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TDMS Study 05120-03 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                  BENZYL ACETATE                                    DATE: 09/15/94       
EXPERIMENT: 05120 TEST: 03                                                                                     TIME: 14:10:55       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-55082          ROUTE: DOSED FEED                                                                  NTP C#: 06508B       
PATHOLOGIST: DR FARNELL                      SCOT EUSTIS                                                       CAS: 140-11-4        
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Southern Research Inst                                  BENZYL ACETATE                                    DATE: 09/15/94      
EXPERIMENT: 05120 TEST: 03                                                                                     TIME: 14:10:55      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-55082          ROUTE: DOSED FEED                                                                  NTP C#: 06508B      
PATHOLOGIST: DR FARNELL                      SCOT EUSTIS                                                       CAS: 140-11-4       
 
 
 
 
 
                                                    RATS(FISCHER344)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                  BENZYL ACETATE                                    DATE: 09/15/94       
EXPERIMENT: 05120 TEST: 03                                                                                     TIME: 14:10:55       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55082          ROUTE: DOSED FEED                                                                  NTP C#: 06508B       
PATHOLOGIST: DR FARNELL                      SCOT EUSTIS                                                       CAS: 140-11-4        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                         IN THE ANALYSIS OF THE STUDY OF BENZYL ACETATE
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Skin                          Keratoacanthoma
                             All Organs                    Malignant Tumors
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Islets, Pancreatic            Adenoma
                                                           Carcinoma or Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                                                           Carcinoma or Adenoma
                             Thyroid Gland: C-Cell         Carcinoma
                             Uterus                        Polyp Stromal
                                                           Sarcoma Stromal
                                                           Sarcoma Stromal or Polyp Stromal
                             All Organs                    Benign Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/16/94                     EXPERIMENT: 05120 TEST: 03                                                 PAGE   1
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0%           0.3%         0.6%         1.2%      |   0%           0.3%         0.6%         1.2%      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    2/60 (3%)    0/60 (0%)  |  3/60 (5%)    2/60 (3%)    1/60 (2%)    1/60 (2%)  |
|ADJUSTED (b)           |   2.6%         0.0%         6.2%         0.0%      |   8.7%         6.7%         2.5%         2.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/27 (0%)    0/34 (0%)    1/30 (3%)    0/33 (0%)  |  2/30 (7%)    2/30 (7%)    0/37 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   654          ---          701          ---       |   603          731 (T)      725          707       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.449N     P=0.495N     P=0.520      P=0.500N   |  P=0.198N     P=0.500N     P=0.247N     P=0.316N   |
|INCIDENTAL TUMOR       |  P=0.535N     P=0.657N     P=0.533      P=0.657N   |  P=0.188N     P=0.550N     P=0.402N     P=0.301N   |
|LOGISTIC REGRESSION    |  P=0.454N     P=0.500N     P=0.516      P=0.499N   |  P=0.187N     P=0.494N     P=0.282N     P=0.297N   |
|COCHRAN-ARMITAGE       |  P=0.461N                                          |  P=0.200N                                          |
