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TDMS Study 05706-02 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: 02                                                                                     TIME: 23:58:51       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT:                       ROUTE: DOSED FEED                                                                  NTP C#: C60162       
PATHOLOGIST: W. HALL                         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: 02                                                                                     TIME: 23:58:51      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT:                       ROUTE: DOSED FEED                                                                  NTP C#: C60162      
PATHOLOGIST: W. HALL                         S. EUSTIS                                                         CAS: 81-11-8        
 
 
 
 
 
                                                    RATS(FISCHER344)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    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: 02                                                                                     TIME: 23:58:51       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT:                       ROUTE: DOSED FEED                                                                  NTP C#: C60162       
PATHOLOGIST: W. HALL                         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 RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Malignant
                             Clitoral/Preputial Gland      Carcinoma
                                                           Carcinoma or Adenoma
                             Liver                         Hepatocellular Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                             All Organs                    Malignant Tumors
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Clitoral/Preputial Gland      Adenoma
                                                           Carcinoma or Adenoma
                             Mammary Gland                 Fibroadenoma
                                                           Fibroma, Fibroadenoma or Adenoma
                                                           Fibroma, Fibroadenoma, Carcinoma, or Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                             Thyroid Gland: C-Cell         Carcinoma
                                                           Carcinoma or Adenoma
                             All Organs                    Benign Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/19/94                     EXPERIMENT: 05706 TEST: 02                                                 PAGE   1
                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         12500PPM        25000PPM      |      CONTROL         12500PPM        25000PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/49 (0%)       0/50 (0%)      |     0/49 (0%)       0/50 (0%)       2/49 (4%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      0.0%            0.0%            5.9%          |
|TERMINAL (d)           |     0/22 (0%)       0/19 (0%)       0/24 (0%)      |     0/30 (0%)       0/33 (0%)       1/33 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      ---             ---             722           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.104           (e)           P=0.261        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.120           (e)           P=0.268        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.109           (e)           P=0.268        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.095                                        |
|FISHER EXACT           |                       (e)             (e)          |                       (e)           P=0.247        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    16/48 (33%)     18/50 (36%)     19/50 (38%)     |     2/49 (4%)       4/50 (8%)       5/49 (10%)     |
|ADJUSTED (b)           |     50.5%           56.0%           59.6%          |      6.7%           12.1%           14.0%          |
|TERMINAL (d)           |     7/21 (33%)      7/20 (35%)     12/24 (50%)     |     2/30 (7%)       4/33 (12%)      4/33 (12%)     |
|FIRST INCIDENCE (DAYS) |      540             583             520           |      729 (T)         729 (T)         671           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.441         P=0.405         P=0.477        |     P=0.204         P=0.380         P=0.261        |
|INCIDENTAL TUMOR       |     P=0.389         P=0.575         P=0.438        |     P=0.206         P=0.380         P=0.260        |
|LOGISTIC REGRESSION    |     P=0.396         P=0.491         P=0.438        |     P=0.219         P=0.380         P=0.265        |
|COCHRAN-ARMITAGE       |     P=0.354                                        |     P=0.168                                        |
|FISHER EXACT           |                     P=0.474         P=0.393        |                     P=0.349         P=0.218        |
|=================================================================================================================================|
 
         DATE: 09/19/94                     EXPERIMENT: 05706 TEST: 02                                                 PAGE   2
                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         12500PPM        25000PPM      |      CONTROL         12500PPM        25000PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/48 (4%)       4/50 (8%)       8/50 (16%)     |     0/49 (0%)       2/50 (4%)       0/49 (0%)      |
|ADJUSTED (b)           |      8.9%           16.1%           27.6%          |      0.0%            5.7%            0.0%          |
|TERMINAL (d)           |     1/21 (5%)       2/20 (10%)      4/24 (17%)     |     0/30 (0%)       1/33 (3%)       0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |      713             663             658           |      ---             706             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.049 *       P=0.339         P=0.074        |     P=0.641N        P=0.263           (e)          |
|INCIDENTAL TUMOR       |     P=0.031 *       P=0.420         P=0.054        |     P=0.633N        P=0.191           (e)          |
|LOGISTIC REGRESSION    |     P=0.037 *       P=0.358         P=0.059        |     P=0.647N        P=0.243           (e)          |
|COCHRAN-ARMITAGE       |     P=0.033 *                                      |     P=0.669                                        |
|FISHER EXACT           |                     P=0.359         P=0.053        |                     P=0.253           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    17/48 (35%)     21/50 (42%)     26/50 (52%)     |     2/49 (4%)       6/50 (12%)      5/49 (10%)     |
|ADJUSTED (b)           |     52.7%           63.9%           73.6%          |      6.7%           17.4%           14.0%          |
|TERMINAL (d)           |     7/21 (33%)      9/20 (45%)     15/24 (63%)     |     2/30 (7%)       5/33 (15%)      4/33 (12%)     |
|FIRST INCIDENCE (DAYS) |      540             583             520           |      729 (T)         706             671           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.134         P=0.280         P=0.150        |     P=0.232         P=0.167         P=0.261        |
|INCIDENTAL TUMOR       |     P=0.062         P=0.431         P=0.080        |     P=0.235         P=0.138         P=0.260        |
|LOGISTIC REGRESSION    |     P=0.067         P=0.334         P=0.084        |     P=0.244         P=0.151         P=0.265        |
|COCHRAN-ARMITAGE       |     P=0.060                                        |     P=0.186                                        |
|FISHER EXACT           |                     P=0.323         P=0.073        |                     P=0.141         P=0.218        |
|=================================================================================================================================|
 
