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TDMS Study 05043-02 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Mason                                          2,4-DIAMINOPHENOL DIHYDROCHLORIDE                          DATE: 09/05/94       
EXPERIMENT: 05043 TEST: 02                                                                                     TIME: 19:08:48       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01CP9561903          ROUTE: GAVAGE                                                                      NTP C#: C60026       
PATHOLOGIST: S. WYAND                        S. EUSTIS                                                         CAS: 137-09-7        
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Mason                                          2,4-DIAMINOPHENOL DIHYDROCHLORIDE                          DATE: 09/05/94      
EXPERIMENT: 05043 TEST: 02                                                                                     TIME: 19:08:48      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01CP9561903          ROUTE: GAVAGE                                                                      NTP C#: C60026      
PATHOLOGIST: S. WYAND                        S. EUSTIS                                                         CAS: 137-09-7       
 
 
 
 
 
                                                    MICE(B6C3F1)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    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: Mason                                          2,4-DIAMINOPHENOL DIHYDROCHLORIDE                          DATE: 09/05/94       
EXPERIMENT: 05043 TEST: 02                                                                                     TIME: 19:08:48       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01CP9561903          ROUTE: GAVAGE                                                                      NTP C#: C60026       
PATHOLOGIST: S. WYAND                        S. EUSTIS                                                         CAS: 137-09-7        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                               IN THE ANALYSIS OF THE STUDY OF 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Kidney: Renal Tubule          Adenoma
                                                           Carcinoma or Adenoma
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Carcinoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Benign
                             Lung                          Alveolar/Bronchiolar Carcinoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
 
              ====================================================================================================
         DATE: 09/05/94                     EXPERIMENT: 05043 TEST: 02                                                 PAGE   1
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         .019 G/         .038 G/       |      VEHICLE         .019 G/         .038 /G       |
|                       |      72VM            KG 72LM         KG 72HM       |      72VF            KG 72LF         KG 72HF       |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/49 (4%)       0/15 (0%)       2/49 (4%)      |     0/46 (0%)       1/12 (8%)       0/44 (0%)      |
|ADJUSTED (b)           |      6.0%            0.0%            5.7%          |      0.0%          100.0%            0.0%          |
|TERMINAL (d)           |     1/29 (3%)       0/0             2/35 (6%)      |     0/30 (0%)       1/1 (100%)      0/23 (0%)      |
|FIRST INCIDENCE (DAYS) |      602             ---             729 (T)       |      ---             729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.536N        P=0.485N        P=0.629N       |     P=0.647         P=0.004 **        (e)          |
|INCIDENTAL TUMOR       |     P=0.536N        P=0.383N        P=0.625N       |     P=0.647         P=0.004 **        (e)          |
|LOGISTIC REGRESSION    |     P=0.555N        P=0.641N        P=0.657N       |     P=0.647         P=0.004 **        (e)          |
|COCHRAN-ARMITAGE       |     P=0.608N                                       |     P=0.696                                        |
|FISHER EXACT           |                     P=0.583N        P=0.691N       |                     P=0.207           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       1/50 (2%)      |     1/50 (2%)       1/50 (2%)       1/50 (2%)      |
|ADJUSTED (b)           |      6.2%            2.9%            2.8%          |      2.9%            3.2%            3.2%          |
|TERMINAL (d)           |     1/30 (3%)       0/33 (0%)       1/36 (3%)      |     1/34 (3%)       1/31 (3%)       0/28 (0%)      |
|FIRST INCIDENCE (DAYS) |      669             719             729 (T)       |      729 (T)         729 (T)         667           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.330N        P=0.472N        P=0.442N       |     P=0.581         P=0.741         P=0.710        |
