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TDMS Study 05040-02 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: American Biogenics                                       HYDROQUINONE                                     DATE: 09/05/94       
EXPERIMENT: 05040 TEST: 02                                                                                     TIME: 12:08:24       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT:                       ROUTE: GAVAGE                                                                      NTP C#: 55834B       
PATHOLOGIST: S. WYAND                        S. EUSTIS                                                         CAS: 000123319       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: American Biogenics                                       HYDROQUINONE                                     DATE: 09/05/94      
EXPERIMENT: 05040 TEST: 02                                                                                     TIME: 12:08:24      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT:                       ROUTE: GAVAGE                                                                      NTP C#: 55834B      
PATHOLOGIST: S. WYAND                        S. EUSTIS                                                         CAS: 000123319      
 
 
 
 
 
                                                    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
                                                    Clitoral Gland
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: American Biogenics                                       HYDROQUINONE                                     DATE: 09/05/94       
EXPERIMENT: 05040 TEST: 02                                                                                     TIME: 12:08:24       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT:                       ROUTE: GAVAGE                                                                      NTP C#: 55834B       
PATHOLOGIST: S. WYAND                        S. EUSTIS                                                         CAS: 000123319       
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                          IN THE ANALYSIS OF THE STUDY OF HYDROQUINONE
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hepatocellular Adenoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                             Skin: Subcutaneous Tissue     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
                                                            Neurofibroma, or Fibroma
                             All Organs                    Malignant and Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                                                           Carcinoma or Adenoma
                             All Organs                    Malignant Lymphoma And Histiocytic Sarcoma
                                                           Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
                                                            NOS, or Undifferentiated Cell Type
                                                           Benign Tumors
                                                           Malignant Tumors
 
              ====================================================================================================
         DATE: 09/05/94                     EXPERIMENT: 05040 TEST: 02                                                 PAGE   1
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HYDROQUINONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         50 MG/KG        100MG/KG      |      VEHICLE         50 MG/KG        100MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/55 (4%)       2/52 (4%)       0/54 (0%)      |     0/55 (0%)       0/13 (0%)       0/55 (0%)      |
|ADJUSTED (b)           |      6.1%            5.6%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     2/33 (6%)       2/36 (6%)       0/35 (0%)      |     0/37 (0%)       0/0             0/36 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.161N        P=0.664N        P=0.225N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.161N        P=0.664N        P=0.225N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.161N        P=0.664N        P=0.225N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.182N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.670         P=0.252N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/54 (2%)       3/52 (6%)       0/54 (0%)      |     1/51 (2%)       0/11 (0%)       0/52 (0%)      |
|ADJUSTED (b)           |      2.6%            8.3%            0.0%          |      2.5%            0.0%            0.0%          |
|TERMINAL (d)           |     0/32 (0%)       3/36 (8%)       0/35 (0%)      |     0/34 (0%)       0/0             0/35 (0%)      |
|FIRST INCIDENCE (DAYS) |      691             729 (T)         ---           |      691             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.359N        P=0.341         P=0.505N       |     P=0.268N        P=0.490N        P=0.500N       |
|INCIDENTAL TUMOR       |     P=0.373N        P=0.312         P=0.536N       |     P=0.248N        P=0.500N        P=0.464N       |
|LOGISTIC REGRESSION    |     P=0.366N        P=0.311         P=0.498N       |     P=0.300N        P=0.848N        P=0.500N       |
|COCHRAN-ARMITAGE       |     P=0.379N                                       |     P=0.295N                                       |
|FISHER EXACT           |                     P=0.295         P=0.500N       |                     P=0.823N        P=0.495N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05040 TEST: 02                                                 PAGE   2
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HYDROQUINONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         50 MG/KG        100MG/KG      |      VEHICLE         50 MG/KG        100MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/54 (2%)       3/52 (6%)       0/54 (0%)      |     2/51 (4%)       0/11 (0%)       0/52 (0%)      |
|ADJUSTED (b)           |      2.6%            8.3%            0.0%          |      5.4%            0.0%            0.0%          |
|TERMINAL (d)           |     0/32 (0%)       3/36 (8%)       0/35 (0%)      |     1/34 (3%)       0/0             0/35 (0%)      |
