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TR 380 Mouse Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Northwest                                      EPINEPHRINE HCL                                   DATE: 09/13/94       
EXPERIMENT: 05095 TEST: 02                                                                                     TIME: 01:00:16       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-38061          ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                                             NTP C#: 55663        
PATHOLOGIST: E. GIDDENS                      S. EUSTIS                                                         CAS: 55-31-2         
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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: Battelle Northwest                                      EPINEPHRINE HCL                                   DATE: 09/13/94      
EXPERIMENT: 05095 TEST: 02                                                                                     TIME: 01:00:16      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-38061          ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                                             NTP C#: 55663       
PATHOLOGIST: E. GIDDENS                      S. EUSTIS                                                         CAS: 55-31-2        
 
 
 
 
 
                                                    MICE(B6C3F1)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Larynx
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Northwest                                      EPINEPHRINE HCL                                   DATE: 09/13/94       
EXPERIMENT: 05095 TEST: 02                                                                                     TIME: 01:00:16       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-38061          ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                                             NTP C#: 55663        
PATHOLOGIST: E. GIDDENS                      S. EUSTIS                                                         CAS: 55-31-2         
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                        IN THE ANALYSIS OF THE STUDY OF EPINEPHRINE HCL
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Lung                          Alveolar/Bronchiolar Adenoma
                             Thyroid Gland: Follicular Cell
                                                           Adenoma
                                                           Carcinoma or Adenoma
                             Uterus                        Sarcoma Stromal or Polyp Stromal
 
              ====================================================================================================
         DATE: 09/13/94                     EXPERIMENT: 05095 TEST: 02                                                 PAGE   1
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- EPINEPHRINE HCL
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1.5MG/M3        3.0MG/M3      |      CONTROL         1.5MG/M3        3.0MG/M3      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       2/50 (4%)      |     1/50 (2%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      5.5%            2.9%            5.4%          |      3.1%            0.0%            0.0%          |
|TERMINAL (d)           |     1/33 (3%)       1/34 (3%)       1/36 (3%)      |     1/32 (3%)       0/35 (0%)       0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      635             741 (T)         740           |      742 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.580N        P=0.490N        P=0.664N       |     P=0.260N        P=0.482N        P=0.488N       |
|INCIDENTAL TUMOR       |     P=0.507         P=0.648N        P=0.580        |     P=0.260N        P=0.482N        P=0.488N       |
|LOGISTIC REGRESSION    |     P=0.609N        P=0.507N        P=0.693        |     P=0.260N        P=0.482N        P=0.488N       |
|COCHRAN-ARMITAGE       |     P=0.610                                        |     P=0.269N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.691N       |                     P=0.500N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       2/50 (4%)       2/50 (4%)      |     2/50 (4%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      5.5%            5.2%            5.4%          |      6.3%            0.0%            0.0%          |
|TERMINAL (d)           |     1/33 (3%)       1/34 (3%)       1/36 (3%)      |     2/32 (6%)       0/35 (0%)       0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      635             542             740           |      742 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.579N        P=0.690         P=0.664N       |     P=0.088N        P=0.219N        P=0.225N       |
|INCIDENTAL TUMOR       |     P=0.571         P=0.689N        P=0.580        |     P=0.088N        P=0.219N        P=0.225N       |
