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TDMS Study 05110-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Northrop Services                                        NAPHTHALENE                                      DATE: 09/14/94       
EXPERIMENT: 05110 TEST: 01                                                                                     TIME: 02:28:50       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1ES790009           ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                                             NTP C#: 52904B       
PATHOLOGIST: L. BRENNECKE                                                                                      CAS: 91-20-3         
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Northrop Services                                        NAPHTHALENE                                      DATE: 09/14/94      
EXPERIMENT: 05110 TEST: 01                                                                                     TIME: 02:28:50      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1ES790009           ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                                             NTP C#: 52904B      
PATHOLOGIST: L. BRENNECKE                                                                                      CAS: 91-20-3        
 
 
 
 
 
                                                    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
                                                    Larynx
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Northrop Services                                        NAPHTHALENE                                      DATE: 09/14/94       
EXPERIMENT: 05110 TEST: 01                                                                                     TIME: 02:28:50       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1ES790009           ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                                             NTP C#: 52904B       
PATHOLOGIST: L. BRENNECKE                                                                                      CAS: 91-20-3         
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                          IN THE ANALYSIS OF THE STUDY OF NAPHTHALENE
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Benign
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             Skin: Subcutaneous Tissue     Fibroma
                                                           Fibrosarcoma
                                                           Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
                                                            Neurofibroma, or Fibroma
                                                           Neurofibrosarcoma, Fibrosarcoma, or Sarcoma
                                                           Sarcoma
                             All Organs                    Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             Stomach, Forestomach          Squamous Cell Papilloma
                             All Organs                    Hemangiosarcoma
                                                           Hemangiosarcoma or Hemangioma
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/14/94                     EXPERIMENT: 05110 TEST: 01                                                 PAGE   1
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NAPHTHALENE
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         10 PPM          30 PPM        |      CONTROL         10 PPM          30 PPM        |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/66 (0%)       0/9 (0%)        2/133 (2%)     |     0/66 (0%)       0/4 (0%)        0/134 (0%)     |
|ADJUSTED (b)           |      0.0%            0.0%            1.7%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/25 (0%)       0/0             2/117 (2%)     |     0/57 (0%)       0/0             0/101 (0%)     |
|FIRST INCIDENCE (DAYS) |      ---             ---             736 (T)       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.486           (e)           P=0.609        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.486           (e)           P=0.609        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.486           (e)           P=0.609        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.292                                        |       (e)                                          |
|FISHER EXACT           |                       (e)           P=0.446        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/66 (3%)       1/11 (9%)       1/130 (1%)     |     1/64 (2%)       0/4 (0%)        0/132 (0%)     |
|ADJUSTED (b)           |      6.0%           50.0%            0.9%          |      1.8%            0.0%            0.0%          |
|TERMINAL (d)           |     1/25 (4%)       1/2 (50%)       1/115 (1%)     |     1/55 (2%)       0/0             0/99 (0%)      |
|FIRST INCIDENCE (DAYS) |      389             736 (T)         736 (T)       |      736 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.036N*       P=0.633         P=0.104N       |     P=0.259N          (e)           P=0.383N       |
|INCIDENTAL TUMOR       |     P=0.091N        P=0.339         P=0.285N       |     P=0.259N          (e)           P=0.383N       |
|LOGISTIC REGRESSION    |     P=0.108N        P=0.327         P=0.291N       |     P=0.259N          (e)           P=0.383N       |
|COCHRAN-ARMITAGE       |     P=0.160N                                       |     P=0.237N                                       |
|FISHER EXACT           |                     P=0.374         P=0.263N       |                     P=0.941N        P=0.327N       |
|=================================================================================================================================|
 
         DATE: 09/14/94                     EXPERIMENT: 05110 TEST: 01                                                 PAGE   2
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NAPHTHALENE
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         10 PPM          30 PPM        |      CONTROL         10 PPM          30 PPM        |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone                                                                                                                             |
|     Osteosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/70 (0%)       0/69 (0%)       0/135 (0%)     |     0/69 (0%)       0/65 (0%)       2/135 (1%)     |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      0.0%            0.0%            1.7%          |
|TERMINAL (d)           |     0/26 (0%)       0/52 (0%)       0/118 (0%)     |     0/59 (0%)       0/57 (0%)       0/102 (0%)     |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      ---             ---             427           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.197           (e)           P=0.382        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.500           (e)           P=0.814        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.189           (e)           P=0.378        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.207                                        |
|FISHER EXACT           |                       (e)             (e)          |                       (e)           P=0.437        |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/70 (1%)       1/69 (1%)       2/135 (1%)     |     0/69 (0%)       0/65 (0%)       1/135 (1%)     |
|ADJUSTED (b)           |      3.8%            1.9%            1.7%          |      0.0%            0.0%            1.0%          |
|TERMINAL (d)           |     1/26 (4%)       1/52 (2%)       2/118 (2%)     |     0/59 (0%)       0/57 (0%)       1/102 (1%)     |
|FIRST INCIDENCE (DAYS) |      736 (T)         736 (T)         736 (T)       |      ---             ---             736 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.451N        P=0.599N        P=0.525N       |     P=0.399           (e)           P=0.609        |
|INCIDENTAL TUMOR       |     P=0.451N        P=0.599N        P=0.525N       |     P=0.399           (e)           P=0.609        |
|LOGISTIC REGRESSION    |     P=0.451N        P=0.599N        P=0.525N       |     P=0.399           (e)           P=0.609        |
|COCHRAN-ARMITAGE       |     P=0.639                                        |     P=0.423                                        |
|FISHER EXACT           |                     P=0.748         P=0.731        |                       (e)           P=0.662        |
|=================================================================================================================================|
 