|INCIDENTAL TUMOR       |     P=0.354N        P=0.655N        P=0.458N       |     P=0.604         P=0.741         P=0.739        |
|LOGISTIC REGRESSION    |     P=0.336N        P=0.475N        P=0.455N       |     P=0.598         P=0.741         P=0.736        |
|COCHRAN-ARMITAGE       |     P=0.378N                                       |     P=0.640                                        |
|FISHER EXACT           |                     P=0.500N        P=0.500N       |                     P=0.753N        P=0.753N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05043 TEST: 02                                                 PAGE   2
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         .019 G/         .038 G/       |      VEHICLE         .019 G/         .038 /G       |
|                       |      72VM            KG 72LM         KG 72HM       |      72VF            KG 72LF         KG 72HF       |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/48 (0%)       3/50 (6%)      |     0/50 (0%)       0/39 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            8.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/30 (0%)       0/31 (0%)       2/36 (6%)      |     0/34 (0%)       0/23 (0%)       0/28 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             688           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.051           (e)           P=0.158        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.052           (e)           P=0.145        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.047 *         (e)           P=0.146        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.038 *                                      |       (e)                                          |
|FISHER EXACT           |                       (e)           P=0.121        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/48 (0%)       3/50 (6%)      |     0/50 (0%)       1/39 (3%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            8.0%          |      0.0%            4.3%            0.0%          |
|TERMINAL (d)           |     0/30 (0%)       0/31 (0%)       2/36 (6%)      |     0/34 (0%)       1/23 (4%)       0/28 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             688           |      ---             729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.051           (e)           P=0.158        |     P=0.693         P=0.422           (e)          |
|INCIDENTAL TUMOR       |     P=0.052           (e)           P=0.145        |     P=0.693         P=0.422           (e)          |
|LOGISTIC REGRESSION    |     P=0.047 *         (e)           P=0.146        |     P=0.693         P=0.422           (e)          |
|COCHRAN-ARMITAGE       |     P=0.038 *                                      |     P=0.723                                        |
|FISHER EXACT           |                       (e)           P=0.121        |                     P=0.438           (e)          |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05043 TEST: 02                                                 PAGE   3
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         .019 G/         .038 G/       |      VEHICLE         .019 G/         .038 /G       |
|                       |      72VM            KG 72LM         KG 72HM       |      72VF            KG 72LF         KG 72HF       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    11/50 (22%)     14/50 (28%)      5/50 (10%)     |     3/50 (6%)       3/50 (6%)       3/50 (6%)      |
|ADJUSTED (b)           |     32.4%           37.9%           13.1%          |      8.8%            8.8%           10.7%          |
|TERMINAL (d)           |     8/30 (27%)     11/33 (33%)      4/36 (11%)     |     3/34 (9%)       1/31 (3%)       3/28 (11%)     |
|FIRST INCIDENCE (DAYS) |      483             483             579           |      729 (T)         700             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.038N*       P=0.423         P=0.044N*      |     P=0.475         P=0.615         P=0.571        |
|INCIDENTAL TUMOR       |     P=0.045N*       P=0.401         P=0.051N       |     P=0.508         P=0.634         P=0.571        |
|LOGISTIC REGRESSION    |     P=0.052N        P=0.380         P=0.056N       |     P=0.466         P=0.632         P=0.571        |
|COCHRAN-ARMITAGE       |     P=0.085N                                       |     P=0.583                                        |
|FISHER EXACT           |                     P=0.322         P=0.086N       |                     P=0.661N        P=0.661N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      6/50 (12%)      3/50 (6%)      |     1/50 (2%)       4/50 (8%)       0/50 (0%)      |
|ADJUSTED (b)           |     13.1%           15.7%            8.0%          |      2.6%           10.7%            0.0%          |