|LOGISTIC REGRESSION    |     P=0.600         P=0.683N        P=0.693        |     P=0.088N        P=0.217N        P=0.225N       |
|COCHRAN-ARMITAGE       |     P=0.601                                        |     P=0.095N                                       |
|FISHER EXACT           |                     P=0.691N        P=0.691N       |                     P=0.247N        P=0.247N       |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05095 TEST: 02                                                 PAGE   2
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- EPINEPHRINE HCL
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1.5MG/M3        3.0MG/M3      |      CONTROL         1.5MG/M3        3.0MG/M3      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    10/50 (20%)      7/25 (28%)      6/50 (12%)     |     2/50 (4%)       1/20 (5%)       4/50 (8%)      |
|ADJUSTED (b)           |     27.7%           67.4%           13.6%          |      6.3%           20.0%           11.2%          |
|TERMINAL (d)           |     8/33 (24%)      6/9 (67%)       2/36 (6%)      |     2/32 (6%)       1/5 (20%)       3/34 (9%)      |
|FIRST INCIDENCE (DAYS) |      409             456             381           |      742 (T)         742 (T)         704           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.157N        P=0.094         P=0.192N       |     P=0.289         P=0.435         P=0.357        |
|INCIDENTAL TUMOR       |     P=0.086N        P=0.191         P=0.054N       |     P=0.288         P=0.435         P=0.354        |
|LOGISTIC REGRESSION    |     P=0.177N        P=0.160         P=0.174N       |     P=0.276         P=0.435         P=0.342        |
|COCHRAN-ARMITAGE       |     P=0.183N                                       |     P=0.261                                        |
|FISHER EXACT           |                     P=0.308         P=0.207N       |                     P=0.642         P=0.339        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    12/50 (24%)      7/25 (28%)     10/50 (20%)     |     1/50 (2%)       1/20 (5%)       2/50 (4%)      |
|ADJUSTED (b)           |     28.7%           31.3%           23.2%          |      2.3%           20.0%            5.4%          |
|TERMINAL (d)           |     5/33 (15%)      2/9 (22%)       4/36 (11%)     |     0/32 (0%)       1/5 (20%)       1/34 (3%)      |
|FIRST INCIDENCE (DAYS) |      570             465             510           |      667             742 (T)         693           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.338N        P=0.521N        P=0.382N       |     P=0.402         P=0.573         P=0.507        |
|INCIDENTAL TUMOR       |     P=0.497         P=0.459         P=0.546        |     P=0.390         P=0.502         P=0.487        |
|LOGISTIC REGRESSION    |     P=0.510         P=0.538         P=0.538        |     P=0.391         P=0.510         P=0.500        |
|COCHRAN-ARMITAGE       |     P=0.361N                                       |     P=0.390                                        |
|FISHER EXACT           |                     P=0.456         P=0.405N       |                     P=0.493         P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05095 TEST: 02                                                 PAGE   3
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- EPINEPHRINE HCL
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1.5MG/M3        3.0MG/M3      |      CONTROL         1.5MG/M3        3.0MG/M3      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    20/50 (40%)     14/25 (56%)     15/50 (30%)     |     3/50 (6%)       2/20 (10%)      6/50 (12%)     |
|ADJUSTED (b)           |     46.5%           90.4%           32.6%          |      8.4%           40.0%           16.2%          |
|TERMINAL (d)           |    11/33 (33%)      8/9 (89%)       6/36 (17%)     |     2/32 (6%)       2/5 (40%)       4/34 (12%)     |
|FIRST INCIDENCE (DAYS) |      409             456             381           |      667             742 (T)         693           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.168N        P=0.191         P=0.201N       |     P=0.219         P=0.279         P=0.264        |
|INCIDENTAL TUMOR       |     P=0.198N        P=0.099         P=0.159N       |     P=0.212         P=0.234         P=0.249        |
|LOGISTIC REGRESSION    |     P=0.258N        P=0.098         P=0.309N       |     P=0.200         P=0.268         P=0.242        |
|COCHRAN-ARMITAGE       |     P=0.178N                                       |     P=0.193                                        |
|FISHER EXACT           |                     P=0.143         P=0.201N       |                     P=0.444         P=0.243        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    20/50 (40%)     14/25 (56%)     15/50 (30%)     |     3/50 (6%)       2/20 (10%)      6/50 (12%)     |
|ADJUSTED (b)           |     46.5%           90.4%           32.6%          |      8.4%           40.0%           16.2%          |
