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TDMS Study 05706-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: IRDC                                        4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID                       DATE: 09/18/94       
EXPERIMENT: 05706 TEST: 01                                                                                     TIME: 22:57:56       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT:                       ROUTE: DOSED FEED                                                                  NTP C#: 60162        
PATHOLOGIST: M. STEDHAM                      S. EUSTIS                                                         CAS: 81-11-8         
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: IRDC                                        4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID                       DATE: 09/18/94      
EXPERIMENT: 05706 TEST: 01                                                                                     TIME: 22:57:56      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT:                       ROUTE: DOSED FEED                                                                  NTP C#: 60162       
PATHOLOGIST: M. STEDHAM                      S. EUSTIS                                                         CAS: 81-11-8        
 
 
 
 
 
                                                    MICE(B6C3F1)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Larynx
                                                    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: IRDC                                        4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID                       DATE: 09/18/94       
EXPERIMENT: 05706 TEST: 01                                                                                     TIME: 22:57:56       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT:                       ROUTE: DOSED FEED                                                                  NTP C#: 60162        
PATHOLOGIST: M. STEDHAM                      S. EUSTIS                                                         CAS: 81-11-8         
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                             IN THE ANALYSIS OF THE STUDY OF 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hepatocellular Adenoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                                                           Carcinoma or Adenoma
                             All Organs                    Malignant Lymphoma And Histiocytic Sarcoma
                                                           Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
                                                            NOS, or Undifferentiated Cell Type
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/18/94                     EXPERIMENT: 05706 TEST: 01                                                 PAGE   1
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         6250PPM         12500PPM      |      CONTROL         6250PPM         12500PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/7 (0%)        2/48 (4%)      |     1/49 (2%)       0/6 (0%)        0/47 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            5.0%          |      2.3%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/0             0/1 (0%)        0/0            |     1/43 (2%)       0/0             0/38 (0%)      |
|TERMINAL (d)           |     0/43 (0%)       0/0             2/40 (5%)      |      729 (T)         ---             ---           |
|FIRST INCIDENCE (DAYS) |      ---             ---             729 (T)       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |     P=0.330N          (e)           P=0.525N       |
|LIFE TABLE             |     P=0.131           (e)           P=0.223        |     P=0.330N          (e)           P=0.525N       |
|INCIDENTAL TUMOR       |     P=0.131           (e)           P=0.223        |     P=0.330N          (e)           P=0.525N       |
|LOGISTIC REGRESSION    |     P=0.131           (e)           P=0.223        |     P=0.309N                                       |
|COCHRAN-ARMITAGE       |     P=0.128                                        |                     P=0.891N        P=0.510N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       1/50 (2%)       0/50 (0%)      |     0/50 (0%)       1/50 (2%)       2/49 (4%)      |
|ADJUSTED (b)           |      2.3%            2.5%            0.0%          |      0.0%            2.3%            5.3%          |
|INTERIM SACRIFICE 1 (c)|     0/0             0/1 (0%)        0/0            |     0/43 (0%)       1/43 (2%)       2/38 (5%)      |
|TERMINAL (d)           |     1/43 (2%)       1/40 (3%)       0/42 (0%)      |      ---             729 (T)         729 (T)       |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         ---           |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |     P=0.121         P=0.500         P=0.212        |
