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TDMS Study 05058-02 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                    ROXARSONE                                       DATE: 09/08/94       
EXPERIMENT: 05058 TEST: 02                                                                                     TIME: 14:26:00       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NOI-ES-28024          ROUTE: DOSED FEED                                                                  NTP C#: C56508       
PATHOLOGIST: D. FARNELL                                                                                        CAS: 121-19-7        
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Southern Research Inst                                    ROXARSONE                                       DATE: 09/08/94      
EXPERIMENT: 05058 TEST: 02                                                                                     TIME: 14:26:00      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NOI-ES-28024          ROUTE: DOSED FEED                                                                  NTP C#: C56508      
PATHOLOGIST: D. FARNELL                                                                                        CAS: 121-19-7       
 
 
 
 
 
                                                    MICE(B6C3F1)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                    ROXARSONE                                       DATE: 09/08/94       
EXPERIMENT: 05058 TEST: 02                                                                                     TIME: 14:26:00       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NOI-ES-28024          ROUTE: DOSED FEED                                                                  NTP C#: C56508       
PATHOLOGIST: D. FARNELL                                                                                        CAS: 121-19-7        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                           IN THE ANALYSIS OF THE STUDY OF ROXARSONE
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Cortex                Adenoma
                             Adrenal Medulla               Pheochromocytoma Benign
                             Liver                         Hepatocellular Adenoma
                             Lung                          Alveolar/Bronchiolar Carcinoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             All Organs                    Hemangiosarcoma
                                                           Hemangiosarcoma or Hemangioma
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             All Organs                    Malignant Lymphoma And Histiocytic Sarcoma
                                                           Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
                                                            NOS, or Undifferentiated Cell Type
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/08/94                     EXPERIMENT: 05058 TEST: 02                                                 PAGE   1
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ROXARSONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.01%           0.02%         |      UNTREATD        0.01%           0.02%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/50 (4%)       4/49 (8%)      |     0/50 (0%)       0/49 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            5.0%           12.1%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/27 (0%)       2/40 (5%)       4/33 (12%)     |     0/14 (0%)       0/18 (0%)       0/17 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             729 (T)         729 (T)       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.044 *       P=0.328         P=0.090        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.044 *       P=0.328         P=0.090        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.044 *       P=0.328         P=0.090        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.035 *                                      |       (e)                                          |
|FISHER EXACT           |                     P=0.247         P=0.056        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       0/50 (0%)       0/49 (0%)      |     0/50 (0%)       0/49 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      9.1%            0.0%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/27 (4%)       0/40 (0%)       0/33 (0%)      |     0/14 (0%)       0/18 (0%)       0/17 (0%)      |
|FIRST INCIDENCE (DAYS) |      618             ---             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.028N*       P=0.082N        P=0.106N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.049N*       P=0.174N        P=0.132N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.038N*       P=0.117N        P=0.121N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.038N*                                      |       (e)                                          |
|FISHER EXACT           |                     P=0.121N        P=0.125N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05058 TEST: 02                                                 PAGE   2
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ROXARSONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.01%           0.02%         |      UNTREATD        0.01%           0.02%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       0/50 (0%)       1/49 (2%)      |     0/50 (0%)       0/49 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      9.1%            0.0%            2.3%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/27 (4%)       0/40 (0%)       0/33 (0%)      |     0/14 (0%)       0/18 (0%)       0/17 (0%)      |