|TERMINAL (d)           |    11/33 (33%)      8/9 (89%)       6/36 (17%)     |     2/32 (6%)       2/5 (40%)       4/34 (12%)     |
|FIRST INCIDENCE (DAYS) |      409             456             381           |      667             742 (T)         693           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.168N        P=0.191         P=0.201N       |     P=0.219         P=0.279         P=0.264        |
|INCIDENTAL TUMOR       |     P=0.198N        P=0.099         P=0.159N       |     P=0.212         P=0.234         P=0.249        |
|LOGISTIC REGRESSION    |     P=0.258N        P=0.098         P=0.309N       |     P=0.200         P=0.268         P=0.242        |
|COCHRAN-ARMITAGE       |     P=0.178N                                       |     P=0.193                                        |
|FISHER EXACT           |                     P=0.143         P=0.201N       |                     P=0.444         P=0.243        |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05095 TEST: 02                                                 PAGE   4
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- EPINEPHRINE HCL
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1.5MG/M3        3.0MG/M3      |      CONTROL         1.5MG/M3        3.0MG/M3      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    11/50 (22%)      9/32 (28%)     10/50 (20%)     |     3/50 (6%)       5/27 (19%)      1/50 (2%)      |
|ADJUSTED (b)           |     28.1%           46.3%           26.2%          |      9.4%           35.0%            2.8%          |
|TERMINAL (d)           |     7/33 (21%)      7/16 (44%)      8/36 (22%)     |     3/32 (9%)       4/12 (33%)      0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      409             456             694           |      742 (T)         693             730           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.383N        P=0.311         P=0.436N       |     P=0.257N        P=0.041 *       P=0.286N       |
|INCIDENTAL TUMOR       |     P=0.507N        P=0.195         P=0.558N       |     P=0.270N        P=0.031 *       P=0.298N       |
|LOGISTIC REGRESSION    |     P=0.462N        P=0.325         P=0.507N       |     P=0.277N        P=0.024 *       P=0.296N       |
|COCHRAN-ARMITAGE       |     P=0.453N                                       |     P=0.279N                                       |
|FISHER EXACT           |                     P=0.354         P=0.500N       |                     P=0.095         P=0.309N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      3/32 (9%)       6/50 (12%)     |     2/50 (4%)       0/27 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |     14.7%           14.7%           15.3%          |      4.5%            0.0%            2.4%          |
|TERMINAL (d)           |     4/33 (12%)      2/16 (13%)      4/36 (11%)     |     0/32 (0%)       0/12 (0%)       0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      709             659             604           |      558             ---             685           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.488         P=0.640         P=0.552        |     P=0.362N        P=0.245N        P=0.500N       |
|INCIDENTAL TUMOR       |     P=0.343         P=0.640         P=0.391        |     P=0.447N        P=0.262N        P=0.641N       |
|LOGISTIC REGRESSION    |     P=0.436         P=0.574         P=0.497        |     P=0.368N        P=0.358N        P=0.498N       |
|COCHRAN-ARMITAGE       |     P=0.436                                        |     P=0.371N                                       |
|FISHER EXACT           |                     P=0.621N        P=0.500        |                     P=0.419N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05095 TEST: 02                                                 PAGE   5
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- EPINEPHRINE HCL
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1.5MG/M3        3.0MG/M3      |      CONTROL         1.5MG/M3        3.0MG/M3      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    15/50 (30%)     11/32 (34%)     16/50 (32%)     |     5/50 (10%)      5/27 (19%)      2/50 (4%)      |
|ADJUSTED (b)           |     38.3%           53.5%           39.8%          |     13.5%           35.0%            5.1%          |
|TERMINAL (d)           |    10/33 (30%)      8/16 (50%)     12/36 (33%)     |     3/32 (9%)       4/12 (33%)      0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      409             456             604           |      558             693             685           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.530N        P=0.382         P=0.576N       |     P=0.182N        P=0.213         P=0.210N       |
|INCIDENTAL TUMOR       |     P=0.340         P=0.273         P=0.372        |     P=0.217N        P=0.175         P=0.282N       |
|LOGISTIC REGRESSION    |     P=0.444         P=0.351         P=0.488        |     P=0.198N        P=0.179         P=0.216N       |