|LIFE TABLE             |     P=0.338N        P=0.746         P=0.505N       |     P=0.121         P=0.500         P=0.212        |
|INCIDENTAL TUMOR       |     P=0.338N        P=0.746         P=0.505N       |     P=0.121         P=0.500         P=0.212        |
|LOGISTIC REGRESSION    |     P=0.338N        P=0.746         P=0.505N       |     P=0.138                                        |
|COCHRAN-ARMITAGE       |     P=0.331N                                       |                     P=0.500         P=0.242        |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05706 TEST: 01                                                 PAGE   2
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         6250PPM         12500PPM      |      CONTROL         6250PPM         12500PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       9/50 (18%)      6/50 (12%)     |     3/50 (6%)       0/17 (0%)       2/49 (4%)      |
|ADJUSTED (b)           |      4.7%           22.5%           14.3%          |      7.0%            0.0%            5.3%          |
|INTERIM SACRIFICE 1 (c)|     0/0             0/1 (0%)        0/0            |     3/43 (7%)       0/11 (0%)       2/38 (5%)      |
|TERMINAL (d)           |     2/43 (5%)       9/40 (23%)      6/42 (14%)     |      729 (T)         ---             729 (T)       |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         729 (T)       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |     P=0.456N        P=0.436N        P=0.556N       |
|LIFE TABLE             |     P=0.126         P=0.020 *       P=0.127        |     P=0.456N        P=0.436N        P=0.556N       |
|INCIDENTAL TUMOR       |     P=0.126         P=0.020 *       P=0.127        |     P=0.456N        P=0.436N        P=0.556N       |
|LOGISTIC REGRESSION    |     P=0.126         P=0.019 *       P=0.127        |     P=0.411N                                       |
|COCHRAN-ARMITAGE       |     P=0.135                                        |                     P=0.409N        P=0.510N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       3/50 (6%)       3/50 (6%)      |     2/50 (4%)       0/17 (0%)       0/49 (0%)      |
|ADJUSTED (b)           |      7.0%            7.5%            7.1%          |      4.7%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/0             0/1 (0%)        0/0            |     2/43 (5%)       0/11 (0%)       0/38 (0%)      |
|TERMINAL (d)           |     3/43 (7%)       3/40 (8%)       3/42 (7%)      |      729 (T)         ---             ---           |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         729 (T)       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |     P=0.145N        P=0.565N        P=0.266N       |
|LIFE TABLE             |     P=0.571         P=0.629         P=0.652        |     P=0.145N        P=0.565N        P=0.266N       |
|INCIDENTAL TUMOR       |     P=0.571         P=0.629         P=0.652        |     P=0.145N        P=0.565N        P=0.266N       |
|LOGISTIC REGRESSION    |     P=0.571         P=0.629         P=0.652        |     P=0.126N                                       |
|COCHRAN-ARMITAGE       |     P=0.583                                        |                     P=0.554N        P=0.253N       |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05706 TEST: 01                                                 PAGE   3
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         6250PPM         12500PPM      |      CONTROL         6250PPM         12500PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)     11/50 (22%)      8/50 (16%)     |     5/50 (10%)      0/17 (0%)       2/49 (4%)      |
|ADJUSTED (b)           |     11.6%           27.5%           19.0%          |     11.6%            0.0%            5.3%          |
|INTERIM SACRIFICE 1 (c)|     0/0             0/1 (0%)        0/0            |     5/43 (12%)      0/11 (0%)       2/38 (5%)      |
|TERMINAL (d)           |     5/43 (12%)     11/40 (28%)      8/42 (19%)     |      729 (T)         ---             729 (T)       |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         729 (T)       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |     P=0.188N        P=0.275N        P=0.269N       |
|LIFE TABLE             |     P=0.230         P=0.061         P=0.259        |     P=0.188N        P=0.275N        P=0.269N       |
|INCIDENTAL TUMOR       |     P=0.230         P=0.061         P=0.259        |     P=0.188N        P=0.275N        P=0.269N       |
|LOGISTIC REGRESSION    |     P=0.230         P=0.061         P=0.259        |     P=0.152N                                       |
|COCHRAN-ARMITAGE       |     P=0.248                                        |                     P=0.219N        P=0.226N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)     11/50 (22%)      8/50 (16%)     |     5/50 (10%)      0/17 (0%)       2/49 (4%)      |
|ADJUSTED (b)           |     11.6%           27.5%           19.0%          |     11.6%            0.0%            5.3%          |