|FIRST INCIDENCE (DAYS) |      691             729 (T)         ---           |      691             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.359N        P=0.341         P=0.505N       |     P=0.120N        P=0.490N        P=0.237N       |
|INCIDENTAL TUMOR       |     P=0.373N        P=0.312         P=0.536N       |     P=0.112N        P=0.500N        P=0.217N       |
|LOGISTIC REGRESSION    |     P=0.366N        P=0.311         P=0.498N       |     P=0.129N        P=0.734N        P=0.233N       |
|COCHRAN-ARMITAGE       |     P=0.379N                                       |     P=0.127N                                       |
|FISHER EXACT           |                     P=0.295         P=0.500N       |                     P=0.674N        P=0.243N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/55 (9%)       2/54 (4%)       6/55 (11%)     |     2/55 (4%)       2/55 (4%)       2/55 (4%)      |
|ADJUSTED (b)           |     12.6%            5.4%           15.8%          |      5.2%            5.1%            5.6%          |
|TERMINAL (d)           |     2/33 (6%)       2/37 (5%)       5/36 (14%)     |     1/37 (3%)       2/39 (5%)       2/36 (6%)      |
|FIRST INCIDENCE (DAYS) |      635             729 (T)         649           |      693             735 (T)         735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.470         P=0.192N        P=0.544        |     P=0.594         P=0.672N        P=0.688        |
|INCIDENTAL TUMOR       |     P=0.450         P=0.263N        P=0.515        |     P=0.592N        P=0.653N        P=0.675N       |
|LOGISTIC REGRESSION    |     P=0.447         P=0.220N        P=0.518        |     P=0.596N        P=0.664N        P=0.692N       |
|COCHRAN-ARMITAGE       |     P=0.430                                        |     P=0.601                                        |
|FISHER EXACT           |                     P=0.226N        P=0.500        |                     P=0.691N        P=0.691N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05040 TEST: 02                                                 PAGE   3
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HYDROQUINONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         50 MG/KG        100MG/KG      |      VEHICLE         50 MG/KG        100MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/55 (0%)       0/54 (0%)       0/55 (0%)      |     0/55 (0%)       0/55 (0%)       2/55 (4%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      0.0%            0.0%            4.9%          |
|TERMINAL (d)           |     0/33 (0%)       0/37 (0%)       0/36 (0%)      |     0/37 (0%)       0/39 (0%)       1/36 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      ---             ---             641           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.097           (e)           P=0.244        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.094           (e)           P=0.237        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.093           (e)           P=0.233        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.096                                        |
|FISHER EXACT           |                       (e)             (e)          |                       (e)           P=0.248        |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/55 (9%)       2/54 (4%)       6/55 (11%)     |     2/55 (4%)       2/55 (4%)       4/55 (7%)      |
|ADJUSTED (b)           |     12.6%            5.4%           15.8%          |      5.2%            5.1%           10.3%          |
|TERMINAL (d)           |     2/33 (6%)       2/37 (5%)       5/36 (14%)     |     1/37 (3%)       2/39 (5%)       3/36 (8%)      |
|FIRST INCIDENCE (DAYS) |      635             729 (T)         649           |      693             735 (T)         641           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.470         P=0.192N        P=0.544        |     P=0.249         P=0.672N        P=0.338        |
|INCIDENTAL TUMOR       |     P=0.450         P=0.263N        P=0.515        |     P=0.257         P=0.653N        P=0.353        |
|LOGISTIC REGRESSION    |     P=0.447         P=0.220N        P=0.518        |     P=0.248         P=0.664N        P=0.331        |
|COCHRAN-ARMITAGE       |     P=0.430                                        |     P=0.253                                        |
|FISHER EXACT           |                     P=0.226N        P=0.500        |                     P=0.691N        P=0.339        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05040 TEST: 02                                                 PAGE   4
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HYDROQUINONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         50 MG/KG        100MG/KG      |      VEHICLE         50 MG/KG        100MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/55 (2%)       1/54 (2%)       2/55 (4%)      |     1/55 (2%)       0/55 (0%)       0/55 (0%)      |
|ADJUSTED (b)           |      3.0%            2.7%            4.9%          |      2.7%            0.0%            0.0%          |
|TERMINAL (d)           |     1/33 (3%)       1/37 (3%)       1/36 (3%)      |     1/37 (3%)       0/39 (0%)       0/36 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         655           |      735 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.402         P=0.736N        P=0.525        |     P=0.271N        P=0.489N        P=0.505N       |
|INCIDENTAL TUMOR       |     P=0.383         P=0.736N        P=0.499        |     P=0.271N        P=0.489N        P=0.505N       |
|LOGISTIC REGRESSION    |     P=0.388         P=0.736N        P=0.509        |     P=0.271N        P=0.489N        P=0.505N       |
|COCHRAN-ARMITAGE       |     P=0.379                                        |     P=0.270N                                       |
|FISHER EXACT           |                     P=0.748         P=0.500        |                     P=0.500N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     9/55 (16%)     21/54 (39%)     20/55 (36%)     |     2/55 (4%)      15/55 (27%)     12/55 (22%)     |
|ADJUSTED (b)           |     25.5%           49.3%           51.1%          |      5.4%           36.2%           30.3%          |
|TERMINAL (d)           |     7/33 (21%)     16/37 (43%)     17/36 (47%)     |     2/37 (5%)      13/39 (33%)      9/36 (25%)     |
