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TDMS Study 05079-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: LITRI                                                        TALC                                         DATE: 09/10/94       
EXPERIMENT: 05079 TEST: 01                                                                                     TIME: 15:25:13       
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: 01                                                                                     TIME: 15:25:13      
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       
 
 
 
 
 
                                                    RATS(FISCHER344)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    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: 01                                                                                     TIME: 15:25:13       
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 RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Benign
                                                           Pheochromocytoma: Benign, Complex, Malignant, NOS
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Benign
                                                           Pheochromocytoma Malignant
                                                           Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             Thyroid Gland: C-Cell         Adenoma
                                                           Carcinoma or Adenoma
                             All Organs                    Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 01                                                 PAGE   1
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 115 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 124 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      |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    26/60 (43%)     33/63 (52%)     39/57 (68%)     |    14/63 (22%)     19/65 (29%)     21/61 (34%)     |
|ADJUSTED (b)           |     87.8%           90.7%          100.0%          |     63.8%           64.5%           84.0%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        1/2 (50%)      |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     1/3 (33%)       3/6 (50%)       2/2 (100%)     |     0/5 (0%)        5/9 (56%)       3/3 (100%)     |
|TERMINAL (d)           |     6/9 (67%)      11/14 (79%)     16/16 (100%)    |     6/12 (50%)      5/13 (38%)      6/9 (67%)      |
|FIRST INCIDENCE (DAYS) |      429             558             556 (I)       |      678             705             697           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.254         P=0.520N        P=0.318        |     P=0.037 *       P=0.291         P=0.052        |
|INCIDENTAL TUMOR       |     P=0.003 **      P=0.215         P=0.005 **     |     P=0.083         P=0.347         P=0.099        |
|LOGISTIC REGRESSION    |     P=0.001 **      P=0.226         P=0.002 **     |     P=0.083         P=0.247         P=0.080        |
|COCHRAN-ARMITAGE       |     P=0.004 **                                     |     P=0.093                                        |
|FISHER EXACT           |                     P=0.205         P=0.005 **     |                     P=0.241         P=0.095        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Complex                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/60 (0%)       2/63 (3%)       1/57 (2%)      |     0/63 (0%)       0/65 (0%)       0/61 (0%)      |
|ADJUSTED (b)           |      0.0%            8.9%            4.0%          |      0.0%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     0/5 (0%)        0/9 (0%)        0/3 (0%)       |
|TERMINAL (d)           |     0/9 (0%)        1/14 (7%)       0/16 (0%)      |     0/12 (0%)       0/13 (0%)       0/9 (0%)       |
|FIRST INCIDENCE (DAYS) |      ---             558             743           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.555         P=0.297         P=0.517        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.502         P=0.239         P=0.443        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.484         P=0.250         P=0.501        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.481                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.260         P=0.487        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 01                                                 PAGE   2
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 115 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 124 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      |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/60 (5%)       3/63 (5%)       7/57 (12%)     |     0/63 (0%)       1/65 (2%)      10/61 (16%)     |
|ADJUSTED (b)           |     17.1%           14.9%           31.4%          |      0.0%            7.1%           56.9%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     0/5 (0%)        0/9 (0%)        0/3 (0%)       |
|TERMINAL (d)           |     1/9 (11%)       1/14 (7%)       3/16 (19%)     |     0/12 (0%)       0/13 (0%)       3/9 (33%)      |
|FIRST INCIDENCE (DAYS) |      670             544             645           |      ---             849             784           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.237         P=0.541N        P=0.373        |     P<0.001 **      P=0.515         P=0.001 **     |
|INCIDENTAL TUMOR       |     P=0.108         P=0.551N        P=0.174        |     P<0.001 **      P=0.507         P=0.002 **     |
|LOGISTIC REGRESSION    |     P=0.088         P=0.628N        P=0.172        |     P<0.001 **      P=0.499         P<0.001 **     |
|COCHRAN-ARMITAGE       |     P=0.076                                        |     P<0.001 **                                     |
|FISHER EXACT           |                     P=0.637N        P=0.141        |                     P=0.508         P<0.001 **     |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    28/60 (47%)     35/63 (56%)     40/57 (70%)     |    14/63 (22%)     19/65 (29%)     26/61 (43%)     |
|ADJUSTED (b)           |     92.0%           93.9%          100.0%          |     63.8%           64.5%           95.7%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     1/2 (50%)       0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        1/2 (50%)      |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     1/3 (33%)       3/6 (50%)       2/2 (100%)     |     0/5 (0%)        5/9 (56%)       3/3 (100%)     |
|TERMINAL (d)           |     7/9 (78%)      12/14 (86%)     16/16 (100%)    |     6/12 (50%)      5/13 (38%)      8/9 (89%)      |
|FIRST INCIDENCE (DAYS) |      333 (I)         544             556 (I)       |      678             705             697           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.348         P=0.480N        P=0.424        |     P=0.003 **      P=0.291         P=0.006 **     |
|INCIDENTAL TUMOR       |     P=0.007 **      P=0.293         P=0.011 *      |     P=0.006 **      P=0.347         P=0.010 **     |
|LOGISTIC REGRESSION    |     P=0.002 **      P=0.226         P=0.003 **     |     P=0.004 **      P=0.247         P=0.005 **     |
|COCHRAN-ARMITAGE       |     P=0.007 **                                     |     P=0.009 **                                     |
|FISHER EXACT           |                     P=0.210         P=0.008 **     |                     P=0.241         P=0.012 *      |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 01                                                 PAGE   3
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 115 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 124 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      |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/59 (2%)       6/64 (9%)       1/58 (2%)      |     2/62 (3%)       0/62 (0%)       1/58 (2%)      |
|ADJUSTED (b)           |      2.1%           22.1%            2.4%          |     16.7%            0.0%           11.1%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     0/5 (0%)        0/9 (0%)        0/3 (0%)       |
|TERMINAL (d)           |     0/9 (0%)        1/14 (7%)       0/16 (0%)      |     2/12 (17%)      0/13 (0%)       1/9 (11%)      |