|INTERIM SACRIFICE 1 (c)|     0/0             0/1 (0%)        0/0            |     5/43 (12%)      0/11 (0%)       2/38 (5%)      |
|TERMINAL (d)           |     5/43 (12%)     11/40 (28%)      8/42 (19%)     |      729 (T)         ---             729 (T)       |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         729 (T)       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |     P=0.188N        P=0.275N        P=0.269N       |
|LIFE TABLE             |     P=0.230         P=0.061         P=0.259        |     P=0.188N        P=0.275N        P=0.269N       |
|INCIDENTAL TUMOR       |     P=0.230         P=0.061         P=0.259        |     P=0.188N        P=0.275N        P=0.269N       |
|LOGISTIC REGRESSION    |     P=0.230         P=0.061         P=0.259        |     P=0.152N                                       |
|COCHRAN-ARMITAGE       |     P=0.248                                        |                     P=0.219N        P=0.226N       |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05706 TEST: 01                                                 PAGE   4
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         6250PPM         12500PPM      |      CONTROL         6250PPM         12500PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    12/50 (24%)      3/49 (6%)       7/50 (14%)     |    12/50 (24%)      3/49 (6%)       5/49 (10%)     |
|ADJUSTED (b)           |     27.9%            7.5%           16.7%          |     27.3%            7.0%           12.5%          |
|INTERIM SACRIFICE 1 (c)|     0/0             0/1 (0%)        0/0            |    11/43 (26%)      3/43 (7%)       3/38 (8%)      |
|TERMINAL (d)           |    12/43 (28%)      3/40 (8%)       7/42 (17%)     |      714             729 (T)         718           |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         729 (T)       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |     P=0.046N*       P=0.013N*       P=0.096N       |
|LIFE TABLE             |     P=0.110N        P=0.017N*       P=0.164N       |     P=0.022N*       P=0.015N*       P=0.043N*      |
|INCIDENTAL TUMOR       |     P=0.110N        P=0.017N*       P=0.164N       |     P=0.038N*       P=0.014N*       P=0.077N       |
|LOGISTIC REGRESSION    |     P=0.110N        P=0.017N*       P=0.164N       |     P=0.031N*                                      |
|COCHRAN-ARMITAGE       |     P=0.102N                                       |                     P=0.013N*       P=0.059N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       1/49 (2%)       4/50 (8%)      |     2/50 (4%)       0/49 (0%)       0/49 (0%)      |
|ADJUSTED (b)           |      7.0%            2.5%            9.5%          |      4.7%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/0             0/1 (0%)        0/0            |     2/43 (5%)       0/43 (0%)       0/38 (0%)      |
|TERMINAL (d)           |     3/43 (7%)       1/40 (3%)       4/42 (10%)     |      729 (T)         ---             ---           |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         729 (T)       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |     P=0.106N        P=0.238N        P=0.266N       |
|LIFE TABLE             |     P=0.402         P=0.331N        P=0.487        |     P=0.106N        P=0.238N        P=0.266N       |
|INCIDENTAL TUMOR       |     P=0.402         P=0.331N        P=0.487        |     P=0.106N        P=0.238N        P=0.266N       |
|LOGISTIC REGRESSION    |     P=0.402         P=0.331N        P=0.487        |     P=0.098N                                       |
|COCHRAN-ARMITAGE       |     P=0.412                                        |                     P=0.253N        P=0.253N       |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05706 TEST: 01                                                 PAGE   5
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         6250PPM         12500PPM      |      CONTROL         6250PPM         12500PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    15/50 (30%)      4/49 (8%)      10/50 (20%)     |    13/50 (26%)      3/49 (6%)       5/49 (10%)     |
|ADJUSTED (b)           |     34.9%           10.0%           23.8%          |     29.5%            7.0%           12.5%          |
|INTERIM SACRIFICE 1 (c)|     0/0             0/1 (0%)        0/0            |    12/43 (28%)      3/43 (7%)       3/38 (8%)      |
|TERMINAL (d)           |    15/43 (35%)      4/40 (10%)     10/42 (24%)     |      714             729 (T)         718           |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         729 (T)       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |     P=0.027N*       P=0.007N**      P=0.065N       |
|LIFE TABLE             |     P=0.137N        P=0.008N**      P=0.190N       |     P=0.012N*       P=0.008N**      P=0.027N*      |
|INCIDENTAL TUMOR       |     P=0.137N        P=0.008N**      P=0.190N       |     P=0.022N*       P=0.008N**      P=0.050N*      |