         DATE: 09/19/94                     EXPERIMENT: 05706 TEST: 02                                                 PAGE   3
                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         12500PPM        25000PPM      |      CONTROL         12500PPM        25000PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     8/50 (16%)      4/20 (20%)      4/49 (8%)      |     4/47 (9%)       5/13 (38%)      4/46 (9%)      |
|ADJUSTED (b)           |     28.7%           38.5%           14.5%          |     13.8%           69.3%           11.1%          |
|TERMINAL (d)           |     5/22 (23%)      1/3 (33%)       3/24 (13%)     |     4/29 (14%)      2/3 (67%)       2/30 (7%)      |
|FIRST INCIDENCE (DAYS) |      540             580             561           |      729 (T)         663             671           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.129N        P=0.566         P=0.156N       |     P=0.514N        P=0.014 *       P=0.603N       |
|INCIDENTAL TUMOR       |     P=0.147N        P=0.307         P=0.169N       |     P=0.454N        P<0.001 **      P=0.583N       |
|LOGISTIC REGRESSION    |     P=0.147N        P=0.340         P=0.169N       |     P=0.493N        P<0.001 **      P=0.587N       |
|COCHRAN-ARMITAGE       |     P=0.161N                                       |     P=0.547                                        |
|FISHER EXACT           |                     P=0.466         P=0.188N       |                     P=0.018 *       P=0.631        |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       3/20 (15%)      4/49 (8%)      |     0/47 (0%)       0/13 (0%)       0/46 (0%)      |
|ADJUSTED (b)           |     12.5%           38.1%           13.9%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     2/22 (9%)       1/3 (33%)       1/24 (4%)      |     0/29 (0%)       0/3 (0%)        0/30 (0%)      |
|FIRST INCIDENCE (DAYS) |      696             676             676           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.478         P=0.259         P=0.548        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.451         P=0.046 *       P=0.521        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.396         P=0.032 *       P=0.526        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.416                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.222         P=0.489        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/19/94                     EXPERIMENT: 05706 TEST: 02                                                 PAGE   4
                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         12500PPM        25000PPM      |      CONTROL         12500PPM        25000PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    11/50 (22%)      7/20 (35%)      8/49 (16%)     |     4/47 (9%)       5/13 (38%)      4/46 (9%)      |
|ADJUSTED (b)           |     39.4%           71.4%           26.9%          |     13.8%           69.3%           11.1%          |
|TERMINAL (d)           |     7/22 (32%)      2/3 (67%)       4/24 (17%)     |     4/29 (14%)      2/3 (67%)       2/30 (7%)      |
|FIRST INCIDENCE (DAYS) |      540             580             561           |      729 (T)         663             671           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.223N        P=0.293         P=0.258N       |     P=0.514N        P=0.014 *       P=0.603N       |
|INCIDENTAL TUMOR       |     P=0.249N        P=0.037 *       P=0.283N       |     P=0.454N        P<0.001 **      P=0.583N       |
|LOGISTIC REGRESSION    |     P=0.247N        P=0.045 *       P=0.279N       |     P=0.493N        P<0.001 **      P=0.587N       |
|COCHRAN-ARMITAGE       |     P=0.289N                                       |     P=0.547                                        |
|FISHER EXACT           |                     P=0.204         P=0.323N       |                     P=0.018 *       P=0.631        |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       0/16 (0%)       2/49 (4%)      |     0/49 (0%)       0/8 (0%)        1/50 (2%)      |
|ADJUSTED (b)           |      0.0%            0.0%            8.3%          |      0.0%            0.0%            3.0%          |
|TERMINAL (d)           |     0/22 (0%)       0/1 (0%)        2/24 (8%)      |     0/30 (0%)       0/0             1/33 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             729 (T)       |      ---             ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.153           (e)           P=0.257        |     P=0.325           (e)           P=0.519        |
|INCIDENTAL TUMOR       |     P=0.153           (e)           P=0.257        |     P=0.325           (e)           P=0.519        |
|LOGISTIC REGRESSION    |     P=0.153           (e)           P=0.257        |     P=0.325           (e)           P=0.519        |
|COCHRAN-ARMITAGE       |     P=0.124                                        |     P=0.304                                        |
|FISHER EXACT           |                       (e)           P=0.247        |                       (e)           P=0.505        |
|=================================================================================================================================|
 
