National Toxicology Program

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TDMS Study 05099-99 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: SOUTHERN RESEARCH INST                             SALICYLAZOSULFAPYRIDINE                                DATE: 05/05/95       
EXPERIMENT: 05099 TEST: 99                                                                                     TIME: 09:58:26       
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        
                                             05099/08 -VS- 05099/10 COMPARISON 



                                                    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
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    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: 05/05/95       
EXPERIMENT: 05099 TEST: 99                                                                                     TIME: 09:58:26       
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
                                -------                             ------------

                             All Organs                    Hemangiosarcoma or Hemangioma
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma

              ====================================================================================================
         DATE: 05/05/95                     EXPERIMENT: 05099 TEST: 99                                                 PAGE   1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 104 WEEKS

|==============================================================================|
|DOSE                   |          0 MG/KG             RTD                     |
|                       |                              0 MG/KG                 |
|==============================================================================|
|                                                                              |
|Harderian Gland                                                               |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/50 (4%)           2/52 (4%)                |
|ADJUSTED (b)           |          5.0%                4.5%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/42 (0%)                |
|TERMINAL (d)           |         2/40 (5%)           0/0                      |
|FIRST INCIDENCE (DAYS) |          728 (T)             660                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.518                  |
|INCIDENTAL TUMOR       |                             P=0.581                  |
|LOGISTIC REGRESSION    |                             P=0.480N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.676N                 |
|==============================================================================|
|                                                                              |
|Harderian Gland                                                               |
|     Carcinoma or Adenoma                                                     |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         3/50 (6%)           3/52 (6%)                |
|ADJUSTED (b)           |          7.5%                6.7%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/42 (0%)                |
|TERMINAL (d)           |         3/40 (8%)           0/0                      |
|FIRST INCIDENCE (DAYS) |          728 (T)             660                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.258                  |
|INCIDENTAL TUMOR       |                             P=0.323                  |
|LOGISTIC REGRESSION    |                             P=0.462N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.642N                 |
|==============================================================================|
         DATE: 05/05/95                     EXPERIMENT: 05099 TEST: 99                                                 PAGE   2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 104 WEEKS

|==============================================================================|
|DOSE                   |          0 MG/KG             RTD                     |
|                       |                              0 MG/KG                 |
|==============================================================================|
|                                                                              |
|Liver                                                                         |
|     Hemangiosarcoma                                                          |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/50 (4%)           0/52 (0%)                |
|ADJUSTED (b)           |          5.0%                0.0%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/42 (0%)                |
|TERMINAL (d)           |         2/40 (5%)           0/0                      |
|FIRST INCIDENCE (DAYS) |          728 (T)             ---                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |           (e)                 (e)                    |
|INCIDENTAL TUMOR       |           (e)                 (e)                    |
|LOGISTIC REGRESSION    |                             P=0.207N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.238N                 |
|==============================================================================|
|                                                                              |
|Liver                                                                         |
|     Hepatocellular Adenoma                                                   |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        13/50 (26%)         13/52 (25%)               |
|ADJUSTED (b)           |         32.5%               28.7%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/42 (0%)                |
|TERMINAL (d)           |        13/40 (33%)          0/0                      |
|FIRST INCIDENCE (DAYS) |          728 (T)             616                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.145                  |
|INCIDENTAL TUMOR       |                             P=0.196                  |
|LOGISTIC REGRESSION    |                             P=0.004N**               |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.544N                 |
|==============================================================================|
         DATE: 05/05/95                     EXPERIMENT: 05099 TEST: 99                                                 PAGE   3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 104 WEEKS

|==============================================================================|
|DOSE                   |          0 MG/KG             RTD                     |
|                       |                              0 MG/KG                 |
|==============================================================================|
|                                                                              |
|Liver                                                                         |
|     Hepatocellular Carcinoma                                                 |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        13/50 (26%)          7/52 (13%)               |
|ADJUSTED (b)           |         29.2%               14.9%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/42 (0%)                |
|TERMINAL (d)           |         9/40 (23%)          0/0                      |
|FIRST INCIDENCE (DAYS) |          420                 495                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.454N                 |
|INCIDENTAL TUMOR       |                             P=0.438N                 |
|LOGISTIC REGRESSION    |                             P=0.002N**               |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.089N                 |
|==============================================================================|
|                                                                              |
|Liver                                                                         |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                       |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        24/50 (48%)         18/52 (35%)               |
|ADJUSTED (b)           |         54.3%               37.1%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/42 (0%)                |
|TERMINAL (d)           |        20/40 (50%)          0/0                      |
|FIRST INCIDENCE (DAYS) |          420                 495                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.434                  |
|INCIDENTAL TUMOR       |                             P=0.488                  |
|LOGISTIC REGRESSION    |                             P<0.001N**               |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.121N                 |
|==============================================================================|
         DATE: 05/05/95                     EXPERIMENT: 05099 TEST: 99                                                 PAGE   4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 104 WEEKS