|LOGISTIC REGRESSION    |     P=0.137N        P=0.008N**      P=0.190N       |     P=0.017N*                                      |
|COCHRAN-ARMITAGE       |     P=0.128N                                       |                     P=0.007N**      P=0.037N*      |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/48 (0%)       0/8 (0%)        0/44 (0%)      |     7/50 (14%)      2/7 (29%)       6/48 (13%)     |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |     16.3%          100.0%           15.1%          |
|INTERIM SACRIFICE 1 (c)|     0/0             0/1 (0%)        0/0            |     7/43 (16%)      2/2 (100%)      5/38 (13%)     |
|TERMINAL (d)           |     0/42 (0%)       0/0             0/38 (0%)      |      729 (T)         729 (T)         660           |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |     P=0.540N        P=0.025 *       P=0.588N       |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.498N        P=0.025 *       P=0.541N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.501N        P=0.025 *       P=0.546N       |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.475N                                       |
|COCHRAN-ARMITAGE       |       (e)                                          |                     P=0.304         P=0.532N       |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05706 TEST: 01                                                 PAGE   6
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         6250PPM         12500PPM      |      CONTROL         6250PPM         12500PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/48 (0%)       0/8 (0%)        0/44 (0%)      |     8/50 (16%)      2/7 (29%)       7/48 (15%)     |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |     18.6%          100.0%           17.7%          |
|INTERIM SACRIFICE 1 (c)|     0/0             0/1 (0%)        0/0            |     8/43 (19%)      2/2 (100%)      6/38 (16%)     |
|TERMINAL (d)           |     0/42 (0%)       0/0             0/38 (0%)      |      729 (T)         729 (T)         660           |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |     P=0.551N        P=0.035 *       P=0.597N       |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.511N        P=0.035 *       P=0.552N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.511N        P=0.035 *       P=0.553N       |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.481N                                       |
|COCHRAN-ARMITAGE       |       (e)                                          |                     P=0.356         P=0.535N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       0/49 (0%)      |
|ADJUSTED (b)           |      2.3%            5.0%            0.0%          |      0.0%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/0             0/1 (0%)        0/0            |     0/43 (0%)       0/43 (0%)       0/38 (0%)      |
|TERMINAL (d)           |     1/43 (2%)       2/40 (5%)       0/42 (0%)      |      ---             ---             ---           |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         ---           |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |       (e)             (e)             (e)          |
|LIFE TABLE             |     P=0.368N        P=0.475         P=0.505N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.368N        P=0.475         P=0.505N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.368N        P=0.475         P=0.505N       |       (e)                                          |
|COCHRAN-ARMITAGE       |     P=0.360N                                       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05706 TEST: 01                                                 PAGE   7
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         6250PPM         12500PPM      |      CONTROL         6250PPM         12500PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       1/50 (2%)      |     0/50 (0%)       0/50 (0%)       0/49 (0%)      |
|ADJUSTED (b)           |      4.7%            2.5%            2.4%          |      0.0%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/0             0/1 (0%)        0/0            |     0/43 (0%)       0/43 (0%)       0/38 (0%)      |
|TERMINAL (d)           |     2/43 (5%)       1/40 (3%)       1/42 (2%)      |      ---             ---             ---           |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         729 (T)       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |       (e)             (e)             (e)          |
|LIFE TABLE             |     P=0.387N        P=0.525N        P=0.508N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.387N        P=0.525N        P=0.508N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.387N        P=0.525N        P=0.508N       |       (e)                                          |
|COCHRAN-ARMITAGE       |     P=0.378N                                       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       1/49 (2%)      |