|FIRST INCIDENCE (DAYS) |      694             441             661           |      735 (T)         534             656           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.025 *       P=0.022 *       P=0.025 *      |     P=0.007 **      P=0.001 **      P=0.005 **     |
|INCIDENTAL TUMOR       |     P=0.015 *       P=0.016 *       P=0.017 *      |     P=0.005 **      P<0.001 **      P=0.006 **     |
|LOGISTIC REGRESSION    |     P=0.018 *       P=0.008 **      P=0.015 *      |     P=0.007 **      P=0.001 **      P=0.005 **     |
|COCHRAN-ARMITAGE       |     P=0.015 *                                      |     P=0.009 **                                     |
|FISHER EXACT           |                     P=0.007 **      P=0.015 *      |                     P<0.001 **      P=0.004 **     |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05040 TEST: 02                                                 PAGE   5
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HYDROQUINONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         50 MG/KG        100MG/KG      |      VEHICLE         50 MG/KG        100MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    13/55 (24%)     11/54 (20%)      7/55 (13%)     |     1/55 (2%)       2/55 (4%)       2/55 (4%)      |
|ADJUSTED (b)           |     29.6%           24.8%           16.8%          |      2.7%            4.0%            5.6%          |
|TERMINAL (d)           |     5/33 (15%)      5/37 (14%)      4/36 (11%)     |     1/37 (3%)       0/39 (0%)       2/36 (6%)      |
|FIRST INCIDENCE (DAYS) |      537             465             526           |      735 (T)         534             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.088N        P=0.367N        P=0.106N       |     P=0.386         P=0.528         P=0.490        |
|INCIDENTAL TUMOR       |     P=0.099N        P=0.524N        P=0.111N       |     P=0.294         P=0.461         P=0.490        |
|LOGISTIC REGRESSION    |     P=0.064N        P=0.521N        P=0.078N       |     P=0.387         P=0.449         P=0.490        |
|COCHRAN-ARMITAGE       |     P=0.090N                                       |     P=0.390                                        |
|FISHER EXACT           |                     P=0.429N        P=0.108N       |                     P=0.500         P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    20/55 (36%)     29/54 (54%)     25/55 (45%)     |     3/55 (5%)      16/55 (29%)     13/55 (24%)     |
|ADJUSTED (b)           |     46.2%           64.1%           59.0%          |      8.1%           37.6%           32.9%          |
|TERMINAL (d)           |    11/33 (33%)     21/37 (57%)     19/36 (53%)     |     3/37 (8%)      13/39 (33%)     10/36 (28%)     |
|FIRST INCIDENCE (DAYS) |      537             441             526           |      735 (T)         534             656           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.299         P=0.151         P=0.317        |     P=0.009 **      P=0.002 **      P=0.007 **     |
|INCIDENTAL TUMOR       |     P=0.213         P=0.061         P=0.247        |     P=0.007 **      P=0.002 **      P=0.008 **     |
|LOGISTIC REGRESSION    |     P=0.222         P=0.053         P=0.249        |     P=0.009 **      P=0.002 **      P=0.007 **     |
|COCHRAN-ARMITAGE       |     P=0.194                                        |     P=0.011 *                                      |
|FISHER EXACT           |                     P=0.052         P=0.219        |                     P<0.001 **      P=0.006 **     |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05040 TEST: 02                                                 PAGE   6
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HYDROQUINONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         50 MG/KG        100MG/KG      |      VEHICLE         50 MG/KG        100MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    20/55 (36%)     29/54 (54%)     25/55 (45%)     |     3/55 (5%)      16/55 (29%)     13/55 (24%)     |
|ADJUSTED (b)           |     46.2%           64.1%           59.0%          |      8.1%           37.6%           32.9%          |
|TERMINAL (d)           |    11/33 (33%)     21/37 (57%)     19/36 (53%)     |     3/37 (8%)      13/39 (33%)     10/36 (28%)     |
|FIRST INCIDENCE (DAYS) |      537             441             526           |      735 (T)         534             656           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.299         P=0.151         P=0.317        |     P=0.009 **      P=0.002 **      P=0.007 **     |
|INCIDENTAL TUMOR       |     P=0.213         P=0.061         P=0.247        |     P=0.007 **      P=0.002 **      P=0.008 **     |
|LOGISTIC REGRESSION    |     P=0.222         P=0.053         P=0.249        |     P=0.009 **      P=0.002 **      P=0.007 **     |
|COCHRAN-ARMITAGE       |     P=0.194                                        |     P=0.011 *                                      |
|FISHER EXACT           |                     P=0.052         P=0.219        |                     P<0.001 **      P=0.006 **     |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/55 (11%)      9/31 (29%)      4/55 (7%)      |     3/55 (5%)       6/55 (11%)      2/55 (4%)      |
|ADJUSTED (b)           |     18.2%           58.3%           11.1%          |      7.1%           14.4%            5.6%          |
|TERMINAL (d)           |     6/33 (18%)      8/14 (57%)      4/36 (11%)     |     1/37 (3%)       4/39 (10%)      2/36 (6%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         701             729 (T)       |      558             660             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.271N        P=0.006 **      P=0.313N       |     P=0.434N        P=0.283         P=0.507N       |
|INCIDENTAL TUMOR       |     P=0.278N        P=0.006 **      P=0.313N       |     P=0.392N        P=0.308         P=0.482N       |
|LOGISTIC REGRESSION    |     P=0.288N        P=0.004 **      P=0.313N       |     P=0.435N        P=0.256         P=0.510N       |
|COCHRAN-ARMITAGE       |     P=0.338N                                       |     P=0.424N                                       |
|FISHER EXACT           |                     P=0.035 *       P=0.371N       |                     P=0.244         P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05040 TEST: 02                                                 PAGE   7