         DATE: 09/19/94                     EXPERIMENT: 05706 TEST: 02                                                 PAGE   5
                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         12500PPM        25000PPM      |      CONTROL         12500PPM        25000PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/49 (2%)       0/16 (0%)       2/49 (4%)      |     0/49 (0%)       0/8 (0%)        0/50 (0%)      |
|ADJUSTED (b)           |      3.3%            0.0%            6.7%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/22 (0%)       0/1 (0%)        1/24 (4%)      |     0/30 (0%)       0/0             0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |      687             ---             624           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.380         P=0.529N        P=0.506        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.371         P=0.923N        P=0.489        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.386         P=0.853N        P=0.506        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.376                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.754N        P=0.500        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/49 (2%)       0/16 (0%)       4/49 (8%)      |     0/49 (0%)       0/8 (0%)        1/50 (2%)      |
|ADJUSTED (b)           |      3.3%            0.0%           14.8%          |      0.0%            0.0%            3.0%          |
|TERMINAL (d)           |     0/22 (0%)       0/1 (0%)        3/24 (13%)     |     0/30 (0%)       0/0             1/33 (3%)      |
|FIRST INCIDENCE (DAYS) |      687             ---             624           |      ---             ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.122         P=0.529N        P=0.196        |     P=0.325           (e)           P=0.519        |
|INCIDENTAL TUMOR       |     P=0.124         P=0.923N        P=0.187        |     P=0.325           (e)           P=0.519        |
|LOGISTIC REGRESSION    |     P=0.122         P=0.853N        P=0.186        |     P=0.325           (e)           P=0.519        |
|COCHRAN-ARMITAGE       |     P=0.109                                        |     P=0.304                                        |
|FISHER EXACT           |                     P=0.754N        P=0.181        |                       (e)           P=0.505        |
|=================================================================================================================================|
 
         DATE: 09/19/94                     EXPERIMENT: 05706 TEST: 02                                                 PAGE   6
                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         12500PPM        25000PPM      |      CONTROL         12500PPM        25000PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       1/49 (2%)       5/50 (10%)     |     3/50 (6%)       0/42 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      4.5%            5.3%           20.0%          |     10.0%            0.0%            3.0%          |
|TERMINAL (d)           |     1/22 (5%)       1/19 (5%)       4/24 (17%)     |     3/30 (10%)      0/27 (0%)       1/33 (3%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         720           |      729 (T)         ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.063         P=0.730         P=0.124        |     P=0.160N        P=0.139N        P=0.271N       |
|INCIDENTAL TUMOR       |     P=0.059         P=0.730         P=0.119        |     P=0.160N        P=0.139N        P=0.271N       |
|LOGISTIC REGRESSION    |     P=0.058         P=0.730         P=0.118        |     P=0.160N        P=0.139N        P=0.271N       |
|COCHRAN-ARMITAGE       |     P=0.049 *                                      |     P=0.182N                                       |
|FISHER EXACT           |                     P=0.747         P=0.102        |                     P=0.156N        P=0.309N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       1/30 (3%)       2/50 (4%)      |     0/50 (0%)       1/29 (3%)       1/50 (2%)      |
|ADJUSTED (b)           |      4.5%           10.0%            7.2%          |      0.0%            5.3%            3.0%          |
|TERMINAL (d)           |     1/22 (5%)       1/10 (10%)      1/24 (4%)      |     0/30 (0%)       1/19 (5%)       1/33 (3%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         676           |      ---             729 (T)         729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.416         P=0.577         P=0.528        |     P=0.364         P=0.409         P=0.519        |
|INCIDENTAL TUMOR       |     P=0.412         P=0.577         P=0.520        |     P=0.364         P=0.409         P=0.519        |
|LOGISTIC REGRESSION    |     P=0.408         P=0.577         P=0.517        |     P=0.364         P=0.409         P=0.519        |
|COCHRAN-ARMITAGE       |     P=0.386                                        |     P=0.343                                        |
|FISHER EXACT           |                     P=0.612         P=0.500        |                     P=0.367         P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/19/94                     EXPERIMENT: 05706 TEST: 02                                                 PAGE   7
                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         12500PPM        25000PPM      |      CONTROL         12500PPM        25000PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       2/30 (7%)       3/50 (6%)      |     0/50 (0%)       1/29 (3%)       1/50 (2%)      |
|ADJUSTED (b)           |      9.1%           13.6%           11.2%          |      0.0%            5.3%            3.0%          |
|TERMINAL (d)           |     2/22 (9%)       1/10 (10%)      2/24 (8%)      |     0/30 (0%)       1/19 (5%)       1/33 (3%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         697             676           |      ---             729 (T)         729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.454         P=0.469         P=0.538        |     P=0.364         P=0.409         P=0.519        |
|INCIDENTAL TUMOR       |     P=0.444         P=0.419         P=0.532        |     P=0.364         P=0.409         P=0.519        |
|LOGISTIC REGRESSION    |     P=0.441         P=0.399         P=0.527        |     P=0.364         P=0.409         P=0.519        |
|COCHRAN-ARMITAGE       |     P=0.412                                        |     P=0.343                                        |
|FISHER EXACT           |                     P=0.483         P=0.500        |                     P=0.367         P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     2/50 (4%)       1/50 (2%)       2/50 (4%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      6.7%            3.0%            6.1%          |
|TERMINAL (d)           |     0/22 (0%)       0/20 (0%)       0/24 (0%)      |     2/30 (7%)       1/33 (3%)       2/33 (6%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      729 (T)         729 (T)         729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.577N        P=0.467N        P=0.661N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.577N        P=0.467N        P=0.661N       |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.577N        P=0.467N        P=0.661N       |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.610                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.500N        P=0.691N       |
|=================================================================================================================================|
 