|ADJUSTED (b)           |      4.7%            2.2%            4.8%          |      0.0%            0.0%            2.5%          |
|INTERIM SACRIFICE 1 (c)|     0/0             0/1 (0%)        0/0            |     0/43 (0%)       0/43 (0%)       0/38 (0%)      |
|TERMINAL (d)           |     2/43 (5%)       0/40 (0%)       2/42 (5%)      |      ---             ---             718           |
|FIRST INCIDENCE (DAYS) |      729 (T)         607             729 (T)       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |     P=0.259           (e)           P=0.486        |
|LIFE TABLE             |     P=0.601         P=0.511N        P=0.686        |     P=0.422           (e)           P=0.669        |
|INCIDENTAL TUMOR       |     P=0.606         P=0.398N        P=0.686        |     P=0.266           (e)           P=0.495        |
|LOGISTIC REGRESSION    |     P=0.609         P=0.494N        P=0.686        |     P=0.266                                        |
|COCHRAN-ARMITAGE       |     P=0.610                                        |                       (e)           P=0.495        |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05706 TEST: 01                                                 PAGE   8
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         6250PPM         12500PPM      |      CONTROL         6250PPM         12500PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      3/50 (6%)       5/50 (10%)     |     0/50 (0%)       0/50 (0%)       1/49 (2%)      |
|ADJUSTED (b)           |     11.6%            6.7%           11.9%          |      0.0%            0.0%            2.5%          |
|INTERIM SACRIFICE 1 (c)|     0/0             0/1 (0%)        0/0            |     0/43 (0%)       0/43 (0%)       0/38 (0%)      |
|TERMINAL (d)           |     5/43 (12%)      1/40 (3%)       5/42 (12%)     |      ---             ---             718           |
|FIRST INCIDENCE (DAYS) |      729 (T)         605             729 (T)       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |     P=0.259           (e)           P=0.486        |
|LIFE TABLE             |     P=0.557         P=0.381N        P=0.616        |     P=0.422           (e)           P=0.669        |
|INCIDENTAL TUMOR       |     P=0.560         P=0.244N        P=0.616        |     P=0.266           (e)           P=0.495        |
|LOGISTIC REGRESSION    |     P=0.568         P=0.341N        P=0.616        |     P=0.266                                        |
|COCHRAN-ARMITAGE       |     P=0.571N                                       |                       (e)           P=0.495        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       2/50 (4%)       4/50 (8%)      |     0/50 (0%)       0/50 (0%)       1/49 (2%)      |
|ADJUSTED (b)           |      7.0%            4.3%            9.5%          |      0.0%            0.0%            2.5%          |
|INTERIM SACRIFICE 1 (c)|     0/0             0/1 (0%)        0/0            |     0/43 (0%)       0/43 (0%)       0/38 (0%)      |
|TERMINAL (d)           |     3/43 (7%)       0/40 (0%)       4/42 (10%)     |      ---             ---             718           |
|FIRST INCIDENCE (DAYS) |      729 (T)         605             729 (T)       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |     P=0.259           (e)           P=0.486        |
|LIFE TABLE             |     P=0.409         P=0.509N        P=0.487        |     P=0.422           (e)           P=0.669        |
|INCIDENTAL TUMOR       |     P=0.403         P=0.326N        P=0.487        |     P=0.266           (e)           P=0.495        |
|LOGISTIC REGRESSION    |     P=0.414         P=0.496N        P=0.487        |     P=0.266                                        |
|COCHRAN-ARMITAGE       |     P=0.417                                        |                       (e)           P=0.495        |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05706 TEST: 01                                                 PAGE   9
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         6250PPM         12500PPM      |      CONTROL         6250PPM         12500PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Sarcoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       1/50 (2%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       0/49 (0%)      |
|ADJUSTED (b)           |      2.3%            2.2%            4.8%          |      0.0%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/0             0/1 (0%)        0/0            |     0/43 (0%)       0/43 (0%)       0/38 (0%)      |
|TERMINAL (d)           |     1/43 (2%)       0/40 (0%)       2/42 (5%)      |      ---             ---             ---           |
|FIRST INCIDENCE (DAYS) |      729 (T)         605             729 (T)       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |       (e)             (e)             (e)          |
|LIFE TABLE             |     P=0.374         P=0.760         P=0.492        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.368         P=0.657N        P=0.492        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.376         P=0.762         P=0.492        |       (e)                                          |