|FIRST INCIDENCE (DAYS) |      618             ---             641           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.153N        P=0.082N        P=0.275N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.196N        P=0.174N        P=0.316N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.182N        P=0.117N        P=0.312N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.180N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.121N        P=0.316N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       3/50 (6%)      |     1/50 (2%)       2/50 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |      2.9%            5.0%            8.4%          |      7.1%            8.0%            3.4%          |
|TERMINAL (d)           |     0/27 (0%)       2/40 (5%)       2/33 (6%)      |     1/14 (7%)       1/18 (6%)       0/17 (0%)      |
|FIRST INCIDENCE (DAYS) |      668             729 (T)         659           |      729 (T)         530             601           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.262         P=0.616         P=0.361        |     P=0.604N        P=0.558         P=0.754N       |
|INCIDENTAL TUMOR       |     P=0.214         P=0.521         P=0.275        |     P=0.537N        P=0.584         P=0.669N       |
|LOGISTIC REGRESSION    |     P=0.228         P=0.535         P=0.312        |     P=0.621N        P=0.506         P=0.761        |
|COCHRAN-ARMITAGE       |     P=0.222                                        |     P=0.622N                                       |
|FISHER EXACT           |                     P=0.500         P=0.309        |                     P=0.500         P=0.753N       |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05058 TEST: 02                                                 PAGE   3
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ROXARSONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.01%           0.02%         |      UNTREATD        0.01%           0.02%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     9/50 (18%)      8/50 (16%)      3/50 (6%)      |     1/50 (2%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     27.0%           18.3%            8.3%          |      3.6%            0.0%            0.0%          |
|TERMINAL (d)           |     5/27 (19%)      5/40 (13%)      2/33 (6%)      |     0/14 (0%)       0/18 (0%)       0/17 (0%)      |
|FIRST INCIDENCE (DAYS) |      618             645             653           |      658             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.029N*       P=0.247N        P=0.039N*      |     P=0.295N        P=0.539N        P=0.531N       |
|INCIDENTAL TUMOR       |     P=0.058N        P=0.521N        P=0.063N       |     P=0.387N        P=0.625N        P=0.652N       |
|LOGISTIC REGRESSION    |     P=0.046N*       P=0.435N        P=0.055N       |     P=0.269N        P=0.497N        P=0.500N       |
|COCHRAN-ARMITAGE       |     P=0.053N                                       |     P=0.269N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.061N       |                     P=0.500N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       8/50 (16%)      5/50 (10%)     |     2/50 (4%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     10.9%           17.6%           12.3%          |      6.8%            0.0%            0.0%          |
|TERMINAL (d)           |     0/27 (0%)       4/40 (10%)      1/33 (3%)      |     0/14 (0%)       0/18 (0%)       0/17 (0%)      |
|FIRST INCIDENCE (DAYS) |      623             560             641           |      635             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.519         P=0.339         P=0.565        |     P=0.122N        P=0.279N        P=0.286N       |
|INCIDENTAL TUMOR       |     P=0.336         P=0.056         P=0.355        |     P=0.104N        P=0.275N        P=0.241N       |
|LOGISTIC REGRESSION    |     P=0.357         P=0.161         P=0.437        |     P=0.094N        P=0.234N        P=0.237N       |
|COCHRAN-ARMITAGE       |     P=0.437                                        |     P=0.095N                                       |
|FISHER EXACT           |                     P=0.178         P=0.500        |                     P=0.247N        P=0.247N       |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05058 TEST: 02                                                 PAGE   4
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ROXARSONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.01%           0.02%         |      UNTREATD        0.01%           0.02%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    12/50 (24%)     15/50 (30%)      7/50 (14%)     |     3/50 (6%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     33.3%           32.3%           17.8%          |     10.1%            0.0%            0.0%          |
|TERMINAL (d)           |     5/27 (19%)      9/40 (23%)      3/33 (9%)      |     0/14 (0%)       0/18 (0%)       0/17 (0%)      |
|FIRST INCIDENCE (DAYS) |      618             560             641           |      635             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.086N        P=0.496N        P=0.105N       |     P=0.054N        P=0.158N        P=0.160N       |
|INCIDENTAL TUMOR       |     P=0.168N        P=0.210         P=0.188N       |     P=0.059N        P=0.179N        P=0.163N       |
|LOGISTIC REGRESSION    |     P=0.154N        P=0.211         P=0.142N       |     P=0.037N*       P=0.117N        P=0.120N       |
|COCHRAN-ARMITAGE       |     P=0.141N                                       |     P=0.037N*                                      |
|FISHER EXACT           |                     P=0.326         P=0.154N       |                     P=0.121N        P=0.121N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    12/50 (24%)     15/50 (30%)      7/50 (14%)     |     3/50 (6%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     33.3%           32.3%           17.8%          |     10.1%            0.0%            0.0%          |