|==============================================================================|
|DOSE                   |          0 MG/KG             RTD                     |
|                       |                              0 MG/KG                 |
|==============================================================================|
|                                                                              |
|Liver                                                                         |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma      |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        24/50 (48%)         18/52 (35%)               |
|ADJUSTED (b)           |         54.3%               37.1%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/42 (0%)                |
|TERMINAL (d)           |        20/40 (50%)          0/0                      |
|FIRST INCIDENCE (DAYS) |          420                 495                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.434                  |
|INCIDENTAL TUMOR       |                             P=0.488                  |
|LOGISTIC REGRESSION    |                             P<0.001N**               |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.121N                 |
|==============================================================================|
|                                                                              |
|Lung                                                                          |
|     Alveolar/Bronchiolar Adenoma                                             |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        11/50 (22%)         11/52 (21%)               |
|ADJUSTED (b)           |         27.5%               24.9%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/42 (0%)                |
|TERMINAL (d)           |        11/40 (28%)          0/0                      |
|FIRST INCIDENCE (DAYS) |          728 (T)             717                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.263                  |
|INCIDENTAL TUMOR       |                             P=0.323                  |
|LOGISTIC REGRESSION    |                             P=0.004N**               |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.554N                 |
|==============================================================================|
         DATE: 05/05/95                     EXPERIMENT: 05099 TEST: 99                                                 PAGE   5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 104 WEEKS

|==============================================================================|
|DOSE                   |          0 MG/KG             RTD                     |
|                       |                              0 MG/KG                 |
|==============================================================================|
|                                                                              |
|Lung                                                                          |
|     Alveolar/Bronchiolar Carcinoma                                           |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         3/50 (6%)           2/52 (4%)                |
|ADJUSTED (b)           |          7.3%                4.5%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/42 (0%)                |
|TERMINAL (d)           |         2/40 (5%)           0/0                      |
|FIRST INCIDENCE (DAYS) |          689                 661                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.742N                 |
|INCIDENTAL TUMOR       |                             P=0.677N                 |
|LOGISTIC REGRESSION    |                             P=0.288N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.481N                 |
|==============================================================================|
|                                                                              |
|Lung                                                                          |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma           |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        14/50 (28%)         13/52 (25%)               |
|ADJUSTED (b)           |         34.1%               28.8%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/42 (0%)                |
|TERMINAL (d)           |        13/40 (33%)          0/0                      |
|FIRST INCIDENCE (DAYS) |          689                 661                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.342                  |
|INCIDENTAL TUMOR       |                             P=0.450                  |
|LOGISTIC REGRESSION    |                             P=0.005N**               |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.453N                 |
|==============================================================================|
         DATE: 05/05/95                     EXPERIMENT: 05099 TEST: 99                                                 PAGE   6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 104 WEEKS

|==============================================================================|
|DOSE                   |          0 MG/KG             RTD                     |
|                       |                              0 MG/KG                 |
|==============================================================================|
|                                                                              |
|Stomach, Forestomach                                                          |
|     Squamous Cell Papilloma                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         3/50 (6%)           2/52 (4%)                |
|ADJUSTED (b)           |          7.5%                4.8%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/42 (0%)                |
|TERMINAL (d)           |         3/40 (8%)           0/0                      |
|FIRST INCIDENCE (DAYS) |          728 (T)             728 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |           (e)                 (e)                    |
|INCIDENTAL TUMOR       |           (e)                 (e)                    |
|LOGISTIC REGRESSION    |                             P=0.096N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.481N                 |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Hemangiosarcoma                                                          |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         3/50 (6%)           1/52 (2%)                |
|ADJUSTED (b)           |          7.5%                2.4%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/42 (0%)                |
|TERMINAL (d)           |         3/40 (8%)           0/0                      |
|FIRST INCIDENCE (DAYS) |          728 (T)             728 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |           (e)                 (e)                    |
|INCIDENTAL TUMOR       |           (e)                 (e)                    |
|LOGISTIC REGRESSION    |                             P=0.096N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.294N                 |
|==============================================================================|
         DATE: 05/05/95                     EXPERIMENT: 05099 TEST: 99                                                 PAGE   7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 104 WEEKS