|TERMINAL (d)           |     1/30 (3%)       3/33 (9%)       2/36 (6%)      |     0/34 (0%)       1/31 (3%)       0/28 (0%)      |
|FIRST INCIDENCE (DAYS) |      469             590             688           |      710             619             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.230N        P=0.546         P=0.283N       |     P=0.484N        P=0.163         P=0.561N       |
|INCIDENTAL TUMOR       |     P=0.237N        P=0.548N        P=0.315N       |     P=0.400N        P=0.208         P=0.500N       |
|LOGISTIC REGRESSION    |     P=0.298N        P=0.500         P=0.358N       |     P=0.422N        P=0.247         P=0.534N       |
|COCHRAN-ARMITAGE       |     P=0.303N                                       |     P=0.390N                                       |
|FISHER EXACT           |                     P=0.500         P=0.357N       |                     P=0.181         P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05043 TEST: 02                                                 PAGE   4
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         .019 G/         .038 G/       |      VEHICLE         .019 G/         .038 /G       |
|                       |      72VM            KG 72LM         KG 72HM       |      72VF            KG 72LF         KG 72HF       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    15/50 (30%)     18/50 (36%)      8/50 (16%)     |     4/50 (8%)       7/50 (14%)      3/50 (6%)      |
|ADJUSTED (b)           |     40.4%           46.3%           20.7%          |     11.2%           18.7%           10.7%          |
|TERMINAL (d)           |     9/30 (30%)     13/33 (39%)      6/36 (17%)     |     3/34 (9%)       2/31 (6%)       3/28 (11%)     |
|FIRST INCIDENCE (DAYS) |      469             483             579           |      710             619             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.031N*       P=0.452         P=0.037N*      |     P=0.557         P=0.223         P=0.614N       |
|INCIDENTAL TUMOR       |     P=0.033N*       P=0.497         P=0.043N*      |     P=0.502N        P=0.264         P=0.590N       |
|LOGISTIC REGRESSION    |     P=0.045N*       P=0.388         P=0.051N       |     P=0.537N        P=0.322         P=0.640N       |
|COCHRAN-ARMITAGE       |     P=0.072N                                       |     P=0.432N                                       |
|FISHER EXACT           |                     P=0.335         P=0.077N       |                     P=0.262         P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    15/50 (30%)     18/50 (36%)      8/50 (16%)     |     4/50 (8%)       7/50 (14%)      3/50 (6%)      |
|ADJUSTED (b)           |     40.4%           46.3%           20.7%          |     11.2%           18.7%           10.7%          |
|TERMINAL (d)           |     9/30 (30%)     13/33 (39%)      6/36 (17%)     |     3/34 (9%)       2/31 (6%)       3/28 (11%)     |
|FIRST INCIDENCE (DAYS) |      469             483             579           |      710             619             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.031N*       P=0.452         P=0.037N*      |     P=0.557         P=0.223         P=0.614N       |
|INCIDENTAL TUMOR       |     P=0.033N*       P=0.497         P=0.043N*      |     P=0.502N        P=0.264         P=0.590N       |
|LOGISTIC REGRESSION    |     P=0.045N*       P=0.388         P=0.051N       |     P=0.537N        P=0.322         P=0.640N       |
|COCHRAN-ARMITAGE       |     P=0.072N                                       |     P=0.432N                                       |
|FISHER EXACT           |                     P=0.335         P=0.077N       |                     P=0.262         P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05043 TEST: 02                                                 PAGE   5
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         .019 G/         .038 G/       |      VEHICLE         .019 G/         .038 /G       |
|                       |      72VM            KG 72LM         KG 72HM       |      72VF            KG 72LF         KG 72HF       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       2/19 (11%)      7/50 (14%)     |     1/50 (2%)       1/20 (5%)       3/50 (6%)      |
|ADJUSTED (b)           |      6.7%           35.0%           18.7%          |      2.9%           16.7%           10.7%          |
|TERMINAL (d)           |     2/30 (7%)       1/3 (33%)       6/36 (17%)     |     1/34 (3%)       1/6 (17%)       3/28 (11%)     |
|FIRST INCIDENCE (DAYS) |      729 (T)         613             613           |      729 (T)         729 (T)         729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.112         P=0.154         P=0.130        |     P=0.173         P=0.344         P=0.237        |
|INCIDENTAL TUMOR       |     P=0.108         P=0.195         P=0.131        |     P=0.173         P=0.344         P=0.237        |