|TERMINAL (d)           |     5/27 (19%)      9/40 (23%)      3/33 (9%)      |     0/14 (0%)       0/18 (0%)       0/17 (0%)      |
|FIRST INCIDENCE (DAYS) |      618             560             641           |      635             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.086N        P=0.496N        P=0.105N       |     P=0.054N        P=0.158N        P=0.160N       |
|INCIDENTAL TUMOR       |     P=0.168N        P=0.210         P=0.188N       |     P=0.059N        P=0.179N        P=0.163N       |
|LOGISTIC REGRESSION    |     P=0.154N        P=0.211         P=0.142N       |     P=0.037N*       P=0.117N        P=0.120N       |
|COCHRAN-ARMITAGE       |     P=0.141N                                       |     P=0.037N*                                      |
|FISHER EXACT           |                     P=0.326         P=0.154N       |                     P=0.121N        P=0.121N       |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05058 TEST: 02                                                 PAGE   5
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ROXARSONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.01%           0.02%         |      UNTREATD        0.01%           0.02%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      3/50 (6%)       9/50 (18%)     |     1/50 (2%)       3/50 (6%)       3/50 (6%)      |
|ADJUSTED (b)           |     16.4%            7.2%           25.5%          |      4.3%           16.7%           16.7%          |
|TERMINAL (d)           |     3/27 (11%)      2/40 (5%)       7/33 (21%)     |     0/14 (0%)       3/18 (17%)      2/17 (12%)     |
|FIRST INCIDENCE (DAYS) |      665             678             702           |      684             729 (T)         718           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.197         P=0.196N        P=0.304        |     P=0.288         P=0.360         P=0.356        |
|INCIDENTAL TUMOR       |     P=0.131         P=0.343N        P=0.213        |     P=0.199         P=0.314         P=0.208        |
|LOGISTIC REGRESSION    |     P=0.157         P=0.285N        P=0.246        |     P=0.241         P=0.303         P=0.298        |
|COCHRAN-ARMITAGE       |     P=0.135                                        |     P=0.238                                        |
|FISHER EXACT           |                     P=0.357N        P=0.194        |                     P=0.309         P=0.309        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/50 (12%)      2/50 (4%)       1/50 (2%)      |     2/50 (4%)       1/50 (2%)       2/50 (4%)      |
|ADJUSTED (b)           |     20.8%            5.0%            3.0%          |     12.0%            2.4%            7.6%          |
|TERMINAL (d)           |     5/27 (19%)      2/40 (5%)       1/33 (3%)      |     1/14 (7%)       0/18 (0%)       0/17 (0%)      |
|FIRST INCIDENCE (DAYS) |      668             729 (T)         729 (T)       |      710             521             606           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.013N*       P=0.047N*       P=0.033N*      |     P=0.605         P=0.477N        P=0.689        |
|INCIDENTAL TUMOR       |     P=0.017N*       P=0.063N        P=0.040N*      |     P=0.558         P=0.516N        P=0.639        |
|LOGISTIC REGRESSION    |     P=0.018N*       P=0.074N        P=0.043N*      |     P=0.608N        P=0.494N        P=0.690        |
|COCHRAN-ARMITAGE       |     P=0.029N*                                      |     P=0.610                                        |
|FISHER EXACT           |                     P=0.134N        P=0.056N       |                     P=0.500N        P=0.691N       |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05058 TEST: 02                                                 PAGE   6
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ROXARSONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.01%           0.02%         |      UNTREATD        0.01%           0.02%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    11/50 (22%)      5/50 (10%)     10/50 (20%)     |     3/50 (6%)       4/50 (8%)       5/50 (10%)     |
|ADJUSTED (b)           |     35.7%           12.0%           28.4%          |     15.9%           18.7%           23.0%          |
|TERMINAL (d)           |     8/27 (30%)      4/40 (10%)      8/33 (24%)     |     1/14 (7%)       3/18 (17%)      2/17 (12%)     |
|FIRST INCIDENCE (DAYS) |      665             678             702           |      684             521             606           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.302N        P=0.017N*       P=0.326N       |     P=0.335         P=0.563         P=0.394        |
|INCIDENTAL TUMOR       |     P=0.405N        P=0.043N*       P=0.431N       |     P=0.229         P=0.500         P=0.235        |
|LOGISTIC REGRESSION    |     P=0.372N        P=0.039N*       P=0.400N       |     P=0.272         P=0.499         P=0.336        |
|COCHRAN-ARMITAGE       |     P=0.447N                                       |     P=0.290                                        |
|FISHER EXACT           |                     P=0.086N        P=0.500N       |                     P=0.500         P=0.357        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     2/50 (4%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |     12.9%            0.0%            0.0%          |
|TERMINAL (d)           |     0/27 (0%)       0/40 (0%)       0/33 (0%)      |     1/14 (7%)       0/18 (0%)       0/17 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      716             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.079N        P=0.200N        P=0.206N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.127N        P=0.275N        P=0.295N       |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.088N        P=0.225N        P=0.222N       |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.095N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.247N        P=0.247N       |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05058 TEST: 02                                                 PAGE   7
