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TDMS Study 05079-02 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: LITRI                                                        TALC                                         DATE: 09/10/94       
EXPERIMENT: 05079 TEST: 02                                                                                     TIME: 17:34:05       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT:                       ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                                             NTP C#: 06008        
PATHOLOGIST: B. JONES                        F. HAHN                                                           CAS: 14807966        
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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: LITRI                                                        TALC                                         DATE: 09/10/94      
EXPERIMENT: 05079 TEST: 02                                                                                     TIME: 17:34:05      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT:                       ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                                             NTP C#: 06008       
PATHOLOGIST: B. JONES                        F. HAHN                                                           CAS: 14807966       
 
 
 
 
 
                                                    MICE(B6C3F1)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Larynx
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: LITRI                                                        TALC                                         DATE: 09/10/94       
EXPERIMENT: 05079 TEST: 02                                                                                     TIME: 17:34:05       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT:                       ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                                             NTP C#: 06008        
PATHOLOGIST: B. JONES                        F. HAHN                                                           CAS: 14807966        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                              IN THE ANALYSIS OF THE STUDY OF TALC
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Lung                          Alveolar/Bronchiolar Carcinoma
                             All Organs                    Hemangiosarcoma
                                                           Hemangiosarcoma or Hemangioma
                                                           Malignant Lymphoma And Histiocytic Sarcoma
                                                           Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
                                                            NOS, or Undifferentiated Cell Type
                                                           Malignant Tumors
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             All Organs                    Benign Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 02                                                 PAGE   1
                                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         6 MG/M3         18 MG/M3      |      CONTROL         6 MG/M3         18 MG/M3      |
|                       |      LUNG TOX        LUNG TOX        LUNG TOX      |      LUNG TOX        LUNG TOX        LUNG TOX      |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/58 (2%)       0/59 (0%)       4/61 (7%)      |     2/57 (4%)       1/61 (2%)       0/62 (0%)      |
|ADJUSTED (b)           |      3.3%            0.0%           12.0%          |      6.7%            4.3%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/3 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|TERMINAL (d)           |     1/30 (3%)       0/28 (0%)       3/32 (9%)      |     2/30 (7%)       1/23 (4%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      736 (T)         ---             725           |      729 (T)         729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.073         P=0.514N        P=0.204        |     P=0.207N        P=0.593N        P=0.279N       |
|INCIDENTAL TUMOR       |     P=0.080         P=0.514N        P=0.239        |     P=0.207N        P=0.593N        P=0.279N       |
|LOGISTIC REGRESSION    |     P=0.075         P=0.514N        P=0.216        |     P=0.207N        P=0.593N        P=0.279N       |
|COCHRAN-ARMITAGE       |     P=0.064                                        |     P=0.162N                                       |
|FISHER EXACT           |                     P=0.496N        P=0.198        |                     P=0.474N        P=0.227N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/58 (2%)       0/59 (0%)       4/61 (7%)      |     2/57 (4%)       1/61 (2%)       1/62 (2%)      |
|ADJUSTED (b)           |      3.3%            0.0%           12.0%          |      6.7%            4.3%            3.6%          |