|LOGISTIC REGRESSION    |     P=0.098         P=0.139         P=0.117        |     P=0.173         P=0.344         P=0.237        |
|COCHRAN-ARMITAGE       |     P=0.060                                        |     P=0.226                                        |
|FISHER EXACT           |                     P=0.303         P=0.080        |                     P=0.493         P=0.309        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/19 (11%)      0/50 (0%)      |     1/50 (2%)       4/20 (20%)      0/50 (0%)      |
|ADJUSTED (b)           |      3.3%           66.7%            0.0%          |      2.6%           51.6%            0.0%          |
|TERMINAL (d)           |     1/30 (3%)       2/3 (67%)       0/36 (0%)      |     0/34 (0%)       3/6 (50%)       0/28 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         ---           |      705             726             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.324N        P=0.005 **      P=0.464N       |     P=0.490N        P=0.011 *       P=0.566N       |
|INCIDENTAL TUMOR       |     P=0.324N        P=0.005 **      P=0.464N       |     P=0.455N        P<0.001 **      P=0.500N       |
|LOGISTIC REGRESSION    |     P=0.324N        P=0.005 **      P=0.464N       |     P=0.506N        P<0.001 **      P=0.530N       |
|COCHRAN-ARMITAGE       |     P=0.375N                                       |     P=0.401N                                       |
|FISHER EXACT           |                     P=0.182         P=0.500N       |                     P=0.021 *       P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05043 TEST: 02                                                 PAGE   6
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         .019 G/         .038 G/       |      VEHICLE         .019 G/         .038 /G       |
|                       |      72VM            KG 72LM         KG 72HM       |      72VF            KG 72LF         KG 72HF       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       4/19 (21%)      7/50 (14%)     |     2/50 (4%)       5/20 (25%)      3/50 (6%)      |
|ADJUSTED (b)           |     10.0%          100.0%           18.7%          |      5.4%           67.7%           10.7%          |
|TERMINAL (d)           |     3/30 (10%)      3/3 (100%)      6/36 (17%)     |     1/34 (3%)       4/6 (67%)       3/28 (11%)     |
|FIRST INCIDENCE (DAYS) |      729 (T)         613             613           |      705             726             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.238         P=0.001 **      P=0.239        |     P=0.309         P=0.003 **      P=0.400        |
|INCIDENTAL TUMOR       |     P=0.234         P=0.002 **      P=0.241        |     P=0.336         P<0.001 **      P=0.430        |
|LOGISTIC REGRESSION    |     P=0.216         P=0.002 **      P=0.221        |     P=0.275         P<0.001 **      P=0.391        |
|COCHRAN-ARMITAGE       |     P=0.139                                        |     P=0.428                                        |
|FISHER EXACT           |                     P=0.085         P=0.159        |                     P=0.018 *       P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     1/50 (2%)       2/50 (4%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      2.9%            6.5%            0.0%          |
|TERMINAL (d)           |     0/30 (0%)       0/33 (0%)       0/36 (0%)      |     1/34 (3%)       2/31 (6%)       0/28 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      729 (T)         729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.413N        P=0.468         P=0.539N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.413N        P=0.468         P=0.539N       |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.413N        P=0.468         P=0.539N       |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.360N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.500         P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05043 TEST: 02                                                 PAGE   7
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         .019 G/         .038 G/       |      VEHICLE         .019 G/         .038 /G       |
|                       |      72VM            KG 72LM         KG 72HM       |      72VF            KG 72LF         KG 72HF       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/41 (0%)       0/15 (0%)       0/50 (0%)      |     7/46 (15%)      3/13 (23%)      4/44 (9%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |     19.0%          100.0%           16.7%          |