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ROXARSONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.01%           0.02%         |      UNTREATD        0.01%           0.02%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/45 (0%)       0/46 (0%)       0/45 (0%)      |     6/49 (12%)      3/46 (7%)       4/49 (8%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |     32.1%           16.7%           19.4%          |
|TERMINAL (d)           |     0/24 (0%)       0/38 (0%)       0/30 (0%)      |     3/14 (21%)      3/18 (17%)      3/17 (18%)     |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      676             729 (T)         483           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.224N        P=0.177N        P=0.295N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.318N        P=0.270N        P=0.421N       |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.315N        P=0.239N        P=0.392N       |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.298N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.276N        P=0.370N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Intermedia                                                                                                 |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/45 (0%)       0/46 (0%)       0/45 (0%)      |     0/49 (0%)       0/46 (0%)       2/49 (4%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      0.0%            0.0%           10.2%          |
|TERMINAL (d)           |     0/24 (0%)       0/38 (0%)       0/30 (0%)      |     0/14 (0%)       0/18 (0%)       1/17 (6%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      ---             ---             679           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.103           (e)           P=0.256        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.067           (e)           P=0.176        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.092           (e)           P=0.228        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.098                                        |
|FISHER EXACT           |                       (e)             (e)          |                       (e)           P=0.247        |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05058 TEST: 02                                                 PAGE   8
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ROXARSONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.01%           0.02%         |      UNTREATD        0.01%           0.02%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       4/50 (8%)       4/50 (8%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     14.0%           10.0%           11.8%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     3/27 (11%)      4/40 (10%)      3/33 (9%)      |     0/14 (0%)       0/18 (0%)       0/17 (0%)      |
|FIRST INCIDENCE (DAYS) |      714             729 (T)         711           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.477N        P=0.426N        P=0.547N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.527N        P=0.491N        P=0.611N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.506N        P=0.467N        P=0.577N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.573                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.643N        P=0.643N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/50 (12%)      3/50 (6%)       7/50 (14%)     |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     15.8%            7.3%           16.7%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/27 (4%)       2/40 (5%)       2/33 (6%)      |     0/14 (0%)       0/18 (0%)       0/17 (0%)      |
|FIRST INCIDENCE (DAYS) |      618             712             603           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.507         P=0.143N        P=0.574        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.364         P=0.397N        P=0.419        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.363         P=0.247N        P=0.394        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.436                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.243N        P=0.500        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05058 TEST: 02                                                 PAGE   9
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ROXARSONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.01%           0.02%         |      UNTREATD        0.01%           0.02%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    14/50 (28%)     13/50 (26%)     16/50 (32%)     |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     36.1%           28.8%           35.9%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     4/27 (15%)      8/40 (20%)      6/33 (18%)     |     0/14 (0%)       0/18 (0%)       0/17 (0%)      |
|FIRST INCIDENCE (DAYS) |      618             645             432           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.515         P=0.209N        P=0.559        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.226         P=0.473         P=0.263        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.255         P=0.460         P=0.259        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.370                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.500N        P=0.414        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    11/50 (22%)      9/50 (18%)     13/50 (26%)     |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     27.7%           19.9%           29.1%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/27 (4%)       4/40 (10%)      4/33 (12%)     |     0/14 (0%)       0/18 (0%)       0/17 (0%)      |
