5/60 (8%)   10/130 (8%) |  3/60 (5%)    5/60 (8%)    2/60 (3%)    5/60 (8%)  |
|ADJUSTED (b)           |  13.2%        25.4%        14.6%        16.8%      |   7.8%        12.9%         5.6%        17.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  8/66 (12%)   7/33 (21%)   3/31 (10%)   6/53 (11%) |  1/35 (3%)    2/34 (6%)    1/31 (3%)    4/26 (15%) |
|FIRST INCIDENCE (DAYS) |   646          680          680          648       |   684          544          695          495       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.403      P=0.089      P=0.491      P=0.324    |  P=0.240      P=0.345      P=0.506N     P=0.230    |
|INCIDENTAL TUMOR       |  P=0.543      P=0.090      P=0.460      P=0.428    |  P=0.402      P=0.361      P=0.371N     P=0.323    |
|LOGISTIC REGRESSION    |  P=0.472      P=0.078      P=0.481      P=0.377    |  P=0.293      P=0.218      P=0.482N     P=0.257    |
|COCHRAN-ARMITAGE       |  P=0.466N                                          |  P=0.376                                           |
|FISHER EXACT           |               P=0.070      P=0.468      P=0.500    |               P=0.359      P=0.500N     P=0.359    |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE  25
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/130 (2%)   2/60 (3%)    2/60 (3%)    3/130 (2%) |  0/60 (0%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   3.0%         6.1%         6.5%         5.1%      |   0.0%         2.9%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/66 (3%)    2/33 (6%)    2/31 (6%)    2/53 (4%)  |  0/35 (0%)    1/34 (3%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      729 (T)      653       |   ---          737 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.353      P=0.429      P=0.405      P=0.412    |  P=0.614N     P=0.494        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.379      P=0.429      P=0.405      P=0.449    |  P=0.614N     P=0.494        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.384      P=0.429      P=0.405      P=0.441    |  P=0.614N     P=0.494        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.467                                           |  P=0.568N                                          |
|FISHER EXACT           |               P=0.376      P=0.376      P=0.500    |               P=0.500        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 11/130 (8%)  11/60 (18%)   7/60 (12%)  13/130 (10%)|  3/60 (5%)    6/60 (10%)   2/60 (3%)    5/60 (8%)  |
|ADJUSTED (b)           |  16.2%        31.2%        20.7%        21.4%      |   7.8%        15.6%         5.6%        17.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 10/66 (15%)   9/33 (27%)   5/31 (16%)   8/53 (15%) |  1/35 (3%)    3/34 (9%)    1/31 (3%)    4/26 (15%) |
|FIRST INCIDENCE (DAYS) |   646          680          680          648       |   684          544          695          495       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.306      P=0.058      P=0.341      P=0.231    |  P=0.280      P=0.236      P=0.506N     P=0.230    |
|INCIDENTAL TUMOR       |  P=0.438      P=0.058      P=0.313      P=0.327    |  P=0.447      P=0.240      P=0.371N     P=0.323    |
|LOGISTIC REGRESSION    |  P=0.379      P=0.049 *    P=0.325      P=0.282    |  P=0.338      P=0.137      P=0.482N     P=0.257    |
|COCHRAN-ARMITAGE       |  P=0.524N                                          |  P=0.430                                           |
|FISHER EXACT           |               P=0.045 *    P=0.324      P=0.415    |               P=0.245      P=0.500N     P=0.359    |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE  26
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/130 (3%)   0/60 (0%)    3/60 (5%)    1/130 (1%) |  0/60 (0%)    0/60 (0%)    2/60 (3%)    0/60 (0%)  |
|ADJUSTED (b)           |   6.1%         0.0%         8.5%         1.9%      |   0.0%         0.0%         5.2%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  4/66 (6%)    0/33 (0%)    2/31 (6%)    1/53 (2%)  |  0/35 (0%)    0/34 (0%)    1/31 (3%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          502          729 (T)   |   ---          ---          544          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.290N     P=0.185N     P=0.416      P=0.253N   |  P=0.543        (e)        P=0.233        (e)      |
|INCIDENTAL TUMOR       |  P=0.283N     P=0.185N     P=0.453      P=0.253N   |  P=0.626N       (e)        P=0.226        (e)      |