|INTERIM SACRIFICE 1 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/3 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|TERMINAL (d)           |     1/30 (3%)       0/28 (0%)       3/32 (9%)      |     2/30 (7%)       1/23 (4%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      736 (T)         ---             725           |      729 (T)         729 (T)         706           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.073         P=0.514N        P=0.204        |     P=0.490N        P=0.593N        P=0.554N       |
|INCIDENTAL TUMOR       |     P=0.080         P=0.514N        P=0.239        |     P=0.453N        P=0.593N        P=0.476N       |
|LOGISTIC REGRESSION    |     P=0.075         P=0.514N        P=0.216        |     P=0.479N        P=0.593N        P=0.536N       |
|COCHRAN-ARMITAGE       |     P=0.064                                        |     P=0.421N                                       |
|FISHER EXACT           |                     P=0.496N        P=0.198        |                     P=0.474N        P=0.468N       |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 02                                                 PAGE   2
                                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         6 MG/M3         18 MG/M3      |      CONTROL         6 MG/M3         18 MG/M3      |
|                       |      LUNG TOX        LUNG TOX        LUNG TOX      |      LUNG TOX        LUNG TOX        LUNG TOX      |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/57 (7%)      10/59 (17%)      6/60 (10%)     |     5/57 (9%)       1/59 (2%)       5/62 (8%)      |
|ADJUSTED (b)           |     11.7%           30.8%           15.2%          |     16.7%            4.3%           16.0%          |
|INTERIM SACRIFICE 1 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 2 (c)|     1/4 (25%)       1/4 (25%)       2/4 (50%)      |     0/3 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        1/4 (25%)      |
|TERMINAL (d)           |     3/30 (10%)      7/28 (25%)      3/32 (9%)      |     5/30 (17%)      1/23 (4%)       2/25 (8%)      |
|FIRST INCIDENCE (DAYS) |      369 (I)         369 (I)         369 (I)       |      729 (T)         729 (T)         549 (I)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.535         P=0.063         P=0.399        |     P=0.399         P=0.169N        P=0.535        |
|INCIDENTAL TUMOR       |     P=0.514         P=0.080         P=0.436        |     P=0.446         P=0.169N        P=0.629        |
|LOGISTIC REGRESSION    |     P=0.499         P=0.082         P=0.398        |     P=0.440         P=0.169N        P=0.602        |
|COCHRAN-ARMITAGE       |     P=0.512                                        |     P=0.514                                        |
|FISHER EXACT           |                     P=0.087         P=0.404        |                     P=0.095N        P=0.574N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     8/57 (14%)      5/59 (8%)      11/60 (18%)     |     7/57 (12%)      5/59 (8%)       4/62 (6%)      |
|ADJUSTED (b)           |     20.6%           13.5%           26.7%          |     18.7%           18.4%           15.4%          |
|INTERIM SACRIFICE 1 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/3 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 3 (c)|     2/4 (50%)       0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|TERMINAL (d)           |     2/30 (7%)       1/28 (4%)       5/32 (16%)     |     3/30 (10%)      3/23 (13%)      3/25 (12%)     |
|FIRST INCIDENCE (DAYS) |      549 (I)         546             438           |      426             645             718           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.236         P=0.280N        P=0.354        |     P=0.308N        P=0.487N        P=0.344N       |
|INCIDENTAL TUMOR       |     P=0.073         P=0.193N        P=0.118        |     P=0.271N        P=0.392N        P=0.306N       |
|LOGISTIC REGRESSION    |     P=0.079         P=0.211N        P=0.153        |     P=0.255N        P=0.387N        P=0.273N       |
|COCHRAN-ARMITAGE       |     P=0.219                                        |     P=0.200N                                       |
|FISHER EXACT           |                     P=0.257N        P=0.353        |                     P=0.357N        P=0.218N       |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 02                                                 PAGE   3
                                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         6 MG/M3         18 MG/M3      |      CONTROL         6 MG/M3         18 MG/M3      |
|                       |      LUNG TOX        LUNG TOX        LUNG TOX      |      LUNG TOX        LUNG TOX        LUNG TOX      |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    12/57 (21%)     14/59 (24%)     16/60 (27%)     |    11/57 (19%)      6/59 (10%)      8/62 (13%)     |
|ADJUSTED (b)           |     30.4%           39.2%           36.5%          |     30.8%           22.5%           27.0%          |
|INTERIM SACRIFICE 1 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 2 (c)|     1/4 (25%)       1/4 (25%)       2/4 (50%)      |     0/3 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 3 (c)|     2/4 (50%)       0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        1/4 (25%)      |
|TERMINAL (d)           |     5/30 (17%)      8/28 (29%)      7/32 (22%)     |     7/30 (23%)      4/23 (17%)      5/25 (20%)     |