|FIRST INCIDENCE (DAYS) |      586             527             628           |      862 (T)         ---             862 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.369N        P=0.096         P=0.758N       |     P=0.594N        P=0.217N        P=0.604N       |
|INCIDENTAL TUMOR       |     P=0.428N        P=0.066         P=0.741        |     P=0.594N        P=0.217N        P=0.604N       |
|LOGISTIC REGRESSION    |     P=0.438N        P=0.075         P=0.757        |     P=0.594N        P=0.217N        P=0.604N       |
|COCHRAN-ARMITAGE       |     P=0.439N                                       |     P=0.521N                                       |
|FISHER EXACT           |                     P=0.071         P=0.748        |                     P=0.248N        P=0.525N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/59 (3%)       7/64 (11%)      2/58 (3%)      |     2/62 (3%)       0/62 (0%)       2/58 (3%)      |
|ADJUSTED (b)           |      4.0%           28.1%            8.5%          |     16.7%            0.0%           16.3%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     0/5 (0%)        0/9 (0%)        0/3 (0%)       |
|TERMINAL (d)           |     0/9 (0%)        2/14 (14%)      1/16 (6%)      |     2/12 (17%)      0/13 (0%)       1/9 (11%)      |
|FIRST INCIDENCE (DAYS) |      429             527             628           |      862 (T)         ---             835           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.341N        P=0.142         P=0.640N       |     P=0.484         P=0.217N        P=0.624        |
|INCIDENTAL TUMOR       |     P=0.370N        P=0.130         P=0.604N       |     P=0.492         P=0.217N        P=0.631        |
|LOGISTIC REGRESSION    |     P=0.452N        P=0.104         P=0.686        |     P=0.521         P=0.217N        P=0.667        |
|COCHRAN-ARMITAGE       |     P=0.453N                                       |     P=0.530                                        |
|FISHER EXACT           |                     P=0.103         P=0.684        |                     P=0.248N        P=0.665        |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 01                                                 PAGE   4
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 115 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 124 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      |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/58 (2%)       0/56 (0%)       2/53 (4%)      |     1/65 (2%)       1/63 (2%)       1/61 (2%)      |
|ADJUSTED (b)           |     12.5%            0.0%            9.8%          |      5.6%            7.7%            2.1%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     0/5 (0%)        0/9 (0%)        0/3 (0%)       |
|TERMINAL (d)           |     1/8 (13%)       0/13 (0%)       1/13 (8%)      |     0/12 (0%)       1/13 (8%)       0/9 (0%)       |
|FIRST INCIDENCE (DAYS) |      799 (T)         ---             617           |      824             862 (T)         646           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.383         P=0.403N        P=0.610        |     P=0.662         P=0.749         P=0.752N       |
|INCIDENTAL TUMOR       |     P=0.393         P=0.403N        P=0.612        |     P=0.663N        P=0.757         P=0.720N       |
|LOGISTIC REGRESSION    |     P=0.298         P=0.403N        P=0.475        |     P=0.669         P=0.751         P=0.750        |
|COCHRAN-ARMITAGE       |     P=0.296                                        |     P=0.664                                        |
|FISHER EXACT           |                     P=0.509N        P=0.466        |                     P=0.744         P=0.736        |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/58 (3%)       0/56 (0%)       2/53 (4%)      |     1/65 (2%)       1/63 (2%)       1/61 (2%)      |
|ADJUSTED (b)           |     25.0%            0.0%            9.8%          |      5.6%            7.7%            2.1%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     0/5 (0%)        0/9 (0%)        0/3 (0%)       |
|TERMINAL (d)           |     2/8 (25%)       0/13 (0%)       1/13 (8%)      |     0/12 (0%)       1/13 (8%)       0/9 (0%)       |
|FIRST INCIDENCE (DAYS) |      799 (T)         ---             617           |      824             862 (T)         646           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.647         P=0.135N        P=0.563N       |     P=0.662         P=0.749         P=0.752N       |
|INCIDENTAL TUMOR       |     P=0.653         P=0.135N        P=0.560N       |     P=0.663N        P=0.757         P=0.720N       |
|LOGISTIC REGRESSION    |     P=0.534         P=0.135N        P=0.678        |     P=0.669         P=0.751         P=0.750        |
|COCHRAN-ARMITAGE       |     P=0.524                                        |     P=0.664                                        |
|FISHER EXACT           |                     P=0.257N        P=0.656        |                     P=0.744         P=0.736        |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 01                                                 PAGE   5
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 115 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 124 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      |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/60 (3%)       0/64 (0%)       0/58 (0%)      |     0/64 (0%)       0/65 (0%)       0/61 (0%)      |
|ADJUSTED (b)           |     14.8%            0.0%            0.0%          |      0.0%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     0/5 (0%)        0/9 (0%)        0/3 (0%)       |
|TERMINAL (d)           |     0/9 (0%)        0/14 (0%)       0/16 (0%)      |     0/12 (0%)       0/13 (0%)       0/9 (0%)       |
|FIRST INCIDENCE (DAYS) |      782             ---             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.111N        P=0.200N        P=0.138N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.216N        P=0.263N        P=0.314N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.138N        P=0.194N        P=0.188N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.175N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.232N        P=0.256N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/60 (3%)       2/65 (3%)       4/58 (7%)      |     0/65 (0%)       3/66 (5%)       1/62 (2%)      |
|ADJUSTED (b)           |     11.0%           14.3%           14.3%          |      0.0%           13.0%           10.0%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     0/5 (0%)        0/9 (0%)        0/3 (0%)       |
|TERMINAL (d)           |     0/9 (0%)        2/14 (14%)      1/16 (6%)      |     0/12 (0%)       0/13 (0%)       0/9 (0%)       |
|FIRST INCIDENCE (DAYS) |      698             799 (T)         615           |      ---             724             857           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.347         P=0.578N        P=0.424        |     P=0.530         P=0.112         P=0.448        |
|INCIDENTAL TUMOR       |     P=0.258         P=0.637N        P=0.278        |     P=0.620         P=0.120         P=0.538        |
|LOGISTIC REGRESSION    |     P=0.234         P=0.642N        P=0.329        |     P=0.537         P=0.124         P=0.482        |
|COCHRAN-ARMITAGE       |     P=0.226                                        |     P=0.536                                        |
|FISHER EXACT           |                     P=0.660N        P=0.324        |                     P=0.125         P=0.488        |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 01                                                 PAGE   6
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 115 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 124 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)            |     2/60 (3%)       2/65 (3%)       4/58 (7%)      |     0/65 (0%)       4/66 (6%)       1/62 (2%)      |
|ADJUSTED (b)           |     11.0%           14.3%           14.3%          |      0.0%           19.7%           10.0%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     0/5 (0%)        0/9 (0%)        0/3 (0%)       |
|TERMINAL (d)           |     0/9 (0%)        2/14 (14%)      1/16 (6%)      |     0/12 (0%)       1/13 (8%)       0/9 (0%)       |