|FISHER EXACT           |               P=0.500N     P=0.500      P=0.500N   |               P=0.500N     P=0.309N     P=0.309N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 17/60 (28%)  12/60 (20%)  16/60 (27%)  14/60 (23%) |  1/60 (2%)    5/60 (8%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |  51.8%        32.2%        45.1%        40.0%      |   3.3%        16.1%         2.2%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    1/10 (10%)   0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 12/27 (44%)  10/34 (29%)  11/30 (37%)  12/33 (36%) |  1/30 (3%)    4/30 (13%)   0/37 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   600          457 (I)      633          724       |   731 (T)      726          700          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.270N     P=0.075N     P=0.389N     P=0.158N   |  P=0.133N     P=0.104      P=0.709N     P=0.514N   |
|INCIDENTAL TUMOR       |  P=0.369N     P=0.129N     P=0.380N     P=0.305N   |  P=0.110N     P=0.114      P=0.737N     P=0.514N   |
|LOGISTIC REGRESSION    |  P=0.351N     P=0.163N     P=0.402N     P=0.261N   |  P=0.125N     P=0.096      P=0.737N     P=0.514N   |
|COCHRAN-ARMITAGE       |  P=0.410N                                          |  P=0.135N                                          |
|FISHER EXACT           |               P=0.197N     P=0.500N     P=0.339N   |               P=0.103      P=0.752N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05120 TEST: 03                                                 PAGE   2
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0%           0.3%         0.6%         1.2%      |   0%           0.3%         0.6%         1.2%      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Complex                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    2/60 (3%)    0/60 (0%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   2.3%         5.1%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/27 (0%)    0/34 (0%)    0/30 (0%)    0/33 (0%)  |  0/30 (0%)    0/30 (0%)    0/37 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   600          618          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.183N     P=0.506      P=0.482N     P=0.495N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.200N     P=0.410      P=0.531N     P=0.473N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.189N     P=0.500      P=0.510N     P=0.504N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.188N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.500N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    2/60 (3%)    2/60 (3%)    2/60 (3%)  |  1/60 (2%)    1/60 (2%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   2.8%         5.0%         6.7%         6.1%      |   3.3%         3.3%         2.7%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/27 (0%)    1/34 (3%)    2/30 (7%)    2/33 (6%)  |  1/30 (3%)    1/30 (3%)    1/37 (3%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   682          504          729 (T)      729 (T)   |   731 (T)      731 (T)      731 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.462      P=0.535      P=0.534      P=0.550    |  P=0.314N     P=0.762      P=0.715N     P=0.514N   |
|INCIDENTAL TUMOR       |  P=0.418      P=0.413      P=0.534      P=0.458    |  P=0.314N     P=0.762      P=0.715N     P=0.514N   |
|LOGISTIC REGRESSION    |  P=0.432      P=0.499      P=0.522      P=0.516    |  P=0.314N     P=0.762      P=0.715N     P=0.514N   |
|COCHRAN-ARMITAGE       |  P=0.423                                           |  P=0.312N                                          |
|FISHER EXACT           |               P=0.500      P=0.500      P=0.500    |               P=0.752N     P=0.752N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05120 TEST: 03                                                 PAGE   3
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0%           0.3%         0.6%         1.2%      |   0%           0.3%         0.6%         1.2%      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 19/60 (32%)  16/60 (27%)  18/60 (30%)  15/60 (25%) |  2/60 (3%)    6/60 (10%)   2/60 (3%)    0/60 (0%)  |
|ADJUSTED (b)           |  54.2%        39.6%        50.9%        42.9%      |   6.7%        19.4%         4.8%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    1/10 (10%)   0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 12/27 (44%)  11/34 (32%)  13/30 (43%)  13/33 (39%) |  2/30 (7%)    5/30 (17%)   1/37 (3%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   600          457 (I)      633          724       |   731 (T)      726          700          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.165N     P=0.175N     P=0.379N     P=0.117N   |  P=0.075N     P=0.133      P=0.613N     P=0.253N   |