|LOGISTIC REGRESSION    |  P=0.254N     P=0.185N     P=0.413      P=0.253N   |  P=0.598        (e)        P=0.230        (e)      |
|COCHRAN-ARMITAGE       |  P=0.215N                                          |  P=0.597                                           |
|FISHER EXACT           |               P=0.216N     P=0.388      P=0.185N   |                 (e)        P=0.248        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/130 (1%)   0/60 (0%)    1/60 (2%)    2/130 (2%) |  0/60 (0%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   1.5%         0.0%         2.9%         3.8%      |   0.0%         0.0%         0.0%         3.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/66 (2%)    0/33 (0%)    0/31 (0%)    2/53 (4%)  |  0/35 (0%)    0/34 (0%)    0/31 (0%)    1/26 (4%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          702          729 (T)   |   ---          ---          ---          737 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.245      P=0.638N     P=0.581      P=0.424    |  P=0.161        (e)          (e)        P=0.441    |
|INCIDENTAL TUMOR       |  P=0.285      P=0.638N     P=0.557      P=0.424    |  P=0.161        (e)          (e)        P=0.441    |
|LOGISTIC REGRESSION    |  P=0.261      P=0.638N     P=0.580      P=0.424    |  P=0.161        (e)          (e)        P=0.441    |
|COCHRAN-ARMITAGE       |  P=0.314                                           |  P=0.199                                           |
|FISHER EXACT           |               P=0.684N     P=0.533      P=0.500    |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE  27
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/130 (4%)   0/60 (0%)    4/60 (7%)    3/130 (2%) |  0/60 (0%)    0/60 (0%)    2/60 (3%)    1/60 (2%)  |
|ADJUSTED (b)           |   7.6%         0.0%        11.2%         5.7%      |   0.0%         0.0%         5.2%         3.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  5/66 (8%)    0/33 (0%)    2/31 (6%)    3/53 (6%)  |  0/35 (0%)    0/34 (0%)    1/31 (3%)    1/26 (4%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          502          729 (T)   |   ---          ---          544          737 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.552N     P=0.129N     P=0.324      P=0.482N   |  P=0.185        (e)        P=0.233      P=0.441    |
|INCIDENTAL TUMOR       |  P=0.520N     P=0.129N     P=0.343      P=0.482N   |  P=0.334        (e)        P=0.226      P=0.441    |
|LOGISTIC REGRESSION    |  P=0.499N     P=0.129N     P=0.320      P=0.482N   |  P=0.224        (e)        P=0.230      P=0.441    |
|COCHRAN-ARMITAGE       |  P=0.424N                                          |  P=0.247                                           |
|FISHER EXACT           |               P=0.146N     P=0.304      P=0.361N   |                 (e)        P=0.248      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Urinary Bladder                                                                                                                  |
|     Papilloma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/130 (0%)   0/59 (0%)    2/60 (3%)    6/127 (5%) |  0/59 (0%)    0/60 (0%)    2/60 (3%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         6.5%        10.3%      |   0.0%         0.0%         5.6%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/66 (0%)    0/33 (0%)    2/31 (6%)    3/53 (6%)  |  0/34 (0%)    0/34 (0%)    1/31 (3%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          729 (T)      653       |   ---          ---          695          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.002 **     (e)        P=0.095      P=0.010 *  |  P=0.554        (e)        P=0.238        (e)      |
|INCIDENTAL TUMOR       |  P=0.004 **     (e)        P=0.095      P=0.021 *  |  P=0.564        (e)        P=0.289        (e)      |
|LOGISTIC REGRESSION    |  P=0.002 **     (e)        P=0.095      P=0.012 *  |  P=0.562        (e)        P=0.252        (e)      |
|COCHRAN-ARMITAGE       |  P=0.004 **                                        |  P=0.599                                           |
|FISHER EXACT           |                 (e)        P=0.099      P=0.014 *  |                 (e)        P=0.252        (e)      |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE  28
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  6/60 (10%)   8/60 (13%)   8/60 (13%)   5/60 (8%)  |