         DATE: 09/19/94                     EXPERIMENT: 05706 TEST: 02                                                 PAGE   8
                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         12500PPM        25000PPM      |      CONTROL         12500PPM        25000PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/50 (2%)       0/50 (0%)      |     1/50 (2%)       2/50 (4%)       3/50 (6%)      |
|ADJUSTED (b)           |      0.0%            4.3%            0.0%          |      3.3%            5.1%            7.9%          |
|TERMINAL (d)           |     0/22 (0%)       0/20 (0%)       0/24 (0%)      |     1/30 (3%)       1/33 (3%)       2/33 (6%)      |
|FIRST INCIDENCE (DAYS) |      ---             725             ---           |      729 (T)         565             351           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.718N        P=0.509           (e)          |     P=0.246         P=0.524         P=0.334        |
|INCIDENTAL TUMOR       |     P=0.746         P=0.581           (e)          |     P=0.199         P=0.569         P=0.332        |
|LOGISTIC REGRESSION    |     P=0.719N        P=0.500           (e)          |     P=0.175         P=0.499         P=0.235        |
|COCHRAN-ARMITAGE       |     P=0.731                                        |     P=0.222                                        |
|FISHER EXACT           |                     P=0.500           (e)          |                     P=0.500         P=0.309        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/50 (2%)       0/50 (0%)      |     3/50 (6%)       3/50 (6%)       5/50 (10%)     |
|ADJUSTED (b)           |      0.0%            4.3%            0.0%          |     10.0%            8.0%           13.9%          |
|TERMINAL (d)           |     0/22 (0%)       0/20 (0%)       0/24 (0%)      |     3/30 (10%)      2/33 (6%)       4/33 (12%)     |
|FIRST INCIDENCE (DAYS) |      ---             725             ---           |      729 (T)         565             351           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.718N        P=0.509           (e)          |     P=0.322         P=0.624N        P=0.404        |
|INCIDENTAL TUMOR       |     P=0.746         P=0.581           (e)          |     P=0.284         P=0.594N        P=0.403        |
|LOGISTIC REGRESSION    |     P=0.719N        P=0.500           (e)          |     P=0.261         P=0.661N        P=0.326        |
|COCHRAN-ARMITAGE       |     P=0.731                                        |     P=0.283                                        |
|FISHER EXACT           |                     P=0.500           (e)          |                     P=0.661N        P=0.357        |
|=================================================================================================================================|
 
         DATE: 09/19/94                     EXPERIMENT: 05706 TEST: 02                                                 PAGE   9
                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         12500PPM        25000PPM      |      CONTROL         12500PPM        25000PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       2/50 (4%)       4/50 (8%)      |    11/50 (22%)     21/50 (42%)     21/50 (42%)     |
|ADJUSTED (b)           |      9.1%           10.0%           15.1%          |     29.0%           53.1%           49.9%          |
|TERMINAL (d)           |     1/22 (5%)       2/20 (10%)      2/24 (8%)      |     5/30 (17%)     15/33 (45%)     13/33 (39%)     |
|FIRST INCIDENCE (DAYS) |       67             729 (T)         700           |      528             583             638           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.456         P=0.526N        P=0.537        |     P=0.074         P=0.061         P=0.082        |
|INCIDENTAL TUMOR       |     P=0.379         P=0.489N        P=0.352        |     P=0.017 *       P=0.014 *       P=0.016 *      |
|LOGISTIC REGRESSION    |     P=0.311         P=0.518N        P=0.437        |     P=0.029 *       P=0.027 *       P=0.029 *      |
|COCHRAN-ARMITAGE       |     P=0.417                                        |     P=0.023 *                                      |
|FISHER EXACT           |                     P=0.500N        P=0.500        |                     P=0.026 *       P=0.026 *      |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       2/50 (4%)       4/50 (8%)      |    13/50 (26%)     21/50 (42%)     23/50 (46%)     |
|ADJUSTED (b)           |      9.1%           10.0%           15.1%          |     34.7%           53.1%           54.9%          |
|TERMINAL (d)           |     1/22 (5%)       2/20 (10%)      2/24 (8%)      |     7/30 (23%)     15/33 (45%)     15/33 (45%)     |
|FIRST INCIDENCE (DAYS) |       67             729 (T)         700           |      528             583             638           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.456         P=0.526N        P=0.537        |     P=0.080         P=0.131         P=0.093        |
|INCIDENTAL TUMOR       |     P=0.379         P=0.489N        P=0.352        |     P=0.019 *       P=0.044 *       P=0.021 *      |
|LOGISTIC REGRESSION    |     P=0.311         P=0.518N        P=0.437        |     P=0.033 *       P=0.071         P=0.037 *      |
|COCHRAN-ARMITAGE       |     P=0.417                                        |     P=0.025 *                                      |
|FISHER EXACT           |                     P=0.500N        P=0.500        |                     P=0.069         P=0.030 *      |
|=================================================================================================================================|
 