         DATE: 09/14/94                     EXPERIMENT: 05110 TEST: 01                                                 PAGE   3
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NAPHTHALENE
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         10 PPM          30 PPM        |      CONTROL         10 PPM          30 PPM        |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/70 (0%)       0/69 (0%)       0/135 (0%)     |     0/69 (0%)       2/65 (3%)       0/135 (0%)     |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      0.0%            3.5%            0.0%          |
|TERMINAL (d)           |     0/26 (0%)       0/52 (0%)       0/118 (0%)     |     0/59 (0%)       2/57 (4%)       0/102 (0%)     |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      ---             736 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.429N        P=0.231           (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.429N        P=0.231           (e)          |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.429N        P=0.231           (e)          |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.394N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.233           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/70 (1%)       1/69 (1%)       2/135 (1%)     |     0/69 (0%)       2/65 (3%)       1/135 (1%)     |
|ADJUSTED (b)           |      3.8%            1.9%            1.7%          |      0.0%            3.5%            1.0%          |
|TERMINAL (d)           |     1/26 (4%)       1/52 (2%)       2/118 (2%)     |     0/59 (0%)       2/57 (4%)       1/102 (1%)     |
|FIRST INCIDENCE (DAYS) |      736 (T)         736 (T)         736 (T)       |      ---             736 (T)         736 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.451N        P=0.599N        P=0.525N       |     P=0.671         P=0.231         P=0.609        |
|INCIDENTAL TUMOR       |     P=0.451N        P=0.599N        P=0.525N       |     P=0.671         P=0.231         P=0.609        |
|LOGISTIC REGRESSION    |     P=0.451N        P=0.599N        P=0.525N       |     P=0.671         P=0.231         P=0.609        |
|COCHRAN-ARMITAGE       |     P=0.639                                        |     P=0.632N                                       |
|FISHER EXACT           |                     P=0.748         P=0.731        |                     P=0.233         P=0.662        |
|=================================================================================================================================|
 
         DATE: 09/14/94                     EXPERIMENT: 05110 TEST: 01                                                 PAGE   4
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NAPHTHALENE
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         10 PPM          30 PPM        |      CONTROL         10 PPM          30 PPM        |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Duodenum                                                                                                        |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/70 (0%)       0/69 (0%)       2/135 (1%)     |     0/69 (0%)       1/65 (2%)       0/135 (0%)     |
|ADJUSTED (b)           |      0.0%            0.0%            1.7%          |      0.0%            1.8%            0.0%          |
|TERMINAL (d)           |     0/26 (0%)       0/52 (0%)       2/118 (2%)     |     0/59 (0%)       1/57 (2%)       0/102 (0%)     |
|FIRST INCIDENCE (DAYS) |      ---             ---             736 (T)       |      ---             736 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.303           (e)           P=0.601        |     P=0.601N        P=0.493           (e)          |
|INCIDENTAL TUMOR       |     P=0.303           (e)           P=0.601        |     P=0.601N        P=0.493           (e)          |
|LOGISTIC REGRESSION    |     P=0.303           (e)           P=0.601        |     P=0.601N        P=0.493           (e)          |
|COCHRAN-ARMITAGE       |     P=0.200                                        |     P=0.577N                                       |
|FISHER EXACT           |                       (e)           P=0.433        |                     P=0.485           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/70 (4%)      10/33 (30%)     16/135 (12%)    |     2/68 (3%)       2/12 (17%)      2/134 (1%)     |
|ADJUSTED (b)           |      9.3%           53.7%           13.6%          |      3.4%           33.3%            1.8%          |
|TERMINAL (d)           |     1/26 (4%)       9/17 (53%)     16/118 (14%)    |     2/59 (3%)       2/6 (33%)       1/101 (1%)     |
|FIRST INCIDENCE (DAYS) |      382             536             736 (T)       |      736 (T)         736 (T)         668           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.126N        P=0.010 **      P=0.493        |     P=0.276N        P=0.023 *       P=0.480N       |
|INCIDENTAL TUMOR       |     P=0.282N        P=0.001 **      P=0.260        |     P=0.207N        P=0.023 *       P=0.401N       |
|LOGISTIC REGRESSION    |     P=0.373N        P<0.001 **      P=0.232        |     P=0.227N        P=0.023 *       P=0.443N       |
|COCHRAN-ARMITAGE       |     P=0.299                                        |     P=0.220N                                       |
|FISHER EXACT           |                     P<0.001 **      P=0.059        |                     P=0.105         P=0.413N       |
|=================================================================================================================================|
 