|ADJUSTED (b)           |                                                    |  16.2%        20.8%        23.9%        16.4%      |
|INTERIM SACRIFICE 1 (c)|                                                    |                                                    |
|INTERIM SACRIFICE 2 (c)|                                                    |  0/10 (0%)    1/10 (10%)   1/10 (10%)   1/10 (10%) |
|TERMINAL (d)           |                                                    |  5/35 (14%)   5/34 (15%)   7/31 (23%)   3/26 (12%) |
|FIRST INCIDENCE (DAYS) |                                                    |   635          458 (I)      458 (I)      458 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.529      P=0.370      P=0.310      P=0.568    |
|INCIDENTAL TUMOR       |                                                    |  P=0.547      P=0.308      P=0.309      P=0.567    |
|LOGISTIC REGRESSION    |                                                    |  P=0.506N     P=0.349      P=0.418      P=0.616    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.378N                                          |
|FISHER EXACT           |                                                    |               P=0.389      P=0.389      P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  6/60 (10%)   8/60 (13%)   8/60 (13%)   6/60 (10%) |
|ADJUSTED (b)           |                                                    |  16.2%        20.8%        23.9%        17.9%      |
|INTERIM SACRIFICE 1 (c)|                                                    |                                                    |
|INTERIM SACRIFICE 2 (c)|                                                    |  0/10 (0%)    1/10 (10%)   1/10 (10%)   1/10 (10%) |
|TERMINAL (d)           |                                                    |  5/35 (14%)   5/34 (15%)   7/31 (23%)   3/26 (12%) |
|FIRST INCIDENCE (DAYS) |                                                    |   635          458 (I)      458 (I)      375       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.403      P=0.370      P=0.310      P=0.442    |
|INCIDENTAL TUMOR       |                                                    |  P=0.475      P=0.308      P=0.309      P=0.546    |
|LOGISTIC REGRESSION    |                                                    |  P=0.502      P=0.349      P=0.418      P=0.529    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.500N                                          |
|FISHER EXACT           |                                                    |               P=0.389      P=0.389      P=0.619N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE  29
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/130 (2%)   0/60 (0%)    0/60 (0%)    0/130 (0%) |  0/60 (0%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   3.4%         0.0%         0.0%         0.0%      |   0.0%         2.7%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/66 (0%)    0/33 (0%)    0/31 (0%)    0/53 (0%)  |  0/35 (0%)    0/34 (0%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   578          ---          ---          ---       |   ---          703          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.069N     P=0.273N     P=0.288N     P=0.142N   |  P=0.601N     P=0.500        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.030N*    P=0.395N     P=0.166N     P=0.069N   |  P=0.589N     P=0.443        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.060N     P=0.291N     P=0.293N     P=0.122N   |  P=0.596N     P=0.491        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.061N                                          |  P=0.568N                                          |
|FISHER EXACT           |               P=0.318N     P=0.318N     P=0.124N   |               P=0.500        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 23/130 (18%) 18/60 (30%)  12/60 (20%)  13/130 (10%)| 15/60 (25%)   9/60 (15%)   9/60 (15%)   3/60 (5%)  |
|ADJUSTED (b)           |  29.4%        44.1%        29.2%        20.4%      |  32.9%        23.4%        20.6%         8.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  1/10 (10%)   0/10 (0%)    1/10 (10%)   0/10 (0%)  |
|TERMINAL (d)           | 13/66 (20%)  11/33 (33%)   4/31 (13%)   8/53 (15%) |  7/35 (20%)   6/34 (18%)   2/31 (6%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   477          414          435          428       |   260          396          458 (I)      495       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.081N     P=0.080      P=0.441      P=0.158N   |  P=0.014N*    P=0.162N     P=0.160N     P=0.016N*  |