|TERMINAL (d)           |     0/23 (0%)       0/0             0/36 (0%)      |     5/34 (15%)      1/1 (100%)      4/24 (17%)     |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      670             516             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.439N        P=0.351         P=0.484N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.387N        P=0.027 *       P=0.442N       |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.405N        P=0.062         P=0.485N       |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.247N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.383         P=0.287N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       3/50 (6%)       4/50 (8%)      |     0/50 (0%)       2/50 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |      5.7%            8.1%            8.8%          |      0.0%            5.1%            3.0%          |
|TERMINAL (d)           |     0/30 (0%)       2/33 (6%)       0/36 (0%)      |     0/34 (0%)       0/31 (0%)       0/28 (0%)      |
|FIRST INCIDENCE (DAYS) |      607             449             453           |      ---             631             662           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.334         P=0.535         P=0.412        |     P=0.317         P=0.229         P=0.462        |
|INCIDENTAL TUMOR       |     P=0.248         P=0.463         P=0.332        |     P=0.353         P=0.314         P=0.500        |
|LOGISTIC REGRESSION    |     P=0.218         P=0.498         P=0.243        |     P=0.360         P=0.242         P=0.494        |
|COCHRAN-ARMITAGE       |     P=0.264                                        |     P=0.360                                        |
|FISHER EXACT           |                     P=0.500         P=0.339        |                     P=0.247         P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05043 TEST: 02                                                 PAGE   8
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         .019 G/         .038 G/       |      VEHICLE         .019 G/         .038 /G       |
|                       |      72VM            KG 72LM         KG 72HM       |      72VF            KG 72LF         KG 72HF       |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/19 (5%)       0/50 (0%)      |     0/50 (0%)       1/24 (4%)       0/50 (0%)      |
|ADJUSTED (b)           |      6.7%            2.3%            0.0%          |      0.0%            2.5%            0.0%          |
|TERMINAL (d)           |     2/30 (7%)       0/3 (0%)        0/36 (0%)      |     0/34 (0%)       0/9 (0%)        0/28 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         570             ---           |      ---             620             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.138N        P=0.634         P=0.199N       |     P=0.707         P=0.490           (e)          |
|INCIDENTAL TUMOR       |     P=0.134N        P=0.698         P=0.199N       |     P=0.760         P=0.638           (e)          |
|LOGISTIC REGRESSION    |     P=0.155N        P=0.595         P=0.199N       |     P=0.710N        P=0.365           (e)          |
|COCHRAN-ARMITAGE       |     P=0.169N                                       |     P=0.712                                        |
|FISHER EXACT           |                     P=0.626         P=0.247N       |                     P=0.324           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       1/50 (2%)      |     2/50 (4%)       2/50 (4%)       3/50 (6%)      |
|ADJUSTED (b)           |      6.7%            3.0%            2.8%          |      5.9%            6.5%           10.7%          |
|TERMINAL (d)           |     2/30 (7%)       1/33 (3%)       1/36 (3%)      |     2/34 (6%)       2/31 (6%)       3/28 (11%)     |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         729 (T)       |      729 (T)         729 (T)         729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.322N        P=0.467N        P=0.436N       |     P=0.324         P=0.662         P=0.411        |
|INCIDENTAL TUMOR       |     P=0.322N        P=0.467N        P=0.436N       |     P=0.324         P=0.662         P=0.411        |
|LOGISTIC REGRESSION    |     P=0.322N        P=0.467N        P=0.436N       |     P=0.324         P=0.662         P=0.411        |
|COCHRAN-ARMITAGE       |     P=0.378N                                       |     P=0.406                                        |
|FISHER EXACT           |                     P=0.500N        P=0.500N       |                     P=0.691N        P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05043 TEST: 02                                                 PAGE   9
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         .019 G/         .038 G/       |      VEHICLE         .019 G/         .038 /G       |
|                       |      72VM            KG 72LM         KG 72HM       |      72VF            KG 72LF         KG 72HF       |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       1/50 (2%)      |     1/50 (2%)       2/50 (4%)       3/50 (6%)      |
|ADJUSTED (b)           |      6.7%            3.0%            2.8%          |      2.9%            6.5%           10.7%          |