|FIRST INCIDENCE (DAYS) |      618             645             432           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.466         P=0.204N        P=0.520        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.168         P=0.424         P=0.207        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.199         P=0.436         P=0.202        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.359                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.402N        P=0.408        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05058 TEST: 02                                                 PAGE  10
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ROXARSONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.01%           0.02%         |      UNTREATD        0.01%           0.02%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Sarcoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      6/50 (12%)      6/50 (12%)     |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     14.1%           13.4%           14.6%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/27 (0%)       2/40 (5%)       2/33 (6%)      |     0/14 (0%)       0/18 (0%)       0/17 (0%)      |
|FIRST INCIDENCE (DAYS) |      653             645             432           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.508         P=0.563N        P=0.569        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.263         P=0.185         P=0.341        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.436         P=0.196         P=0.498        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.437                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.500         P=0.500        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Schwannoma NOS                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       0/50 (0%)       1/50 (2%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      6.7%            0.0%            2.1%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/27 (4%)       0/40 (0%)       0/33 (0%)      |     0/14 (0%)       0/18 (0%)       0/17 (0%)      |
|FIRST INCIDENCE (DAYS) |      710             ---             480           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.331N        P=0.168N        P=0.464N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.476N        P=0.257N        P=0.597N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.360N        P=0.194N        P=0.500N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.360N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.247N        P=0.500N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05058 TEST: 02                                                 PAGE  11
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ROXARSONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.01%           0.02%         |      UNTREATD        0.01%           0.02%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       0/50 (0%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       0/49 (0%)      |
|ADJUSTED (b)           |      7.4%            0.0%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     2/27 (7%)       0/40 (0%)       0/33 (0%)      |     0/14 (0%)       0/18 (0%)       0/17 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         ---             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.068N        P=0.157N        P=0.195N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.068N        P=0.157N        P=0.195N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.068N        P=0.157N        P=0.195N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.095N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.247N        P=0.247N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/48 (4%)       2/50 (4%)      |     0/49 (0%)       0/49 (0%)       0/49 (0%)      |
|ADJUSTED (b)           |      0.0%            5.3%            6.1%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/27 (0%)       2/38 (5%)       2/33 (6%)      |     0/14 (0%)       0/18 (0%)       0/17 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             729 (T)         729 (T)       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.207         P=0.316         P=0.283        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.207         P=0.316         P=0.283        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.207         P=0.316         P=0.283        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.177                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.237         P=0.247        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05058 TEST: 02                                                 PAGE  12
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ROXARSONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.01%           0.02%         |      UNTREATD        0.01%           0.02%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/48 (4%)       3/50 (6%)      |     0/49 (0%)       0/49 (0%)       0/49 (0%)      |
|ADJUSTED (b)           |      0.0%            5.3%            9.1%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/27 (0%)       2/38 (5%)       3/33 (9%)      |     0/14 (0%)       0/18 (0%)       0/17 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             729 (T)         729 (T)       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.099         P=0.316         P=0.158        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.099         P=0.316         P=0.158        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.099         P=0.316         P=0.158        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.083                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.237         P=0.121        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/50 (2%)       0/50 (0%)      |     0/50 (0%)       2/50 (4%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            2.5%            0.0%          |      0.0%            9.8%            0.0%          |