|INCIDENTAL TUMOR       |  P=0.249N     P=0.317N     P=0.378N     P=0.251N   |  P=0.062N     P=0.144      P=0.636N     P=0.253N   |
|LOGISTIC REGRESSION    |  P=0.225N     P=0.314N     P=0.395N     P=0.202N   |  P=0.070N     P=0.123      P=0.639N     P=0.253N   |
|COCHRAN-ARMITAGE       |  P=0.281N                                          |  P=0.078N                                          |
|FISHER EXACT           |               P=0.344N     P=0.500N     P=0.272N   |               P=0.136      P=0.691N     P=0.248N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Oligodendroglioma, Glioma, or Astrocytoma                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    2/60 (3%)    0/60 (0%)    1/60 (2%)  |  1/60 (2%)    1/60 (2%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         5.2%         0.0%         2.2%      |   1.8%         2.9%         2.7%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/27 (0%)    1/34 (3%)    0/30 (0%)    0/33 (0%)  |  0/30 (0%)    0/30 (0%)    1/37 (3%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          600          ---          573       |   457 (I)      710          731 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.558      P=0.265        (e)        P=0.509    |  P=0.318N     P=0.757N     P=0.737N     P=0.500N   |
|INCIDENTAL TUMOR       |  P=0.571      P=0.265        (e)        P=0.527    |  P=0.280N     P=0.732N     P=0.737N     P=0.500N   |
|LOGISTIC REGRESSION    |  P=0.537      P=0.239        (e)        P=0.494    |  P=0.318N     P=0.760      P=0.750      P=0.551N   |
|COCHRAN-ARMITAGE       |  P=0.539                                           |  P=0.312N                                          |
|FISHER EXACT           |               P=0.248        (e)        P=0.500    |               P=0.752N     P=0.752N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05120 TEST: 03                                                 PAGE   4
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0%           0.3%         0.6%         1.2%      |   0%           0.3%         0.6%         1.2%      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    2/60 (3%)    3/60 (5%)    2/60 (3%)  |  0/60 (0%)    1/60 (2%)    1/60 (2%)    1/59 (2%)  |
|ADJUSTED (b)           |   9.1%         4.6%        10.0%         6.1%      |   0.0%         3.2%         2.7%         3.6%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   1/10 (10%)   0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/27 (7%)    1/34 (3%)    3/30 (10%)   2/33 (6%)  |  0/30 (0%)    0/30 (0%)    1/37 (3%)    1/28 (4%)  |
|FIRST INCIDENCE (DAYS) |   458 (I)      456 (I)      729 (T)      729 (T)   |   ---          726          731 (T)      731 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.406N     P=0.437N     P=0.622N     P=0.427N   |  P=0.370      P=0.500      P=0.542      P=0.486    |
|INCIDENTAL TUMOR       |  P=0.406N     P=0.437N     P=0.622N     P=0.427N   |  P=0.412      P=0.552      P=0.542      P=0.486    |
|LOGISTIC REGRESSION    |  P=0.450N     P=0.502N     P=0.647N     P=0.493N   |  P=0.371      P=0.502      P=0.542      P=0.486    |
|COCHRAN-ARMITAGE       |  P=0.457N                                          |  P=0.380                                           |
|FISHER EXACT           |               P=0.500N     P=0.660N     P=0.500N   |               P=0.500      P=0.500      P=0.496    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    3/60 (5%)    4/60 (7%)    2/60 (3%)  |  1/60 (2%)    2/60 (3%)    1/60 (2%)    1/59 (2%)  |
|ADJUSTED (b)           |   9.1%         7.0%        12.9%         6.1%      |   3.3%         6.0%         2.7%         3.6%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   1/10 (10%)   0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/27 (7%)    1/34 (3%)    3/30 (10%)   2/33 (6%)  |  1/30 (3%)    0/30 (0%)    1/37 (3%)    1/28 (4%)  |
|FIRST INCIDENCE (DAYS) |   458 (I)      456 (I)      724          729 (T)   |   731 (T)      710          731 (T)      731 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.371N     P=0.603N     P=0.541      P=0.427N   |  P=0.549N     P=0.503      P=0.715N     P=0.747    |