         DATE: 09/19/94                     EXPERIMENT: 05706 TEST: 02                                                 PAGE  10
                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         12500PPM        25000PPM      |      CONTROL         12500PPM        25000PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       3/50 (6%)       4/50 (8%)      |    14/50 (28%)     22/50 (44%)     26/50 (52%)     |
|ADJUSTED (b)           |      9.1%           13.9%           15.1%          |     37.5%           54.1%           60.7%          |
|TERMINAL (d)           |     1/22 (5%)       2/20 (10%)      2/24 (8%)      |     8/30 (27%)     15/33 (45%)     17/33 (52%)     |
|FIRST INCIDENCE (DAYS) |       67             725             700           |      528             565             351           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.463         P=0.642         P=0.537        |     P=0.044 *       P=0.139         P=0.053        |
|INCIDENTAL TUMOR       |     P=0.384         P=0.622N        P=0.352        |     P=0.007 **      P=0.052         P=0.010 **     |
|LOGISTIC REGRESSION    |     P=0.323         P=0.653         P=0.437        |     P=0.011 *       P=0.073         P=0.012 *      |
|COCHRAN-ARMITAGE       |     P=0.421                                        |     P=0.010 **                                     |
|FISHER EXACT           |                     P=0.661N        P=0.500        |                     P=0.072         P=0.012 *      |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Granulosa Cell Tumor Benign                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     0/50 (0%)       0/8 (0%)        2/50 (4%)      |
|ADJUSTED (b)           |                                                    |      0.0%            0.0%            6.1%          |
|TERMINAL (d)           |                                                    |     0/30 (0%)       0/0             2/33 (6%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      ---             ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.158           (e)           P=0.259        |
|INCIDENTAL TUMOR       |                                                    |     P=0.158           (e)           P=0.259        |
|LOGISTIC REGRESSION    |                                                    |     P=0.158           (e)           P=0.259        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.133                                        |
|FISHER EXACT           |                                                    |                       (e)           P=0.247        |
|=================================================================================================================================|
 
         DATE: 09/19/94                     EXPERIMENT: 05706 TEST: 02                                                 PAGE  11
                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         12500PPM        25000PPM      |      CONTROL         12500PPM        25000PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    17/50 (34%)      8/49 (16%)     10/50 (20%)     |    15/50 (30%)     20/37 (54%)     14/49 (29%)     |
|ADJUSTED (b)           |     51.2%           24.6%           32.5%          |     38.1%           64.1%           39.4%          |
|TERMINAL (d)           |     8/22 (36%)      2/20 (10%)      5/24 (21%)     |     8/30 (27%)     14/24 (58%)     12/33 (36%)     |
|FIRST INCIDENCE (DAYS) |      443             327             624           |      528             558             686           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.059N        P=0.056N        P=0.076N       |     P=0.329N        P=0.107         P=0.380N       |
|INCIDENTAL TUMOR       |     P=0.068N        P=0.044N*       P=0.081N       |     P=0.498N        P=0.011 *       P=0.552N       |
|LOGISTIC REGRESSION    |     P=0.061N        P=0.037N*       P=0.077N       |     P=0.446N        P=0.019 *       P=0.511N       |
|COCHRAN-ARMITAGE       |     P=0.063N                                       |     P=0.488N                                       |
|FISHER EXACT           |                     P=0.036N*       P=0.088N       |                     P=0.021 *       P=0.526N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       2/50 (4%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      7.3%            7.8%            6.8%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/22 (5%)       1/20 (5%)       1/24 (4%)      |     0/30 (0%)       0/33 (0%)       0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |      630             658             635           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.566N        P=0.686         P=0.664N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.592N        P=0.689         P=0.693N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.589N        P=0.691N        P=0.686N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.601                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.691N        P=0.691N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/19/94                     EXPERIMENT: 05706 TEST: 02                                                 PAGE  12
                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         12500PPM        25000PPM      |      CONTROL         12500PPM        25000PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       1/50 (2%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      9.1%            5.0%            4.2%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     2/22 (9%)       1/20 (5%)       1/24 (4%)      |     0/30 (0%)       0/33 (0%)       0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         729 (T)       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.352N        P=0.534N        P=0.469N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.352N        P=0.534N        P=0.469N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.352N        P=0.534N        P=0.469N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.378N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.500N        P=0.500N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma                                                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            5.5%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/22 (0%)       0/20 (0%)       0/24 (0%)      |     0/30 (0%)       0/33 (0%)       0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             588           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.101           (e)           P=0.250        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.089           (e)           P=0.231        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.087           (e)           P=0.218        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.095                                        |       (e)                                          |
|FISHER EXACT           |                       (e)           P=0.247        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/19/94                     EXPERIMENT: 05706 TEST: 02                                                 PAGE  13
                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         12500PPM        25000PPM      |      CONTROL         12500PPM        25000PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       3/50 (6%)       5/50 (10%)     |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     16.1%           12.6%           15.7%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     3/22 (14%)      2/20 (10%)      2/24 (8%)      |     0/30 (0%)       0/33 (0%)       0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |      630             658             588           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.474         P=0.528N        P=0.545        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.446         P=0.526N        P=0.513        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.447         P=0.492N        P=0.520        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.427                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.500N        P=0.500        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       0/50 (0%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      2.9%            0.0%            6.5%          |      0.0%            0.0%            5.6%          |
|TERMINAL (d)           |     0/22 (0%)       0/20 (0%)       1/24 (4%)      |     0/30 (0%)       0/33 (0%)       1/33 (3%)      |
|FIRST INCIDENCE (DAYS) |      630             ---             588           |      ---             ---             718           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.378         P=0.494N        P=0.519        |     P=0.111           (e)           P=0.273        |
|INCIDENTAL TUMOR       |     P=0.357         P=0.552N        P=0.491        |     P=0.120           (e)           P=0.268        |
|LOGISTIC REGRESSION    |     P=0.353         P=0.502N        P=0.490        |     P=0.109           (e)           P=0.266        |
|COCHRAN-ARMITAGE       |     P=0.360                                        |     P=0.095                                        |
|FISHER EXACT           |                     P=0.500N        P=0.500        |                       (e)           P=0.247        |
|=================================================================================================================================|
 