|FIRST INCIDENCE (DAYS) |      369 (I)         369 (I)         369 (I)       |      426             645             549 (I)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.315         P=0.395         P=0.316        |     P=0.440N        P=0.262N        P=0.428N       |
|INCIDENTAL TUMOR       |     P=0.170         P=0.479         P=0.136        |     P=0.395N        P=0.190N        P=0.365N       |
|LOGISTIC REGRESSION    |     P=0.164         P=0.440         P=0.155        |     P=0.368N        P=0.156N        P=0.329N       |
|COCHRAN-ARMITAGE       |     P=0.287                                        |     P=0.279N                                       |
|FISHER EXACT           |                     P=0.451         P=0.311        |                     P=0.130N        P=0.242N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    12/57 (21%)     14/59 (24%)     16/60 (27%)     |    11/57 (19%)      6/59 (10%)      8/62 (13%)     |
|ADJUSTED (b)           |     30.4%           39.2%           36.5%          |     30.8%           22.5%           27.0%          |
|INTERIM SACRIFICE 1 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 2 (c)|     1/4 (25%)       1/4 (25%)       2/4 (50%)      |     0/3 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 3 (c)|     2/4 (50%)       0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        1/4 (25%)      |
|TERMINAL (d)           |     5/30 (17%)      8/28 (29%)      7/32 (22%)     |     7/30 (23%)      4/23 (17%)      5/25 (20%)     |
|FIRST INCIDENCE (DAYS) |      369 (I)         369 (I)         369 (I)       |      426             645             549 (I)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.315         P=0.395         P=0.316        |     P=0.440N        P=0.262N        P=0.428N       |
|INCIDENTAL TUMOR       |     P=0.170         P=0.479         P=0.136        |     P=0.395N        P=0.190N        P=0.365N       |
|LOGISTIC REGRESSION    |     P=0.164         P=0.440         P=0.155        |     P=0.368N        P=0.156N        P=0.329N       |
|COCHRAN-ARMITAGE       |     P=0.287                                        |     P=0.279N                                       |
|FISHER EXACT           |                     P=0.451         P=0.311        |                     P=0.130N        P=0.242N       |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 02                                                 PAGE   4
                                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         6 MG/M3         18 MG/M3      |      CONTROL         6 MG/M3         18 MG/M3      |
|                       |      LUNG TOX        LUNG TOX        LUNG TOX      |      LUNG TOX        LUNG TOX        LUNG TOX      |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/57 (11%)      5/59 (8%)       9/60 (15%)     |     4/57 (7%)       2/61 (3%)       2/62 (3%)      |
|ADJUSTED (b)           |     20.0%           16.1%           27.0%          |     12.1%            6.7%            6.2%          |
|INTERIM SACRIFICE 1 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/3 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/4 (0%)        1/4 (25%)       0/4 (0%)       |     1/4 (25%)       0/4 (0%)        0/4 (0%)       |
|TERMINAL (d)           |     6/30 (20%)      4/28 (14%)      8/32 (25%)     |     3/30 (10%)      1/23 (4%)       1/25 (4%)      |
|FIRST INCIDENCE (DAYS) |      736 (T)         549 (I)         672           |      549 (I)         559             548           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.250         P=0.545N        P=0.333        |     P=0.356N        P=0.415N        P=0.392N       |
|INCIDENTAL TUMOR       |     P=0.263         P=0.545N        P=0.362        |     P=0.311N        P=0.346N        P=0.341N       |
|LOGISTIC REGRESSION    |     P=0.259         P=0.485N        P=0.373        |     P=0.322N        P=0.331N        P=0.347N       |
|COCHRAN-ARMITAGE       |     P=0.233                                        |     P=0.283N                                       |
|FISHER EXACT           |                     P=0.476N        P=0.329        |                     P=0.308N        P=0.301N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     8/57 (14%)      2/59 (3%)       2/60 (3%)      |     2/57 (4%)       4/61 (7%)       1/62 (2%)      |
|ADJUSTED (b)           |     25.1%            5.9%            5.1%          |      6.7%           11.4%            2.6%          |
|INTERIM SACRIFICE 1 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/3 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 3 (c)|     1/4 (25%)       0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|TERMINAL (d)           |     7/30 (23%)      1/28 (4%)       0/32 (0%)      |     2/30 (7%)       0/23 (0%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      549 (I)         558             438           |      729 (T)         491             558           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.041N*       P=0.057N        P=0.042N*      |     P=0.383N        P=0.286         P=0.539N       |
|INCIDENTAL TUMOR       |     P=0.047N*       P=0.052N        P=0.036N*      |     P=0.311N        P=0.428         P=0.464N       |
|LOGISTIC REGRESSION    |     P=0.040N*       P=0.043N*       P=0.041N*      |     P=0.343N        P=0.344         P=0.509N       |