         DATE: 09/14/94                     EXPERIMENT: 05110 TEST: 01                                                 PAGE   5
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NAPHTHALENE
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         10 PPM          30 PPM        |      CONTROL         10 PPM          30 PPM        |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/70 (9%)       4/33 (12%)      7/135 (5%)     |     0/68 (0%)       0/12 (0%)       1/134 (1%)     |
|ADJUSTED (b)           |     19.2%           19.1%            5.9%          |      0.0%            0.0%            0.9%          |
|TERMINAL (d)           |     3/26 (12%)      3/17 (18%)      7/118 (6%)     |     0/59 (0%)       0/6 (0%)        0/101 (0%)     |
|FIRST INCIDENCE (DAYS) |      655             640             736 (T)       |      ---             ---             714           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.006N**      P=0.418N        P=0.014N*      |     P=0.402           (e)           P=0.613        |
|INCIDENTAL TUMOR       |     P=0.041N*       P=0.473         P=0.135N       |     P=0.651           (e)           P=0.814        |
|LOGISTIC REGRESSION    |     P=0.019N*       P=0.527         P=0.048N*      |     P=0.481           (e)           P=0.634        |
|COCHRAN-ARMITAGE       |     P=0.164N                                       |     P=0.481                                        |
|FISHER EXACT           |                     P=0.404         P=0.256N       |                       (e)           P=0.663        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     8/70 (11%)     14/33 (42%)     23/135 (17%)    |     2/68 (3%)       2/12 (17%)      3/134 (2%)     |
|ADJUSTED (b)           |     23.7%           71.6%           19.5%          |      3.4%           33.3%            2.8%          |
|TERMINAL (d)           |     3/26 (12%)     12/17 (71%)     23/118 (19%)    |     2/59 (3%)       2/6 (33%)       1/101 (1%)     |
|FIRST INCIDENCE (DAYS) |      382             536             736 (T)       |      736 (T)         736 (T)         668           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.008N**      P=0.049 *       P=0.201N       |     P=0.424N        P=0.023 *       P=0.615N       |
|INCIDENTAL TUMOR       |     P=0.071N        P=0.001 **      P=0.533        |     P=0.268N        P=0.023 *       P=0.475N       |
|LOGISTIC REGRESSION    |     P=0.070N        P=0.001 **      P=0.530N       |     P=0.342N        P=0.023 *       P=0.577N       |
|COCHRAN-ARMITAGE       |     P=0.539                                        |     P=0.336N                                       |
|FISHER EXACT           |                     P<0.001 **      P=0.197        |                     P=0.105         P=0.547N       |
|=================================================================================================================================|
 
         DATE: 09/14/94                     EXPERIMENT: 05110 TEST: 01                                                 PAGE   6
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NAPHTHALENE
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         10 PPM          30 PPM        |      CONTROL         10 PPM          30 PPM        |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     8/70 (11%)     14/33 (42%)     23/135 (17%)    |     2/68 (3%)       2/12 (17%)      3/134 (2%)     |
|ADJUSTED (b)           |     23.7%           71.6%           19.5%          |      3.4%           33.3%            2.8%          |
|TERMINAL (d)           |     3/26 (12%)     12/17 (71%)     23/118 (19%)    |     2/59 (3%)       2/6 (33%)       1/101 (1%)     |
|FIRST INCIDENCE (DAYS) |      382             536             736 (T)       |      736 (T)         736 (T)         668           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.008N**      P=0.049 *       P=0.201N       |     P=0.424N        P=0.023 *       P=0.615N       |
|INCIDENTAL TUMOR       |     P=0.071N        P=0.001 **      P=0.533        |     P=0.268N        P=0.023 *       P=0.475N       |
|LOGISTIC REGRESSION    |     P=0.070N        P=0.001 **      P=0.530N       |     P=0.342N        P=0.023 *       P=0.577N       |
|COCHRAN-ARMITAGE       |     P=0.539                                        |     P=0.336N                                       |
|FISHER EXACT           |                     P<0.001 **      P=0.197        |                     P=0.105         P=0.547N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     7/70 (10%)     15/69 (22%)     27/135 (20%)    |     5/69 (7%)       2/65 (3%)      28/135 (21%)    |
|ADJUSTED (b)           |     25.7%           28.8%           22.7%          |      8.3%            3.5%           25.6%          |
|TERMINAL (d)           |     6/26 (23%)     15/52 (29%)     26/118 (22%)    |     4/59 (7%)       2/57 (4%)      22/102 (22%)    |
|FIRST INCIDENCE (DAYS) |      714             736 (T)         656           |      729             736 (T)         471           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.274N        P=0.529         P=0.441N       |     P<0.001 **      P=0.236N        P=0.006 **     |
|INCIDENTAL TUMOR       |     P=0.386N        P=0.454         P=0.555        |     P<0.001 **      P=0.249N        P=0.018 *      |
|LOGISTIC REGRESSION    |     P=0.411N        P=0.450         P=0.541        |     P<0.001 **      P=0.233N        P=0.010 *      |
|COCHRAN-ARMITAGE       |     P=0.108                                        |     P<0.001 **                                     |
|FISHER EXACT           |                     P=0.047 *       P=0.049 *      |                     P=0.246N        P=0.009 **     |
|=================================================================================================================================|
 