|COCHRAN-ARMITAGE       |     P=0.457                                        |     P=0.196N                                       |
|FISHER EXACT           |                     P=0.429         P=0.500        |                     P=0.237         P=0.218N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     1/50 (2%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      3.1%            0.0%            5.9%          |
|TERMINAL (d)           |     0/33 (0%)       0/34 (0%)       0/36 (0%)      |     1/32 (3%)       0/35 (0%)       2/34 (6%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      742 (T)         ---             742 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.375         P=0.482N        P=0.521        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.375         P=0.482N        P=0.521        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.375         P=0.482N        P=0.521        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.360                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.500N        P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05095 TEST: 02                                                 PAGE   6
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- EPINEPHRINE HCL
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1.5MG/M3        3.0MG/M3      |      CONTROL         1.5MG/M3        3.0MG/M3      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Cystadenoma                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     3/50 (6%)       0/26 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |                                                    |      9.4%            0.0%            2.9%          |
|TERMINAL (d)           |                                                    |     3/32 (9%)       0/12 (0%)       1/34 (3%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      742 (T)         ---             742 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.187N        P=0.336N        P=0.283N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.187N        P=0.336N        P=0.283N       |
|LOGISTIC REGRESSION    |                                                    |     P=0.187N        P=0.336N        P=0.283N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.196N                                       |
|FISHER EXACT           |                                                    |                     P=0.279N        P=0.309N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/16 (0%)       0/48 (0%)      |     7/49 (14%)     11/46 (24%)     12/49 (24%)     |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |     21.1%           32.9%           33.5%          |
|TERMINAL (d)           |     0/33 (0%)       0/0             0/34 (0%)      |     6/31 (19%)     10/32 (31%)     10/33 (30%)     |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      615             661             680           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.159         P=0.229         P=0.186        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.134         P=0.211         P=0.144        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.131         P=0.163         P=0.152        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.132                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.175         P=0.153        |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05095 TEST: 02                                                 PAGE   7
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- EPINEPHRINE HCL
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1.5MG/M3        3.0MG/M3      |      CONTROL         1.5MG/M3        3.0MG/M3      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       0/50 (0%)       0/50 (0%)      |     0/50 (0%)       2/50 (4%)       0/50 (0%)      |
|ADJUSTED (b)           |      5.2%            0.0%            0.0%          |      0.0%            5.1%            0.0%          |
|TERMINAL (d)           |     0/33 (0%)       0/34 (0%)       0/36 (0%)      |     0/32 (0%)       1/35 (3%)       0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      635             ---             ---           |      ---             616             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.094N        P=0.240N        P=0.231N       |     P=0.659N        P=0.250           (e)          |
|INCIDENTAL TUMOR       |     P=0.202N        P=0.387N        P=0.409N       |     P=0.602         P=0.282           (e)          |
|LOGISTIC REGRESSION    |     P=0.093N        P=0.231N        P=0.232N       |     P=0.668N        P=0.234           (e)          |
|COCHRAN-ARMITAGE       |     P=0.095N                                       |     P=0.669                                        |
|FISHER EXACT           |                     P=0.247N        P=0.247N       |                     P=0.247           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       1/20 (5%)       3/50 (6%)      |     0/50 (0%)       0/25 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      3.0%           25.0%            7.5%          |      0.0%            0.0%            2.9%          |