|COCHRAN-ARMITAGE       |     P=0.040N*                                      |     P=0.310N                                       |
|FISHER EXACT           |                     P=0.042N*       P=0.039N*      |                     P=0.373         P=0.468N       |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 02                                                 PAGE   5
                                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         6 MG/M3         18 MG/M3      |      CONTROL         6 MG/M3         18 MG/M3      |
|                       |      LUNG TOX        LUNG TOX        LUNG TOX      |      LUNG TOX        LUNG TOX        LUNG TOX      |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    13/57 (23%)      6/59 (10%)     11/60 (18%)     |     6/57 (11%)      6/61 (10%)      3/62 (5%)      |
|ADJUSTED (b)           |     41.4%           18.2%           30.7%          |     18.7%           17.4%            8.7%          |
|INTERIM SACRIFICE 1 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/3 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 3 (c)|     1/4 (25%)       1/4 (25%)       0/4 (0%)       |     1/4 (25%)       0/4 (0%)        0/4 (0%)       |
|TERMINAL (d)           |    12/30 (40%)      4/28 (14%)      8/32 (25%)     |     5/30 (17%)      1/23 (4%)       1/25 (4%)      |
|FIRST INCIDENCE (DAYS) |      549 (I)         549 (I)         438           |      549 (I)         491             548           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.424N        P=0.075N        P=0.338N       |     P=0.246N        P=0.516         P=0.303N       |
|INCIDENTAL TUMOR       |     P=0.436N        P=0.071N        P=0.297N       |     P=0.176N        P=0.560N        P=0.226N       |
|LOGISTIC REGRESSION    |     P=0.439N        P=0.052N        P=0.329N       |     P=0.199N        P=0.611N        P=0.253N       |
|COCHRAN-ARMITAGE       |     P=0.453N                                       |     P=0.161N                                       |
|FISHER EXACT           |                     P=0.056N        P=0.356N       |                     P=0.570N        P=0.205N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Luteoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     2/49 (4%)       0/55 (0%)       0/58 (0%)      |
|ADJUSTED (b)           |                                                    |      8.0%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|                                                    |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 2 (c)|                                                    |     0/3 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 3 (c)|                                                    |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|TERMINAL (d)           |                                                    |     2/25 (8%)       0/21 (0%)       0/24 (0%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      729 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.177N        P=0.277N        P=0.246N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.177N        P=0.277N        P=0.246N       |
|LOGISTIC REGRESSION    |                                                    |     P=0.177N        P=0.277N        P=0.246N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.149N                                       |
|FISHER EXACT           |                                                    |                     P=0.220N        P=0.207N       |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 02                                                 PAGE   6
                                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         6 MG/M3         18 MG/M3      |      CONTROL         6 MG/M3         18 MG/M3      |
|                       |      LUNG TOX        LUNG TOX        LUNG TOX      |      LUNG TOX        LUNG TOX        LUNG TOX      |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/56 (2%)       0/56 (0%)       0/58 (0%)      |     5/53 (9%)       4/55 (7%)       2/60 (3%)      |
|ADJUSTED (b)           |      2.8%            0.0%            0.0%          |     15.1%           18.2%            7.1%          |
|INTERIM SACRIFICE 1 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/3 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|TERMINAL (d)           |     0/29 (0%)       0/27 (0%)       0/32 (0%)      |     2/30 (7%)       4/22 (18%)      1/25 (4%)      |
|FIRST INCIDENCE (DAYS) |      587             ---             ---           |      683             729 (T)         665           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.388N        P=0.484N        P=0.489N       |     P=0.239N        P=0.610         P=0.290N       |
|INCIDENTAL TUMOR       |     P=0.807N        P=0.443N          (e)          |     P=0.145N        P=0.533N        P=0.114N       |
|LOGISTIC REGRESSION    |     P=0.387N        P=0.500N        P=0.491N       |     P=0.193N        P=0.611N        P=0.229N       |