         DATE: 09/14/94                     EXPERIMENT: 05110 TEST: 01                                                 PAGE   7
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NAPHTHALENE
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         10 PPM          30 PPM        |      CONTROL         10 PPM          30 PPM        |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/70 (0%)       3/69 (4%)       7/135 (5%)     |     0/69 (0%)       0/65 (0%)       1/135 (1%)     |
|ADJUSTED (b)           |      0.0%            5.5%            5.9%          |      0.0%            0.0%            1.0%          |
|TERMINAL (d)           |     0/26 (0%)       2/52 (4%)       7/118 (6%)     |     0/59 (0%)       0/57 (0%)       1/102 (1%)     |
|FIRST INCIDENCE (DAYS) |      ---             629             736 (T)       |      ---             ---             736 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.256         P=0.246         P=0.222        |     P=0.399           (e)           P=0.609        |
|INCIDENTAL TUMOR       |     P=0.235         P=0.153         P=0.222        |     P=0.399           (e)           P=0.609        |
|LOGISTIC REGRESSION    |     P=0.180         P=0.176         P=0.222        |     P=0.399           (e)           P=0.609        |
|COCHRAN-ARMITAGE       |     P=0.079                                        |     P=0.423                                        |
|FISHER EXACT           |                     P=0.120         P=0.051        |                       (e)           P=0.662        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     7/70 (10%)     17/69 (25%)     31/135 (23%)    |     5/69 (7%)       2/65 (3%)      29/135 (21%)    |
|ADJUSTED (b)           |     25.7%           31.9%           26.0%          |      8.3%            3.5%           26.5%          |
|TERMINAL (d)           |     6/26 (23%)     16/52 (31%)     30/118 (25%)    |     4/59 (7%)       2/57 (4%)      23/102 (23%)    |
|FIRST INCIDENCE (DAYS) |      714             629             656           |      729             736 (T)         471           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.363N        P=0.384         P=0.580N       |     P<0.001 **      P=0.236N        P=0.004 **     |
|INCIDENTAL TUMOR       |     P=0.494N        P=0.270         P=0.416        |     P<0.001 **      P=0.249N        P=0.013 *      |
|LOGISTIC REGRESSION    |     P=0.530         P=0.212         P=0.394        |     P<0.001 **      P=0.233N        P=0.007 **     |
|COCHRAN-ARMITAGE       |     P=0.054                                        |     P<0.001 **                                     |
|FISHER EXACT           |                     P=0.019 *       P=0.016 *      |                     P=0.246N        P=0.006 **     |
|=================================================================================================================================|
 
         DATE: 09/14/94                     EXPERIMENT: 05110 TEST: 01                                                 PAGE   8
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NAPHTHALENE
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         10 PPM          30 PPM        |      CONTROL         10 PPM          30 PPM        |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/70 (0%)       0/69 (0%)       0/135 (0%)     |     2/69 (3%)       1/65 (2%)       3/135 (2%)     |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      3.4%            1.8%            2.6%          |
|TERMINAL (d)           |     0/26 (0%)       0/52 (0%)       0/118 (0%)     |     2/59 (3%)       1/57 (2%)       0/102 (0%)     |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      736 (T)         736 (T)         659           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.608N        P=0.512N        P=0.603N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.368N        P=0.512N        P=0.385N       |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.566N        P=0.512N        P=0.352N       |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.565N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.523N        P=0.550N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Nose                                                                                                                             |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/70 (0%)       0/69 (0%)       0/135 (0%)     |     0/69 (0%)       2/65 (3%)       0/135 (0%)     |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      0.0%            3.5%            0.0%          |
|TERMINAL (d)           |     0/26 (0%)       0/52 (0%)       0/118 (0%)     |     0/59 (0%)       2/57 (4%)       0/102 (0%)     |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      ---             736 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.429N        P=0.231           (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.429N        P=0.231           (e)          |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.429N        P=0.231           (e)          |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.394N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.233           (e)          |
|=================================================================================================================================|
 
         DATE: 09/14/94                     EXPERIMENT: 05110 TEST: 01                                                 PAGE   9
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NAPHTHALENE
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         10 PPM          30 PPM        |      CONTROL         10 PPM          30 PPM        |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Cystadenoma                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     2/69 (3%)       0/14 (0%)       4/131 (3%)     |
|ADJUSTED (b)           |                                                    |      3.4%            0.0%            4.0%          |
|TERMINAL (d)           |                                                    |     2/59 (3%)       0/12 (0%)       4/101 (4%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      736 (T)         ---             736 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.499         P=0.621N        P=0.598        |
|INCIDENTAL TUMOR       |                                                    |     P=0.499         P=0.621N        P=0.598        |
|LOGISTIC REGRESSION    |                                                    |     P=0.499         P=0.621N        P=0.598        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.548                                        |
|FISHER EXACT           |                                                    |                     P=0.689N        P=0.659        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/70 (6%)       3/69 (4%)       1/135 (1%)     |     0/69 (0%)       0/65 (0%)       1/135 (1%)     |
|ADJUSTED (b)           |     15.4%            5.8%            0.8%          |      0.0%            0.0%            1.0%          |
|TERMINAL (d)           |     4/26 (15%)      3/52 (6%)       1/118 (1%)     |     0/59 (0%)       0/57 (0%)       1/102 (1%)     |
|FIRST INCIDENCE (DAYS) |      736 (T)         736 (T)         736 (T)       |      ---             ---             736 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.002N**      P=0.165N        P=0.001N**     |     P=0.399           (e)           P=0.609        |
|INCIDENTAL TUMOR       |     P=0.002N**      P=0.165N        P=0.001N**     |     P=0.399           (e)           P=0.609        |
|LOGISTIC REGRESSION    |     P=0.002N**      P=0.165N        P=0.001N**     |     P=0.399           (e)           P=0.609        |
|COCHRAN-ARMITAGE       |     P=0.030N*                                      |     P=0.423                                        |
|FISHER EXACT           |                     P=0.508N        P=0.047N*      |                       (e)           P=0.662        |
|=================================================================================================================================|
 