|TERMINAL (d)           |     1/33 (3%)       1/4 (25%)       1/36 (3%)      |     0/32 (0%)       0/10 (0%)       1/34 (3%)      |
|FIRST INCIDENCE (DAYS) |      741 (T)         741 (T)         637           |      ---             ---             742 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.255         P=0.256         P=0.335        |     P=0.306           (e)           P=0.512        |
|INCIDENTAL TUMOR       |     P=0.168         P=0.256         P=0.200        |     P=0.306           (e)           P=0.512        |
|LOGISTIC REGRESSION    |     P=0.231         P=0.256         P=0.302        |     P=0.306           (e)           P=0.512        |
|COCHRAN-ARMITAGE       |     P=0.226                                        |     P=0.287                                        |
|FISHER EXACT           |                     P=0.493         P=0.309        |                       (e)           P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05095 TEST: 02                                                 PAGE   8
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- EPINEPHRINE HCL
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1.5MG/M3        3.0MG/M3      |      CONTROL         1.5MG/M3        3.0MG/M3      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       0/15 (0%)       1/50 (2%)      |     3/49 (6%)       2/18 (11%)      1/48 (2%)      |
|ADJUSTED (b)           |      0.0%            0.0%            2.8%          |      9.1%           66.7%            2.9%          |
|TERMINAL (d)           |     0/33 (0%)       0/0             1/36 (3%)      |     2/32 (6%)       2/3 (67%)       1/34 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             741 (T)       |      732             742 (T)         742 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.324           (e)           P=0.517        |     P=0.233N        P=0.190         P=0.288N       |
|INCIDENTAL TUMOR       |     P=0.324           (e)           P=0.517        |     P=0.241N        P=0.137         P=0.298N       |
|LOGISTIC REGRESSION    |     P=0.324           (e)           P=0.517        |     P=0.243N        P=0.041 *       P=0.295N       |
|COCHRAN-ARMITAGE       |     P=0.298                                        |     P=0.254N                                       |
|FISHER EXACT           |                       (e)           P=0.505        |                     P=0.408         P=0.316N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       0/15 (0%)       1/50 (2%)      |     3/49 (6%)       2/18 (11%)      2/48 (4%)      |
|ADJUSTED (b)           |      0.0%            0.0%            2.8%          |      9.1%           66.7%            5.9%          |
|TERMINAL (d)           |     0/33 (0%)       0/0             1/36 (3%)      |     2/32 (6%)       2/3 (67%)       2/34 (6%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             741 (T)       |      732             742 (T)         742 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.324           (e)           P=0.517        |     P=0.390N        P=0.190         P=0.475N       |
|INCIDENTAL TUMOR       |     P=0.324           (e)           P=0.517        |     P=0.397N        P=0.137         P=0.486N       |
|LOGISTIC REGRESSION    |     P=0.324           (e)           P=0.517        |     P=0.400N        P=0.041 *       P=0.487N       |
|COCHRAN-ARMITAGE       |     P=0.298                                        |     P=0.426N                                       |
|FISHER EXACT           |                       (e)           P=0.505        |                     P=0.408         P=0.510N       |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05095 TEST: 02                                                 PAGE   9
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- EPINEPHRINE HCL
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1.5MG/M3        3.0MG/M3      |      CONTROL         1.5MG/M3        3.0MG/M3      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     0/50 (0%)       1/50 (2%)       2/50 (4%)      |
|ADJUSTED (b)           |                                                    |      0.0%            2.9%            5.9%          |
|TERMINAL (d)           |                                                    |     0/32 (0%)       1/35 (3%)       2/34 (6%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      ---             742 (T)         742 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.149         P=0.518         P=0.252        |
|INCIDENTAL TUMOR       |                                                    |     P=0.149         P=0.518         P=0.252        |
|LOGISTIC REGRESSION    |                                                    |     P=0.149         P=0.518         P=0.252        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.142                                        |