|COCHRAN-ARMITAGE       |     P=0.389N                                       |     P=0.139N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.491N       |                     P=0.476N        P=0.171N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/56 (0%)       0/56 (0%)       0/58 (0%)      |     0/53 (0%)       2/55 (4%)       0/60 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      0.0%            5.3%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/3 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|TERMINAL (d)           |     0/29 (0%)       0/27 (0%)       0/32 (0%)      |     0/30 (0%)       0/22 (0%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      ---             534             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.591N        P=0.236           (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.576N        P=0.263           (e)          |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.551N        P=0.244           (e)          |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.546N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.257           (e)          |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 02                                                 PAGE   7
                                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         6 MG/M3         18 MG/M3      |      CONTROL         6 MG/M3         18 MG/M3      |
|                       |      LUNG TOX        LUNG TOX        LUNG TOX      |      LUNG TOX        LUNG TOX        LUNG TOX      |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/56 (2%)       0/56 (0%)       0/58 (0%)      |     5/53 (9%)       6/55 (11%)      2/60 (3%)      |
|ADJUSTED (b)           |      2.8%            0.0%            0.0%          |     15.1%           22.5%            7.1%          |
|INTERIM SACRIFICE 1 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/3 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|TERMINAL (d)           |     0/29 (0%)       0/27 (0%)       0/32 (0%)      |     2/30 (7%)       4/22 (18%)      1/25 (4%)      |
|FIRST INCIDENCE (DAYS) |      587             ---             ---           |      683             534             665           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.388N        P=0.484N        P=0.489N       |     P=0.216N        P=0.352         P=0.290N       |
|INCIDENTAL TUMOR       |     P=0.807N        P=0.443N          (e)          |     P=0.126N        P=0.485         P=0.114N       |
|LOGISTIC REGRESSION    |     P=0.387N        P=0.500N        P=0.491N       |     P=0.159N        P=0.429         P=0.229N       |
|COCHRAN-ARMITAGE       |     P=0.389N                                       |     P=0.117N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.491N       |                     P=0.526         P=0.171N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Intermedia                                                                                                 |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/56 (0%)       2/56 (4%)       0/58 (0%)      |     0/53 (0%)       0/55 (0%)       0/60 (0%)      |
|ADJUSTED (b)           |      0.0%            6.5%            0.0%          |      0.0%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/3 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|TERMINAL (d)           |     0/29 (0%)       1/27 (4%)       0/32 (0%)      |     0/30 (0%)       0/22 (0%)       0/25 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             681             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.547N        P=0.238           (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.523N        P=0.305           (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.560N        P=0.240           (e)          |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.566N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.248           (e)          |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 02                                                 PAGE   8
                                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         6 MG/M3         18 MG/M3      |      CONTROL         6 MG/M3         18 MG/M3      |
|                       |      LUNG TOX        LUNG TOX        LUNG TOX      |      LUNG TOX        LUNG TOX        LUNG TOX      |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/56 (4%)       0/56 (0%)       2/59 (3%)      |     0/56 (0%)       0/57 (0%)       1/62 (2%)      |
|ADJUSTED (b)           |      6.9%            0.0%            5.5%          |      0.0%            0.0%            4.0%          |
|INTERIM SACRIFICE 1 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/3 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|TERMINAL (d)           |     2/29 (7%)       0/28 (0%)       0/32 (0%)      |     0/30 (0%)       0/23 (0%)       1/25 (4%)      |
|FIRST INCIDENCE (DAYS) |      736 (T)         ---             672           |      ---             ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.595         P=0.246N        P=0.650N       |     P=0.278           (e)           P=0.464        |
|INCIDENTAL TUMOR       |     P=0.658         P=0.246N        P=0.550N       |     P=0.278           (e)           P=0.464        |
|LOGISTIC REGRESSION    |     P=0.588         P=0.246N        P=0.659N       |     P=0.278           (e)           P=0.464        |
|COCHRAN-ARMITAGE       |     P=0.572                                        |     P=0.313                                        |