|FIRST INCIDENCE (DAYS) |      698             799 (T)         615           |      ---             724             857           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.347         P=0.578N        P=0.424        |     P=0.552         P=0.063         P=0.448        |
|INCIDENTAL TUMOR       |     P=0.258         P=0.637N        P=0.278        |     P=0.633         P=0.067         P=0.538        |
|LOGISTIC REGRESSION    |     P=0.234         P=0.642N        P=0.329        |     P=0.577         P=0.063         P=0.482        |
|COCHRAN-ARMITAGE       |     P=0.226                                        |     P=0.577                                        |
|FISHER EXACT           |                     P=0.660N        P=0.324        |                     P=0.062         P=0.488        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/60 (3%)       2/65 (3%)       4/58 (7%)      |     0/65 (0%)       4/66 (6%)       1/62 (2%)      |
|ADJUSTED (b)           |     11.0%           14.3%           14.3%          |      0.0%           19.7%           10.0%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     0/5 (0%)        0/9 (0%)        0/3 (0%)       |
|TERMINAL (d)           |     0/9 (0%)        2/14 (14%)      1/16 (6%)      |     0/12 (0%)       1/13 (8%)       0/9 (0%)       |
|FIRST INCIDENCE (DAYS) |      698             799 (T)         615           |      ---             724             857           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.347         P=0.578N        P=0.424        |     P=0.552         P=0.063         P=0.448        |
|INCIDENTAL TUMOR       |     P=0.258         P=0.637N        P=0.278        |     P=0.633         P=0.067         P=0.538        |
|LOGISTIC REGRESSION    |     P=0.234         P=0.642N        P=0.329        |     P=0.577         P=0.063         P=0.482        |
|COCHRAN-ARMITAGE       |     P=0.226                                        |     P=0.577                                        |
|FISHER EXACT           |                     P=0.660N        P=0.324        |                     P=0.062         P=0.488        |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 01                                                 PAGE   7
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 115 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 124 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)            |     0/60 (0%)       1/65 (2%)       1/60 (2%)      |     1/65 (2%)       1/66 (2%)       9/62 (15%)     |
|ADJUSTED (b)           |      0.0%            5.6%            6.3%          |      4.3%            1.7%           40.6%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        1/3 (33%)       0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     0/5 (0%)        0/9 (0%)        0/3 (0%)       |
|TERMINAL (d)           |     0/9 (0%)        0/14 (0%)       1/16 (6%)      |     0/12 (0%)       0/13 (0%)       1/9 (11%)      |
|FIRST INCIDENCE (DAYS) |      ---             781             799 (T)       |      805             556 (I)         716           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.526         P=0.523         P=0.615        |     P=0.001 **      P=0.739         P=0.012 *      |
|INCIDENTAL TUMOR       |     P=0.455         P=0.477         P=0.615        |     P=0.002 **      P=0.760         P=0.017 *      |
|LOGISTIC REGRESSION    |     P=0.495         P=0.535         P=0.615        |     P<0.001 **      P=0.760N        P=0.003 **     |
|COCHRAN-ARMITAGE       |     P=0.420                                        |     P<0.001 **                                     |
|FISHER EXACT           |                     P=0.520         P=0.500        |                     P=0.748N        P=0.007 **     |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/60 (0%)       0/65 (0%)       1/60 (2%)      |     0/65 (0%)       0/66 (0%)       5/62 (8%)      |
|ADJUSTED (b)           |      0.0%            0.0%            6.3%          |      0.0%            0.0%           41.7%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     0/5 (0%)        0/9 (0%)        0/3 (0%)       |
|TERMINAL (d)           |     0/9 (0%)        0/14 (0%)       1/16 (6%)      |     0/12 (0%)       0/13 (0%)       3/9 (33%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             799 (T)       |      ---             ---             828           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.370           (e)           P=0.615        |     P=0.002 **        (e)           P=0.022 *      |
|INCIDENTAL TUMOR       |     P=0.370           (e)           P=0.615        |     P=0.002 **        (e)           P=0.024 *      |
|LOGISTIC REGRESSION    |     P=0.370           (e)           P=0.615        |     P=0.003 **        (e)           P=0.024 *      |
|COCHRAN-ARMITAGE       |     P=0.291                                        |     P=0.003 **                                     |
|FISHER EXACT           |                       (e)           P=0.500        |                       (e)           P=0.025 *      |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 01                                                 PAGE   8
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 115 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 124 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)            |     0/60 (0%)       1/65 (2%)       1/60 (2%)      |     1/65 (2%)       1/66 (2%)      13/62 (21%)     |
|ADJUSTED (b)           |      0.0%            5.6%            6.3%          |      4.3%            1.7%           65.7%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        1/3 (33%)       0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     0/5 (0%)        0/9 (0%)        0/3 (0%)       |
|TERMINAL (d)           |     0/9 (0%)        0/14 (0%)       1/16 (6%)      |     0/12 (0%)       0/13 (0%)       4/9 (44%)      |
|FIRST INCIDENCE (DAYS) |      ---             781             799 (T)       |      805             556 (I)         716           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.526         P=0.523         P=0.615        |     P<0.001 **      P=0.739         P<0.001 **     |
|INCIDENTAL TUMOR       |     P=0.455         P=0.477         P=0.615        |     P<0.001 **      P=0.760         P<0.001 **     |
|LOGISTIC REGRESSION    |     P=0.495         P=0.535         P=0.615        |     P<0.001 **      P=0.760N        P<0.001 **     |
|COCHRAN-ARMITAGE       |     P=0.420                                        |     P<0.001 **                                     |
|FISHER EXACT           |                     P=0.520         P=0.500        |                     P=0.748N        P<0.001 **     |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/60 (0%)       0/65 (0%)       0/60 (0%)      |     3/65 (5%)       2/67 (3%)       3/62 (5%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |     13.3%           15.4%           14.4%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        1/3 (33%)      |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     2/5 (40%)       0/9 (0%)        0/3 (0%)       |
|TERMINAL (d)           |     0/9 (0%)        0/14 (0%)       0/16 (0%)      |     1/12 (8%)       2/13 (15%)      0/9 (0%)       |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      739 (I)         862 (T)         556 (I)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.465         P=0.371N        P=0.570        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.483         P=0.371N        P=0.592        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.555         P=0.501N        P=0.646        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.550                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.486N        P=0.637        |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 01                                                 PAGE   9
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 115 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 124 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      |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/60 (2%)       0/65 (0%)       0/60 (0%)      |     2/65 (3%)       0/67 (0%)       2/62 (3%)      |