|FISHER EXACT           |                                                    |                     P=0.500         P=0.247        |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     0/50 (0%)       1/50 (2%)       3/50 (6%)      |
|ADJUSTED (b)           |                                                    |      0.0%            2.9%            8.5%          |
|TERMINAL (d)           |                                                    |     0/32 (0%)       1/35 (3%)       2/34 (6%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      ---             742 (T)         730           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.066         P=0.518         P=0.134        |
|INCIDENTAL TUMOR       |                                                    |     P=0.066         P=0.518         P=0.125        |
|LOGISTIC REGRESSION    |                                                    |     P=0.062         P=0.518         P=0.123        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.060                                        |
|FISHER EXACT           |                                                    |                     P=0.500         P=0.121        |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05095 TEST: 02                                                 PAGE  10
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- EPINEPHRINE HCL
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1.5MG/M3        3.0MG/M3      |      CONTROL         1.5MG/M3        3.0MG/M3      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     0/50 (0%)       1/50 (2%)       4/50 (8%)      |
|ADJUSTED (b)           |                                                    |      0.0%            2.9%           11.1%          |
|TERMINAL (d)           |                                                    |     0/32 (0%)       1/35 (3%)       2/34 (6%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      ---             742 (T)         730           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.029 *       P=0.518         P=0.073        |
|INCIDENTAL TUMOR       |                                                    |     P=0.029 *       P=0.518         P=0.062        |
|LOGISTIC REGRESSION    |                                                    |     P=0.027 *       P=0.518         P=0.064        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.026 *                                      |
|FISHER EXACT           |                                                    |                     P=0.500         P=0.059        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       0/50 (0%)       1/50 (2%)      |     2/50 (4%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |      2.4%            0.0%            2.8%          |      6.3%            2.9%            0.0%          |
|TERMINAL (d)           |     0/33 (0%)       0/34 (0%)       1/36 (3%)      |     2/32 (6%)       1/35 (3%)       0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      610             ---             741 (T)       |      742 (T)         742 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.661N        P=0.505N        P=0.753N       |     P=0.130N        P=0.469N        P=0.225N       |
|INCIDENTAL TUMOR       |     P=0.535         P=0.795N        P=0.659        |     P=0.130N        P=0.469N        P=0.225N       |
|LOGISTIC REGRESSION    |     P=0.667N        P=0.469N        P=0.760N       |     P=0.130N        P=0.469N        P=0.225N       |
|COCHRAN-ARMITAGE       |     P=0.669N                                       |     P=0.142N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.753N       |                     P=0.500N        P=0.247N       |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05095 TEST: 02                                                 PAGE  11
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- EPINEPHRINE HCL
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1.5MG/M3        3.0MG/M3      |      CONTROL         1.5MG/M3        3.0MG/M3      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       2/50 (4%)       4/50 (8%)      |     2/50 (4%)       2/50 (4%)       2/50 (4%)      |
|ADJUSTED (b)           |     11.0%            5.9%           10.2%          |      4.6%            5.1%            5.9%          |
|TERMINAL (d)           |     2/33 (6%)       2/34 (6%)       2/36 (6%)      |     0/32 (0%)       1/35 (3%)       2/34 (6%)      |
|FIRST INCIDENCE (DAYS) |      635             741 (T)         637           |      615             616             742 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.540N        P=0.330N        P=0.602N       |     P=0.586N        P=0.690N        P=0.681N       |
|INCIDENTAL TUMOR       |     P=0.431         P=0.428N        P=0.466        |     P=0.506         P=0.689N        P=0.606        |
|LOGISTIC REGRESSION    |     P=0.576         P=0.349N        P=0.427        |     P=0.600N        P=0.685         P=0.695N       |