|COCHRAN-ARMITAGE       |     P=0.378                                        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       0/50 (0%)      |     1/50 (2%)       1/50 (2%)       1/49 (2%)      |
|ADJUSTED (b)           |      2.3%            4.8%            0.0%          |      2.3%            2.3%            2.6%          |
|INTERIM SACRIFICE 1 (c)|     0/0             0/1 (0%)        0/0            |     1/43 (2%)       1/43 (2%)       1/38 (3%)      |
|TERMINAL (d)           |     1/43 (2%)       1/40 (3%)       0/42 (0%)      |      729 (T)         729 (T)         729 (T)       |
|FIRST INCIDENCE (DAYS) |      729 (T)         711             ---           |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |     P=0.608         P=0.762         P=0.734        |
|LIFE TABLE             |     P=0.369N        P=0.481         P=0.505N       |     P=0.608         P=0.762         P=0.734        |
|INCIDENTAL TUMOR       |     P=0.277N        P=0.746         P=0.505N       |     P=0.608         P=0.762         P=0.734        |
|LOGISTIC REGRESSION    |     P=0.362N        P=0.507         P=0.505N       |     P=0.634                                        |
|COCHRAN-ARMITAGE       |     P=0.360N                                       |                     P=0.753N        P=0.747        |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05706 TEST: 01                                                 PAGE  10
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         6250PPM         12500PPM      |      CONTROL         6250PPM         12500PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       2/50 (4%)       1/50 (2%)      |     1/50 (2%)       1/50 (2%)       2/49 (4%)      |
|ADJUSTED (b)           |      4.7%            4.8%            2.4%          |      2.3%            2.3%            5.3%          |
|INTERIM SACRIFICE 1 (c)|     0/0             0/1 (0%)        0/0            |     1/43 (2%)       1/43 (2%)       2/38 (5%)      |
|TERMINAL (d)           |     2/43 (5%)       1/40 (3%)       1/42 (2%)      |      729 (T)         729 (T)         729 (T)       |
|FIRST INCIDENCE (DAYS) |      729 (T)         711             729 (T)       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |     P=0.339         P=0.762         P=0.457        |
|LIFE TABLE             |     P=0.400N        P=0.672         P=0.508N       |     P=0.339         P=0.762         P=0.457        |
|INCIDENTAL TUMOR       |     P=0.335N        P=0.525N        P=0.508N       |     P=0.339         P=0.762         P=0.457        |
|LOGISTIC REGRESSION    |     P=0.393N        P=0.690N        P=0.508N       |     P=0.372                                        |
|COCHRAN-ARMITAGE       |     P=0.390N                                       |                     P=0.753N        P=0.492        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       6/50 (12%)      6/50 (12%)     |    19/50 (38%)     10/50 (20%)     11/49 (22%)     |
|ADJUSTED (b)           |      4.7%           13.9%           13.6%          |     39.6%           22.1%           25.3%          |
|INTERIM SACRIFICE 1 (c)|     0/0             0/1 (0%)        0/0            |    14/43 (33%)      8/43 (19%)      6/38 (16%)     |
|TERMINAL (d)           |     2/43 (5%)       3/40 (8%)       4/42 (10%)     |      587             601             639           |
|FIRST INCIDENCE (DAYS) |      729 (T)         628             438           |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |     P=0.097N        P=0.052N        P=0.140N       |
|LIFE TABLE             |     P=0.117         P=0.126         P=0.134        |     P=0.017N*       P=0.051N        P=0.025N*      |
|INCIDENTAL TUMOR       |     P=0.182         P=0.386         P=0.326        |     P=0.051N        P=0.040N*       P=0.071N       |
|LOGISTIC REGRESSION    |     P=0.112         P=0.491         P=0.133        |     P=0.050N                                       |
|COCHRAN-ARMITAGE       |     P=0.114                                        |                     P=0.038N*       P=0.071N       |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05706 TEST: 01                                                 PAGE  11
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         6250PPM         12500PPM      |      CONTROL         6250PPM         12500PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       6/50 (12%)      6/50 (12%)     |    19/50 (38%)     10/50 (20%)     11/49 (22%)     |
|ADJUSTED (b)           |      4.7%           13.9%           13.6%          |     39.6%           22.1%           25.3%          |
|INTERIM SACRIFICE 1 (c)|     0/0             0/1 (0%)        0/0            |    14/43 (33%)      8/43 (19%)      6/38 (16%)     |
|TERMINAL (d)           |     2/43 (5%)       3/40 (8%)       4/42 (10%)     |      587             601             639           |