|ADJUSTED (b)           |      7.7%            0.0%            0.0%          |      3.7%            0.0%           10.7%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     0/5 (0%)        0/9 (0%)        0/3 (0%)       |
|TERMINAL (d)           |     0/9 (0%)        0/14 (0%)       0/16 (0%)      |     0/12 (0%)       0/13 (0%)       0/9 (0%)       |
|FIRST INCIDENCE (DAYS) |      786             ---             ---           |      370             ---             822           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.316N        P=0.459N        P=0.395N       |     P=0.572         P=0.234N        P=0.675N       |
|INCIDENTAL TUMOR       |     P=0.431N        P=0.523N        P=0.548N       |     P=0.488         P=0.300N        P=0.607        |
|LOGISTIC REGRESSION    |     P=0.356N        P=0.462N        P=0.450N       |     P=0.532         P=0.243N        P=0.674        |
|COCHRAN-ARMITAGE       |     P=0.396N                                       |     P=0.535                                        |
|FISHER EXACT           |                     P=0.480N        P=0.500N       |                     P=0.241N        P=0.672        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/60 (2%)       0/65 (0%)       0/60 (0%)      |     5/65 (8%)       2/67 (3%)       5/62 (8%)      |
|ADJUSTED (b)           |      7.7%            0.0%            0.0%          |     16.5%           15.4%           23.6%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        1/3 (33%)      |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     2/5 (40%)       0/9 (0%)        0/3 (0%)       |
|TERMINAL (d)           |     0/9 (0%)        0/14 (0%)       0/16 (0%)      |     1/12 (8%)       2/13 (15%)      0/9 (0%)       |
|FIRST INCIDENCE (DAYS) |      786             ---             ---           |      370             862 (T)         556 (I)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.316N        P=0.459N        P=0.395N       |     P=0.420         P=0.142N        P=0.565        |
|INCIDENTAL TUMOR       |     P=0.431N        P=0.523N        P=0.548N       |     P=0.382         P=0.169N        P=0.509        |
|LOGISTIC REGRESSION    |     P=0.356N        P=0.462N        P=0.450N       |     P=0.471         P=0.205N        P=0.603        |
|COCHRAN-ARMITAGE       |     P=0.396N                                       |     P=0.466                                        |
|FISHER EXACT           |                     P=0.480N        P=0.500N       |                     P=0.208N        P=0.598        |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 01                                                 PAGE  10
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 115 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 124 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      |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/60 (0%)       0/65 (0%)       0/60 (0%)      |    12/65 (18%)     12/67 (18%)     14/62 (23%)     |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |     46.5%           43.9%           64.4%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        1/3 (33%)      |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     1/5 (20%)       2/9 (22%)       0/3 (0%)       |
|TERMINAL (d)           |     0/9 (0%)        0/14 (0%)       0/16 (0%)      |     2/12 (17%)      3/13 (23%)      4/9 (44%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      634             482             556 (I)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.240         P=0.535N        P=0.319        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.329         P=0.544N        P=0.439        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.313         P=0.556N        P=0.365        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.307                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.557N        P=0.361        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/60 (0%)       0/65 (0%)       0/60 (0%)      |    16/65 (25%)     15/67 (22%)     17/62 (27%)     |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |     55.6%           60.7%           69.5%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        2/3 (67%)      |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     3/5 (60%)       2/9 (22%)       0/3 (0%)       |
|TERMINAL (d)           |     0/9 (0%)        0/14 (0%)       0/16 (0%)      |     3/12 (25%)      6/13 (46%)      4/9 (44%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      634             482             556 (I)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.264         P=0.395N        P=0.361        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.365         P=0.397N        P=0.497        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.382         P=0.459N        P=0.449        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.373                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.461N        P=0.437        |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 01                                                 PAGE  11
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 115 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 124 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      |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/60 (2%)       0/65 (0%)       0/60 (0%)      |    18/65 (28%)     15/67 (22%)     18/62 (29%)     |
|ADJUSTED (b)           |      7.7%            0.0%            0.0%          |     57.2%           60.7%           71.0%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        2/3 (67%)      |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     3/5 (60%)       2/9 (22%)       0/3 (0%)       |
|TERMINAL (d)           |     0/9 (0%)        0/14 (0%)       0/16 (0%)      |     3/12 (25%)      6/13 (46%)      4/9 (44%)      |
|FIRST INCIDENCE (DAYS) |      786             ---             ---           |      370             482             556 (I)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.316N        P=0.459N        P=0.395N       |     P=0.318         P=0.262N        P=0.439        |
|INCIDENTAL TUMOR       |     P=0.431N        P=0.523N        P=0.548N       |     P=0.393         P=0.271N        P=0.531        |
|LOGISTIC REGRESSION    |     P=0.356N        P=0.462N        P=0.450N       |     P=0.435         P=0.297N        P=0.530        |
|COCHRAN-ARMITAGE       |     P=0.396N                                       |     P=0.422                                        |
|FISHER EXACT           |                     P=0.480N        P=0.500N       |                     P=0.308N        P=0.511        |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Granulosa Cell Tumor Benign                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     0/65 (0%)       2/65 (3%)       0/62 (0%)      |
|ADJUSTED (b)           |                                                    |      0.0%           16.7%            0.0%          |
|INTERIM SACRIFICE 1 (c)|                                                    |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|                                                    |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|                                                    |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|                                                    |     0/5 (0%)        0/9 (0%)        0/3 (0%)       |
|TERMINAL (d)           |                                                    |     0/12 (0%)       2/12 (17%)      0/9 (0%)       |
|FIRST INCIDENCE (DAYS) |                                                    |      ---             862 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.649N        P=0.235           (e)          |
|INCIDENTAL TUMOR       |                                                    |     P=0.649N        P=0.235           (e)          |
|LOGISTIC REGRESSION    |                                                    |     P=0.649N        P=0.235           (e)          |
|COCHRAN-ARMITAGE       |                                                    |     P=0.587N                                       |
|FISHER EXACT           |                                                    |                     P=0.248           (e)          |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 01                                                 PAGE  12