|TERMINAL (d)           |     2/30 (7%)       1/33 (3%)       1/36 (3%)      |     1/34 (3%)       2/31 (6%)       3/28 (11%)     |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         729 (T)       |      729 (T)         729 (T)         729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.322N        P=0.467N        P=0.436N       |     P=0.165         P=0.468         P=0.237        |
|INCIDENTAL TUMOR       |     P=0.322N        P=0.467N        P=0.436N       |     P=0.165         P=0.468         P=0.237        |
|LOGISTIC REGRESSION    |     P=0.322N        P=0.467N        P=0.436N       |     P=0.165         P=0.468         P=0.237        |
|COCHRAN-ARMITAGE       |     P=0.378N                                       |     P=0.222                                        |
|FISHER EXACT           |                     P=0.500N        P=0.500N       |                     P=0.500         P=0.309        |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/16 (0%)       2/50 (4%)      |                                                    |
|ADJUSTED (b)           |      0.0%            0.0%            5.6%          |                                                    |
|TERMINAL (d)           |     0/30 (0%)       0/1 (0%)        2/36 (6%)      |                                                    |
|FIRST INCIDENCE (DAYS) |      ---             ---             729 (T)       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.171           (e)           P=0.279        |                                                    |
|INCIDENTAL TUMOR       |     P=0.171           (e)           P=0.279        |                                                    |
|LOGISTIC REGRESSION    |     P=0.171           (e)           P=0.279        |                                                    |
|COCHRAN-ARMITAGE       |     P=0.125                                        |                                                    |
|FISHER EXACT           |                       (e)           P=0.247        |                                                    |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05043 TEST: 02                                                 PAGE  10
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         .019 G/         .038 G/       |      VEHICLE         .019 G/         .038 /G       |
|                       |      72VM            KG 72LM         KG 72HM       |      72VF            KG 72LF         KG 72HF       |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/49 (4%)       0/15 (0%)       2/49 (4%)      |     0/50 (0%)       0/13 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      6.9%            0.0%            5.6%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     2/29 (7%)       0/0             2/36 (6%)      |     0/34 (0%)       0/0             0/28 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         ---             729 (T)       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.514N          (e)           P=0.615N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.514N          (e)           P=0.615N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.514N          (e)           P=0.615N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.608N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.583N        P=0.691N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/50 (2%)       1/50 (2%)      |     0/50 (0%)       1/50 (2%)       2/50 (4%)      |
|ADJUSTED (b)           |      0.0%            2.3%            2.8%          |      0.0%            3.2%            7.1%          |
|TERMINAL (d)           |     0/30 (0%)       0/33 (0%)       1/36 (3%)      |     0/34 (0%)       1/31 (3%)       2/28 (7%)      |
|FIRST INCIDENCE (DAYS) |      ---             571             729 (T)       |      ---             729 (T)         729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.369         P=0.525         P=0.536        |     P=0.112         P=0.482         P=0.196        |
|INCIDENTAL TUMOR       |     P=0.362         P=0.617         P=0.536        |     P=0.112         P=0.482         P=0.196        |
|LOGISTIC REGRESSION    |     P=0.328         P=0.485         P=0.536        |     P=0.112         P=0.482         P=0.196        |
|COCHRAN-ARMITAGE       |     P=0.331                                        |     P=0.142                                        |
|FISHER EXACT           |                     P=0.500         P=0.500        |                     P=0.500         P=0.247        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05043 TEST: 02                                                 PAGE  11
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         .019 G/         .038 G/       |      VEHICLE         .019 G/         .038 /G       |