|COCHRAN-ARMITAGE       |     P=0.579                                        |     P=0.601                                        |
|FISHER EXACT           |                     P=0.339N        P=0.643N       |                     P=0.691N        P=0.691N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      2/50 (4%)       5/50 (10%)     |     4/50 (8%)       3/50 (6%)       2/50 (4%)      |
|ADJUSTED (b)           |     13.1%            5.9%           12.8%          |     10.5%            7.9%            5.9%          |
|TERMINAL (d)           |     2/33 (6%)       2/34 (6%)       3/36 (8%)      |     2/32 (6%)       2/35 (6%)       2/34 (6%)      |
|FIRST INCIDENCE (DAYS) |      610             741 (T)         637           |      615             616             742 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.534N        P=0.217N        P=0.588N       |     P=0.249N        P=0.478N        P=0.321N       |
|INCIDENTAL TUMOR       |     P=0.379         P=0.373N        P=0.406        |     P=0.318N        P=0.468N        P=0.403N       |
|LOGISTIC REGRESSION    |     P=0.413         P=0.223N        P=0.371        |     P=0.264N        P=0.501N        P=0.337N       |
|COCHRAN-ARMITAGE       |     P=0.573                                        |     P=0.264N                                       |
|FISHER EXACT           |                     P=0.218N        P=0.630N       |                     P=0.500N        P=0.339N       |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05095 TEST: 02                                                 PAGE  12
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- EPINEPHRINE HCL
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1.5MG/M3        3.0MG/M3      |      CONTROL         1.5MG/M3        3.0MG/M3      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     9/50 (18%)      6/50 (12%)      5/50 (10%)     |    17/50 (34%)     19/50 (38%)     14/50 (28%)     |
|ADJUSTED (b)           |     22.7%           16.4%           13.9%          |     40.8%           44.7%           31.9%          |
|TERMINAL (d)           |     4/33 (12%)      4/34 (12%)      5/36 (14%)     |     8/32 (25%)     12/35 (34%)      6/34 (18%)     |
|FIRST INCIDENCE (DAYS) |      551             654             741 (T)       |      503             504             421           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.133N        P=0.300N        P=0.171N       |     P=0.288N        P=0.479         P=0.328N       |
|INCIDENTAL TUMOR       |     P=0.236N        P=0.401N        P=0.299N       |     P=0.321N        P=0.350         P=0.363N       |
|LOGISTIC REGRESSION    |     P=0.155N        P=0.299N        P=0.198N       |     P=0.352N        P=0.419         P=0.396N       |
|COCHRAN-ARMITAGE       |     P=0.152N                                       |     P=0.298N                                       |
|FISHER EXACT           |                     P=0.288N        P=0.194N       |                     P=0.418         P=0.333N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     8/50 (16%)      6/50 (12%)      5/50 (10%)     |    16/50 (32%)     19/50 (38%)     14/50 (28%)     |
|ADJUSTED (b)           |     21.1%           16.4%           13.9%          |     39.3%           44.7%           31.9%          |
|TERMINAL (d)           |     4/33 (12%)      4/34 (12%)      5/36 (14%)     |     8/32 (25%)     12/35 (34%)      6/34 (18%)     |
|FIRST INCIDENCE (DAYS) |      573             654             741 (T)       |      503             504             421           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.194N        P=0.388N        P=0.238N       |     P=0.352N        P=0.408         P=0.395N       |
|INCIDENTAL TUMOR       |     P=0.287N        P=0.442N        P=0.348N       |     P=0.401N        P=0.293         P=0.448N       |
|LOGISTIC REGRESSION    |     P=0.226N        P=0.405N        P=0.276N       |     P=0.434N        P=0.339         P=0.482N       |
|COCHRAN-ARMITAGE       |     P=0.226N                                       |     P=0.375N                                       |
|FISHER EXACT           |                     P=0.387N        P=0.277N       |                     P=0.338         P=0.414N       |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05095 TEST: 02                                                 PAGE  13
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- EPINEPHRINE HCL
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1.5MG/M3        3.0MG/M3      |      CONTROL         1.5MG/M3        3.0MG/M3      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    20/50 (40%)     17/50 (34%)     19/50 (38%)     |    19/50 (38%)     19/50 (38%)     19/50 (38%)     |
|ADJUSTED (b)           |     50.0%           46.6%           44.5%          |     53.6%           49.5%           49.6%          |
|TERMINAL (d)           |    14/33 (42%)     15/34 (44%)     13/36 (36%)     |    16/32 (50%)     16/35 (46%)     15/34 (44%)     |