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 115 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 124 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      |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Granulosa Cell Tumor, Benign, Malignant, NOS                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     1/65 (2%)       2/65 (3%)       0/62 (0%)      |
|ADJUSTED (b)           |                                                    |      3.3%           16.7%            0.0%          |
|INTERIM SACRIFICE 1 (c)|                                                    |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|                                                    |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|                                                    |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|                                                    |     0/5 (0%)        0/9 (0%)        0/3 (0%)       |
|TERMINAL (d)           |                                                    |     0/12 (0%)       2/12 (17%)      0/9 (0%)       |
|FIRST INCIDENCE (DAYS) |                                                    |      767             862 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.380N        P=0.479         P=0.529N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.350N        P=0.500         P=0.462N       |
|LOGISTIC REGRESSION    |                                                    |     P=0.331N        P=0.474         P=0.507N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.333N                                       |
|FISHER EXACT           |                                                    |                     P=0.500         P=0.512N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    13/58 (22%)     13/65 (20%)     11/59 (19%)     |    23/65 (35%)     25/65 (38%)     26/62 (42%)     |
|ADJUSTED (b)           |     53.9%           45.4%           43.9%          |     63.1%           66.8%           80.5%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        1/3 (33%)      |
|INTERIM SACRIFICE 3 (c)|     1/3 (33%)       0/3 (0%)        0/2 (0%)       |     1/3 (33%)       0/3 (0%)        2/3 (67%)      |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        2/6 (33%)       1/2 (50%)      |     3/5 (60%)       7/9 (78%)       2/3 (67%)      |
|TERMINAL (d)           |     3/9 (33%)       3/14 (21%)      4/16 (25%)     |     3/12 (25%)      3/13 (23%)      4/9 (44%)      |
|FIRST INCIDENCE (DAYS) |      556 (I)         558             697           |      556 (I)         697             333 (I)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.216N        P=0.345N        P=0.202N       |     P=0.172         P=0.550N        P=0.232        |
|INCIDENTAL TUMOR       |     P=0.369N        P=0.490N        P=0.372N       |     P=0.303         P=0.542         P=0.323        |
|LOGISTIC REGRESSION    |     P=0.333N        P=0.438N        P=0.355N       |     P=0.271         P=0.538         P=0.295        |
|COCHRAN-ARMITAGE       |     P=0.371N                                       |     P=0.265                                        |
|FISHER EXACT           |                     P=0.457N        P=0.391N       |                     P=0.428         P=0.282        |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 01                                                 PAGE  13
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 115 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 124 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                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/58 (0%)       1/65 (2%)       0/59 (0%)      |     4/65 (6%)       3/65 (5%)       2/62 (3%)      |
|ADJUSTED (b)           |      0.0%            5.3%            0.0%          |     23.4%           11.4%            5.2%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     0/5 (0%)        0/9 (0%)        0/3 (0%)       |
|TERMINAL (d)           |     0/9 (0%)        0/14 (0%)       0/16 (0%)      |     2/12 (17%)      1/13 (8%)       0/9 (0%)       |
|FIRST INCIDENCE (DAYS) |      ---             780             ---           |      696             566             676           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.649N        P=0.534           (e)          |     P=0.350N        P=0.474N        P=0.395N       |
|INCIDENTAL TUMOR       |     P=0.731N        P=0.492           (e)          |     P=0.297N        P=0.532N        P=0.323N       |
|LOGISTIC REGRESSION    |     P=0.681N        P=0.536           (e)          |     P=0.309N        P=0.492N        P=0.355N       |
|COCHRAN-ARMITAGE       |     P=0.708N                                       |     P=0.313N                                       |
|FISHER EXACT           |                     P=0.528           (e)          |                     P=0.500N        P=0.363N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    13/58 (22%)     14/65 (22%)     11/59 (19%)     |    27/65 (42%)     28/65 (43%)     28/62 (45%)     |
|ADJUSTED (b)           |     53.9%           48.3%           43.9%          |     73.6%           71.3%           81.5%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        1/3 (33%)      |
|INTERIM SACRIFICE 3 (c)|     1/3 (33%)       0/3 (0%)        0/2 (0%)       |     1/3 (33%)       0/3 (0%)        2/3 (67%)      |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        2/6 (33%)       1/2 (50%)      |     3/5 (60%)       7/9 (78%)       2/3 (67%)      |
|TERMINAL (d)           |     3/9 (33%)       3/14 (21%)      4/16 (25%)     |     5/12 (42%)      4/13 (31%)      4/9 (44%)      |
|FIRST INCIDENCE (DAYS) |      556 (I)         558             697           |      556 (I)         566             333 (I)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.199N        P=0.418N        P=0.202N       |     P=0.254         P=0.477N        P=0.325        |
|INCIDENTAL TUMOR       |     P=0.356N        P=0.580N        P=0.372N       |     P=0.443         P=0.551N        P=0.473        |
|LOGISTIC REGRESSION    |     P=0.314N        P=0.520N        P=0.355N       |     P=0.401         P=0.546N        P=0.430        |
|COCHRAN-ARMITAGE       |     P=0.354N                                       |     P=0.385                                        |
|FISHER EXACT           |                     P=0.539N        P=0.391N       |                     P=0.500         P=0.408        |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 01                                                 PAGE  14
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 115 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 124 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 Intermedia                                                                                                 |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/58 (0%)       0/65 (0%)       2/59 (3%)      |     0/65 (0%)       0/65 (0%)       0/62 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            4.7%          |      0.0%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     0/5 (0%)        0/9 (0%)        0/3 (0%)       |
|TERMINAL (d)           |     0/9 (0%)        0/14 (0%)       0/16 (0%)      |     0/12 (0%)       0/13 (0%)       0/9 (0%)       |
|FIRST INCIDENCE (DAYS) |      ---             ---             617           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.088           (e)           P=0.237        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.085           (e)           P=0.207        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.087           (e)           P=0.240        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.088                                        |       (e)                                          |
|FISHER EXACT           |                       (e)           P=0.252        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/60 (0%)       2/65 (3%)       0/60 (0%)      |     0/65 (0%)       0/67 (0%)       0/62 (0%)      |
|ADJUSTED (b)           |      0.0%            9.3%            0.0%          |      0.0%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     0/5 (0%)        0/9 (0%)        0/3 (0%)       |