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HYDROQUINONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         50 MG/KG        100MG/KG      |      VEHICLE         50 MG/KG        100MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     8/55 (15%)      4/31 (13%)      6/55 (11%)     |     1/55 (2%)       0/55 (0%)       2/55 (4%)      |
|ADJUSTED (b)           |     21.1%           23.3%           14.7%          |      2.7%            0.0%            5.6%          |
|TERMINAL (d)           |     4/33 (12%)      3/14 (21%)      3/36 (8%)      |     1/37 (3%)       0/39 (0%)       2/36 (6%)      |
|FIRST INCIDENCE (DAYS) |      649             662             563           |      735 (T)         ---             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.297N        P=0.467N        P=0.354N       |     P=0.352         P=0.489N        P=0.490        |
|INCIDENTAL TUMOR       |     P=0.333N        P=0.538N        P=0.403N       |     P=0.352         P=0.489N        P=0.490        |
|LOGISTIC REGRESSION    |     P=0.314N        P=0.615         P=0.371N       |     P=0.352         P=0.489N        P=0.490        |
|COCHRAN-ARMITAGE       |     P=0.334N                                       |     P=0.361                                        |
|FISHER EXACT           |                     P=0.554N        P=0.388N       |                     P=0.500N        P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    14/55 (25%)     11/31 (35%)     10/55 (18%)     |     4/55 (7%)       6/55 (11%)      4/55 (7%)      |
|ADJUSTED (b)           |     37.4%           66.1%           25.0%          |      9.6%           14.4%           11.1%          |
|TERMINAL (d)           |    10/33 (30%)      9/14 (64%)      7/36 (19%)     |     2/37 (5%)       4/39 (10%)      4/36 (11%)     |
|FIRST INCIDENCE (DAYS) |      649             662             563           |      558             660             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.164N        P=0.185         P=0.197N       |     P=0.556         P=0.414         P=0.631        |
|INCIDENTAL TUMOR       |     P=0.185N        P=0.131         P=0.223N       |     P=0.544N        P=0.445         P=0.634N       |
|LOGISTIC REGRESSION    |     P=0.186N        P=0.076         P=0.213N       |     P=0.560         P=0.393         P=0.633        |
|COCHRAN-ARMITAGE       |     P=0.220N                                       |     P=0.568                                        |
|FISHER EXACT           |                     P=0.230         P=0.245N       |                     P=0.371         P=0.642N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05040 TEST: 02                                                 PAGE   8
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HYDROQUINONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         50 MG/KG        100MG/KG      |      VEHICLE         50 MG/KG        100MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/55 (0%)       0/54 (0%)       0/55 (0%)      |     3/55 (5%)       5/55 (9%)       2/55 (4%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      7.2%           12.8%            5.0%          |
|TERMINAL (d)           |     0/33 (0%)       0/37 (0%)       0/36 (0%)      |     2/37 (5%)       5/39 (13%)      1/36 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      372             735 (T)         656           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.434N        P=0.384         P=0.512N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.497N        P=0.336         P=0.615N       |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.430N        P=0.355         P=0.491N       |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.421N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.358         P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       0/14 (0%)       0/50 (0%)      |    11/52 (21%)     14/29 (48%)     11/52 (21%)     |
|ADJUSTED (b)           |      9.3%            0.0%            0.0%          |     30.0%           76.0%           29.8%          |
|TERMINAL (d)           |     2/30 (7%)       0/0             0/31 (0%)      |     9/34 (26%)     12/16 (75%)      8/33 (24%)     |
|FIRST INCIDENCE (DAYS) |      701             ---             ---           |      664             616             644           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.058N        P=0.484N        P=0.117N       |     P=0.518         P=0.007 **      P=0.575        |
|INCIDENTAL TUMOR       |     P=0.065N        P=0.590N        P=0.124N       |     P=0.542N        P=0.006 **      P=0.566N       |
|LOGISTIC REGRESSION    |     P=0.067N        P=0.786N        P=0.120N       |     P=0.530N        P=0.008 **      P=0.585N       |
|COCHRAN-ARMITAGE       |     P=0.059N                                       |     P=0.544N                                       |
|FISHER EXACT           |                     P=0.470N        P=0.121N       |                     P=0.012 *       P=0.595N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05040 TEST: 02                                                 PAGE   9
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HYDROQUINONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         50 MG/KG        100MG/KG      |      VEHICLE         50 MG/KG        100MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/14 (0%)       0/50 (0%)      |     1/52 (2%)       2/29 (7%)       0/52 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      2.2%            8.4%            0.0%          |
|TERMINAL (d)           |     0/30 (0%)       0/0             0/31 (0%)      |     0/34 (0%)       1/16 (6%)       0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      631             683             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.365N        P=0.432         P=0.496N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.346N        P=0.408         P=0.500N       |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.376N        P=0.302         P=0.492N       |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.371N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.290         P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       0/14 (0%)       0/50 (0%)      |    12/52 (23%)     16/29 (55%)     11/52 (21%)     |
|ADJUSTED (b)           |      9.3%            0.0%            0.0%          |     31.5%           82.4%           29.8%          |