|TERMINAL (d)           |     0/27 (0%)       1/40 (3%)       0/33 (0%)      |     0/14 (0%)       1/18 (6%)       0/17 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             729 (T)         ---           |      ---             662             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.716N        P=0.578           (e)          |     P=0.666N        P=0.243           (e)          |
|INCIDENTAL TUMOR       |     P=0.716N        P=0.578           (e)          |     P=0.602         P=0.196           (e)          |
|LOGISTIC REGRESSION    |     P=0.716N        P=0.578           (e)          |     P=0.663         P=0.235           (e)          |
|COCHRAN-ARMITAGE       |     P=0.731                                        |     P=0.669                                        |
|FISHER EXACT           |                     P=0.500           (e)          |                     P=0.247           (e)          |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05058 TEST: 02                                                 PAGE  13
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ROXARSONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.01%           0.02%         |      UNTREATD        0.01%           0.02%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       0/50 (0%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      9.4%            0.0%            0.0%          |      0.0%            0.0%            3.1%          |
|TERMINAL (d)           |     2/27 (7%)       0/40 (0%)       0/33 (0%)      |     0/14 (0%)       0/18 (0%)       0/17 (0%)      |
|FIRST INCIDENCE (DAYS) |      535             ---             ---           |      ---             ---             591           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.026N*       P=0.077N        P=0.100N       |     P=0.261           (e)           P=0.488        |
|INCIDENTAL TUMOR       |     P=0.056N        P=0.157N        P=0.134N       |     P=0.358           (e)           P=0.623        |
|LOGISTIC REGRESSION    |     P=0.038N*       P=0.129N        P=0.121N       |     P=0.261           (e)           P=0.492        |
|COCHRAN-ARMITAGE       |     P=0.037N*                                      |     P=0.269                                        |
|FISHER EXACT           |                     P=0.121N        P=0.121N       |                       (e)           P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       1/50 (2%)       0/50 (0%)      |     0/50 (0%)       2/50 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |      9.4%            2.5%            0.0%          |      0.0%            9.8%            3.1%          |
|TERMINAL (d)           |     2/27 (7%)       1/40 (3%)       0/33 (0%)      |     0/14 (0%)       1/18 (6%)       0/17 (0%)      |
|FIRST INCIDENCE (DAYS) |      535             729 (T)         ---           |      ---             662             591           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.042N*       P=0.204N        P=0.100N       |     P=0.357         P=0.243         P=0.488        |
|INCIDENTAL TUMOR       |     P=0.074N        P=0.364N        P=0.134N       |     P=0.360         P=0.196         P=0.623        |
|LOGISTIC REGRESSION    |     P=0.061N        P=0.310N        P=0.121N       |     P=0.359         P=0.235         P=0.492        |
|COCHRAN-ARMITAGE       |     P=0.060N                                       |     P=0.360                                        |
|FISHER EXACT           |                     P=0.309N        P=0.121N       |                     P=0.247         P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05058 TEST: 02                                                 PAGE  14
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ROXARSONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.01%           0.02%         |      UNTREATD        0.01%           0.02%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      1/50 (2%)       3/50 (6%)      |    13/50 (26%)      2/50 (4%)       3/50 (6%)      |
|ADJUSTED (b)           |     15.6%            2.5%            8.3%          |     52.0%            9.3%            9.6%          |
|TERMINAL (d)           |     3/27 (11%)      1/40 (3%)       1/33 (3%)      |     5/14 (36%)      0/18 (0%)       0/17 (0%)      |
|FIRST INCIDENCE (DAYS) |      647             729 (T)         702           |      170             662             534           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.205N        P=0.050N        P=0.285N       |     P=0.003N**      P=0.003N**      P=0.010N*      |
|INCIDENTAL TUMOR       |     P=0.297N        P=0.086N        P=0.400N       |     P=0.010N**      P=0.010N**      P=0.021N*      |
|LOGISTIC REGRESSION    |     P=0.249N        P=0.086N        P=0.336N       |     P=0.002N**      P=0.002N**      P=0.007N**     |
|COCHRAN-ARMITAGE       |     P=0.264N                                       |     P=0.002N**                                     |
|FISHER EXACT           |                     P=0.102N        P=0.357N       |                     P=0.002N**      P=0.006N**     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      1/50 (2%)       3/50 (6%)      |    13/50 (26%)      2/50 (4%)       3/50 (6%)      |
|ADJUSTED (b)           |     15.6%            2.5%            8.3%          |     52.0%            9.3%            9.6%          |
|TERMINAL (d)           |     3/27 (11%)      1/40 (3%)       1/33 (3%)      |     5/14 (36%)      0/18 (0%)       0/17 (0%)      |
|FIRST INCIDENCE (DAYS) |      647             729 (T)         702           |      170             662             534           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.205N        P=0.050N        P=0.285N       |     P=0.003N**      P=0.003N**      P=0.010N*      |