         DATE: 09/14/94                     EXPERIMENT: 05110 TEST: 01                                                 PAGE  10
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NAPHTHALENE
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         10 PPM          30 PPM        |      CONTROL         10 PPM          30 PPM        |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    11/70 (16%)      6/69 (9%)       4/135 (3%)     |     1/69 (1%)       1/65 (2%)       2/135 (1%)     |
|ADJUSTED (b)           |     31.0%           10.4%            3.2%          |      1.7%            1.7%            1.8%          |
|TERMINAL (d)           |     4/26 (15%)      2/52 (4%)       2/118 (2%)     |     1/59 (2%)       0/57 (0%)       1/102 (1%)     |
|FIRST INCIDENCE (DAYS) |      558             536             611           |      736 (T)         718             623           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001N**      P=0.016N*       P<0.001N**     |     P=0.614         P=0.753         P=0.698        |
|INCIDENTAL TUMOR       |     P=0.003N**      P=0.322N        P=0.001N**     |     P=0.593N        P=0.725         P=0.669        |
|LOGISTIC REGRESSION    |     P=0.001N**      P=0.189N        P=0.001N**     |     P=0.649         P=0.748         P=0.725        |
|COCHRAN-ARMITAGE       |     P=0.001N**                                     |     P=0.649                                        |
|FISHER EXACT           |                     P=0.158N        P=0.002N**     |                     P=0.737         P=0.735        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma                                                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/70 (3%)       0/69 (0%)       1/135 (1%)     |     0/69 (0%)       0/65 (0%)       0/135 (0%)     |
|ADJUSTED (b)           |      5.5%            0.0%            0.8%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/26 (0%)       0/52 (0%)       0/118 (0%)     |     0/59 (0%)       0/57 (0%)       0/102 (0%)     |
|FIRST INCIDENCE (DAYS) |      589             ---             493           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.189N        P=0.152N        P=0.139N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.621N        P=0.432N        P=0.681N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.384N        P=0.199N        P=0.407N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.298N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.252N        P=0.269N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/14/94                     EXPERIMENT: 05110 TEST: 01                                                 PAGE  11
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NAPHTHALENE
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         10 PPM          30 PPM        |      CONTROL         10 PPM          30 PPM        |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    23/70 (33%)     11/69 (16%)      8/135 (6%)     |     1/69 (1%)       2/65 (3%)       4/135 (3%)     |
|ADJUSTED (b)           |     57.8%           19.1%            6.4%          |      1.7%            3.4%            3.5%          |
|TERMINAL (d)           |    10/26 (38%)      6/52 (12%)      4/118 (3%)     |     1/59 (2%)       0/57 (0%)       2/102 (2%)     |
|FIRST INCIDENCE (DAYS) |      558             536             493           |      736 (T)         669             623           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001N**      P<0.001N**      P<0.001N**     |     P=0.372         P=0.490         P=0.397        |
|INCIDENTAL TUMOR       |     P<0.001N**      P=0.015N*       P<0.001N**     |     P=0.514         P=0.426         P=0.353        |
|LOGISTIC REGRESSION    |     P<0.001N**      P=0.003N**      P<0.001N**     |     P=0.411         P=0.479         P=0.428        |
|COCHRAN-ARMITAGE       |     P<0.001N**                                     |     P=0.411                                        |
|FISHER EXACT           |                     P=0.016N*       P<0.001N**     |                     P=0.477         P=0.450        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    19/70 (27%)      8/69 (12%)      8/135 (6%)     |     1/69 (1%)       2/65 (3%)       3/135 (2%)     |
|ADJUSTED (b)           |     47.2%           13.8%            6.4%          |      1.7%            3.4%            2.6%          |
|TERMINAL (d)           |     6/26 (23%)      3/52 (6%)       4/118 (3%)     |     1/59 (2%)       0/57 (0%)       1/102 (1%)     |
|FIRST INCIDENCE (DAYS) |      558             536             493           |      736 (T)         669             623           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001N**      P<0.001N**      P<0.001N**     |     P=0.526         P=0.490         P=0.537        |
|INCIDENTAL TUMOR       |     P<0.001N**      P=0.058N        P<0.001N**     |     P=0.570N        P=0.426         P=0.486        |
|LOGISTIC REGRESSION    |     P<0.001N**      P=0.009N**      P<0.001N**     |     P=0.560         P=0.479         P=0.562        |
|COCHRAN-ARMITAGE       |     P<0.001N**                                     |     P=0.561                                        |
|FISHER EXACT           |                     P=0.017N*       P<0.001N**     |                     P=0.477         P=0.584        |
|=================================================================================================================================|
 