         DATE: 09/19/94                     EXPERIMENT: 05706 TEST: 02                                                 PAGE  14
                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         12500PPM        25000PPM      |      CONTROL         12500PPM        25000PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       3/50 (6%)       4/50 (8%)      |     1/50 (2%)       0/50 (0%)       3/50 (6%)      |
|ADJUSTED (b)           |      2.9%            7.6%           11.5%          |      2.4%            0.0%            7.5%          |
|TERMINAL (d)           |     0/22 (0%)       0/20 (0%)       1/24 (4%)      |     0/30 (0%)       0/33 (0%)       1/33 (3%)      |
|FIRST INCIDENCE (DAYS) |      630             595             491           |      653             ---             638           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.153         P=0.326         P=0.208        |     P=0.209         P=0.510N        P=0.355        |
|INCIDENTAL TUMOR       |     P=0.127         P=0.266         P=0.179        |     P=0.163         P=0.607N        P=0.249        |
|LOGISTIC REGRESSION    |     P=0.111         P=0.299         P=0.151        |     P=0.168         P=0.501N        P=0.287        |
|COCHRAN-ARMITAGE       |     P=0.133                                        |     P=0.176                                        |
|FISHER EXACT           |                     P=0.309         P=0.181        |                     P=0.500N        P=0.309        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       3/50 (6%)      |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      2.9%            5.4%            8.4%          |      0.0%            0.0%            5.6%          |
|TERMINAL (d)           |     0/22 (0%)       0/20 (0%)       1/24 (4%)      |     0/30 (0%)       0/33 (0%)       1/33 (3%)      |
|FIRST INCIDENCE (DAYS) |      630             615             491           |      ---             ---             718           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.243         P=0.517         P=0.331        |     P=0.111           (e)           P=0.273        |
|INCIDENTAL TUMOR       |     P=0.219         P=0.486         P=0.300        |     P=0.120           (e)           P=0.268        |
|LOGISTIC REGRESSION    |     P=0.191         P=0.497         P=0.253        |     P=0.109           (e)           P=0.266        |
|COCHRAN-ARMITAGE       |     P=0.222                                        |     P=0.095                                        |
|FISHER EXACT           |                     P=0.500         P=0.309        |                       (e)           P=0.247        |
|=================================================================================================================================|
 
         DATE: 09/19/94                     EXPERIMENT: 05706 TEST: 02                                                 PAGE  15
                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         12500PPM        25000PPM      |      CONTROL         12500PPM        25000PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Sarcoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/50 (4%)       1/50 (2%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            5.4%            2.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/22 (0%)       0/20 (0%)       0/24 (0%)      |     0/30 (0%)       0/33 (0%)       0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             615             491           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.374         P=0.253         P=0.517        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.355         P=0.252         P=0.500        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.309         P=0.235         P=0.384        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.360                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.247         P=0.500        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    42/50 (84%)     40/50 (80%)     46/50 (92%)     |                                                    |
|ADJUSTED (b)           |     97.6%           97.5%          100.0%          |                                                    |
|TERMINAL (d)           |    21/22 (95%)     19/20 (95%)     24/24 (100%)    |                                                    |
|FIRST INCIDENCE (DAYS) |      446             510             508           |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.466         P=0.538N        P=0.491        |                                                    |
|INCIDENTAL TUMOR       |     P=0.235         P=0.322N        P=0.262        |                                                    |
|LOGISTIC REGRESSION    |     P=0.252         P=0.293N        P=0.307        |                                                    |
|COCHRAN-ARMITAGE       |     P=0.161                                        |                                                    |
|FISHER EXACT           |                     P=0.398N        P=0.178        |                                                    |
|=================================================================================================================================|
 