|INCIDENTAL TUMOR       |  P=0.416N     P=0.659      P=0.547      P=0.427N   |  P=0.482N     P=0.561      P=0.715N     P=0.747    |
|LOGISTIC REGRESSION    |  P=0.412N     P=0.661      P=0.522      P=0.493N   |  P=0.530N     P=0.505      P=0.715N     P=0.747    |
|COCHRAN-ARMITAGE       |  P=0.421N                                          |  P=0.536N                                          |
|FISHER EXACT           |               P=0.660N     P=0.500      P=0.500N   |               P=0.500      P=0.752N     P=0.748    |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05120 TEST: 03                                                 PAGE   5
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0%           0.3%         0.6%         1.2%      |   0%           0.3%         0.6%         1.2%      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/60 (0%)    1/60 (2%)    1/60 (2%)  |  3/60 (5%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   7.4%         0.0%         2.2%         3.0%      |  10.0%         3.3%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/27 (7%)    0/34 (0%)    0/30 (0%)    1/33 (3%)  |  3/30 (10%)   1/30 (3%)    0/37 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          633          729 (T)   |   731 (T)      731 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.467N     P=0.189N     P=0.459N     P=0.430N   |  P=0.040N*    P=0.304N     P=0.086N     P=0.132N   |
|INCIDENTAL TUMOR       |  P=0.461N     P=0.189N     P=0.493N     P=0.430N   |  P=0.040N*    P=0.304N     P=0.086N     P=0.132N   |
|LOGISTIC REGRESSION    |  P=0.490N     P=0.189N     P=0.483N     P=0.430N   |  P=0.040N*    P=0.304N     P=0.086N     P=0.132N   |
|COCHRAN-ARMITAGE       |  P=0.500N                                          |  P=0.044N*                                         |
|FISHER EXACT           |               P=0.248N     P=0.500N     P=0.500N   |               P=0.309N     P=0.122N     P=0.122N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/60 (0%)    1/60 (2%)    2/60 (3%)  |  3/60 (5%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   7.4%         0.0%         2.2%         5.2%      |  10.0%         3.3%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/27 (7%)    0/34 (0%)    0/30 (0%)    1/33 (3%)  |  3/30 (10%)   1/30 (3%)    0/37 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          633          613       |   731 (T)      731 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.504      P=0.189N     P=0.459N     P=0.632N   |  P=0.040N*    P=0.304N     P=0.086N     P=0.132N   |
|INCIDENTAL TUMOR       |  P=0.513      P=0.189N     P=0.493N     P=0.626N   |  P=0.040N*    P=0.304N     P=0.086N     P=0.132N   |
|LOGISTIC REGRESSION    |  P=0.477      P=0.189N     P=0.483N     P=0.683N   |  P=0.040N*    P=0.304N     P=0.086N     P=0.132N   |
|COCHRAN-ARMITAGE       |  P=0.470                                           |  P=0.044N*                                         |
|FISHER EXACT           |               P=0.248N     P=0.500N     P=0.691N   |               P=0.309N     P=0.122N     P=0.122N   |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05120 TEST: 03                                                 PAGE   6
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0%           0.3%         0.6%         1.2%      |   0%           0.3%         0.6%         1.2%      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/60 (10%)   6/60 (10%)   3/60 (5%)    3/60 (5%)  |  2/60 (3%)    1/60 (2%)    1/60 (2%)    3/60 (5%)  |
|ADJUSTED (b)           |  18.5%        17.1%         8.0%         9.1%      |   5.0%         2.3%         2.2%         8.4%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  4/27 (15%)   5/34 (15%)   0/30 (0%)    3/33 (9%)  |  1/30 (3%)    0/30 (0%)    0/37 (0%)    1/28 (4%)  |
|FIRST INCIDENCE (DAYS) |   458 (I)      710          641          729 (T)   |   457 (I)      633          700          658       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.109N     P=0.492N     P=0.216N     P=0.172N   |  P=0.335      P=0.492N     P=0.448N     P=0.498    |
|INCIDENTAL TUMOR       |  P=0.130N     P=0.542N     P=0.231N     P=0.167N   |  P=0.382      P=0.563N     P=0.476N     P=0.582    |
|LOGISTIC REGRESSION    |  P=0.127N     P=0.606N     P=0.232N     P=0.231N   |  P=0.324      P=0.503N     P=0.513N     P=0.499    |