|TERMINAL (d)           |     2/30 (7%)       0/0             0/31 (0%)      |     9/34 (26%)     13/16 (81%)      8/33 (24%)     |
|FIRST INCIDENCE (DAYS) |      701             ---             ---           |      631             616             644           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.058N        P=0.484N        P=0.117N       |     P=0.482N        P=0.005 **      P=0.518N       |
|INCIDENTAL TUMOR       |     P=0.065N        P=0.590N        P=0.124N       |     P=0.446N        P=0.003 **      P=0.470N       |
|LOGISTIC REGRESSION    |     P=0.067N        P=0.786N        P=0.120N       |     P=0.448N        P=0.003 **      P=0.497N       |
|COCHRAN-ARMITAGE       |     P=0.059N                                       |     P=0.457N                                       |
|FISHER EXACT           |                     P=0.470N        P=0.121N       |                     P=0.004 **      P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05040 TEST: 02                                                 PAGE  10
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HYDROQUINONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         50 MG/KG        100MG/KG      |      VEHICLE         50 MG/KG        100MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/55 (4%)       1/54 (2%)       1/55 (2%)      |     0/55 (0%)       0/55 (0%)       0/55 (0%)      |
|ADJUSTED (b)           |      4.8%            2.4%            2.3%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/33 (0%)       0/37 (0%)       0/36 (0%)      |     0/37 (0%)       0/39 (0%)       0/36 (0%)      |
|FIRST INCIDENCE (DAYS) |      648             662             661           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.382N        P=0.495N        P=0.501N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.437N        P=0.566N        P=0.566N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.386N        P=0.507N        P=0.511N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.379N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.507N        P=0.500N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/55 (2%)       2/54 (4%)       0/55 (0%)      |     0/55 (0%)       0/55 (0%)       0/55 (0%)      |
|ADJUSTED (b)           |      3.0%            5.4%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/33 (3%)       2/37 (5%)       0/36 (0%)      |     0/37 (0%)       0/39 (0%)       0/36 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.336N        P=0.540         P=0.483N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.336N        P=0.540         P=0.483N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.336N        P=0.540         P=0.483N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.361N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.493         P=0.500N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05040 TEST: 02                                                 PAGE  11
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HYDROQUINONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         50 MG/KG        100MG/KG      |      VEHICLE         50 MG/KG        100MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/55 (9%)       8/54 (15%)      2/55 (4%)      |     1/55 (2%)       1/55 (2%)       0/55 (0%)      |
|ADJUSTED (b)           |     12.1%           18.9%            5.6%          |      2.4%            2.5%            0.0%          |
|TERMINAL (d)           |     1/33 (3%)       4/37 (11%)      2/36 (6%)      |     0/37 (0%)       0/39 (0%)       0/36 (0%)      |
|FIRST INCIDENCE (DAYS) |      635             596             729 (T)       |      676             729             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.189N        P=0.326         P=0.209N       |     P=0.330N        P=0.744N        P=0.500N       |
|INCIDENTAL TUMOR       |     P=0.208N        P=0.169         P=0.224N       |     P=0.267N        P=0.702N        P=0.443N       |
|LOGISTIC REGRESSION    |     P=0.197N        P=0.268         P=0.211N       |     P=0.335N        P=0.756N        P=0.503N       |
|COCHRAN-ARMITAGE       |     P=0.204N                                       |     P=0.332N                                       |
|FISHER EXACT           |                     P=0.266         P=0.219N       |                     P=0.752N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibroma or Fibroma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/55 (4%)       2/54 (4%)       0/55 (0%)      |     0/55 (0%)       0/55 (0%)       0/55 (0%)      |
|ADJUSTED (b)           |      6.1%            5.4%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     2/33 (6%)       2/37 (5%)       0/36 (0%)      |     0/37 (0%)       0/39 (0%)       0/36 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.155N        P=0.654N        P=0.219N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.155N        P=0.654N        P=0.219N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.154N        P=0.654N        P=0.219N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.177N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.684         P=0.248N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05040 TEST: 02                                                 PAGE  12
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HYDROQUINONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         50 MG/KG        100MG/KG      |      VEHICLE         50 MG/KG        100MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     8/55 (15%)     12/54 (22%)      2/55 (4%)      |     1/55 (2%)       1/55 (2%)       0/55 (0%)      |
|ADJUSTED (b)           |     19.7%           28.8%            5.6%          |      2.4%            2.5%            0.0%          |
|TERMINAL (d)           |     3/33 (9%)       8/37 (22%)      2/36 (6%)      |     0/37 (0%)       0/39 (0%)       0/36 (0%)      |
|FIRST INCIDENCE (DAYS) |      635             596             729 (T)       |      676             729             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.054N        P=0.300         P=0.048N*      |     P=0.330N        P=0.744N        P=0.500N       |
|INCIDENTAL TUMOR       |     P=0.060N        P=0.165         P=0.050N       |     P=0.267N        P=0.702N        P=0.443N       |
|LOGISTIC REGRESSION    |     P=0.055N        P=0.222         P=0.045N*      |     P=0.335N        P=0.756N        P=0.503N       |