         DATE: 09/14/94                     EXPERIMENT: 05110 TEST: 01                                                 PAGE  12
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NAPHTHALENE
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         10 PPM          30 PPM        |      CONTROL         10 PPM          30 PPM        |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Sarcoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/70 (9%)       2/69 (3%)       3/135 (2%)     |     0/69 (0%)       1/65 (2%)       1/135 (1%)     |
|ADJUSTED (b)           |     17.7%            3.7%            2.5%          |      0.0%            1.7%            0.8%          |
|TERMINAL (d)           |     2/26 (8%)       1/52 (2%)       2/118 (2%)     |     0/59 (0%)       0/57 (0%)       0/102 (0%)     |
|FIRST INCIDENCE (DAYS) |      652             692             696           |      ---             669             627           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.005N**      P=0.031N*       P=0.001N**     |     P=0.597         P=0.497         P=0.630        |
|INCIDENTAL TUMOR       |     P=0.164N        P=0.228N        P=0.157N       |     P=0.696N        P=0.443         P=0.581        |
|LOGISTIC REGRESSION    |     P=0.109N        P=0.054N        P=0.006N**     |     P=0.601         P=0.491         P=0.629        |
|COCHRAN-ARMITAGE       |     P=0.048N*                                      |     P=0.606                                        |
|FISHER EXACT           |                     P=0.142N        P=0.044N*      |                     P=0.485         P=0.662        |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/69 (0%)       0/18 (0%)       0/135 (0%)     |     0/67 (0%)       0/13 (0%)       3/134 (2%)     |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      0.0%            0.0%            2.7%          |
|TERMINAL (d)           |     0/26 (0%)       0/7 (0%)        0/118 (0%)     |     0/59 (0%)       0/9 (0%)        1/101 (1%)     |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      ---             ---             658           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.122           (e)           P=0.250        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.274           (e)           P=0.387        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.181           (e)           P=0.273        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.181                                        |
|FISHER EXACT           |                       (e)             (e)          |                       (e)           P=0.294        |
|=================================================================================================================================|
 
         DATE: 09/14/94                     EXPERIMENT: 05110 TEST: 01                                                 PAGE  13
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NAPHTHALENE
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         10 PPM          30 PPM        |      CONTROL         10 PPM          30 PPM        |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/70 (0%)       0/69 (0%)       0/135 (0%)     |     2/69 (3%)       0/65 (0%)       1/135 (1%)     |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      3.3%            0.0%            1.0%          |
|TERMINAL (d)           |     0/26 (0%)       0/52 (0%)       0/118 (0%)     |     1/59 (2%)       0/57 (0%)       1/102 (1%)     |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      662             ---             736 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.321N        P=0.247N        P=0.306N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.222N        P=0.275N        P=0.219N       |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.291N        P=0.251N        P=0.276N       |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.290N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.263N        P=0.265N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/70 (0%)       0/69 (0%)       0/135 (0%)     |     2/69 (3%)       0/65 (0%)       0/135 (0%)     |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      3.3%            0.0%            0.0%          |
|TERMINAL (d)           |     0/26 (0%)       0/52 (0%)       0/118 (0%)     |     1/59 (2%)       0/57 (0%)       0/102 (0%)     |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      662             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.098N        P=0.247N        P=0.123N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.043N*       P=0.275N        P=0.056N       |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.088N        P=0.251N        P=0.108N       |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.088N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.263N        P=0.113N       |
|=================================================================================================================================|
 
         DATE: 09/14/94                     EXPERIMENT: 05110 TEST: 01                                                 PAGE  14
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NAPHTHALENE
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         10 PPM          30 PPM        |      CONTROL         10 PPM          30 PPM        |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     1/69 (1%)       2/65 (3%)       0/135 (0%)     |
|ADJUSTED (b)           |                                                    |      1.7%            3.5%            0.0%          |
|TERMINAL (d)           |                                                    |     1/59 (2%)       2/57 (4%)       0/102 (0%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      736 (T)         736 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.187N        P=0.488         P=0.391N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.187N        P=0.488         P=0.391N       |
|LOGISTIC REGRESSION    |                                                    |     P=0.187N        P=0.488         P=0.391N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.159N                                       |
|FISHER EXACT           |                                                    |                     P=0.477         P=0.338N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     1/69 (1%)       3/65 (5%)       1/135 (1%)     |
|ADJUSTED (b)           |                                                    |      1.7%            5.3%            1.0%          |
|TERMINAL (d)           |                                                    |     1/59 (2%)       3/57 (5%)       1/102 (1%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      736 (T)         736 (T)         736 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.323N        P=0.294         P=0.634N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.323N        P=0.294         P=0.634N       |
|LOGISTIC REGRESSION    |                                                    |     P=0.323N        P=0.294         P=0.634N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.274N                                       |
|FISHER EXACT           |                                                    |                     P=0.287         P=0.563N       |
|=================================================================================================================================|
 
