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TDMS Study 05099-08 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                             SALICYLAZOSULFAPYRIDINE                                DATE: 04/03/96       
EXPERIMENT: 05099 TEST: 08                                                                                     TIME: 20:35:39       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85233                              ROUTE: GAVAGE                                                  NTP C#: 61552B       
PATHOLOGIST: R.B. THOMPSON                                                                                     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: 08                                                                                     TIME: 20:35:39       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85233                              ROUTE: GAVAGE                                                  NTP C#: 61552B       
PATHOLOGIST: R.B. THOMPSON                                                                                     CAS: 599-79-1        




                                                    MICE(B6C3F1)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
                                                                    

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

                                                    Adrenal Cortex
                                                    Adrenal Medulla
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                             SALICYLAZOSULFAPYRIDINE                                DATE: 04/03/96       
EXPERIMENT: 05099 TEST: 08                                                                                     TIME: 20:35:39       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85233                              ROUTE: GAVAGE                                                  NTP C#: 61552B       
PATHOLOGIST: R.B. THOMPSON                                                                                     CAS: 599-79-1        




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

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

                                                           MALE MICE
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------

              Liver                         Hepatocellular Adenoma
                                            Hepatocellular Carcinoma
                                            Hepatocellular Carcinoma or Hepatoblastoma
                                            Hepatocellular Carcinoma or Hepatocellular Adenoma
                                            Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
              Lung                          Alveolar/Bronchiolar Adenoma
              Stomach, Forestomach          Squamous Cell Papilloma
              All Organs                    Benign Tumors
                                            Malignant Tumors
                                            Malignant and Benign Tumors

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

                                                           FEMALE MICE
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------

              Liver                         Hepatocellular Adenoma
                                            Hepatocellular Carcinoma
                                            Hepatocellular Carcinoma or Hepatoblastoma
                                            Hepatocellular Carcinoma or Hepatocellular Adenoma
                                            Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
              Skin                          Squamous Cell Papilloma
              Stomach, Forestomach          Squamous Cell Papilloma
              All Organs                    Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated
                                             Cell Type
                                            Benign Tumors

              ====================================================================================================
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 08                                                 PAGE   1
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE

                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      675          1350         2700      |   0 MG/KG      675          1350         2700      |
|                       |   FEED RTD     MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/120 (1%)   0/59 (0%)    2/59 (3%)    0/60 (0%)  |  0/60 (0%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   1.2%         0.0%         5.0%         0.0%      |   0.0%         2.4%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/85 (1%)    0/40 (0%)    2/40 (5%)    0/46 (0%)  |  0/41 (0%)    1/41 (2%)    0/37 (0%)    0/38 (0%)  |
|FIRST INCIDENCE (DAYS) |   728 (T)      ---          728 (T)      ---       |   ---          735 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.601N     P=0.650N     P=0.250      P=0.622N   |  P=0.580N     P=0.500        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.601N     P=0.650N     P=0.250      P=0.622N   |  P=0.580N     P=0.500        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.601N     P=0.650N     P=0.250      P=0.622N   |  P=0.580N     P=0.500        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.622N                                          |  P=0.567N                                          |
|FISHER EXACT           |               P=0.670N     P=0.253      P=0.667N   |               P=0.500        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/120 (0%)   0/59 (0%)    0/59 (0%)    0/60 (0%)  |  1/60 (2%)    2/60 (3%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   2.4%         4.7%         0.0%         2.6%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/85 (0%)    0/40 (0%)    0/40 (0%)    0/46 (0%)  |  1/41 (2%)    1/41 (2%)    0/37 (0%)    1/38 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   735 (T)      620          ---          735 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.522N     P=0.503      P=0.520N     P=0.745    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.427N     P=0.578      P=0.520N     P=0.745    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.510N     P=0.505      P=0.520N     P=0.745    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.500N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.500      P=0.500N     P=0.752N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 08                                                 PAGE   2
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE

                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      675          1350         2700      |   0 MG/KG      675          1350         2700      |
|                       |   FEED RTD     MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/120 (2%)   4/60 (7%)    1/60 (2%)    2/60 (3%)  |  2/60 (3%)    0/60 (0%)    1/60 (2%)    2/60 (3%)  |
|ADJUSTED (b)           |   2.4%         9.8%         2.4%         4.3%      |   4.9%         0.0%         2.7%         5.3%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/85 (2%)    4/41 (10%)   1/41 (2%)    2/46 (4%)  |  2/41 (5%)    0/41 (0%)    1/37 (3%)    2/38 (5%)  |
|FIRST INCIDENCE (DAYS) |   728 (T)      728 (T)      728 (T)      728 (T)   |   735 (T)      ---          735 (T)      735 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.498      P=0.084      P=0.723      P=0.460    |  P=0.439      P=0.238N     P=0.536N     P=0.667    |
|INCIDENTAL TUMOR       |  P=0.498      P=0.084      P=0.723      P=0.460    |  P=0.439      P=0.238N     P=0.536N     P=0.667    |
|LOGISTIC REGRESSION    |  P=0.498      P=0.084      P=0.723      P=0.460    |  P=0.439      P=0.238N     P=0.536N     P=0.667    |
|COCHRAN-ARMITAGE       |  P=0.464                                           |  P=0.469                                           |
|FISHER EXACT           |               P=0.096      P=0.742N     P=0.407    |               P=0.248N     P=0.500N     P=0.691N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/120 (3%)   0/60 (0%)    0/60 (0%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   3.5%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/85 (4%)    0/41 (0%)    0/41 (0%)    0/46 (0%)  |  0/41 (0%)    0/41 (0%)    0/37 (0%)    0/38 (0%)  |
|FIRST INCIDENCE (DAYS) |   728 (T)      ---          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.104N     P=0.277N     P=0.277N     P=0.250N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.104N     P=0.277N     P=0.277N     P=0.250N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.104N     P=0.277N     P=0.277N     P=0.250N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.107N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.294N     P=0.294N     P=0.294N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 08                                                 PAGE   3
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE

                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      675          1350         2700      |   0 MG/KG      675          1350         2700      |
|                       |   FEED RTD     MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/120 (4%)   4/60 (7%)    1/60 (2%)    2/60 (3%)  |  2/60 (3%)    0/60 (0%)    1/60 (2%)    2/60 (3%)  |
|ADJUSTED (b)           |   5.9%         9.8%         2.4%         4.3%      |   4.9%         0.0%         2.7%         5.3%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  5/85 (6%)    4/41 (10%)   1/41 (2%)    2/46 (4%)  |  2/41 (5%)    0/41 (0%)    1/37 (3%)    2/38 (5%)  |
|FIRST INCIDENCE (DAYS) |   728 (T)      728 (T)      728 (T)      728 (T)   |   735 (T)      ---          735 (T)      735 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.328N     P=0.337      P=0.344N     P=0.514N   |  P=0.439      P=0.238N     P=0.536N     P=0.667    |
|INCIDENTAL TUMOR       |  P=0.328N     P=0.337      P=0.344N     P=0.514N   |  P=0.439      P=0.238N     P=0.536N     P=0.667    |
|LOGISTIC REGRESSION    |  P=0.328N     P=0.337      P=0.344N     P=0.514N   |  P=0.439      P=0.238N     P=0.536N     P=0.667    |
|COCHRAN-ARMITAGE       |  P=0.361N                                          |  P=0.469                                           |
|FISHER EXACT           |               P=0.347      P=0.347N     P=0.571N   |               P=0.248N     P=0.500N     P=0.691N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/120 (2%)   0/60 (0%)    0/60 (0%)    0/60 (0%)  |  2/60 (3%)    1/60 (2%)    0/60 (0%)    0/59 (0%)  |
|ADJUSTED (b)           |   2.4%         0.0%         0.0%         0.0%      |   4.9%         2.4%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/85 (2%)    0/41 (0%)    0/41 (0%)    0/46 (0%)  |  2/41 (5%)    1/41 (2%)    0/37 (0%)    0/38 (0%)  |
|FIRST INCIDENCE (DAYS) |   728 (T)      ---          ---          ---       |   735 (T)      735 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.192N     P=0.410N     P=0.410N     P=0.382N   |  P=0.111N     P=0.500N     P=0.261N     P=0.255N   |
|INCIDENTAL TUMOR       |  P=0.192N     P=0.410N     P=0.410N     P=0.382N   |  P=0.111N     P=0.500N     P=0.261N     P=0.255N   |
|LOGISTIC REGRESSION    |  P=0.192N     P=0.410N     P=0.410N     P=0.382N   |  P=0.111N     P=0.500N     P=0.261N     P=0.255N   |
|COCHRAN-ARMITAGE       |  P=0.197N                                          |  P=0.102N                                          |
|FISHER EXACT           |               P=0.443N     P=0.443N     P=0.443N   |               P=0.500N     P=0.248N     P=0.252N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 08                                                 PAGE   4
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE

                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      675          1350         2700      |   0 MG/KG      675          1350         2700      |
|                       |   FEED RTD     MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 24/120 (20%) 34/60 (57%)  28/60 (47%)  44/60 (73%) | 13/60 (22%)  28/60 (47%)  26/60 (43%)  30/59 (51%) |
|ADJUSTED (b)           |  26.7%        77.0%        66.6%        87.9%      |  30.5%        63.6%        66.3%        72.8%      |
|INTERIM SACRIFICE 1 (c)|  3/20 (15%)   2/10 (20%)   0/10 (0%)    2/10 (20%) |  1/10 (10%)   0/10 (0%)    1/10 (10%)   2/10 (20%) |
|TERMINAL (d)           | 21/85 (25%)  31/41 (76%)  27/41 (66%)  40/46 (87%) | 12/41 (29%)  25/41 (61%)  24/37 (65%)  27/38 (71%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      456 (I)      678          456 (I)   |   457 (I)      539          457 (I)      457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.002 **   P=0.002 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.003 **   P=0.002 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P=0.001 **   P=0.002 **   P=0.005 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.004 **                                        |
|FISHER EXACT           |               P<0.001 **   P<0.001 **   P<0.001 ** |               P=0.003 **   P=0.009 **   P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 19/120 (16%) 15/60 (25%)  24/60 (40%)   8/60 (13%) |  3/60 (5%)   10/60 (17%)  10/60 (17%)  10/59 (17%) |
|ADJUSTED (b)           |  20.8%        33.8%        51.8%        17.4%      |   6.6%        23.7%        27.0%        25.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |  1/10 (10%)   0/10 (0%)    0/10 (0%)    1/10 (10%) |
|TERMINAL (d)           | 14/85 (16%)  12/41 (29%)  19/41 (46%)   8/46 (17%) |  2/41 (5%)    9/41 (22%)  10/37 (27%)   9/38 (24%) |
|FIRST INCIDENCE (DAYS) |   420          567          456 (I)      728 (T)   |   457 (I)      551          735 (T)      457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.529      P=0.090      P<0.001 **   P=0.346N   |  P=0.050      P=0.040 *    P=0.024 *    P=0.029 *  |
|INCIDENTAL TUMOR       |  P=0.335      P=0.089      P<0.001 **   P=0.508N   |  P=0.060      P=0.048 *    P=0.024 *    P=0.029 *  |
|LOGISTIC REGRESSION    |  P=0.369      P=0.111      P<0.001 **   P=0.396N   |  P=0.061      P=0.040 *    P=0.033 *    P=0.035 *  |
|COCHRAN-ARMITAGE       |  P=0.441                                           |  P=0.071                                           |
|FISHER EXACT           |               P=0.102      P<0.001 **   P=0.419N   |               P=0.037 *    P=0.037 *    P=0.035 *  |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 08                                                 PAGE   5
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE

                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      675          1350         2700      |   0 MG/KG      675          1350         2700      |
|                       |   FEED RTD     MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatoblastoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 19/120 (16%) 15/60 (25%)  24/60 (40%)   8/60 (13%) |  3/60 (5%)   10/60 (17%)  10/60 (17%)  10/59 (17%) |
|ADJUSTED (b)           |  20.8%        33.8%        51.8%        17.4%      |   6.6%        23.7%        27.0%        25.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |  1/10 (10%)   0/10 (0%)    0/10 (0%)    1/10 (10%) |
|TERMINAL (d)           | 14/85 (16%)  12/41 (29%)  19/41 (46%)   8/46 (17%) |  2/41 (5%)    9/41 (22%)  10/37 (27%)   9/38 (24%) |
|FIRST INCIDENCE (DAYS) |   420          567          456 (I)      728 (T)   |   457 (I)      551          735 (T)      457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.529      P=0.090      P<0.001 **   P=0.346N   |  P=0.050      P=0.040 *    P=0.024 *    P=0.029 *  |
|INCIDENTAL TUMOR       |  P=0.335      P=0.089      P<0.001 **   P=0.508N   |  P=0.060      P=0.048 *    P=0.024 *    P=0.029 *  |
|LOGISTIC REGRESSION    |  P=0.369      P=0.111      P<0.001 **   P=0.396N   |  P=0.061      P=0.040 *    P=0.033 *    P=0.035 *  |
|COCHRAN-ARMITAGE       |  P=0.441                                           |  P=0.071                                           |
|FISHER EXACT           |               P=0.102      P<0.001 **   P=0.419N   |               P=0.037 *    P=0.037 *    P=0.035 *  |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 41/120 (34%) 40/60 (67%)  39/60 (65%)  46/60 (77%) | 15/60 (25%)  32/60 (53%)  29/60 (48%)  31/59 (53%) |
|ADJUSTED (b)           |  43.5%        84.9%        82.9%        92.0%      |  35.3%        71.1%        74.1%        75.2%      |
|INTERIM SACRIFICE 1 (c)|  3/20 (15%)   2/10 (20%)   1/10 (10%)   2/10 (20%) |  1/10 (10%)   0/10 (0%)    1/10 (10%)   2/10 (20%) |
|TERMINAL (d)           | 33/85 (39%)  34/41 (83%)  33/41 (80%)  42/46 (91%) | 14/41 (34%)  28/41 (68%)  27/37 (73%)  28/38 (74%) |
|FIRST INCIDENCE (DAYS) |   420          456 (I)      456 (I)      456 (I)   |   457 (I)      539          457 (I)      457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P=0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P=0.002 **   P=0.001 **   P<0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P=0.003 **   P<0.001 **   P=0.003 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.009 **                                        |
|FISHER EXACT           |               P<0.001 **   P<0.001 **   P<0.001 ** |               P=0.001 **   P=0.007 **   P=0.002 ** |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 08                                                 PAGE   6
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE

                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      675          1350         2700      |   0 MG/KG      675          1350         2700      |
|                       |   FEED RTD     MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 41/120 (34%) 40/60 (67%)  39/60 (65%)  46/60 (77%) | 15/60 (25%)  32/60 (53%)  29/60 (48%)  31/59 (53%) |
|ADJUSTED (b)           |  43.5%        84.9%        82.9%        92.0%      |  35.3%        71.1%        74.1%        75.2%      |
|INTERIM SACRIFICE 1 (c)|  3/20 (15%)   2/10 (20%)   1/10 (10%)   2/10 (20%) |  1/10 (10%)   0/10 (0%)    1/10 (10%)   2/10 (20%) |
|TERMINAL (d)           | 33/85 (39%)  34/41 (83%)  33/41 (80%)  42/46 (91%) | 14/41 (34%)  28/41 (68%)  27/37 (73%)  28/38 (74%) |
|FIRST INCIDENCE (DAYS) |   420          456 (I)      456 (I)      456 (I)   |   457 (I)      539          457 (I)      457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P=0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P=0.002 **   P=0.001 **   P<0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P=0.003 **   P<0.001 **   P=0.003 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.009 **                                        |
|FISHER EXACT           |               P<0.001 **   P<0.001 **   P<0.001 ** |               P=0.001 **   P=0.007 **   P=0.002 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 18/120 (15%) 11/60 (18%)  16/60 (27%)   6/60 (10%) |  3/60 (5%)    3/60 (5%)    3/60 (5%)    4/60 (7%)  |
|ADJUSTED (b)           |  20.1%        26.8%        35.5%        13.0%      |   6.6%         7.0%         8.1%        10.5%      |
|INTERIM SACRIFICE 1 (c)|  1/20 (5%)    0/10 (0%)    2/10 (20%)   0/10 (0%)  |  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 15/85 (18%)  11/41 (27%)  13/41 (32%)   6/46 (13%) |  2/41 (5%)    2/41 (5%)    3/37 (8%)    4/38 (11%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      728 (T)      456 (I)      728 (T)   |   457 (I)      620          735 (T)      735 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.296N     P=0.324      P=0.038 *    P=0.194N   |  P=0.363      P=0.659N     P=0.622      P=0.465    |
|INCIDENTAL TUMOR       |  P=0.364N     P=0.324      P=0.030 *    P=0.280N   |  P=0.416      P=0.610N     P=0.622      P=0.465    |
|LOGISTIC REGRESSION    |  P=0.339N     P=0.351      P=0.048 *    P=0.227N   |  P=0.387      P=0.658N     P=0.658      P=0.489    |
|COCHRAN-ARMITAGE       |  P=0.363N                                          |  P=0.405                                           |
|FISHER EXACT           |               P=0.355      P=0.048 *    P=0.246N   |               P=0.660N     P=0.660N     P=0.500    |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 08                                                 PAGE   7
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE

                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      675          1350         2700      |   0 MG/KG      675          1350         2700      |
|                       |   FEED RTD     MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/120 (6%)   8/60 (13%)   3/60 (5%)    5/60 (8%)  |  1/60 (2%)    1/60 (2%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   8.1%        18.4%         6.5%        10.9%      |   2.4%         2.4%         2.7%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  6/85 (7%)    6/41 (15%)   2/41 (5%)    5/46 (11%) |  1/41 (2%)    1/41 (2%)    1/37 (3%)    0/38 (0%)  |
|FIRST INCIDENCE (DAYS) |   689          588          456 (I)      728 (T)   |   735 (T)      735 (T)      735 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.504      P=0.069      P=0.565N     P=0.428    |  P=0.332N     P=0.762      P=0.739      P=0.515N   |
|INCIDENTAL TUMOR       |  P=0.433      P=0.098      P=0.502N     P=0.390    |  P=0.332N     P=0.762      P=0.739      P=0.515N   |
|LOGISTIC REGRESSION    |  P=0.471      P=0.072      P=0.541N     P=0.410    |  P=0.332N     P=0.762      P=0.739      P=0.515N   |
|COCHRAN-ARMITAGE       |  P=0.454                                           |  P=0.312N                                          |
|FISHER EXACT           |               P=0.079      P=0.559N     P=0.366    |               P=0.752N     P=0.752N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 24/120 (20%) 18/60 (30%)  17/60 (28%)  11/60 (18%) |  4/60 (7%)    4/60 (7%)    4/60 (7%)    4/60 (7%)  |
|ADJUSTED (b)           |  26.7%        41.7%        37.8%        23.9%      |   9.0%         9.4%        10.8%        10.5%      |
|INTERIM SACRIFICE 1 (c)|  1/20 (5%)    0/10 (0%)    2/10 (20%)   0/10 (0%)  |  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 20/85 (24%)  16/41 (39%)  14/41 (34%)  11/46 (24%) |  3/41 (7%)    3/41 (7%)    4/37 (11%)   4/38 (11%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      588          456 (I)      728 (T)   |   457 (I)      620          735 (T)      735 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.372N     P=0.076      P=0.120      P=0.386N   |  P=0.520      P=0.640N     P=0.593      P=0.606    |
|INCIDENTAL TUMOR       |  P=0.482N     P=0.093      P=0.121      P=0.513N   |  P=0.569N     P=0.596N     P=0.593      P=0.606    |
|LOGISTIC REGRESSION    |  P=0.429N     P=0.085      P=0.146      P=0.442N   |  P=0.548      P=0.635N     P=0.636      P=0.631    |
|COCHRAN-ARMITAGE       |  P=0.464N                                          |  P=0.569                                           |
|FISHER EXACT           |               P=0.096      P=0.143      P=0.479N   |               P=0.641N     P=0.641N     P=0.641N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 08                                                 PAGE   8
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE

                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      675          1350         2700      |   0 MG/KG      675          1350         2700      |
|                       |   FEED RTD     MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Cystadenoma                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  2/59 (3%)    5/59 (8%)    5/59 (8%)    2/59 (3%)  |
|ADJUSTED (b)           |                                                    |   4.2%        12.5%        13.1%         5.3%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |                                                    |  1/40 (3%)    5/40 (13%)   4/36 (11%)   2/38 (5%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   457 (I)      735 (T)      618          735 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.496N     P=0.218      P=0.193      P=0.679    |
|INCIDENTAL TUMOR       |                                                    |  P=0.443N     P=0.218      P=0.226      P=0.679    |
|LOGISTIC REGRESSION    |                                                    |  P=0.470N     P=0.223      P=0.215      P=0.694    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.463N                                          |
|FISHER EXACT           |                                                    |               P=0.219      P=0.219      P=0.691N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Luteoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/59 (0%)    1/59 (2%)    3/59 (5%)    1/59 (2%)  |
|ADJUSTED (b)           |                                                    |   0.0%         2.5%         8.3%         2.6%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |                                                    |  0/40 (0%)    1/40 (3%)    3/36 (8%)    1/38 (3%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          735 (T)      735 (T)      735 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.331      P=0.500      P=0.103      P=0.490    |
|INCIDENTAL TUMOR       |                                                    |  P=0.331      P=0.500      P=0.103      P=0.490    |
|LOGISTIC REGRESSION    |                                                    |  P=0.331      P=0.500      P=0.103      P=0.490    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.351                                           |
|FISHER EXACT           |                                                    |               P=0.500      P=0.122      P=0.500    |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 08                                                 PAGE   9
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE

                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      675          1350         2700      |   0 MG/KG      675          1350         2700      |
|                       |   FEED RTD     MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/110 (1%)   0/56 (0%)    0/57 (0%)    0/57 (0%)  |  7/59 (12%)   7/55 (13%)   7/60 (12%)   2/56 (4%)  |
|ADJUSTED (b)           |   1.3%         0.0%         0.0%         0.0%      |  17.5%        17.5%        17.8%         5.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/76 (1%)    0/40 (0%)    0/39 (0%)    0/44 (0%)  |  7/40 (18%)   7/40 (18%)   5/37 (14%)   1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |   728 (T)      ---          ---          ---       |   735 (T)      735 (T)      663          603       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.378N     P=0.628N     P=0.633N     P=0.609N   |  P=0.097N     P=0.615      P=0.553      P=0.112N   |
|INCIDENTAL TUMOR       |  P=0.378N     P=0.628N     P=0.633N     P=0.609N   |  P=0.056N     P=0.615      P=0.555N     P=0.080N   |
|LOGISTIC REGRESSION    |  P=0.378N     P=0.628N     P=0.633N     P=0.609N   |  P=0.084N     P=0.615      P=0.594      P=0.104N   |
|COCHRAN-ARMITAGE       |  P=0.389N                                          |  P=0.070N                                          |
|FISHER EXACT           |               P=0.663N     P=0.659N     P=0.659N   |               P=0.556      P=0.598N     P=0.094N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Intermedia                                                                                                 |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/110 (0%)   1/56 (2%)    0/57 (0%)    0/57 (0%)  |  1/59 (2%)    0/55 (0%)    0/60 (0%)    2/56 (4%)  |
|ADJUSTED (b)           |   0.0%         2.5%         0.0%         0.0%      |   2.5%         0.0%         0.0%         5.7%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/76 (0%)    1/40 (3%)    0/39 (0%)    0/44 (0%)  |  1/40 (3%)    0/40 (0%)    0/37 (0%)    2/35 (6%)  |
|FIRST INCIDENCE (DAYS) |   ---          728 (T)      ---          ---       |   735 (T)      ---          ---          735 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.634N     P=0.372        (e)          (e)      |  P=0.214      P=0.500N     P=0.516N     P=0.453    |
|INCIDENTAL TUMOR       |  P=0.634N     P=0.372        (e)          (e)      |  P=0.214      P=0.500N     P=0.516N     P=0.453    |
|LOGISTIC REGRESSION    |  P=0.634N     P=0.372        (e)          (e)      |  P=0.214      P=0.500N     P=0.516N     P=0.453    |
|COCHRAN-ARMITAGE       |  P=0.650N                                          |  P=0.239                                           |
|FISHER EXACT           |               P=0.337        (e)          (e)      |               P=0.518N     P=0.496N     P=0.480    |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 08                                                 PAGE  10
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE

                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      675          1350         2700      |   0 MG/KG      675          1350         2700      |
|                       |   FEED RTD     MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Intermedia                                                                                                 |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/110 (1%)   1/56 (2%)    0/57 (0%)    0/57 (0%)  |  1/59 (2%)    0/55 (0%)    0/60 (0%)    2/56 (4%)  |
|ADJUSTED (b)           |   1.1%         2.5%         0.0%         0.0%      |   2.5%         0.0%         0.0%         5.7%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/76 (0%)    1/40 (3%)    0/39 (0%)    0/44 (0%)  |  1/40 (3%)    0/40 (0%)    0/37 (0%)    2/35 (6%)  |
|FIRST INCIDENCE (DAYS) |   610          728 (T)      ---          ---       |   735 (T)      ---          ---          735 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.340N     P=0.604      P=0.636N     P=0.636N   |  P=0.214      P=0.500N     P=0.516N     P=0.453    |
|INCIDENTAL TUMOR       |  P=0.505N     P=0.605      P=0.846N       (e)      |  P=0.214      P=0.500N     P=0.516N     P=0.453    |
|LOGISTIC REGRESSION    |  P=0.345N     P=0.605      P=0.637N     P=0.626N   |  P=0.214      P=0.500N     P=0.516N     P=0.453    |
|COCHRAN-ARMITAGE       |  P=0.345N                                          |  P=0.239                                           |
|FISHER EXACT           |               P=0.562      P=0.659N     P=0.659N   |               P=0.518N     P=0.496N     P=0.480    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/120 (0%)   0/60 (0%)    0/60 (0%)    0/60 (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%         5.3%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/85 (0%)    0/41 (0%)    0/41 (0%)    0/46 (0%)  |  0/41 (0%)    0/41 (0%)    0/37 (0%)    2/38 (5%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          ---          ---          735 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.042 *      (e)          (e)        P=0.222    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.042 *      (e)          (e)        P=0.222    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.042 *      (e)          (e)        P=0.222    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.046 *                                         |
|FISHER EXACT           |                 (e)          (e)          (e)      |                 (e)          (e)        P=0.248    |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 08                                                 PAGE  11
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE

                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      675          1350         2700      |   0 MG/KG      675          1350         2700      |
|                       |   FEED RTD     MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/120 (2%)   0/60 (0%)    0/59 (0%)    1/60 (2%)  |  0/60 (0%)    2/60 (3%)    4/60 (7%)    1/59 (2%)  |
|ADJUSTED (b)           |   2.2%         0.0%         0.0%         2.2%      |   0.0%         4.7%        10.3%         2.6%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/85 (1%)    0/41 (0%)    0/41 (0%)    1/46 (2%)  |  0/41 (0%)    1/41 (2%)    3/37 (8%)    1/38 (3%)  |
|FIRST INCIDENCE (DAYS) |   601          ---          ---          728 (T)   |   ---          620          661          735 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.607N     P=0.408N     P=0.406N     P=0.714N   |  P=0.391      P=0.242      P=0.055      P=0.485    |
|INCIDENTAL TUMOR       |  P=0.567      P=0.406N     P=0.522N     P=0.618    |  P=0.509      P=0.314      P=0.083      P=0.485    |
|LOGISTIC REGRESSION    |  P=0.621N     P=0.401N     P=0.404N     P=0.730N   |  P=0.408      P=0.241      P=0.059      P=0.485    |
|COCHRAN-ARMITAGE       |  P=0.623N                                          |  P=0.416                                           |
|FISHER EXACT           |               P=0.443N     P=0.448N     P=0.742N   |               P=0.248      P=0.059      P=0.496    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  9/120 (8%)   0/60 (0%)    1/60 (2%)    0/60 (0%)  |  5/60 (8%)    2/60 (3%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |  10.0%         0.0%         2.4%         0.0%      |  12.2%         4.1%         2.7%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  1/20 (5%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    1/10 (10%)   0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  7/85 (8%)    0/41 (0%)    1/41 (2%)    0/46 (0%)  |  5/41 (12%)   1/41 (2%)    1/37 (3%)    0/38 (0%)  |
|FIRST INCIDENCE (DAYS) |   456 (I)      ---          728 (T)      ---       |   735 (T)      457 (I)      735 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.009N**   P=0.038N*    P=0.111N     P=0.031N*  |  P=0.018N*    P=0.219N     P=0.128N     P=0.040N*  |
|INCIDENTAL TUMOR       |  P=0.011N*    P=0.038N*    P=0.132N     P=0.041N*  |  P=0.018N*    P=0.219N     P=0.128N     P=0.040N*  |
|LOGISTIC REGRESSION    |  P=0.009N**   P=0.035N*    P=0.101N     P=0.034N*  |  P=0.015N*    P=0.211N     P=0.128N     P=0.040N*  |
|COCHRAN-ARMITAGE       |  P=0.009N**                                        |  P=0.014N*                                         |
|FISHER EXACT           |               P=0.023N*    P=0.097N     P=0.023N*  |               P=0.219N     P=0.103N     P=0.029N*  |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 08                                                 PAGE  12
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE

                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      675          1350         2700      |   0 MG/KG      675          1350         2700      |
|                       |   FEED RTD     MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/120 (3%)   0/60 (0%)    0/60 (0%)    1/60 (2%)  |  1/60 (2%)    0/60 (0%)    2/60 (3%)    1/60 (2%)  |
|ADJUSTED (b)           |   3.5%         0.0%         0.0%         2.2%      |   2.4%         0.0%         5.1%         2.6%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/85 (4%)    0/41 (0%)    0/41 (0%)    1/46 (2%)  |  1/41 (2%)    0/41 (0%)    1/37 (3%)    1/38 (3%)  |
|FIRST INCIDENCE (DAYS) |   728 (T)      ---          ---          728 (T)   |   735 (T)      ---          686          735 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.401N     P=0.277N     P=0.277N     P=0.540N   |  P=0.472      P=0.500N     P=0.468      P=0.745    |
|INCIDENTAL TUMOR       |  P=0.401N     P=0.277N     P=0.277N     P=0.540N   |  P=0.534      P=0.500N     P=0.595      P=0.745    |
|LOGISTIC REGRESSION    |  P=0.401N     P=0.277N     P=0.277N     P=0.540N   |  P=0.485      P=0.500N     P=0.490      P=0.745    |
|COCHRAN-ARMITAGE       |  P=0.420N                                          |  P=0.500                                           |
|FISHER EXACT           |               P=0.294N     P=0.294N     P=0.593N   |               P=0.500N     P=0.500      P=0.752N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/120 (3%)   0/60 (0%)    0/60 (0%)    2/60 (3%)  |  1/60 (2%)    0/60 (0%)    2/60 (3%)    2/60 (3%)  |
|ADJUSTED (b)           |   3.5%         0.0%         0.0%         4.3%      |   2.4%         0.0%         5.1%         5.3%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/85 (4%)    0/41 (0%)    0/41 (0%)    2/46 (4%)  |  1/41 (2%)    0/41 (0%)    1/37 (3%)    2/38 (5%)  |
|FIRST INCIDENCE (DAYS) |   728 (T)      ---          ---          728 (T)   |   735 (T)      ---          686          735 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.524      P=0.277N     P=0.277N     P=0.596    |  P=0.222      P=0.500N     P=0.468      P=0.473    |
|INCIDENTAL TUMOR       |  P=0.524      P=0.277N     P=0.277N     P=0.596    |  P=0.262      P=0.500N     P=0.595      P=0.473    |
|LOGISTIC REGRESSION    |  P=0.524      P=0.277N     P=0.277N     P=0.596    |  P=0.230      P=0.500N     P=0.490      P=0.473    |
|COCHRAN-ARMITAGE       |  P=0.500                                           |  P=0.246                                           |
|FISHER EXACT           |               P=0.294N     P=0.294N     P=0.541    |               P=0.500N     P=0.500      P=0.500    |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 08                                                 PAGE  13
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE

                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      675          1350         2700      |   0 MG/KG      675          1350         2700      |
|                       |   FEED RTD     MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/120 (1%)   0/60 (0%)    0/60 (0%)    1/60 (2%)  |  1/60 (2%)    0/60 (0%)    2/60 (3%)    0/60 (0%)  |
|ADJUSTED (b)           |   1.2%         0.0%         0.0%         2.2%      |   2.4%         0.0%         5.1%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/85 (1%)    0/41 (0%)    0/41 (0%)    1/46 (2%)  |  1/41 (2%)    0/41 (0%)    1/37 (3%)    0/38 (0%)  |
|FIRST INCIDENCE (DAYS) |   728 (T)      ---          ---          728 (T)   |   735 (T)      ---          686          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.478      P=0.645N     P=0.645N     P=0.618    |  P=0.486N     P=0.500N     P=0.468      P=0.515N   |
|INCIDENTAL TUMOR       |  P=0.478      P=0.645N     P=0.645N     P=0.618    |  P=0.413N     P=0.500N     P=0.595      P=0.515N   |
|LOGISTIC REGRESSION    |  P=0.478      P=0.645N     P=0.645N     P=0.618    |  P=0.472N     P=0.500N     P=0.490      P=0.515N   |
|COCHRAN-ARMITAGE       |  P=0.462                                           |  P=0.461N                                          |
|FISHER EXACT           |               P=0.667N     P=0.667N     P=0.557    |               P=0.500N     P=0.500      P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/120 (4%)   0/60 (0%)    0/60 (0%)    1/60 (2%)  |  3/60 (5%)    2/60 (3%)    4/60 (7%)    2/60 (3%)  |
|ADJUSTED (b)           |   5.6%         0.0%         0.0%         2.2%      |   7.3%         4.7%        10.3%         5.3%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/85 (4%)    0/41 (0%)    0/41 (0%)    1/46 (2%)  |  3/41 (7%)    1/41 (2%)    3/37 (8%)    2/38 (5%)  |
|FIRST INCIDENCE (DAYS) |   574          ---          ---          728 (T)   |   735 (T)      620          661          735 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.168N     P=0.138N     P=0.138N     P=0.311N   |  P=0.522N     P=0.498N     P=0.450      P=0.535N   |
|INCIDENTAL TUMOR       |  P=0.289N     P=0.131N     P=0.205N     P=0.540N   |  P=0.426N     P=0.439N     P=0.530      P=0.535N   |
|LOGISTIC REGRESSION    |  P=0.229N     P=0.131N     P=0.130N     P=0.479N   |  P=0.501N     P=0.493N     P=0.479      P=0.535N   |
|COCHRAN-ARMITAGE       |  P=0.174N                                          |  P=0.479N                                          |
|FISHER EXACT           |               P=0.128N     P=0.128N     P=0.347N   |               P=0.500N     P=0.500      P=0.500N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 08                                                 PAGE  14
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE

                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      675          1350         2700      |   0 MG/KG      675          1350         2700      |
|                       |   FEED RTD     MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/120 (5%)   0/60 (0%)    0/60 (0%)    2/60 (3%)  |  4/60 (7%)    2/60 (3%)    6/60 (10%)   2/60 (3%)  |
|ADJUSTED (b)           |   6.7%         0.0%         0.0%         4.3%      |   9.8%         4.7%        15.1%         5.3%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  4/85 (5%)    0/41 (0%)    0/41 (0%)    2/46 (4%)  |  4/41 (10%)   1/41 (2%)    4/37 (11%)   2/38 (5%)  |
|FIRST INCIDENCE (DAYS) |   574          ---          ---          728 (T)   |   735 (T)      620          661          735 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.283N     P=0.100N     P=0.099N     P=0.419N   |  P=0.439N     P=0.337N     P=0.316      P=0.372N   |
|INCIDENTAL TUMOR       |  P=0.433N     P=0.094N     P=0.146N     P=0.634N   |  P=0.323N     P=0.287N     P=0.444      P=0.372N   |
|LOGISTIC REGRESSION    |  P=0.295N     P=0.094N     P=0.092N     P=0.582N   |  P=0.413N     P=0.330N     P=0.347      P=0.372N   |
|COCHRAN-ARMITAGE       |  P=0.299N                                          |  P=0.390N                                          |
|FISHER EXACT           |               P=0.084N     P=0.084N     P=0.466N   |               P=0.340N     P=0.372      P=0.340N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Histiocytic Sarcoma                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/120 (0%)   0/60 (0%)    2/60 (3%)    0/60 (0%)  |  2/60 (3%)    0/60 (0%)    4/60 (7%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         4.9%         0.0%      |   4.9%         0.0%         9.5%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/85 (0%)    0/41 (0%)    2/41 (5%)    0/46 (0%)  |  2/41 (5%)    0/41 (0%)    2/37 (5%)    0/38 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          728 (T)      ---       |   735 (T)      ---          420          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.478        (e)        P=0.099        (e)      |  P=0.365N     P=0.238N     P=0.303      P=0.255N   |
|INCIDENTAL TUMOR       |  P=0.478        (e)        P=0.099        (e)      |  P=0.403N     P=0.238N     P=0.350      P=0.255N   |
|LOGISTIC REGRESSION    |  P=0.478        (e)        P=0.099        (e)      |  P=0.345N     P=0.238N     P=0.334      P=0.255N   |
|COCHRAN-ARMITAGE       |  P=0.462                                           |  P=0.338N                                          |
|FISHER EXACT           |                 (e)        P=0.110        (e)      |               P=0.248N     P=0.340      P=0.248N   |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 08                                                 PAGE  15
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE

                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      675          1350         2700      |   0 MG/KG      675          1350         2700      |
|                       |   FEED RTD     MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated                                               |
|     Cell Type                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/120 (6%)   3/60 (5%)    1/60 (2%)    2/60 (3%)  | 13/60 (22%)   6/60 (10%)   7/60 (12%)   6/60 (10%) |
|ADJUSTED (b)           |   8.0%         7.3%         2.4%         4.3%      |  30.2%        13.7%        17.4%        14.7%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  5/85 (6%)    3/41 (7%)    1/41 (2%)    2/46 (4%)  | 11/41 (27%)   4/41 (10%)   5/37 (14%)   4/38 (11%) |
|FIRST INCIDENCE (DAYS) |   633          728 (T)      728 (T)      728 (T)   |   708          493          618          583       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.191N     P=0.564N     P=0.194N     P=0.323N   |  P=0.113N     P=0.068N     P=0.160N     P=0.095N   |
|INCIDENTAL TUMOR       |  P=0.238N     P=0.517N     P=0.184N     P=0.452N   |  P=0.050N*    P=0.057N     P=0.062N     P=0.033N*  |
|LOGISTIC REGRESSION    |  P=0.200N     P=0.551N     P=0.182N     P=0.344N   |  P=0.039N*    P=0.058N     P=0.119N     P=0.073N   |
|COCHRAN-ARMITAGE       |  P=0.213N                                          |  P=0.079N                                          |
|FISHER EXACT           |               P=0.559N     P=0.189N     P=0.372N   |               P=0.066N     P=0.110N     P=0.066N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 50/120 (42%) 38/60 (63%)  34/60 (57%)  45/60 (75%) | 25/60 (42%)  33/60 (55%)  35/60 (58%)  34/60 (57%) |
|ADJUSTED (b)           |  53.1%        86.2%        75.2%        89.9%      |  56.1%        73.2%        83.2%        80.6%      |
|INTERIM SACRIFICE 1 (c)|  5/20 (25%)   2/10 (20%)   2/10 (20%)   2/10 (20%) |  3/10 (30%)   1/10 (10%)   1/10 (10%)   2/10 (20%) |
|TERMINAL (d)           | 42/85 (49%)  35/41 (85%)  30/41 (73%)  41/46 (89%) | 22/41 (54%)  29/41 (71%)  30/37 (81%)  30/38 (79%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      456 (I)      456 (I)      456 (I)   |   457 (I)      457 (I)      457 (I)      457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.001 **   P=0.023 *    P<0.001 ** |  P=0.018 *    P=0.086      P=0.009 **   P=0.021 *  |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.002 **   P=0.018 *    P<0.001 ** |  P=0.033 *    P=0.095      P=0.021 *    P=0.031 *  |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.003 **   P=0.039 *    P<0.001 ** |  P=0.038 *    P=0.095      P=0.026 *    P=0.042 *  |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.084                                           |
|FISHER EXACT           |               P=0.005 **   P=0.041 *    P<0.001 ** |               P=0.100      P=0.050 *    P=0.072    |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 08                                                 PAGE  16
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE

                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      675          1350         2700      |   0 MG/KG      675          1350         2700      |
|                       |   FEED RTD     MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 41/120 (34%) 26/60 (43%)  30/60 (50%)  15/60 (25%) | 20/60 (33%)  19/60 (32%)  26/60 (43%)  18/60 (30%) |
|ADJUSTED (b)           |  43.0%        55.2%        62.2%        32.6%      |  43.9%        41.3%        57.1%        42.2%      |
|INTERIM SACRIFICE 1 (c)|  0/20 (0%)    0/10 (0%)    2/10 (20%)   0/10 (0%)  |  1/10 (10%)   0/10 (0%)    0/10 (0%)    1/10 (10%) |
|TERMINAL (d)           | 31/85 (36%)  20/41 (49%)  23/41 (56%)  15/46 (33%) | 16/41 (39%)  14/41 (34%)  18/37 (49%)  14/38 (37%) |
|FIRST INCIDENCE (DAYS) |   420          567          456 (I)      728 (T)   |   429          493          171          457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.146N     P=0.132      P=0.028 *    P=0.090N   |  P=0.488      P=0.493N     P=0.108      P=0.520N   |
|INCIDENTAL TUMOR       |  P=0.351N     P=0.154      P=0.028 *    P=0.253N   |  P=0.364N     P=0.444N     P=0.243      P=0.413N   |
|LOGISTIC REGRESSION    |  P=0.293N     P=0.173      P=0.030 *    P=0.207N   |  P=0.499N     P=0.475N     P=0.157      P=0.451N   |
|COCHRAN-ARMITAGE       |  P=0.217N                                          |  P=0.454N                                          |
|FISHER EXACT           |               P=0.150      P=0.030 *    P=0.139N   |               P=0.500N     P=0.174      P=0.422N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 75/120 (63%) 47/60 (78%)  44/60 (73%)  47/60 (78%) | 37/60 (62%)  38/60 (63%)  43/60 (72%)  38/60 (63%) |
|ADJUSTED (b)           |  74.0%        94.0%        87.9%        94.0%      |  78.4%        79.1%        91.3%        86.1%      |
|INTERIM SACRIFICE 1 (c)|  5/20 (25%)   2/10 (20%)   3/10 (30%)   2/10 (20%) |  3/10 (30%)   1/10 (10%)   1/10 (10%)   2/10 (20%) |
|TERMINAL (d)           | 59/85 (69%)  38/41 (93%)  35/41 (85%)  43/46 (93%) | 31/41 (76%)  31/41 (76%)  33/37 (89%)  32/38 (84%) |
|FIRST INCIDENCE (DAYS) |   420          456 (I)      456 (I)      456 (I)   |   429          457 (I)      171          457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.098      P=0.019 *    P=0.081      P=0.099    |  P=0.203      P=0.508      P=0.051      P=0.302    |
|INCIDENTAL TUMOR       |  P=0.003 **   P=0.012 *    P=0.082      P=0.005 ** |  P=0.367      P=0.557      P=0.150      P=0.422    |
|LOGISTIC REGRESSION    |  P=0.007 **   P=0.016 *    P=0.114      P=0.009 ** |  P=0.345      P=0.557      P=0.118      P=0.457    |
|COCHRAN-ARMITAGE       |  P=0.022 *                                         |  P=0.427                                           |
|FISHER EXACT           |               P=0.023 *    P=0.099      P=0.023 *  |               P=0.500      P=0.166      P=0.500    |
|=================================================================================================================================|
         DATE: 04/03/96                     EXPERIMENT: 05099 TEST: 08                                                 PAGE  17
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE

                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 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):   456
          Female interim sacrifices(days): 457
 (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).