|FISHER EXACT           |                     P=0.248N        P=0.671N       |                       (e)           P=0.525        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/57 (0%)       0/58 (0%)       2/57 (4%)      |     1/54 (2%)       2/60 (3%)       2/61 (3%)      |
|ADJUSTED (b)           |      0.0%            0.0%            6.5%          |      3.4%            8.7%            8.0%          |
|INTERIM SACRIFICE 1 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/3 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|TERMINAL (d)           |     0/30 (0%)       0/28 (0%)       2/31 (6%)      |     1/29 (3%)       2/23 (9%)       2/25 (8%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             736 (T)       |      729 (T)         729 (T)         729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.100           (e)           P=0.245        |     P=0.409         P=0.419         P=0.448        |
|INCIDENTAL TUMOR       |     P=0.100           (e)           P=0.245        |     P=0.409         P=0.419         P=0.448        |
|LOGISTIC REGRESSION    |     P=0.100           (e)           P=0.245        |     P=0.409         P=0.419         P=0.448        |
|COCHRAN-ARMITAGE       |     P=0.091                                        |     P=0.492                                        |
|FISHER EXACT           |                       (e)           P=0.248        |                     P=0.540         P=0.546        |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 02                                                 PAGE   9
                                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         6 MG/M3         18 MG/M3      |      CONTROL         6 MG/M3         18 MG/M3      |
|                       |      LUNG TOX        LUNG TOX        LUNG TOX      |      LUNG TOX        LUNG TOX        LUNG TOX      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/58 (0%)       0/59 (0%)       1/61 (2%)      |     2/57 (4%)       1/61 (2%)       1/62 (2%)      |
|ADJUSTED (b)           |      0.0%            0.0%            3.1%          |      6.7%            4.3%            4.0%          |
|INTERIM SACRIFICE 1 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/3 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|TERMINAL (d)           |     0/30 (0%)       0/28 (0%)       1/32 (3%)      |     2/30 (7%)       1/23 (4%)       1/25 (4%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             736 (T)       |      729 (T)         729 (T)         729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.312           (e)           P=0.513        |     P=0.496N        P=0.593N        P=0.564N       |
|INCIDENTAL TUMOR       |     P=0.312           (e)           P=0.513        |     P=0.496N        P=0.593N        P=0.564N       |
|LOGISTIC REGRESSION    |     P=0.312           (e)           P=0.513        |     P=0.496N        P=0.593N        P=0.564N       |
|COCHRAN-ARMITAGE       |     P=0.304                                        |     P=0.421N                                       |
|FISHER EXACT           |                       (e)           P=0.513        |                     P=0.474N        P=0.468N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/58 (7%)       0/59 (0%)       3/61 (5%)      |     0/57 (0%)       0/61 (0%)       2/62 (3%)      |
|ADJUSTED (b)           |     12.9%            0.0%            8.4%          |      0.0%            0.0%            6.0%          |
|INTERIM SACRIFICE 1 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/3 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|TERMINAL (d)           |     3/30 (10%)      0/28 (0%)       1/32 (3%)      |     0/30 (0%)       0/23 (0%)       1/25 (4%)      |
|FIRST INCIDENCE (DAYS) |      710             ---             672           |      ---             ---             473           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.529N        P=0.071N        P=0.448N       |     P=0.086           (e)           P=0.220        |
|INCIDENTAL TUMOR       |     P=0.461N        P=0.048N*       P=0.320N       |     P=0.051           (e)           P=0.135        |
|LOGISTIC REGRESSION    |     P=0.539N        P=0.060N        P=0.450N       |     P=0.095           (e)           P=0.248        |
|COCHRAN-ARMITAGE       |     P=0.559N                                       |     P=0.099                                        |
|FISHER EXACT           |                     P=0.057N        P=0.472N       |                       (e)           P=0.269        |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 02                                                 PAGE  10
                                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         6 MG/M3         18 MG/M3      |      CONTROL         6 MG/M3         18 MG/M3      |
|                       |      LUNG TOX        LUNG TOX        LUNG TOX      |      LUNG TOX        LUNG TOX        LUNG TOX      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/58 (7%)       0/59 (0%)       4/61 (7%)      |     2/57 (4%)       1/61 (2%)       3/62 (5%)      |
|ADJUSTED (b)           |     12.9%            0.0%           11.4%          |      6.7%            4.3%           10.0%          |