|==============================================================================|
|DOSE                   |          0 MG/KG             RTD                     |
|                       |                              0 MG/KG                 |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Hemangiosarcoma or Hemangioma                                            |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         4/50 (8%)           1/52 (2%)                |
|ADJUSTED (b)           |         10.0%                2.4%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/42 (0%)                |
|TERMINAL (d)           |         4/40 (10%)          0/0                      |
|FIRST INCIDENCE (DAYS) |          728 (T)             728 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |           (e)                 (e)                    |
|INCIDENTAL TUMOR       |           (e)                 (e)                    |
|LOGISTIC REGRESSION    |                             P=0.046N*                |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.169N                 |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Malignant Lymphoma And Histiocytic Sarcoma                               |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         5/50 (10%)          6/52 (12%)               |
|ADJUSTED (b)           |         12.1%               13.4%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/42 (0%)                |
|TERMINAL (d)           |         4/40 (10%)          0/0                      |
|FIRST INCIDENCE (DAYS) |          666                 647                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.529                  |
|INCIDENTAL TUMOR       |                             P=0.656                  |
|LOGISTIC REGRESSION    |                             P=0.191N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.528                  |
|==============================================================================|
         DATE: 05/05/95                     EXPERIMENT: 05099 TEST: 99                                                 PAGE   8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 104 WEEKS

|==============================================================================|
|DOSE                   |          0 MG/KG             RTD                     |
|                       |                              0 MG/KG                 |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                     |
|     NOS, or Undifferentiated Cell Type                                       |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         5/50 (10%)          6/52 (12%)               |
|ADJUSTED (b)           |         12.1%               13.4%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/42 (0%)                |
|TERMINAL (d)           |         4/40 (10%)          0/0                      |
|FIRST INCIDENCE (DAYS) |          666                 647                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.529                  |
|INCIDENTAL TUMOR       |                             P=0.656                  |
|LOGISTIC REGRESSION    |                             P=0.191N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.528                  |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Benign Tumors                                                            |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |        26/50 (52%)         26/52 (50%)               |
|ADJUSTED (b)           |         65.0%               56.4%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/42 (0%)                |
|TERMINAL (d)           |        26/40 (65%)          0/0                      |
|FIRST INCIDENCE (DAYS) |          728 (T)             616                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.082                  |
|INCIDENTAL TUMOR       |                             P=0.109                  |
|LOGISTIC REGRESSION    |                             P<0.001N**               |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.498N                 |
|==============================================================================|
         DATE: 05/05/95                     EXPERIMENT: 05099 TEST: 99                                                 PAGE   9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 104 WEEKS

|==============================================================================|
|DOSE                   |          0 MG/KG             RTD                     |
|                       |                              0 MG/KG                 |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Malignant Tumors                                                         |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |        25/50 (50%)         19/52 (37%)               |
|ADJUSTED (b)           |         53.2%               37.8%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/42 (0%)                |
|TERMINAL (d)           |        18/40 (45%)          0/0                      |
|FIRST INCIDENCE (DAYS) |          420                 495                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.567                  |
|INCIDENTAL TUMOR       |                             P=0.516N                 |
|LOGISTIC REGRESSION    |                             P<0.001N**               |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.120N                 |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Malignant and Benign Tumors                                              |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |        40/50 (80%)         37/52 (71%)               |
|ADJUSTED (b)           |         85.1%               72.5%                    |
|INTERIM SACRIFICE 1 (c)|         0/0                 0/42 (0%)                |
|TERMINAL (d)           |        33/40 (83%)          0/0                      |
|FIRST INCIDENCE (DAYS) |          420                 495                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.471                  |
|INCIDENTAL TUMOR       |                             P=0.738N                 |
|LOGISTIC REGRESSION    |                             P<0.001N**               |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.210N                 |
|==============================================================================|
         DATE: 05/05/95                     EXPERIMENT: 05099 TEST: 99                                                 PAGE  10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE

                       TERMINAL SACRIFICE AT 104 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):   729
          Female interim sacrifices(days):
 (d)  Observed incidence at terminal kill.
 (f)  Beneath the control incidence are the P-values associated with the trend 
      test.  Beneath the dosed group incidence are the P-values corresponding to 
      pairwise comparisons between the controls and that dosed group.  The life
      table analysis regards tumors in animals dying  prior to terminal kill as
      being (directly or indirectly) the cause of death.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's exact tests compare directly the overall incidence rates.  
      For all tests, a negative trend is indicated by "N".
 (e)  Value of Statistic cannot be computed. 
 (I)  Interim sacrifice
 (T)  Terminal sacrifice
  #   Tumor rates based on number of animals necropsied.

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