|COCHRAN-ARMITAGE       |  P=0.141N                                          |  P=0.325                                           |
|FISHER EXACT           |               P=0.619N     P=0.245N     P=0.245N   |               P=0.500N     P=0.500N     P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/60 (10%)   6/60 (10%)   3/60 (5%)    3/60 (5%)  |  2/60 (3%)    1/60 (2%)    1/60 (2%)    4/60 (7%)  |
|ADJUSTED (b)           |  18.5%        17.1%         8.0%         9.1%      |   5.0%         2.3%         2.2%        11.1%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  4/27 (15%)   5/34 (15%)   0/30 (0%)    3/33 (9%)  |  1/30 (3%)    0/30 (0%)    0/37 (0%)    1/28 (4%)  |
|FIRST INCIDENCE (DAYS) |   458 (I)      710          641          729 (T)   |   457 (I)      633          700          658       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.109N     P=0.492N     P=0.216N     P=0.172N   |  P=0.172      P=0.492N     P=0.448N     P=0.339    |
|INCIDENTAL TUMOR       |  P=0.130N     P=0.542N     P=0.231N     P=0.167N   |  P=0.227      P=0.563N     P=0.476N     P=0.451    |
|LOGISTIC REGRESSION    |  P=0.127N     P=0.606N     P=0.232N     P=0.231N   |  P=0.166      P=0.503N     P=0.513N     P=0.340    |
|COCHRAN-ARMITAGE       |  P=0.141N                                          |  P=0.165                                           |
|FISHER EXACT           |               P=0.619N     P=0.245N     P=0.245N   |               P=0.500N     P=0.500N     P=0.340    |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05120 TEST: 03                                                 PAGE   7
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0%           0.3%         0.6%         1.2%      |   0%           0.3%         0.6%         1.2%      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/60 (10%)   6/60 (10%)   3/60 (5%)    3/60 (5%)  |  2/60 (3%)    1/60 (2%)    1/60 (2%)    4/60 (7%)  |
|ADJUSTED (b)           |  18.5%        17.1%         8.0%         9.1%      |   5.0%         2.3%         2.2%        11.1%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  4/27 (15%)   5/34 (15%)   0/30 (0%)    3/33 (9%)  |  1/30 (3%)    0/30 (0%)    0/37 (0%)    1/28 (4%)  |
|FIRST INCIDENCE (DAYS) |   458 (I)      710          641          729 (T)   |   457 (I)      633          700          658       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.109N     P=0.492N     P=0.216N     P=0.172N   |  P=0.172      P=0.492N     P=0.448N     P=0.339    |
|INCIDENTAL TUMOR       |  P=0.130N     P=0.542N     P=0.231N     P=0.167N   |  P=0.227      P=0.563N     P=0.476N     P=0.451    |
|LOGISTIC REGRESSION    |  P=0.127N     P=0.606N     P=0.232N     P=0.231N   |  P=0.166      P=0.503N     P=0.513N     P=0.340    |
|COCHRAN-ARMITAGE       |  P=0.141N                                          |  P=0.165                                           |
|FISHER EXACT           |               P=0.619N     P=0.245N     P=0.245N   |               P=0.500N     P=0.500N     P=0.340    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/60 (0%)    2/60 (3%)    2/60 (3%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   5.4%         0.0%         4.6%         4.7%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   0/10 (0%)    1/10 (10%)   1/10 (10%) |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/27 (4%)    0/34 (0%)    0/30 (0%)    1/33 (3%)  |  0/30 (0%)    0/30 (0%)    0/37 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   457 (I)      ---          456 (I)      456 (I)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.461      P=0.215N     P=0.687N     P=0.658N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.430      P=0.215N     P=0.677N     P=0.658N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.433      P=0.238N     P=0.673      P=0.687    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.444                                           |    (e)                                             |
|FISHER EXACT           |               P=0.248N     P=0.691N     P=0.691N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05120 TEST: 03                                                 PAGE   8