|INCIDENTAL TUMOR       |     P=0.297N        P=0.086N        P=0.400N       |     P=0.010N**      P=0.010N**      P=0.021N*      |
|LOGISTIC REGRESSION    |     P=0.249N        P=0.086N        P=0.336N       |     P=0.002N**      P=0.002N**      P=0.007N**     |
|COCHRAN-ARMITAGE       |     P=0.264N                                       |     P=0.002N**                                     |
|FISHER EXACT           |                     P=0.102N        P=0.357N       |                     P=0.002N**      P=0.006N**     |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05058 TEST: 02                                                 PAGE  15
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ROXARSONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.01%           0.02%         |      UNTREATD        0.01%           0.02%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    18/50 (36%)     20/50 (40%)     20/50 (40%)     |    11/50 (22%)      9/50 (18%)     13/50 (26%)     |
|ADJUSTED (b)           |     50.4%           46.3%           52.4%          |     46.3%           40.1%           56.7%          |
|TERMINAL (d)           |    10/27 (37%)     17/40 (43%)     15/33 (45%)     |     3/14 (21%)      6/18 (33%)      8/17 (47%)     |
|FIRST INCIDENCE (DAYS) |      618             645             653           |      635             530             483           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.465N        P=0.249N        P=0.497N       |     P=0.429         P=0.344N        P=0.485        |
|INCIDENTAL TUMOR       |     P=0.410         P=0.578         P=0.441        |     P=0.282         P=0.495N        P=0.283        |
|LOGISTIC REGRESSION    |     P=0.473         P=0.528N        P=0.522        |     P=0.313         P=0.404N        P=0.358        |
|COCHRAN-ARMITAGE       |     P=0.379                                        |     P=0.359                                        |
|FISHER EXACT           |                     P=0.418         P=0.418        |                     P=0.402N        P=0.408        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    26/50 (52%)     18/50 (36%)     21/50 (42%)     |    18/50 (36%)      3/50 (6%)       5/50 (10%)     |
|ADJUSTED (b)           |     58.6%           36.7%           45.2%          |     64.8%           11.5%           14.7%          |
|TERMINAL (d)           |     9/27 (33%)      9/40 (23%)      8/33 (24%)     |     6/14 (43%)      0/18 (0%)       0/17 (0%)      |
|FIRST INCIDENCE (DAYS) |      456             560             432           |      170             521             485           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.122N        P=0.018N*       P=0.144N       |     P=0.001N**      P<0.001N**      P=0.005N**     |
|INCIDENTAL TUMOR       |     P=0.367N        P=0.384N        P=0.397N       |     P=0.003N**      P=0.001N**      P=0.007N**     |
|LOGISTIC REGRESSION    |     P=0.345N        P=0.262N        P=0.369N       |     P<0.001N**      P<0.001N**      P=0.002N**     |
|COCHRAN-ARMITAGE       |     P=0.182N                                       |     P<0.001N**                                     |
|FISHER EXACT           |                     P=0.079N        P=0.212N       |                     P<0.001N**      P=0.002N**     |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05058 TEST: 02                                                 PAGE  16
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ROXARSONE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.01%           0.02%         |      UNTREATD        0.01%           0.02%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    35/50 (70%)     30/50 (60%)     34/50 (68%)     |    24/50 (48%)     11/50 (22%)     18/50 (36%)     |
|ADJUSTED (b)           |     77.7%           61.2%           70.8%          |     80.8%           44.5%           63.1%          |
|TERMINAL (d)           |    17/27 (63%)     21/40 (53%)     19/33 (58%)     |     9/14 (64%)      6/18 (33%)      8/17 (47%)     |
|FIRST INCIDENCE (DAYS) |      456             560             432           |      170             521             483           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.221N        P=0.016N*       P=0.239N       |     P=0.118N        P=0.006N**      P=0.153N       |
|INCIDENTAL TUMOR       |     P=0.460         P=0.339N        P=0.526        |     P=0.233N        P=0.013N*       P=0.287N       |
|LOGISTIC REGRESSION    |     P=0.481         P=0.257N        P=0.561        |     P=0.121N        P=0.005N**      P=0.148N       |
|COCHRAN-ARMITAGE       |     P=0.458N                                       |     P=0.125N                                       |
|FISHER EXACT           |                     P=0.201N        P=0.500N       |                     P=0.006N**      P=0.156N       |
|=================================================================================================================================|
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (d)  Observed incidence at terminal kill.
 (f)  Beneath the control incidence are the P-values associated with the trend 
      test.  Beneath the dosed group incidence are the P-values corresponding to 
      pairwise comparisons between the controls and that dosed group.  The life
      table analysis regards tumors in animals dying  prior to terminal kill as
      being (directly or indirectly) the cause of death.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's exact tests compare directly the overall incidence rates.  
      For all tests, a negative trend is indicated by "N".
 (e)  Value of Statistic cannot be computed. 
 (I)  Interim sacrifice
 (T)  Terminal sacrifice
  #   Tumor rates based on number of animals necropsied.
 
  *   To the right of any statistical result, indicates significance at (P<=0.05).
  **  To the right of any statistical result, indicates significance at (P<=0.01).

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