|COCHRAN-ARMITAGE       |     P=0.062N                                       |     P=0.332N                                       |
|FISHER EXACT           |                     P=0.216         P=0.047N*      |                     P=0.752N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/55 (11%)     11/54 (20%)      2/55 (4%)      |     1/55 (2%)       1/55 (2%)       0/55 (0%)      |
|ADJUSTED (b)           |     14.3%           26.3%            5.6%          |      2.4%            2.5%            0.0%          |
|TERMINAL (d)           |     1/33 (3%)       7/37 (19%)      2/36 (6%)      |     0/37 (0%)       0/39 (0%)       0/36 (0%)      |
|FIRST INCIDENCE (DAYS) |      635             596             729 (T)       |      676             729             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.135N        P=0.197         P=0.135N       |     P=0.330N        P=0.744N        P=0.500N       |
|INCIDENTAL TUMOR       |     P=0.149N        P=0.085         P=0.145N       |     P=0.267N        P=0.702N        P=0.443N       |
|LOGISTIC REGRESSION    |     P=0.139N        P=0.139         P=0.130N       |     P=0.335N        P=0.756N        P=0.503N       |
|COCHRAN-ARMITAGE       |     P=0.149N                                       |     P=0.332N                                       |
|FISHER EXACT           |                     P=0.136         P=0.135N       |                     P=0.752N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05040 TEST: 02                                                 PAGE  13
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HYDROQUINONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         50 MG/KG        100MG/KG      |      VEHICLE         50 MG/KG        100MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Sarcoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/55 (2%)       3/54 (6%)       0/55 (0%)      |     0/55 (0%)       0/55 (0%)       0/55 (0%)      |
|ADJUSTED (b)           |      2.5%            8.1%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/33 (0%)       3/37 (8%)       0/36 (0%)      |     0/37 (0%)       0/39 (0%)       0/36 (0%)      |
|FIRST INCIDENCE (DAYS) |      683             729 (T)         ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.361N        P=0.340         P=0.510N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.373N        P=0.321         P=0.536N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.367N        P=0.312         P=0.500N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.379N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.302         P=0.500N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/55 (4%)       0/54 (0%)       0/55 (0%)      |     0/55 (0%)       1/55 (2%)       0/55 (0%)      |
|ADJUSTED (b)           |      5.1%            0.0%            0.0%          |      0.0%            2.6%            0.0%          |
|TERMINAL (d)           |     1/33 (3%)       0/37 (0%)       0/36 (0%)      |     0/37 (0%)       1/39 (3%)       0/36 (0%)      |
|FIRST INCIDENCE (DAYS) |      635             ---             ---           |      ---             735 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.089N        P=0.225N        P=0.226N       |     P=0.729         P=0.511           (e)          |
|INCIDENTAL TUMOR       |     P=0.094N        P=0.320N        P=0.211N       |     P=0.729         P=0.511           (e)          |
|LOGISTIC REGRESSION    |     P=0.096N        P=0.242N        P=0.238N       |     P=0.729         P=0.511           (e)          |
|COCHRAN-ARMITAGE       |     P=0.096N                                       |     P=0.730                                        |
|FISHER EXACT           |                     P=0.252N        P=0.248N       |                     P=0.500           (e)          |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05040 TEST: 02                                                 PAGE  14
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HYDROQUINONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         50 MG/KG        100MG/KG      |      VEHICLE         50 MG/KG        100MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/55 (2%)       0/18 (0%)       3/55 (5%)      |                                                    |
|ADJUSTED (b)           |      2.6%            0.0%            8.3%          |                                                    |
|TERMINAL (d)           |     0/33 (0%)       0/1 (0%)        3/36 (8%)      |                                                    |
|FIRST INCIDENCE (DAYS) |      691             ---             729 (T)       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.231         P=0.495N        P=0.328        |                                                    |
|INCIDENTAL TUMOR       |     P=0.223         P=0.536N        P=0.313        |                                                    |
|LOGISTIC REGRESSION    |     P=0.226         P=0.802N        P=0.318        |                                                    |
|COCHRAN-ARMITAGE       |     P=0.206                                        |                                                    |
|FISHER EXACT           |                     P=0.753N        P=0.309        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/55 (4%)       1/53 (2%)       2/54 (4%)      |     3/55 (5%)       5/55 (9%)       6/55 (11%)     |
|ADJUSTED (b)           |      5.7%            2.8%            5.2%          |      7.7%           12.2%           15.3%          |
|TERMINAL (d)           |     1/33 (3%)       1/36 (3%)       1/35 (3%)      |     2/37 (5%)       4/39 (10%)      4/36 (11%)     |
|FIRST INCIDENCE (DAYS) |      694             729 (T)         663           |      664             668             548           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.597N        P=0.477N        P=0.682N       |     P=0.190         P=0.394         P=0.240        |
|INCIDENTAL TUMOR       |     P=0.595         P=0.501N        P=0.672        |     P=0.212         P=0.419         P=0.268        |
|LOGISTIC REGRESSION    |     P=0.606N        P=0.501N        P=0.693N       |     P=0.186         P=0.397         P=0.233        |
|COCHRAN-ARMITAGE       |     P=0.602                                        |     P=0.196                                        |