|TERMINAL (d)           |     0/9 (0%)        1/14 (7%)       0/16 (0%)      |     0/12 (0%)       0/13 (0%)       0/9 (0%)       |
|FIRST INCIDENCE (DAYS) |      ---             657             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.528N        P=0.303           (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.545N        P=0.274           (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.574N        P=0.261           (e)          |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.580N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.268           (e)          |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 01                                                 PAGE  15
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 115 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 124 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      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/60 (0%)       2/65 (3%)       2/60 (3%)      |     0/65 (0%)       1/67 (1%)       1/62 (2%)      |
|ADJUSTED (b)           |      0.0%            9.4%            6.5%          |      0.0%            7.7%            1.9%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     0/5 (0%)        0/9 (0%)        0/3 (0%)       |
|TERMINAL (d)           |     0/9 (0%)        1/14 (7%)       0/16 (0%)      |     0/12 (0%)       1/13 (8%)       0/9 (0%)       |
|FIRST INCIDENCE (DAYS) |      ---             663             594           |      ---             862 (T)         558           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.337         P=0.300         P=0.328        |     P=0.384         P=0.516         P=0.496        |
|INCIDENTAL TUMOR       |     P=0.256         P=0.274         P=0.213        |     P=0.357         P=0.516         P=0.433        |
|LOGISTIC REGRESSION    |     P=0.246         P=0.261         P=0.239        |     P=0.411         P=0.516         P=0.483        |
|COCHRAN-ARMITAGE       |     P=0.242                                        |     P=0.411                                        |
|FISHER EXACT           |                     P=0.268         P=0.248        |                     P=0.508         P=0.488        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/60 (0%)       3/65 (5%)       2/60 (3%)      |     0/65 (0%)       1/67 (1%)       1/62 (2%)      |
|ADJUSTED (b)           |      0.0%           13.1%            6.5%          |      0.0%            7.7%            1.9%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     0/5 (0%)        0/9 (0%)        0/3 (0%)       |
|TERMINAL (d)           |     0/9 (0%)        1/14 (7%)       0/16 (0%)      |     0/12 (0%)       1/13 (8%)       0/9 (0%)       |
|FIRST INCIDENCE (DAYS) |      ---             663             594           |      ---             862 (T)         558           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.407         P=0.166         P=0.328        |     P=0.384         P=0.516         P=0.496        |
|INCIDENTAL TUMOR       |     P=0.304         P=0.133         P=0.213        |     P=0.357         P=0.516         P=0.433        |
|LOGISTIC REGRESSION    |     P=0.312         P=0.140         P=0.239        |     P=0.411         P=0.516         P=0.483        |
|COCHRAN-ARMITAGE       |     P=0.306                                        |     P=0.411                                        |
|FISHER EXACT           |                     P=0.137         P=0.248        |                     P=0.508         P=0.488        |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 01                                                 PAGE  16
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 115 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 124 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      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/60 (0%)       2/65 (3%)       0/60 (0%)      |     0/65 (0%)       1/67 (1%)       1/62 (2%)      |
|ADJUSTED (b)           |      0.0%           11.2%            0.0%          |      0.0%            3.2%            2.2%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     0/5 (0%)        0/9 (0%)        0/3 (0%)       |
|TERMINAL (d)           |     0/9 (0%)        1/14 (7%)       0/16 (0%)      |     0/12 (0%)       0/13 (0%)       0/9 (0%)       |
|FIRST INCIDENCE (DAYS) |      ---             757             ---           |      ---             740             661           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.498N        P=0.305           (e)          |     P=0.411         P=0.494         P=0.500        |
|INCIDENTAL TUMOR       |     P=0.545N        P=0.274           (e)          |     P=0.474         P=0.500         P=0.538        |
|LOGISTIC REGRESSION    |     P=0.541N        P=0.273           (e)          |     P=0.411         P=0.507         P=0.489        |
|COCHRAN-ARMITAGE       |     P=0.580N                                       |     P=0.411                                        |
|FISHER EXACT           |                     P=0.268           (e)          |                     P=0.508         P=0.488        |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    35/60 (58%)     45/65 (69%)     40/60 (67%)     |                                                    |
|ADJUSTED (b)           |    100.0%          100.0%           97.3%          |                                                    |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |                                                    |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |                                                    |
|INTERIM SACRIFICE 3 (c)|     1/3 (33%)       2/3 (67%)       2/2 (100%)     |                                                    |
|INTERIM SACRIFICE 4 (c)|     3/3 (100%)      4/6 (67%)       2/2 (100%)     |                                                    |
|TERMINAL (d)           |     9/9 (100%)     14/14 (100%)    15/16 (94%)     |                                                    |
|FIRST INCIDENCE (DAYS) |      551             544             556 (I)       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.304N        P=0.532N        P=0.349N       |                                                    |
|INCIDENTAL TUMOR       |     P=0.266         P=0.160         P=0.219        |                                                    |
|LOGISTIC REGRESSION    |     P=0.235         P=0.101         P=0.202        |                                                    |
|COCHRAN-ARMITAGE       |     P=0.263                                        |                                                    |
|FISHER EXACT           |                     P=0.140         P=0.225        |                                                    |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 01                                                 PAGE  17
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 115 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 124 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      |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/56 (7%)       4/61 (7%)       3/56 (5%)      |     6/65 (9%)       0/65 (0%)       6/61 (10%)     |
|ADJUSTED (b)           |     26.9%           28.6%           14.4%          |     33.2%            0.0%           33.7%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     1/3 (33%)       0/6 (0%)        0/2 (0%)       |     1/5 (20%)       0/9 (0%)        0/3 (0%)       |
|TERMINAL (d)           |     2/9 (22%)       4/14 (29%)      2/16 (13%)     |     2/12 (17%)      0/13 (0%)       2/9 (22%)      |
|FIRST INCIDENCE (DAYS) |      682             799 (T)         614           |      739 (I)         ---             678           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.255N        P=0.396N        P=0.357N       |     P=0.315         P=0.014N*       P=0.510        |
|INCIDENTAL TUMOR       |     P=0.264N        P=0.403N        P=0.377N       |     P=0.393         P=0.013N*       P=0.601        |
|LOGISTIC REGRESSION    |     P=0.391N        P=0.491N        P=0.466N       |     P=0.372         P=0.018N*       P=0.585        |
|COCHRAN-ARMITAGE       |     P=0.444N                                       |     P=0.366                                        |