|FIRST INCIDENCE (DAYS) |      409             456             381           |      324             607             680           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.372N        P=0.320N        P=0.418N       |     P=0.461N        P=0.466N        P=0.502N       |
|INCIDENTAL TUMOR       |     P=0.473N        P=0.434N        P=0.437N       |     P=0.525N        P=0.580         P=0.565N       |
|LOGISTIC REGRESSION    |     P=0.469N        P=0.369N        P=0.497N       |     P=0.542N        P=0.576         P=0.582        |
|COCHRAN-ARMITAGE       |     P=0.459N                                       |     P=0.541                                        |
|FISHER EXACT           |                     P=0.339N        P=0.500N       |                     P=0.582N        P=0.582N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    25/50 (50%)     21/50 (42%)     20/50 (40%)     |    25/50 (50%)     27/50 (54%)     23/50 (46%)     |
|ADJUSTED (b)           |     55.0%           47.6%           45.2%          |     55.1%           58.1%           51.6%          |
|TERMINAL (d)           |    13/33 (39%)     11/34 (32%)     12/36 (33%)     |    12/32 (38%)     16/35 (46%)     13/34 (38%)     |
|FIRST INCIDENCE (DAYS) |      551             465             510           |      503             384             421           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.177N        P=0.316N        P=0.199N       |     P=0.356N        P=0.500         P=0.391N       |
|INCIDENTAL TUMOR       |     P=0.471N        P=0.511N        P=0.543N       |     P=0.402N        P=0.490         P=0.488N       |
|LOGISTIC REGRESSION    |     P=0.434N        P=0.464N        P=0.464N       |     P=0.424N        P=0.544         P=0.522N       |
|COCHRAN-ARMITAGE       |     P=0.182N                                       |     P=0.382N                                       |
|FISHER EXACT           |                     P=0.274N        P=0.211N       |                     P=0.421         P=0.421N       |
|=================================================================================================================================|
 
         DATE: 09/13/94                     EXPERIMENT: 05095 TEST: 02                                                 PAGE  14
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- EPINEPHRINE HCL
 
                                                 TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         1.5MG/M3        3.0MG/M3      |      CONTROL         1.5MG/M3        3.0MG/M3      |
|                       |      MALE            MALE            MALE          |      FEMALE          FEMALE          FEMALE        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    38/50 (76%)     33/50 (66%)     33/50 (66%)     |    36/50 (72%)     36/50 (72%)     30/50 (60%)     |
|ADJUSTED (b)           |     79.0%           73.3%           70.1%          |     78.0%           76.3%           66.4%          |
|TERMINAL (d)           |    23/33 (70%)     22/34 (65%)     22/36 (61%)     |    22/32 (69%)     24/35 (69%)     19/34 (56%)     |
|FIRST INCIDENCE (DAYS) |      409             456             381           |      324             384             421           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.157N        P=0.256N        P=0.182N       |     P=0.141N        P=0.449N        P=0.164N       |
|INCIDENTAL TUMOR       |     P=0.304N        P=0.312N        P=0.287N       |     P=0.123N        P=0.516N        P=0.163N       |
|LOGISTIC REGRESSION    |     P=0.310N        P=0.253N        P=0.365N       |     P=0.122N        P=0.587         P=0.145N       |
|COCHRAN-ARMITAGE       |     P=0.165N                                       |     P=0.119N                                       |
|FISHER EXACT           |                     P=0.189N        P=0.189N       |                     P=0.588N        P=0.146N       |
|=================================================================================================================================|
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (d)  Observed incidence at terminal kill.
 (f)  Beneath the control incidence are the P-values associated with the trend 
      test.  Beneath the dosed group incidence are the P-values corresponding to 
      pairwise comparisons between the controls and that dosed group.  The life
      table analysis regards tumors in animals dying  prior to terminal kill as
      being (directly or indirectly) the cause of death.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's exact tests compare directly the overall incidence rates.  
      For all tests, a negative trend is indicated by "N".
 (e)  Value of Statistic cannot be computed. 
 (I)  Interim sacrifice
 (T)  Terminal sacrifice
  #   Tumor rates based on number of animals necropsied.
 
  *   To the right of any statistical result, indicates significance at (P<=0.05).
  **  To the right of any statistical result, indicates significance at (P<=0.01).

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