|FIRST INCIDENCE (DAYS) |      729 (T)         628             438           |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |     P=0.097N        P=0.052N        P=0.140N       |
|LIFE TABLE             |     P=0.117         P=0.126         P=0.134        |     P=0.017N*       P=0.051N        P=0.025N*      |
|INCIDENTAL TUMOR       |     P=0.182         P=0.386         P=0.326        |     P=0.051N        P=0.040N*       P=0.071N       |
|LOGISTIC REGRESSION    |     P=0.112         P=0.491         P=0.133        |     P=0.050N                                       |
|COCHRAN-ARMITAGE       |     P=0.114                                        |                     P=0.038N*       P=0.071N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    15/50 (30%)     10/50 (20%)     15/50 (30%)     |    21/50 (42%)      9/50 (18%)     12/49 (24%)     |
|ADJUSTED (b)           |     34.9%           25.0%           35.7%          |     46.5%           19.9%           29.1%          |
|INTERIM SACRIFICE 1 (c)|     0/0             0/1 (0%)        0/0            |    19/43 (44%)      7/43 (16%)      9/38 (24%)     |
|TERMINAL (d)           |    15/43 (35%)     10/40 (25%)     15/42 (36%)     |      410             601             660           |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         729 (T)       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |     P=0.065N        P=0.010N*       P=0.103N       |
|LIFE TABLE             |     P=0.517         P=0.231N        P=0.558        |     P=0.026N*       P=0.012N*       P=0.046N*      |
|INCIDENTAL TUMOR       |     P=0.517         P=0.231N        P=0.558        |     P=0.034N*       P=0.009N**      P=0.052N       |
|LOGISTIC REGRESSION    |     P=0.517         P=0.231N        P=0.558        |     P=0.033N*                                      |
|COCHRAN-ARMITAGE       |     P=0.545                                        |                     P=0.008N**      P=0.051N       |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05706 TEST: 01                                                 PAGE  12
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         6250PPM         12500PPM      |      CONTROL         6250PPM         12500PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    11/50 (22%)     15/50 (30%)     16/50 (32%)     |    24/50 (48%)     12/50 (24%)     15/49 (31%)     |
|ADJUSTED (b)           |     25.6%           32.6%           36.3%          |     49.0%           26.0%           33.0%          |
|INTERIM SACRIFICE 1 (c)|     0/0             0/1 (0%)        0/0            |    18/43 (42%)      9/43 (21%)      8/38 (21%)     |
|TERMINAL (d)           |    11/43 (26%)      9/40 (23%)     14/42 (33%)     |      587             601             602           |
|FIRST INCIDENCE (DAYS) |      729 (T)         605             438           |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |     P=0.094N        P=0.020N*       P=0.137N       |
|LIFE TABLE             |     P=0.155         P=0.212         P=0.168        |     P=0.013N*       P=0.012N*       P=0.019N*      |
|INCIDENTAL TUMOR       |     P=0.219         P=0.577         P=0.294        |     P=0.010N**      P=0.011N*       P=0.016N*      |
|LOGISTIC REGRESSION    |     P=0.150         P=0.279         P=0.175        |     P=0.042N*                                      |
|COCHRAN-ARMITAGE       |     P=0.158                                        |                     P=0.011N*       P=0.059N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    23/50 (46%)     24/50 (48%)     25/50 (50%)     |    34/50 (68%)     17/50 (34%)     24/49 (49%)     |
|ADJUSTED (b)           |     53.5%           52.2%           56.8%          |     68.0%           36.9%           51.9%          |
|INTERIM SACRIFICE 1 (c)|     0/0             0/1 (0%)        0/0            |    27/43 (63%)     14/43 (33%)     16/38 (42%)     |
|TERMINAL (d)           |    23/43 (53%)     18/40 (45%)     23/42 (55%)     |      410             601             602           |
|FIRST INCIDENCE (DAYS) |      729 (T)         605             438           |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |     P=0.110N        P=0.002N**      P=0.157N       |
|LIFE TABLE             |     P=0.347         P=0.390         P=0.376        |     P=0.017N*       P=0.001N**      P=0.023N*      |
|INCIDENTAL TUMOR       |     P=0.457         P=0.414N        P=0.540        |     P=0.017N*       P<0.001N**      P=0.035N*      |
|LOGISTIC REGRESSION    |     P=0.367         P=0.568         P=0.407        |     P=0.035N*                                      |
|COCHRAN-ARMITAGE       |     P=0.382                                        |                     P<0.001N**      P=0.043N*      |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05706 TEST: 01                                                 PAGE  13
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 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.
 (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).