|INCIDENTAL TUMOR       |  P=0.013N*    P=0.047 *    P=0.537      P=0.059N   |  P=0.001N**   P=0.186N     P=0.109N     P=0.003N** |
|LOGISTIC REGRESSION    |  P=0.020N*    P=0.044 *    P=0.480      P=0.086N   |  P=0.003N**   P=0.137N     P=0.136N     P=0.003N** |
|COCHRAN-ARMITAGE       |  P=0.017N*                                         |  P=0.002N**                                        |
|FISHER EXACT           |               P=0.044 *    P=0.423      P=0.053N   |               P=0.127N     P=0.127N     P=0.002N** |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE  30
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma: Benign, Malignant, NOS                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/130 (2%)   1/60 (2%)    2/60 (3%)    5/130 (4%) |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   3.0%         3.0%         5.9%         8.5%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/66 (3%)    1/33 (3%)    1/31 (3%)    3/53 (6%)  |  0/35 (0%)    0/34 (0%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      695          585       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.084      P=0.732      P=0.407      P=0.150    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.124      P=0.732      P=0.385      P=0.192    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.103      P=0.732      P=0.396      P=0.175    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.146                                           |    (e)                                             |
|FISHER EXACT           |               P=0.682      P=0.376      P=0.223    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Osteosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/130 (0%)   0/60 (0%)    1/60 (2%)    2/130 (2%) |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         1.8%         1.8%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/66 (0%)    0/33 (0%)    0/31 (0%)    0/53 (0%)  |  0/35 (0%)    0/34 (0%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          437          361       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.106        (e)        P=0.351      P=0.227    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.163        (e)        P=0.450      P=0.366    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.158        (e)        P=0.277      P=0.271    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.118                                           |    (e)                                             |
|FISHER EXACT           |                 (e)        P=0.316      P=0.249    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE  31
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Osteosarcoma or Osteoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/130 (0%)   0/60 (0%)    1/60 (2%)    2/130 (2%) |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         1.8%         1.8%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/20 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/66 (0%)    0/33 (0%)    0/31 (0%)    0/53 (0%)  |  0/35 (0%)    0/34 (0%)    0/31 (0%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          437          361       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.106        (e)        P=0.351      P=0.227    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.163        (e)        P=0.450      P=0.366    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.158        (e)        P=0.277      P=0.271    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.118                                           |    (e)                                             |
|FISHER EXACT           |                 (e)        P=0.316      P=0.249    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |117/130 (90%) 54/60 (90%)  58/60 (97%) 109/130 (84%)| 42/60 (70%)  32/60 (53%)  45/60 (75%)  27/60 (45%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  87.4%        70.6%        93.7%        74.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)| 19/20 (95%)  10/10 (100%) 10/10 (100%) 20/20 (100%)|  1/10 (10%)   2/10 (20%)   1/10 (10%)   2/10 (20%) |