         DATE: 09/19/94                     EXPERIMENT: 05706 TEST: 02                                                 PAGE  16
                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         12500PPM        25000PPM      |      CONTROL         12500PPM        25000PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/49 (4%)       1/18 (6%)       0/50 (0%)      |     2/49 (4%)       0/10 (0%)       3/49 (6%)      |
|ADJUSTED (b)           |      8.1%           33.3%            0.0%          |      6.3%            0.0%            9.1%          |
|TERMINAL (d)           |     1/22 (5%)       1/3 (33%)       0/24 (0%)      |     1/30 (3%)       0/2 (0%)        3/33 (9%)      |
|FIRST INCIDENCE (DAYS) |      696             729 (T)         ---           |      713             ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.156N        P=0.634         P=0.223N       |     P=0.449         P=0.445N        P=0.547        |
|INCIDENTAL TUMOR       |     P=0.172N        P=0.376         P=0.230N       |     P=0.457         P=0.965N        P=0.550        |
|LOGISTIC REGRESSION    |     P=0.165N        P=0.446         P=0.225N       |     P=0.470         P=0.865N        P=0.565        |
|COCHRAN-ARMITAGE       |     P=0.166N                                       |     P=0.405                                        |
|FISHER EXACT           |                     P=0.615         P=0.242N       |                     P=0.687N        P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/49 (4%)       1/18 (6%)       3/50 (6%)      |     2/49 (4%)       2/10 (20%)      5/49 (10%)     |
|ADJUSTED (b)           |      8.2%           33.3%           12.5%          |      6.7%          100.0%           14.5%          |
|TERMINAL (d)           |     1/22 (5%)       1/3 (33%)       3/24 (13%)     |     2/30 (7%)       2/2 (100%)      4/33 (12%)     |
|FIRST INCIDENCE (DAYS) |      704             729 (T)         729 (T)       |      729 (T)         729 (T)         719           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.450         P=0.628         P=0.535        |     P=0.225         P=0.003 **      P=0.262        |
|INCIDENTAL TUMOR       |     P=0.449         P=0.376         P=0.532        |     P=0.233         P=0.003 **      P=0.261        |
|LOGISTIC REGRESSION    |     P=0.449         P=0.439         P=0.534        |     P=0.243         P=0.003 **      P=0.271        |
|COCHRAN-ARMITAGE       |     P=0.419                                        |     P=0.180                                        |
|FISHER EXACT           |                     P=0.615         P=0.510        |                     P=0.130         P=0.218        |
|=================================================================================================================================|
 
         DATE: 09/19/94                     EXPERIMENT: 05706 TEST: 02                                                 PAGE  17
                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         12500PPM        25000PPM      |      CONTROL         12500PPM        25000PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/49 (8%)       2/18 (11%)      3/50 (6%)      |     4/49 (8%)       2/10 (20%)      8/49 (16%)     |
|ADJUSTED (b)           |     15.8%           66.7%           12.5%          |     12.7%          100.0%           23.3%          |
|TERMINAL (d)           |     2/22 (9%)       2/3 (67%)       3/24 (13%)     |     3/30 (10%)      2/2 (100%)      7/33 (21%)     |
|FIRST INCIDENCE (DAYS) |      696             729 (T)         729 (T)       |      713             729 (T)         719           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.379N        P=0.479         P=0.458N       |     P=0.195         P=0.172         P=0.233        |
|INCIDENTAL TUMOR       |     P=0.387N        P=0.122         P=0.466N       |     P=0.206         P=0.009 **      P=0.233        |
|LOGISTIC REGRESSION    |     P=0.384N        P=0.193         P=0.464N       |     P=0.221         P=0.014 *       P=0.248        |
|COCHRAN-ARMITAGE       |     P=0.414N                                       |     P=0.146                                        |
|FISHER EXACT           |                     P=0.516         P=0.489N       |                     P=0.266         P=0.178        |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     9/50 (18%)      8/50 (16%)     11/50 (22%)     |
|ADJUSTED (b)           |                                                    |     28.2%           22.7%           28.3%          |
|TERMINAL (d)           |                                                    |     8/30 (27%)      6/33 (18%)      7/33 (21%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      578             706             351           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.444         P=0.419N        P=0.502        |
|INCIDENTAL TUMOR       |                                                    |     P=0.422         P=0.463N        P=0.445        |
|LOGISTIC REGRESSION    |                                                    |     P=0.379         P=0.479N        P=0.398        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.350                                        |
|FISHER EXACT           |                                                    |                     P=0.500N        P=0.402        |
|=================================================================================================================================|
 
         DATE: 09/19/94                     EXPERIMENT: 05706 TEST: 02                                                 PAGE  18
                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         12500PPM        25000PPM      |      CONTROL         12500PPM        25000PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     9/50 (18%)      9/50 (18%)     11/50 (22%)     |
|ADJUSTED (b)           |                                                    |     28.2%           24.6%           28.3%          |
|TERMINAL (d)           |                                                    |     8/30 (27%)      6/33 (18%)      7/33 (21%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      578             643             351           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.448         P=0.525N        P=0.502        |
|INCIDENTAL TUMOR       |                                                    |     P=0.399         P=0.548N        P=0.445        |
|LOGISTIC REGRESSION    |                                                    |     P=0.375         P=0.591N        P=0.398        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.352                                        |
|FISHER EXACT           |                                                    |                     P=0.602N        P=0.402        |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/50 (2%)       0/50 (0%)      |     2/50 (4%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            2.4%            0.0%          |      4.4%            0.0%            0.0%          |
|TERMINAL (d)           |     0/22 (0%)       0/20 (0%)       0/24 (0%)      |     0/30 (0%)       0/33 (0%)       0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             609             ---           |      603             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.732         P=0.510           (e)          |     P=0.090N        P=0.247N        P=0.219N       |
|INCIDENTAL TUMOR       |     P=0.712         P=0.448           (e)          |     P=0.122N        P=0.147N        P=0.500N       |
|LOGISTIC REGRESSION    |     P=0.719         P=0.495           (e)          |     P=0.106N        P=0.239N        P=0.279N       |
|COCHRAN-ARMITAGE       |     P=0.731                                        |     P=0.095N                                       |
|FISHER EXACT           |                     P=0.500           (e)          |                     P=0.247N        P=0.247N       |
|=================================================================================================================================|
 