|                       |      72VM            KG 72LM         KG 72HM       |      72VF            KG 72LF         KG 72HF       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       1/50 (2%)       2/50 (4%)      |     0/50 (0%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |      9.0%            2.3%            5.2%          |      0.0%            2.5%            0.0%          |
|TERMINAL (d)           |     2/30 (7%)       0/33 (0%)       1/36 (3%)      |     0/34 (0%)       0/31 (0%)       0/28 (0%)      |
|FIRST INCIDENCE (DAYS) |      543             570             657           |      ---             620             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.336N        P=0.270N        P=0.424N       |     P=0.707         P=0.490           (e)          |
|INCIDENTAL TUMOR       |     P=0.392N        P=0.281N        P=0.496N       |     P=0.760         P=0.638           (e)          |
|LOGISTIC REGRESSION    |     P=0.393N        P=0.304N        P=0.473N       |     P=0.723N        P=0.513           (e)          |
|COCHRAN-ARMITAGE       |     P=0.399N                                       |     P=0.731                                        |
|FISHER EXACT           |                     P=0.309N        P=0.500N       |                     P=0.500           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       2/50 (4%)       3/50 (6%)      |     0/50 (0%)       2/50 (4%)       2/50 (4%)      |
|ADJUSTED (b)           |      9.0%            4.5%            7.9%          |      0.0%            5.6%            7.1%          |
|TERMINAL (d)           |     2/30 (7%)       0/33 (0%)       2/36 (6%)      |     0/34 (0%)       1/31 (3%)       2/28 (7%)      |
|FIRST INCIDENCE (DAYS) |      543             570             657           |      ---             620             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.508N        P=0.450N        P=0.580N       |     P=0.138         P=0.224         P=0.196        |
|INCIDENTAL TUMOR       |     P=0.560N        P=0.423N        P=0.645N       |     P=0.139         P=0.302         P=0.196        |
|LOGISTIC REGRESSION    |     P=0.585N        P=0.506N        P=0.628N       |     P=0.146         P=0.234         P=0.196        |
|COCHRAN-ARMITAGE       |     P=0.588N                                       |     P=0.176                                        |
|FISHER EXACT           |                     P=0.500N        P=0.661N       |                     P=0.247         P=0.247        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05043 TEST: 02                                                 PAGE  12
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         .019 G/         .038 G/       |      VEHICLE         .019 G/         .038 /G       |
|                       |      72VM            KG 72LM         KG 72HM       |      72VF            KG 72LF         KG 72HF       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/50 (12%)      4/50 (8%)       5/50 (10%)     |    12/50 (24%)     10/50 (20%)      7/50 (14%)     |
|ADJUSTED (b)           |     15.6%           10.4%           13.3%          |     29.5%           29.9%           22.3%          |
|TERMINAL (d)           |     1/30 (3%)       1/33 (3%)       4/36 (11%)     |     6/34 (18%)      8/31 (26%)      5/28 (18%)     |
|FIRST INCIDENCE (DAYS) |      469             590             621           |      558             683             410           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.341N        P=0.327N        P=0.397N       |     P=0.272N        P=0.505N        P=0.311N       |
|INCIDENTAL TUMOR       |     P=0.367N        P=0.279N        P=0.426N       |     P=0.188N        P=0.431N        P=0.210N       |
|LOGISTIC REGRESSION    |     P=0.428N        P=0.375N        P=0.496N       |     P=0.202N        P=0.455N        P=0.219N       |
|COCHRAN-ARMITAGE       |     P=0.434N                                       |     P=0.127N                                       |
|FISHER EXACT           |                     P=0.370N        P=0.500N       |                     P=0.405N        P=0.154N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      4/50 (8%)       5/50 (10%)     |    11/50 (22%)      9/50 (18%)      7/50 (14%)     |
|ADJUSTED (b)           |     13.4%           10.4%           13.3%          |     27.5%           28.0%           22.3%          |
|TERMINAL (d)           |     1/30 (3%)       1/33 (3%)       4/36 (11%)     |     6/34 (18%)      8/31 (26%)      5/28 (18%)     |
|FIRST INCIDENCE (DAYS) |      469             590             621           |      558             704             410           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.470N        P=0.453N        P=0.530N       |     P=0.336N        P=0.496N        P=0.385N       |
|INCIDENTAL TUMOR       |     P=0.510N        P=0.452N        P=0.569N       |     P=0.263N        P=0.431N        P=0.291N       |
|LOGISTIC REGRESSION    |     P=0.554N        P=0.501N        P=0.614N       |     P=0.270N        P=0.449N        P=0.290N       |