|TERMINAL (d)           | 66/66 (100%) 33/33 (100%) 31/31 (100%) 53/53 (100%)| 29/35 (83%)  21/34 (62%)  28/31 (90%)  17/26 (65%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      456 (I)      396          423       |   458 (I)      432          458 (I)      458 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.084      P=0.242N     P=0.343      P=0.152    |  P=0.379N     P=0.103N     P=0.219      P=0.201N   |
|INCIDENTAL TUMOR       |  P=0.223N     P=0.076N     P=0.654N     P=0.167N   |  P=0.088N     P=0.059N     P=0.500      P=0.060N   |
|LOGISTIC REGRESSION    |  P=0.411N     P=0.561N     P=0.757      P=0.322N   |  P=0.120N     P=0.100N     P=0.502      P=0.058N   |
|COCHRAN-ARMITAGE       |  P=0.065N                                          |  P=0.014N*                                         |
|FISHER EXACT           |               P=0.593N     P=0.093      P=0.099N   |               P=0.045N*    P=0.342      P=0.005N** |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE  32
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

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

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      84 MG/KG     168          337.5     |   0 MG/KG      84 MG/KG     168          337.5     |
|                       |   FEED RTD                  MG/KG        STOP      |                             MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 41/130 (32%) 24/60 (40%)  24/60 (40%)  30/130 (23%)| 22/60 (37%)  21/60 (35%)  17/60 (28%)  12/60 (20%) |
|ADJUSTED (b)           |  46.1%        54.8%        51.3%        40.6%      |  46.8%        47.6%        39.2%        32.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)|  2/20 (10%)   0/10 (0%)    0/10 (0%)    0/20 (0%)  |  1/10 (10%)   0/10 (0%)    1/10 (10%)   0/10 (0%)  |
|TERMINAL (d)           | 20/66 (30%)  14/33 (42%)   9/31 (29%)  15/53 (28%) | 11/35 (31%)  12/34 (35%)   7/31 (23%)   4/26 (15%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      414          414          361       |   260          218          458 (I)      358       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.249N     P=0.278      P=0.212      P=0.301N   |  P=0.131N     P=0.546N     P=0.286N     P=0.187N   |
|INCIDENTAL TUMOR       |  P=0.023N*    P=0.169      P=0.293      P=0.065N   |  P=0.010N**   P=0.578N     P=0.154N     P=0.052N   |
|LOGISTIC REGRESSION    |  P=0.065N     P=0.151      P=0.212      P=0.130N   |  P=0.028N*    P=0.529N     P=0.202N     P=0.054N   |
|COCHRAN-ARMITAGE       |  P=0.043N*                                         |  P=0.018N*                                         |
|FISHER EXACT           |               P=0.164      P=0.164      P=0.082N   |               P=0.500N     P=0.218N     P=0.034N*  |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |117/130 (90%) 56/60 (93%)  59/60 (98%) 114/130 (88%)| 46/60 (77%)  43/60 (72%)  49/60 (82%)  33/60 (55%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  90.1%        84.0%        94.2%        79.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/0          0/0          0/10 (0%)  |                                                    |
|INTERIM SACRIFICE 2 (c)| 19/20 (95%)  10/10 (100%) 10/10 (100%) 20/20 (100%)|  2/10 (20%)   2/10 (20%)   2/10 (20%)   2/10 (20%) |
|TERMINAL (d)           | 66/66 (100%) 33/33 (100%) 31/31 (100%) 53/53 (100%)| 30/35 (86%)  26/34 (76%)  28/31 (90%)  18/26 (69%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      414          396          361       |   260          218          458 (I)      358       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.029 *    P=0.398N     P=0.273      P=0.056    |  P=0.435N     P=0.470N     P=0.237      P=0.378N   |
|INCIDENTAL TUMOR       |  P=0.134      P=0.585N     P=0.638      P=0.366    |  P=0.014N*    P=0.289N     P=0.437      P=0.069N   |
|LOGISTIC REGRESSION    |  P=0.119      P=0.697N     P=0.472      P=0.309    |  P=0.057N     P=0.448N     P=0.484      P=0.082N   |
|COCHRAN-ARMITAGE       |  P=0.249N                                          |  P=0.007N**                                        |
|FISHER EXACT           |               P=0.326      P=0.032 *    P=0.347N   |               P=0.339N     P=0.327      P=0.010N*  |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 07                                                 PAGE  33
                         STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE

                                                 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):   183  456
          Female interim sacrifices(days): 458
 (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).