|FISHER EXACT           |                     P=0.593N        P=0.500N       |                     P=0.014N*       P=0.573        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/56 (0%)       1/61 (2%)       0/56 (0%)      |     3/65 (5%)       2/65 (3%)       3/61 (5%)      |
|ADJUSTED (b)           |      0.0%            6.3%            0.0%          |     10.5%           12.2%            7.4%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     0/5 (0%)        0/9 (0%)        1/3 (33%)      |
|TERMINAL (d)           |     0/9 (0%)        0/14 (0%)       0/16 (0%)      |     0/12 (0%)       0/13 (0%)       0/9 (0%)       |
|FIRST INCIDENCE (DAYS) |      ---             787             ---           |      677             818             675           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.612N        P=0.557           (e)          |     P=0.547         P=0.520N        P=0.604        |
|INCIDENTAL TUMOR       |     P=0.751N        P=0.492           (e)          |     P=0.595N        P=0.516N        P=0.630N       |
|LOGISTIC REGRESSION    |     P=0.671N        P=0.562           (e)          |     P=0.552         P=0.498N        P=0.637        |
|COCHRAN-ARMITAGE       |     P=0.709N                                       |     P=0.545                                        |
|FISHER EXACT           |                     P=0.521           (e)          |                     P=0.500N        P=0.629        |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 01                                                 PAGE  18
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 115 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 124 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      |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/56 (7%)       5/61 (8%)       3/56 (5%)      |     9/65 (14%)      2/65 (3%)       9/61 (15%)     |
|ADJUSTED (b)           |     26.9%           33.0%           14.4%          |     40.2%           12.2%           38.7%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     1/3 (33%)       0/6 (0%)        0/2 (0%)       |     1/5 (20%)       0/9 (0%)        1/3 (33%)      |
|TERMINAL (d)           |     2/9 (22%)       4/14 (29%)      2/16 (13%)     |     2/12 (17%)      0/13 (0%)       2/9 (22%)      |
|FIRST INCIDENCE (DAYS) |      682             787             614           |      677             818             675           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.216N        P=0.529N        P=0.357N       |     P=0.315         P=0.030N*       P=0.473        |
|INCIDENTAL TUMOR       |     P=0.258N        P=0.560N        P=0.377N       |     P=0.428         P=0.024N*       P=0.597N       |
|LOGISTIC REGRESSION    |     P=0.355N        P=0.614N        P=0.466N       |     P=0.359         P=0.027N*       P=0.561        |
|COCHRAN-ARMITAGE       |     P=0.415N                                       |     P=0.349                                        |
|FISHER EXACT           |                     P=0.554         P=0.500N       |                     P=0.027N*       P=0.543        |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     6/65 (9%)       8/67 (12%)      6/62 (10%)     |
|ADJUSTED (b)           |                                                    |     23.0%           35.3%           23.0%          |
|INTERIM SACRIFICE 1 (c)|                                                    |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|                                                    |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|                                                    |     0/3 (0%)        0/3 (0%)        1/3 (33%)      |
|INTERIM SACRIFICE 4 (c)|                                                    |     1/5 (20%)       1/9 (11%)       1/3 (33%)      |
|TERMINAL (d)           |                                                    |     1/12 (8%)       3/13 (23%)      1/9 (11%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      398             678             556 (I)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.480         P=0.447         P=0.498        |
|INCIDENTAL TUMOR       |                                                    |     P=0.551         P=0.470         P=0.534        |
|LOGISTIC REGRESSION    |                                                    |     P=0.563N        P=0.413         P=0.591        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.570N                                       |
|FISHER EXACT           |                                                    |                     P=0.413         P=0.585        |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 01                                                 PAGE  19
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 115 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 124 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      |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     7/65 (11%)      9/67 (13%)      6/62 (10%)     |
|ADJUSTED (b)           |                                                    |     30.0%           36.5%           23.0%          |
|INTERIM SACRIFICE 1 (c)|                                                    |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|                                                    |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|                                                    |     0/3 (0%)        0/3 (0%)        1/3 (33%)      |
|INTERIM SACRIFICE 4 (c)|                                                    |     1/5 (20%)       1/9 (11%)       1/3 (33%)      |
|TERMINAL (d)           |                                                    |     2/12 (17%)      3/13 (23%)      1/9 (11%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      398             557             556 (I)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.556N        P=0.456         P=0.595        |
|INCIDENTAL TUMOR       |                                                    |     P=0.498N        P=0.447         P=0.601N       |
|LOGISTIC REGRESSION    |                                                    |     P=0.442N        P=0.423         P=0.529N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.450N                                       |
|FISHER EXACT           |                                                    |                     P=0.421         P=0.536N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    24/60 (40%)     22/65 (34%)     23/60 (38%)     |    14/65 (22%)     21/67 (31%)     18/62 (29%)     |
|ADJUSTED (b)           |     69.3%           59.7%           61.7%          |     44.4%           72.8%           59.4%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        1/6 (17%)       0/2 (0%)       |     1/5 (20%)       1/9 (11%)       0/3 (0%)       |
|TERMINAL (d)           |     3/9 (33%)       4/14 (29%)      6/16 (38%)     |     1/12 (8%)       8/13 (62%)      3/9 (33%)      |
|FIRST INCIDENCE (DAYS) |      334             529             492           |      390             526             536           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.325N        P=0.229N        P=0.289N       |     P=0.211         P=0.188         P=0.222        |
|INCIDENTAL TUMOR       |     P=0.535N        P=0.427N        P=0.539N       |     P=0.231         P=0.116         P=0.173        |
|LOGISTIC REGRESSION    |     P=0.520         P=0.297N        P=0.549N       |     P=0.269         P=0.142         P=0.226        |
|COCHRAN-ARMITAGE       |     P=0.531N                                       |     P=0.262                                        |
|FISHER EXACT           |                     P=0.299N        P=0.500N       |                     P=0.140         P=0.221        |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 01                                                 PAGE  20
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 115 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 124 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 And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/60 (2%)       0/65 (0%)       0/60 (0%)      |     0/65 (0%)       3/67 (4%)       0/62 (0%)      |