|COCHRAN-ARMITAGE       |     P=0.568                                        |     P=0.181N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.630N       |                     P=0.402N        P=0.218N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05043 TEST: 02                                                 PAGE  13
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         .019 G/         .038 G/       |      VEHICLE         .019 G/         .038 /G       |
|                       |      72VM            KG 72LM         KG 72HM       |      72VF            KG 72LF         KG 72HF       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    17/50 (34%)     15/50 (30%)     20/50 (40%)     |    14/50 (28%)     12/50 (24%)     13/50 (26%)     |
|ADJUSTED (b)           |     50.8%           40.8%           50.9%          |     35.9%           32.1%           42.7%          |
|TERMINAL (d)           |    14/30 (47%)     12/33 (36%)     17/36 (47%)     |    10/34 (29%)      7/31 (23%)     11/28 (39%)     |
|FIRST INCIDENCE (DAYS) |      483             483             579           |      340             256             479           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.539N        P=0.297N        P=0.561N       |     P=0.410         P=0.512N        P=0.441        |
|INCIDENTAL TUMOR       |     P=0.499         P=0.308N        P=0.572        |     P=0.539N        P=0.396N        P=0.557        |
|LOGISTIC REGRESSION    |     P=0.464         P=0.325N        P=0.535        |     P=0.535         P=0.426N        P=0.535        |
|COCHRAN-ARMITAGE       |     P=0.300                                        |     P=0.455N                                       |
|FISHER EXACT           |                     P=0.415N        P=0.339        |                     P=0.410N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    17/50 (34%)     15/50 (30%)     17/50 (34%)     |    15/50 (30%)     21/50 (42%)      8/50 (16%)     |
|ADJUSTED (b)           |     41.4%           36.6%           38.4%          |     36.2%           51.9%           24.7%          |
|TERMINAL (d)           |     6/30 (20%)      8/33 (24%)      9/36 (25%)     |     8/34 (24%)     12/31 (39%)      5/28 (18%)     |
|FIRST INCIDENCE (DAYS) |      469             449             453           |      558             337             410           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.343N        P=0.329N        P=0.374N       |     P=0.241N        P=0.114         P=0.212N       |
|INCIDENTAL TUMOR       |     P=0.425N        P=0.356N        P=0.466N       |     P=0.106N        P=0.169         P=0.110N       |
|LOGISTIC REGRESSION    |     P=0.488N        P=0.319N        P=0.555N       |     P=0.128N        P=0.118         P=0.127N       |
|COCHRAN-ARMITAGE       |     P=0.542N                                       |     P=0.077N                                       |
|FISHER EXACT           |                     P=0.415N        P=0.583N       |                     P=0.149         P=0.077N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05043 TEST: 02                                                 PAGE  14
                      STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         .019 G/         .038 G/       |      VEHICLE         .019 G/         .038 /G       |
|                       |      72VM            KG 72LM         KG 72HM       |      72VF            KG 72LF         KG 72HF       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    30/50 (60%)     27/50 (54%)     32/50 (64%)     |    24/50 (48%)     29/50 (58%)     17/50 (34%)     |
|ADJUSTED (b)           |     71.4%           63.7%           69.5%          |     55.4%           65.8%           52.1%          |
|TERMINAL (d)           |    18/30 (60%)     18/33 (55%)     22/36 (61%)     |    15/34 (44%)     16/31 (52%)     13/28 (46%)     |
|FIRST INCIDENCE (DAYS) |      469             449             453           |      340             256             410           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.340N        P=0.225N        P=0.357N       |     P=0.370N        P=0.153         P=0.356N       |
|INCIDENTAL TUMOR       |     P=0.441N        P=0.231N        P=0.450N       |     P=0.149N        P=0.275         P=0.195N       |
|LOGISTIC REGRESSION    |     P=0.512N        P=0.243N        P=0.575N       |     P=0.169N        P=0.177         P=0.208N       |
|COCHRAN-ARMITAGE       |     P=0.380                                        |     P=0.096N                                       |
|FISHER EXACT           |                     P=0.343N        P=0.418        |                     P=0.212         P=0.111N       |
|=================================================================================================================================|
 
 (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).

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