|INTERIM SACRIFICE 1 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/3 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|TERMINAL (d)           |     3/30 (10%)      0/28 (0%)       2/32 (6%)      |     2/30 (7%)       1/23 (4%)       2/25 (8%)      |
|FIRST INCIDENCE (DAYS) |      710             ---             672           |      729 (T)         729 (T)         473           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.515         P=0.071N        P=0.590N       |     P=0.323         P=0.593N        P=0.434        |
|INCIDENTAL TUMOR       |     P=0.581         P=0.048N*       P=0.475N       |     P=0.275         P=0.593N        P=0.361        |
|LOGISTIC REGRESSION    |     P=0.510         P=0.060N        P=0.592N       |     P=0.352         P=0.593N        P=0.486        |
|COCHRAN-ARMITAGE       |     P=0.486                                        |     P=0.399                                        |
|FISHER EXACT           |                     P=0.057N        P=0.613N       |                     P=0.474N        P=0.540        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/58 (9%)       1/59 (2%)       0/61 (0%)      |     7/57 (12%)      7/61 (11%)      8/62 (13%)     |
|ADJUSTED (b)           |     16.7%            3.6%            0.0%          |     21.1%           26.7%           27.4%          |
|INTERIM SACRIFICE 1 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/3 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|TERMINAL (d)           |     5/30 (17%)      1/28 (4%)       0/32 (0%)      |     5/30 (17%)      5/23 (22%)      5/25 (20%)     |
|FIRST INCIDENCE (DAYS) |      736 (T)         736 (T)         ---           |      509             628             642           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.019N*       P=0.116N        P=0.027N*      |     P=0.358         P=0.454         P=0.387        |
|INCIDENTAL TUMOR       |     P=0.019N*       P=0.116N        P=0.027N*      |     P=0.419         P=0.572         P=0.487        |
|LOGISTIC REGRESSION    |     P=0.019N*       P=0.116N        P=0.027N*      |     P=0.401         P=0.592         P=0.456        |
|COCHRAN-ARMITAGE       |     P=0.021N*                                      |     P=0.514                                        |
|FISHER EXACT           |                     P=0.099N        P=0.025N*      |                     P=0.558N        P=0.570        |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 02                                                 PAGE  11
                                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         6 MG/M3         18 MG/M3      |      CONTROL         6 MG/M3         18 MG/M3      |
|                       |      LUNG TOX        LUNG TOX        LUNG TOX      |      LUNG TOX        LUNG TOX        LUNG TOX      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/58 (9%)       1/59 (2%)       0/61 (0%)      |     7/57 (12%)      7/61 (11%)      8/62 (13%)     |
|ADJUSTED (b)           |     16.7%            3.6%            0.0%          |     21.1%           26.7%           27.4%          |
|INTERIM SACRIFICE 1 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/3 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|TERMINAL (d)           |     5/30 (17%)      1/28 (4%)       0/32 (0%)      |     5/30 (17%)      5/23 (22%)      5/25 (20%)     |
|FIRST INCIDENCE (DAYS) |      736 (T)         736 (T)         ---           |      509             628             642           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.019N*       P=0.116N        P=0.027N*      |     P=0.358         P=0.454         P=0.387        |
|INCIDENTAL TUMOR       |     P=0.019N*       P=0.116N        P=0.027N*      |     P=0.419         P=0.572         P=0.487        |
|LOGISTIC REGRESSION    |     P=0.019N*       P=0.116N        P=0.027N*      |     P=0.401         P=0.592         P=0.456        |
|COCHRAN-ARMITAGE       |     P=0.021N*                                      |     P=0.514                                        |
|FISHER EXACT           |                     P=0.099N        P=0.025N*      |                     P=0.558N        P=0.570        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    12/58 (21%)     18/59 (31%)     20/61 (33%)     |    19/57 (33%)     10/61 (16%)     11/62 (18%)     |
|ADJUSTED (b)           |     36.4%           53.1%           53.2%          |     55.6%           37.6%           34.4%          |
|INTERIM SACRIFICE 1 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 2 (c)|     1/4 (25%)       1/4 (25%)       2/4 (50%)      |     0/3 (0%)        1/4 (25%)       0/4 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/4 (0%)        1/4 (25%)       0/4 (0%)       |     1/4 (25%)       0/4 (0%)        1/4 (25%)      |
|TERMINAL (d)           |    10/30 (33%)     13/28 (46%)     15/32 (47%)     |    15/30 (50%)      8/23 (35%)      6/25 (24%)     |
|FIRST INCIDENCE (DAYS) |      369 (I)         369 (I)         369 (I)       |      549 (I)         369 (I)         548           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.130         P=0.106         P=0.097        |     P=0.156N        P=0.131N        P=0.155N       |
|INCIDENTAL TUMOR       |     P=0.110         P=0.141         P=0.092        |     P=0.091N        P=0.058N        P=0.052N       |