|FISHER EXACT           |                     P=0.514N        P=0.684        |                     P=0.358         P=0.244        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05040 TEST: 02                                                 PAGE  15
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HYDROQUINONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         50 MG/KG        100MG/KG      |      VEHICLE         50 MG/KG        100MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/55 (4%)       1/53 (2%)       2/54 (4%)      |     3/55 (5%)       5/55 (9%)       7/55 (13%)     |
|ADJUSTED (b)           |      5.7%            2.8%            5.2%          |      7.7%           12.2%           17.9%          |
|TERMINAL (d)           |     1/33 (3%)       1/36 (3%)       1/35 (3%)      |     2/37 (5%)       4/39 (10%)      5/36 (14%)     |
|FIRST INCIDENCE (DAYS) |      694             729 (T)         663           |      664             668             548           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.597N        P=0.477N        P=0.682N       |     P=0.118         P=0.394         P=0.157        |
|INCIDENTAL TUMOR       |     P=0.595         P=0.501N        P=0.672        |     P=0.132         P=0.419         P=0.177        |
|LOGISTIC REGRESSION    |     P=0.606N        P=0.501N        P=0.693N       |     P=0.115         P=0.397         P=0.152        |
|COCHRAN-ARMITAGE       |     P=0.602                                        |     P=0.123                                        |
|FISHER EXACT           |                     P=0.514N        P=0.684        |                     P=0.358         P=0.160        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/55 (2%)       0/54 (0%)       1/55 (2%)      |     1/55 (2%)       2/55 (4%)       0/55 (0%)      |
|ADJUSTED (b)           |      2.0%            0.0%            2.4%          |      2.7%            5.1%            0.0%          |
|TERMINAL (d)           |     0/33 (0%)       0/37 (0%)       0/36 (0%)      |     1/37 (3%)       2/39 (5%)       0/36 (0%)      |
|FIRST INCIDENCE (DAYS) |      604             ---             663           |      735 (T)         735 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.664N        P=0.508N        P=0.758N       |     P=0.366N        P=0.518         P=0.505N       |
|INCIDENTAL TUMOR       |     P=0.653N        P=0.682N        P=0.761        |     P=0.366N        P=0.518         P=0.505N       |
|LOGISTIC REGRESSION    |     P=0.654         P=0.500N        P=0.743        |     P=0.366N        P=0.518         P=0.505N       |
|COCHRAN-ARMITAGE       |     P=0.668                                        |     P=0.361N                                       |
|FISHER EXACT           |                     P=0.505N        P=0.752N       |                     P=0.500         P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05040 TEST: 02                                                 PAGE  16
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HYDROQUINONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         50 MG/KG        100MG/KG      |      VEHICLE         50 MG/KG        100MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/55 (2%)       1/54 (2%)       3/55 (5%)      |     1/55 (2%)       0/55 (0%)       1/55 (2%)      |
|ADJUSTED (b)           |      3.0%            2.7%            7.7%          |      2.7%            0.0%            2.8%          |
|TERMINAL (d)           |     1/33 (3%)       1/37 (3%)       2/36 (6%)      |     1/37 (3%)       0/39 (0%)       1/36 (3%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         655           |      735 (T)         ---             735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.222         P=0.736N        P=0.334        |     P=0.664         P=0.489N        P=0.756        |
|INCIDENTAL TUMOR       |     P=0.209         P=0.736N        P=0.313        |     P=0.664         P=0.489N        P=0.756        |
|LOGISTIC REGRESSION    |     P=0.211         P=0.736N        P=0.316        |     P=0.664         P=0.489N        P=0.756        |
|COCHRAN-ARMITAGE       |     P=0.203                                        |     P=0.668N                                       |
|FISHER EXACT           |                     P=0.748         P=0.309        |                     P=0.500N        P=0.752N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/55 (4%)       1/54 (2%)       4/55 (7%)      |     2/55 (4%)       2/55 (4%)       1/55 (2%)      |
|ADJUSTED (b)           |      5.0%            2.7%            9.9%          |      5.4%            5.1%            2.8%          |
|TERMINAL (d)           |     1/33 (3%)       1/37 (3%)       2/36 (6%)      |     2/37 (5%)       2/39 (5%)       1/36 (3%)      |
|FIRST INCIDENCE (DAYS) |      604             729 (T)         655           |      735 (T)         735 (T)         735 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.261         P=0.478N        P=0.365        |     P=0.399N        P=0.676N        P=0.510N       |
|INCIDENTAL TUMOR       |     P=0.254         P=0.575N        P=0.345        |     P=0.399N        P=0.676N        P=0.510N       |
|LOGISTIC REGRESSION    |     P=0.243         P=0.506N        P=0.337        |     P=0.399N        P=0.677N        P=0.510N       |
|COCHRAN-ARMITAGE       |     P=0.240                                        |     P=0.390N                                       |
|FISHER EXACT           |                     P=0.507N        P=0.339        |                     P=0.691N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05040 TEST: 02                                                 PAGE  17
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HYDROQUINONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         50 MG/KG        100MG/KG      |      VEHICLE         50 MG/KG        100MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/55 (11%)     12/54 (22%)      7/55 (13%)     |    23/55 (42%)     12/55 (22%)     20/55 (36%)     |
|ADJUSTED (b)           |     15.2%           28.7%           17.1%          |     52.8%           25.4%           43.4%          |
|TERMINAL (d)           |     3/33 (9%)       8/37 (22%)      5/36 (14%)     |    17/37 (46%)      6/39 (15%)     10/36 (28%)     |
|FIRST INCIDENCE (DAYS) |      330             648             330           |      469             409             622           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.502         P=0.147         P=0.548        |     P=0.331N        P=0.018N*       P=0.375N       |