|ADJUSTED (b)           |     11.1%            0.0%            0.0%          |      0.0%            9.7%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     0/5 (0%)        0/9 (0%)        0/3 (0%)       |
|TERMINAL (d)           |     1/9 (11%)       0/14 (0%)       0/16 (0%)      |     0/12 (0%)       0/13 (0%)       0/9 (0%)       |
|FIRST INCIDENCE (DAYS) |      799 (T)         ---             ---           |      ---             724             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.316N        P=0.412N        P=0.385N       |     P=0.540N        P=0.123           (e)          |
|INCIDENTAL TUMOR       |     P=0.316N        P=0.412N        P=0.385N       |     P=0.441N        P=0.120           (e)          |
|LOGISTIC REGRESSION    |     P=0.316N        P=0.412N        P=0.385N       |     P=0.514N        P=0.127           (e)          |
|COCHRAN-ARMITAGE       |     P=0.396N                                       |     P=0.516N                                       |
|FISHER EXACT           |                     P=0.480N        P=0.500N       |                     P=0.128           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/60 (2%)       0/65 (0%)       0/60 (0%)      |     0/65 (0%)       3/67 (4%)       0/62 (0%)      |
|ADJUSTED (b)           |     11.1%            0.0%            0.0%          |      0.0%            9.7%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     0/3 (0%)        0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        0/6 (0%)        0/2 (0%)       |     0/5 (0%)        0/9 (0%)        0/3 (0%)       |
|TERMINAL (d)           |     1/9 (11%)       0/14 (0%)       0/16 (0%)      |     0/12 (0%)       0/13 (0%)       0/9 (0%)       |
|FIRST INCIDENCE (DAYS) |      799 (T)         ---             ---           |      ---             724             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.316N        P=0.412N        P=0.385N       |     P=0.540N        P=0.123           (e)          |
|INCIDENTAL TUMOR       |     P=0.316N        P=0.412N        P=0.385N       |     P=0.441N        P=0.120           (e)          |
|LOGISTIC REGRESSION    |     P=0.316N        P=0.412N        P=0.385N       |     P=0.514N        P=0.127           (e)          |
|COCHRAN-ARMITAGE       |     P=0.396N                                       |     P=0.516N                                       |
|FISHER EXACT           |                     P=0.480N        P=0.500N       |                     P=0.128           (e)          |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 01                                                 PAGE  21
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 115 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 124 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                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    47/60 (78%)     53/65 (82%)     49/60 (82%)     |    44/65 (68%)     43/67 (64%)     46/62 (74%)     |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%          |     97.6%           97.4%           97.7%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        1/3 (33%)      |
|INTERIM SACRIFICE 3 (c)|     2/3 (67%)       2/3 (67%)       2/2 (100%)     |     1/3 (33%)       1/3 (33%)       3/3 (100%)     |
|INTERIM SACRIFICE 4 (c)|     3/3 (100%)      6/6 (100%)      2/2 (100%)     |     4/5 (80%)       7/9 (78%)       3/3 (100%)     |
|TERMINAL (d)           |     9/9 (100%)     14/14 (100%)    16/16 (100%)    |    11/12 (92%)     12/13 (92%)      8/9 (89%)      |
|FIRST INCIDENCE (DAYS) |      429             544             556 (I)       |      398             482             333 (I)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.217N        P=0.268N        P=0.198N       |     P=0.126         P=0.353N        P=0.204        |
|INCIDENTAL TUMOR       |     P=0.275         P=0.472         P=0.306        |     P=0.202         P=0.301N        P=0.298        |
|LOGISTIC REGRESSION    |     P=0.371         P=0.434         P=0.401        |     P=0.216         P=0.319N        P=0.308        |
|COCHRAN-ARMITAGE       |     P=0.400                                        |     P=0.206                                        |
|FISHER EXACT           |                     P=0.411         P=0.410        |                     P=0.405N        P=0.271        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    35/60 (58%)     35/65 (54%)     34/60 (57%)     |    25/65 (38%)     32/67 (48%)     36/62 (58%)     |
|ADJUSTED (b)           |     88.2%           80.5%           79.4%          |     70.8%           85.2%           90.5%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/2 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 3 (c)|     1/3 (33%)       0/3 (0%)        0/2 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 4 (c)|     0/3 (0%)        1/6 (17%)       0/2 (0%)       |     1/5 (20%)       1/9 (11%)       1/3 (33%)      |
|TERMINAL (d)           |     6/9 (67%)       7/14 (50%)      9/16 (56%)     |     5/12 (42%)      9/13 (69%)      6/9 (67%)      |
|FIRST INCIDENCE (DAYS) |      334             527             248           |      370             526             536           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.222N        P=0.250N        P=0.208N       |     P=0.031 *       P=0.252         P=0.041 *      |
|INCIDENTAL TUMOR       |     P=0.501N        P=0.560N        P=0.535N       |     P=0.013 *       P=0.096         P=0.010 *      |
|LOGISTIC REGRESSION    |     P=0.537         P=0.371N        P=0.551N       |     P=0.019 *       P=0.188         P=0.021 *      |
|COCHRAN-ARMITAGE       |     P=0.513N                                       |     P=0.019 *                                      |
|FISHER EXACT           |                     P=0.373N        P=0.500N       |                     P=0.183         P=0.021 *      |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05079 TEST: 01                                                 PAGE  22
                                  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC
 
                                                 MALE TERMINAL SACRIFICE AT 115 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 124 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 and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    55/60 (92%)     57/65 (88%)     54/60 (90%)     |    50/65 (77%)     55/67 (82%)     56/62 (90%)     |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%          |     97.8%           98.2%          100.0%          |
|INTERIM SACRIFICE 1 (c)|     0/3 (0%)        0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        0/3 (0%)       |
|INTERIM SACRIFICE 2 (c)|     1/2 (50%)       0/3 (0%)        0/3 (0%)       |     0/3 (0%)        0/3 (0%)        1/3 (33%)      |
|INTERIM SACRIFICE 3 (c)|     3/3 (100%)      2/3 (67%)       2/2 (100%)     |     1/3 (33%)       1/3 (33%)       3/3 (100%)     |
|INTERIM SACRIFICE 4 (c)|     3/3 (100%)      6/6 (100%)      2/2 (100%)     |     4/5 (80%)       7/9 (78%)       3/3 (100%)     |
|TERMINAL (d)           |     9/9 (100%)     14/14 (100%)    16/16 (100%)    |    11/12 (92%)     12/13 (92%)      9/9 (100%)     |
|FIRST INCIDENCE (DAYS) |      333 (I)         527             248           |      370             482             333 (I)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.158N        P=0.133N        P=0.127N       |     P=0.080         P=0.467         P=0.106        |
|INCIDENTAL TUMOR       |     P=0.656N        P=0.198N        P=0.716N       |     P=0.005 **      P=0.217         P=0.006 **     |
|LOGISTIC REGRESSION    |     P=0.578N        P=0.179N        P=0.558N       |     P=0.019 *       P=0.347         P=0.026 *      |
|COCHRAN-ARMITAGE       |     P=0.513N                                       |     P=0.031 *                                      |
|FISHER EXACT           |                     P=0.334N        P=0.500N       |                     P=0.302         P=0.035 *      |
|=================================================================================================================================|
 
 (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):   192  333  556  738
          Female interim sacrifices(days): 192  333  556  739
 (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).