         DATE: 09/14/94                     EXPERIMENT: 05110 TEST: 01                                                 PAGE  15
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NAPHTHALENE
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         10 PPM          30 PPM        |      CONTROL         10 PPM          30 PPM        |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/70 (0%)       0/69 (0%)       1/135 (1%)     |     0/69 (0%)       0/65 (0%)       5/135 (4%)     |
|ADJUSTED (b)           |      0.0%            0.0%            0.8%          |      0.0%            0.0%            4.4%          |
|TERMINAL (d)           |     0/26 (0%)       0/52 (0%)       1/118 (1%)     |     0/59 (0%)       0/57 (0%)       2/102 (2%)     |
|FIRST INCIDENCE (DAYS) |      ---             ---             736 (T)       |      ---             ---             648           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.524           (e)           P=0.797        |     P=0.030 *         (e)           P=0.118        |
|INCIDENTAL TUMOR       |     P=0.524           (e)           P=0.797        |     P=0.084           (e)           P=0.212        |
|LOGISTIC REGRESSION    |     P=0.524           (e)           P=0.797        |     P=0.034 *         (e)           P=0.127        |
|COCHRAN-ARMITAGE       |     P=0.418                                        |     P=0.034 *                                      |
|FISHER EXACT           |                       (e)           P=0.659        |                       (e)           P=0.124        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/70 (0%)       0/69 (0%)       1/135 (1%)     |     0/69 (0%)       0/65 (0%)       5/135 (4%)     |
|ADJUSTED (b)           |      0.0%            0.0%            0.8%          |      0.0%            0.0%            4.4%          |
|TERMINAL (d)           |     0/26 (0%)       0/52 (0%)       1/118 (1%)     |     0/59 (0%)       0/57 (0%)       2/102 (2%)     |
|FIRST INCIDENCE (DAYS) |      ---             ---             736 (T)       |      ---             ---             648           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.524           (e)           P=0.797        |     P=0.030 *         (e)           P=0.118        |
|INCIDENTAL TUMOR       |     P=0.524           (e)           P=0.797        |     P=0.084           (e)           P=0.212        |
|LOGISTIC REGRESSION    |     P=0.524           (e)           P=0.797        |     P=0.034 *         (e)           P=0.127        |
|COCHRAN-ARMITAGE       |     P=0.418                                        |     P=0.034 *                                      |
|FISHER EXACT           |                       (e)           P=0.659        |                       (e)           P=0.124        |
|=================================================================================================================================|
 
         DATE: 09/14/94                     EXPERIMENT: 05110 TEST: 01                                                 PAGE  16
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NAPHTHALENE
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         10 PPM          30 PPM        |      CONTROL         10 PPM          30 PPM        |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/70 (6%)       3/69 (4%)       4/135 (3%)     |     8/69 (12%)      8/65 (12%)     14/135 (10%)    |
|ADJUSTED (b)           |     12.5%            5.8%            3.3%          |     12.4%           14.0%           12.2%          |
|TERMINAL (d)           |     2/26 (8%)       3/52 (6%)       2/118 (2%)     |     3/59 (5%)       8/57 (14%)      7/102 (7%)     |
|FIRST INCIDENCE (DAYS) |      282             736 (T)         280           |      574             736 (T)         423           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.057N        P=0.205N        P=0.059N       |     P=0.520N        P=0.568         P=0.557N       |
|INCIDENTAL TUMOR       |     P=0.349N        P=0.374N        P=0.623N       |     P=0.225N        P=0.410         P=0.285N       |
|LOGISTIC REGRESSION    |     P=0.218N        P=0.389N        P=0.332N       |     P=0.293N        P=0.331         P=0.396N       |
|COCHRAN-ARMITAGE       |     P=0.237N                                       |     P=0.417N                                       |
|FISHER EXACT           |                     P=0.508N        P=0.272N       |                     P=0.554         P=0.481N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/70 (6%)       3/69 (4%)       4/135 (3%)     |     8/69 (12%)      8/65 (12%)     14/135 (10%)    |
|ADJUSTED (b)           |     12.5%            5.8%            3.3%          |     12.4%           14.0%           12.2%          |
|TERMINAL (d)           |     2/26 (8%)       3/52 (6%)       2/118 (2%)     |     3/59 (5%)       8/57 (14%)      7/102 (7%)     |
|FIRST INCIDENCE (DAYS) |      282             736 (T)         280           |      574             736 (T)         423           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.057N        P=0.205N        P=0.059N       |     P=0.520N        P=0.568         P=0.557N       |
|INCIDENTAL TUMOR       |     P=0.349N        P=0.374N        P=0.623N       |     P=0.225N        P=0.410         P=0.285N       |
|LOGISTIC REGRESSION    |     P=0.218N        P=0.389N        P=0.332N       |     P=0.293N        P=0.331         P=0.396N       |
|COCHRAN-ARMITAGE       |     P=0.237N                                       |     P=0.417N                                       |
|FISHER EXACT           |                     P=0.508N        P=0.272N       |                     P=0.554         P=0.481N       |
|=================================================================================================================================|
 