|INCIDENTAL TUMOR       |     P=0.426         P=0.075         P=0.472        |     P=0.353N        P=0.018N*       P=0.381N       |
|LOGISTIC REGRESSION    |     P=0.439         P=0.092         P=0.447        |     P=0.403N        P=0.021N*       P=0.388N       |
|COCHRAN-ARMITAGE       |     P=0.447                                        |     P=0.307N                                       |
|FISHER EXACT           |                     P=0.091         P=0.500        |                     P=0.020N*       P=0.348N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/55 (11%)     11/54 (20%)      7/55 (13%)     |    23/55 (42%)     12/55 (22%)     19/55 (35%)     |
|ADJUSTED (b)           |     15.2%           26.3%           17.1%          |     52.8%           25.4%           41.2%          |
|TERMINAL (d)           |     3/33 (9%)       7/37 (19%)      5/36 (14%)     |    17/37 (46%)      6/39 (15%)      9/36 (25%)     |
|FIRST INCIDENCE (DAYS) |      330             648             330           |      469             409             622           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.499         P=0.203         P=0.548        |     P=0.266N        P=0.018N*       P=0.309N       |
|INCIDENTAL TUMOR       |     P=0.422         P=0.110         P=0.472        |     P=0.276N        P=0.018N*       P=0.305N       |
|LOGISTIC REGRESSION    |     P=0.436         P=0.137         P=0.447        |     P=0.324N        P=0.021N*       P=0.313N       |
|COCHRAN-ARMITAGE       |     P=0.446                                        |     P=0.238N                                       |
|FISHER EXACT           |                     P=0.136         P=0.500        |                     P=0.020N*       P=0.278N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05040 TEST: 02                                                 PAGE  18
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HYDROQUINONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         50 MG/KG        100MG/KG      |      VEHICLE         50 MG/KG        100MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    23/55 (42%)     31/54 (57%)     29/55 (53%)     |    21/55 (38%)     33/55 (60%)     27/55 (49%)     |
|ADJUSTED (b)           |     56.8%           71.8%           70.5%          |     48.3%           71.4%           62.4%          |
|TERMINAL (d)           |    16/33 (48%)     25/37 (68%)     24/36 (67%)     |    15/37 (41%)     26/39 (67%)     20/36 (56%)     |
|FIRST INCIDENCE (DAYS) |      604             441             649           |      406             534             548           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.250         P=0.208         P=0.276        |     P=0.144         P=0.049 *       P=0.168        |
|INCIDENTAL TUMOR       |     P=0.176         P=0.116         P=0.210        |     P=0.118         P=0.034 *       P=0.157        |
|LOGISTIC REGRESSION    |     P=0.179         P=0.078         P=0.198        |     P=0.115         P=0.032 *       P=0.136        |
|COCHRAN-ARMITAGE       |     P=0.147                                        |     P=0.147                                        |
|FISHER EXACT           |                     P=0.075         P=0.170        |                     P=0.018 *       P=0.168        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    30/55 (55%)     34/54 (63%)     23/55 (42%)     |    31/55 (56%)     21/55 (38%)     27/55 (49%)     |
|ADJUSTED (b)           |     59.7%           69.4%           48.8%          |     65.4%           41.1%           57.4%          |
|TERMINAL (d)           |    13/33 (39%)     22/37 (59%)     13/36 (36%)     |    21/37 (57%)     10/39 (26%)     16/36 (44%)     |
|FIRST INCIDENCE (DAYS) |      330             465             330           |      372             409             622           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.111N        P=0.459         P=0.134N       |     P=0.300N        P=0.045N*       P=0.334N       |
|INCIDENTAL TUMOR       |     P=0.117N        P=0.142         P=0.152N       |     P=0.378N        P=0.041N*       P=0.404N       |
|LOGISTIC REGRESSION    |     P=0.083N        P=0.199         P=0.140N       |     P=0.417N        P=0.040N*       P=0.338N       |
|COCHRAN-ARMITAGE       |     P=0.107N                                       |     P=0.252N                                       |
|FISHER EXACT           |                     P=0.243         P=0.126N       |                     P=0.043N*       P=0.283N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05040 TEST: 02                                                 PAGE  19
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HYDROQUINONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         50 MG/KG        100MG/KG      |      VEHICLE         50 MG/KG        100MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    39/55 (71%)     46/54 (85%)     44/55 (80%)     |    43/55 (78%)     42/55 (76%)     39/55 (71%)     |
|ADJUSTED (b)           |     77.8%           92.0%           87.9%          |     85.9%           82.2%           81.2%          |
|TERMINAL (d)           |    22/33 (67%)     33/37 (89%)     30/36 (83%)     |    30/37 (81%)     30/39 (77%)     27/36 (75%)     |
|FIRST INCIDENCE (DAYS) |      330             441             330           |      372             409             548           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.382         P=0.346         P=0.405        |     P=0.317N        P=0.338N        P=0.349N       |
|INCIDENTAL TUMOR       |     P=0.152         P=0.050 *       P=0.186        |     P=0.410N        P=0.426N        P=0.451N       |
|LOGISTIC REGRESSION    |     P=0.186         P=0.053         P=0.218        |     P=0.325N        P=0.438N        P=0.368N       |
|COCHRAN-ARMITAGE       |     P=0.148                                        |     P=0.220N                                       |
|FISHER EXACT           |                     P=0.058         P=0.188        |                     P=0.500N        P=0.256N       |
|=================================================================================================================================|
 
 (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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