         DATE: 09/19/94                     EXPERIMENT: 05706 TEST: 02                                                 PAGE  19
                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         12500PPM        25000PPM      |      CONTROL         12500PPM        25000PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    23/50 (46%)     29/50 (58%)     28/50 (56%)     |    16/50 (32%)     14/50 (28%)     15/50 (30%)     |
|ADJUSTED (b)           |     60.6%           71.1%           64.7%          |     43.9%           35.3%           34.1%          |
|TERMINAL (d)           |     8/22 (36%)      9/20 (45%)     10/24 (42%)     |    10/30 (33%)      8/33 (24%)      5/33 (15%)     |
|FIRST INCIDENCE (DAYS) |      561             510             508           |      644             630             638           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.335         P=0.207         P=0.350        |     P=0.326N        P=0.337N        P=0.354N       |
|INCIDENTAL TUMOR       |     P=0.185         P=0.191         P=0.212        |     P=0.378N        P=0.492N        P=0.429N       |
|LOGISTIC REGRESSION    |     P=0.240         P=0.184         P=0.268        |     P=0.333N        P=0.399N        P=0.427N       |
|COCHRAN-ARMITAGE       |     P=0.184                                        |     P=0.457N                                       |
|FISHER EXACT           |                     P=0.158         P=0.212        |                     P=0.414N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma Benign, Malignant, NOS                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       1/50 (2%)       3/50 (6%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     13.6%            2.4%           11.6%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     3/22 (14%)      0/20 (0%)       2/24 (8%)      |     0/30 (0%)       0/33 (0%)       0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         595             700           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.561N        P=0.327N        P=0.624N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.570N        P=0.355N        P=0.630N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.575N        P=0.299N        P=0.631N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.594                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.309N        P=0.661N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/19/94                     EXPERIMENT: 05706 TEST: 02                                                 PAGE  20
                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         12500PPM        25000PPM      |      CONTROL         12500PPM        25000PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    47/50 (94%)     44/50 (88%)     48/50 (96%)     |    32/50 (64%)     36/50 (72%)     44/50 (88%)     |
|ADJUSTED (b)           |    100.0%           97.7%          100.0%          |     77.3%           81.5%           97.7%          |
|TERMINAL (d)           |    22/22 (100%)    19/20 (95%)     24/24 (100%)    |    21/30 (70%)     25/33 (76%)     32/33 (97%)     |
|FIRST INCIDENCE (DAYS) |       67             327             508           |      528             558             351           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.416N        P=0.474N        P=0.446N       |     P=0.087         P=0.458         P=0.103        |
|INCIDENTAL TUMOR       |     P=0.487         P=0.204N        P=0.516        |     P=0.004 **      P=0.243         P=0.005 **     |
|LOGISTIC REGRESSION    |     P=0.521         P=0.205N        P=0.682        |     P=0.007 **      P=0.263         P=0.008 **     |
|COCHRAN-ARMITAGE       |     P=0.424                                        |     P=0.004 **                                     |
|FISHER EXACT           |                     P=0.243N        P=0.500        |                     P=0.260         P=0.005 **     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    32/50 (64%)     38/50 (76%)     42/50 (84%)     |    23/50 (46%)     21/50 (42%)     22/50 (44%)     |
|ADJUSTED (b)           |     77.6%           82.4%           85.6%          |     55.3%           49.4%           49.2%          |
|TERMINAL (d)           |    13/22 (59%)     12/20 (60%)     17/24 (71%)     |    12/30 (40%)     12/33 (36%)     11/33 (33%)     |
|FIRST INCIDENCE (DAYS) |      379             134             491           |      559             565             351           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.170         P=0.214         P=0.179        |     P=0.309N        P=0.341N        P=0.334N       |
|INCIDENTAL TUMOR       |     P=0.013 *       P=0.196         P=0.022 *      |     P=0.439N        P=0.452N        P=0.514N       |
|LOGISTIC REGRESSION    |     P=0.017 *       P=0.143         P=0.025 *      |     P=0.441N        P=0.414N        P=0.501N       |
|COCHRAN-ARMITAGE       |     P=0.014 *                                      |     P=0.460N                                       |
|FISHER EXACT           |                     P=0.138         P=0.020 *      |                     P=0.420N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/19/94                     EXPERIMENT: 05706 TEST: 02                                                 PAGE  21
                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         12500PPM        25000PPM      |      CONTROL         12500PPM        25000PPM      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    50/50 (100%)    50/50 (100%)    50/50 (100%)    |    45/50 (90%)     44/50 (88%)     50/50 (100%)    |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%          |     93.7%           91.6%          100.0%          |
|TERMINAL (d)           |    22/22 (100%)    20/20 (100%)    24/24 (100%)    |    27/30 (90%)     29/33 (88%)     33/33 (100%)    |
|FIRST INCIDENCE (DAYS) |       67             134             491           |      528             558             351           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.364N        P=0.473         P=0.392N       |     P=0.522         P=0.318N        P=0.562N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.034 *       P=0.538N        P=0.028 *      |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.063         P=0.491N        P=0.051        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.042 *                                      |
|FISHER EXACT           |                     P=1.000N        P=1.000N       |                     P=0.500N        P=0.028 *      |
|=================================================================================================================================|
 
 (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).