         DATE: 09/14/94                     EXPERIMENT: 05110 TEST: 01                                                 PAGE  17
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NAPHTHALENE
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         10 PPM          30 PPM        |      CONTROL         10 PPM          30 PPM        |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Osteosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/70 (0%)       0/69 (0%)       0/135 (0%)     |     0/69 (0%)       0/65 (0%)       2/135 (1%)     |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      0.0%            0.0%            1.7%          |
|TERMINAL (d)           |     0/26 (0%)       0/52 (0%)       0/118 (0%)     |     0/59 (0%)       0/57 (0%)       0/102 (0%)     |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      ---             ---             427           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.197           (e)           P=0.382        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.500           (e)           P=0.814        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.189           (e)           P=0.378        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.207                                        |
|FISHER EXACT           |                       (e)             (e)          |                       (e)           P=0.437        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Osteosarcoma or Osteoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/70 (0%)       0/69 (0%)       0/135 (0%)     |     0/69 (0%)       0/65 (0%)       2/135 (1%)     |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      0.0%            0.0%            1.7%          |
|TERMINAL (d)           |     0/26 (0%)       0/52 (0%)       0/118 (0%)     |     0/59 (0%)       0/57 (0%)       0/102 (0%)     |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      ---             ---             427           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.197           (e)           P=0.382        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.500           (e)           P=0.814        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.189           (e)           P=0.378        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.207                                        |
|FISHER EXACT           |                       (e)             (e)          |                       (e)           P=0.437        |
|=================================================================================================================================|
 
         DATE: 09/14/94                     EXPERIMENT: 05110 TEST: 01                                                 PAGE  18
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NAPHTHALENE
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         10 PPM          30 PPM        |      CONTROL         10 PPM          30 PPM        |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    15/70 (21%)     24/69 (35%)     44/135 (33%)    |    15/69 (22%)      7/65 (11%)     41/135 (30%)    |
|ADJUSTED (b)           |     48.6%           45.2%           36.6%          |     24.6%           12.3%           36.6%          |
|TERMINAL (d)           |    11/26 (42%)     23/52 (44%)     42/118 (36%)    |    13/59 (22%)      7/57 (12%)     32/102 (31%)    |
|FIRST INCIDENCE (DAYS) |      382             536             504           |      662             736 (T)         471           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.052N        P=0.310N        P=0.075N       |     P=0.006 **      P=0.063N        P=0.064        |
|INCIDENTAL TUMOR       |     P=0.232N        P=0.583         P=0.416N       |     P=0.031 *       P=0.068N        P=0.180        |
|LOGISTIC REGRESSION    |     P=0.346N        P=0.393         P=0.534N       |     P=0.015 *       P=0.066N        P=0.112        |
|COCHRAN-ARMITAGE       |     P=0.124                                        |     P=0.018 *                                      |
|FISHER EXACT           |                     P=0.059         P=0.064        |                     P=0.069N        P=0.126        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    26/70 (37%)     16/69 (23%)     32/135 (24%)    |    12/69 (17%)     18/65 (28%)     32/135 (24%)    |
|ADJUSTED (b)           |     60.1%           27.4%           25.1%          |     18.7%           30.5%           25.5%          |
|TERMINAL (d)           |     9/26 (35%)     10/52 (19%)     23/118 (19%)    |     7/59 (12%)     16/57 (28%)     11/102 (11%)    |
|FIRST INCIDENCE (DAYS) |      282             536             182           |      574             669             423           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001N**      P<0.001N**      P<0.001N**     |     P=0.201         P=0.135         P=0.158        |
|INCIDENTAL TUMOR       |     P=0.152N        P=0.080N        P=0.112N       |     P=0.336N        P=0.056         P=0.548        |
|LOGISTIC REGRESSION    |     P=0.021N*       P=0.018N*       P=0.006N**     |     P=0.525         P=0.036 *       P=0.315        |
|COCHRAN-ARMITAGE       |     P=0.058N                                       |     P=0.302                                        |
|FISHER EXACT           |                     P=0.054N        P=0.032N*      |                     P=0.111         P=0.197        |
|=================================================================================================================================|
 
         DATE: 09/14/94                     EXPERIMENT: 05110 TEST: 01                                                 PAGE  19
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NAPHTHALENE
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         10 PPM          30 PPM        |      CONTROL         10 PPM          30 PPM        |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    36/70 (51%)     36/69 (52%)     67/135 (50%)    |    23/69 (33%)     22/65 (34%)     64/135 (47%)    |
|ADJUSTED (b)           |     79.7%           62.0%           51.9%          |     35.4%           37.3%           49.9%          |
|TERMINAL (d)           |    17/26 (65%)     30/52 (58%)     56/118 (47%)    |    17/59 (29%)     20/57 (35%)     38/102 (37%)    |
|FIRST INCIDENCE (DAYS) |      282             536             182           |      574             669             423           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001N**      P<0.001N**      P<0.001N**     |     P=0.006 **      P=0.557N        P=0.025 *      |
|INCIDENTAL TUMOR       |     P=0.084N        P=0.190N        P=0.179N       |     P=0.108         P=0.447         P=0.153        |
|LOGISTIC REGRESSION    |     P=0.026N*       P=0.111N        P=0.038N*      |     P=0.041 *       P=0.374         P=0.070        |
|COCHRAN-ARMITAGE       |     P=0.410N                                       |     P=0.016 *                                      |
|FISHER EXACT           |                     P=0.533         P=0.461N       |                     P=0.548         P=0.037 *      |
|=================================================================================================================================|
 
 (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).
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.