|LOGISTIC REGRESSION    |     P=0.100         P=0.151         P=0.088        |     P=0.100N        P=0.039N*       P=0.077N       |
|COCHRAN-ARMITAGE       |     P=0.115                                        |     P=0.059N                                       |
|FISHER EXACT           |                     P=0.158         P=0.100        |                     P=0.027N*       P=0.040N*      |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 02                                                 PAGE  12
                                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         6 MG/M3         18 MG/M3      |      CONTROL         6 MG/M3         18 MG/M3      |
|                       |      LUNG TOX        LUNG TOX        LUNG TOX      |      LUNG TOX        LUNG TOX        LUNG TOX      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    22/58 (38%)      8/59 (14%)     15/61 (25%)     |    19/57 (33%)     19/61 (31%)     15/62 (24%)     |
|ADJUSTED (b)           |     60.3%           23.1%           35.3%          |     51.6%           55.2%           45.5%          |
|INTERIM SACRIFICE 1 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/3 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 3 (c)|     2/4 (50%)       0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|TERMINAL (d)           |    16/30 (53%)      4/28 (14%)      6/32 (19%)     |    13/30 (43%)      9/23 (39%)      8/25 (32%)     |
|FIRST INCIDENCE (DAYS) |      549 (I)         546             438           |      426             491             473           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.160N        P=0.005N**      P=0.095N       |     P=0.372N        P=0.339         P=0.441N       |
|INCIDENTAL TUMOR       |     P=0.207N        P=0.002N**      P=0.121N       |     P=0.275N        P=0.586N        P=0.314N       |
|LOGISTIC REGRESSION    |     P=0.232N        P=0.002N**      P=0.082N       |     P=0.258N        P=0.573N        P=0.300N       |
|COCHRAN-ARMITAGE       |     P=0.161N                                       |     P=0.156N                                       |
|FISHER EXACT           |                     P=0.002N**      P=0.085N       |                     P=0.477N        P=0.184N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    29/58 (50%)     22/59 (37%)     30/61 (49%)     |    32/57 (56%)     27/61 (44%)     22/62 (35%)     |
|ADJUSTED (b)           |     77.7%           59.6%           67.5%          |     81.7%           75.5%           59.7%          |
|INTERIM SACRIFICE 1 (c)|     0/4 (0%)        0/4 (0%)        0/4 (0%)       |     0/4 (0%)        0/4 (0%)        0/4 (0%)       |
|INTERIM SACRIFICE 2 (c)|     1/4 (25%)       1/4 (25%)       2/4 (50%)      |     0/3 (0%)        1/4 (25%)       0/4 (0%)       |
|INTERIM SACRIFICE 3 (c)|     2/4 (50%)       1/4 (25%)       0/4 (0%)       |     1/4 (25%)       0/4 (0%)        1/4 (25%)      |
|TERMINAL (d)           |    22/30 (73%)     14/28 (50%)     18/32 (56%)     |    23/30 (77%)     15/23 (65%)     11/25 (44%)     |
|FIRST INCIDENCE (DAYS) |      369 (I)         369 (I)         369 (I)       |      426             369 (I)         473           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.507         P=0.173N        P=0.520N       |     P=0.144N        P=0.545         P=0.175N       |
|INCIDENTAL TUMOR       |     P=0.431         P=0.099N        P=0.535        |     P=0.046N*       P=0.237N        P=0.036N*      |
|LOGISTIC REGRESSION    |     P=0.421         P=0.087N        P=0.577N       |     P=0.043N*       P=0.179N        P=0.043N*      |
|COCHRAN-ARMITAGE       |     P=0.458                                        |     P=0.020N*                                      |
|FISHER EXACT           |                     P=0.115N        P=0.537N       |                     P=0.134N        P=0.019N*      |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 02                                                 PAGE  13
                                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 106 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (c)  Observed incidence at interim kill.
          Male interim sacrifices(days):   185  369  549
          Female interim sacrifices(days): 185  369  549
 (d)  Observed incidence at terminal kill.
 (f)  Beneath the control incidence are the P-values associated with the trend 
      test.  Beneath the dosed group incidence are the P-values corresponding to 
      pairwise comparisons between the controls and that dosed group.  The life
      table analysis regards tumors in animals dying  prior to terminal kill as
      being (directly or indirectly) the cause of death.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's exact tests compare directly the overall incidence rates.  
      For all tests, a negative trend is indicated by "N".
 (e)  Value of Statistic cannot be computed. 
 (I)  Interim sacrifice
 (T)  Terminal sacrifice
  #   Tumor rates based on number of animals necropsied.
 
  *   To the right of any statistical result, indicates significance at (P<=0.05).
  **  To the right of any statistical result, indicates significance at (P<=0.01).
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.