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0%           0.3%         0.6%         1.2%      |   0%           0.3%         0.6%         1.2%      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/60 (0%)    2/60 (3%)    2/60 (3%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   5.4%         0.0%         4.6%         4.7%      |   3.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   0/10 (0%)    1/10 (10%)   1/10 (10%) |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/27 (4%)    0/34 (0%)    0/30 (0%)    1/33 (3%)  |  0/30 (0%)    0/30 (0%)    0/37 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   457 (I)      ---          456 (I)      456 (I)   |   721          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.461      P=0.215N     P=0.687N     P=0.658N   |  P=0.309N     P=0.512N     P=0.462N     P=0.526N   |
|INCIDENTAL TUMOR       |  P=0.430      P=0.215N     P=0.677N     P=0.658N   |  P=0.256N     P=0.448N     P=0.500N     P=0.394N   |
|LOGISTIC REGRESSION    |  P=0.433      P=0.238N     P=0.673      P=0.687    |  P=0.298N     P=0.497N     P=0.471N     P=0.498N   |
|COCHRAN-ARMITAGE       |  P=0.444                                           |  P=0.306N                                          |
|FISHER EXACT           |               P=0.248N     P=0.691N     P=0.691N   |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/60 (7%)    2/60 (3%)    0/60 (0%)    1/60 (2%)  | 12/60 (20%)  17/60 (28%)  12/60 (20%)  18/60 (30%) |
|ADJUSTED (b)           |  12.0%         5.9%         0.0%         3.0%      |  30.3%        44.6%        29.3%        43.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    2/10 (20%) |
|TERMINAL (d)           |  2/27 (7%)    2/34 (6%)    0/30 (0%)    1/33 (3%)  |  4/30 (13%)  10/30 (33%)   8/37 (22%)   7/28 (25%) |
|FIRST INCIDENCE (DAYS) |   631          729 (T)      ---          729 (T)   |   584          430          715          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.071N     P=0.273N     P=0.053N     P=0.146N   |  P=0.185      P=0.225      P=0.381N     P=0.157    |
|INCIDENTAL TUMOR       |  P=0.069N     P=0.269N     P=0.065N     P=0.131N   |  P=0.318      P=0.250      P=0.575      P=0.307    |
|LOGISTIC REGRESSION    |  P=0.080N     P=0.326N     P=0.059N     P=0.172N   |  P=0.212      P=0.200      P=0.482N     P=0.159    |
|COCHRAN-ARMITAGE       |  P=0.087N                                          |  P=0.188                                           |
|FISHER EXACT           |               P=0.340N     P=0.059N     P=0.182N   |               P=0.197      P=0.590N     P=0.146    |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05120 TEST: 03                                                 PAGE   9
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0%           0.3%         0.6%         1.2%      |   0%           0.3%         0.6%         1.2%      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/60 (7%)    2/60 (3%)    0/60 (0%)    1/60 (2%)  | 12/60 (20%)  17/60 (28%)  12/60 (20%)  18/60 (30%) |
|ADJUSTED (b)           |  12.0%         5.9%         0.0%         3.0%      |  30.3%        44.6%        29.3%        43.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    2/10 (20%) |
|TERMINAL (d)           |  2/27 (7%)    2/34 (6%)    0/30 (0%)    1/33 (3%)  |  4/30 (13%)  10/30 (33%)   8/37 (22%)   7/28 (25%) |
|FIRST INCIDENCE (DAYS) |   631          729 (T)      ---          729 (T)   |   584          430          715          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.071N     P=0.273N     P=0.053N     P=0.146N   |  P=0.185      P=0.225      P=0.381N     P=0.157    |
|INCIDENTAL TUMOR       |  P=0.069N     P=0.269N     P=0.065N     P=0.131N   |  P=0.318      P=0.250      P=0.575      P=0.307    |
|LOGISTIC REGRESSION    |  P=0.080N     P=0.326N     P=0.059N     P=0.172N   |  P=0.212      P=0.200      P=0.482N     P=0.159    |
|COCHRAN-ARMITAGE       |  P=0.087N                                          |  P=0.188                                           |
|FISHER EXACT           |               P=0.340N     P=0.059N     P=0.182N   |               P=0.197      P=0.590N     P=0.146    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/60 (7%)    2/60 (3%)    0/60 (0%)    1/60 (2%)  | 12/60 (20%)  17/60 (28%)  13/60 (22%)  18/60 (30%) |
|ADJUSTED (b)           |  12.0%         5.9%         0.0%         3.0%      |  30.3%        44.6%        31.7%        43.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    2/10 (20%) |
|TERMINAL (d)           |  2/27 (7%)    2/34 (6%)    0/30 (0%)    1/33 (3%)  |  4/30 (13%)  10/30 (33%)   9/37 (24%)   7/28 (25%) |
|FIRST INCIDENCE (DAYS) |   631          729 (T)      ---          729 (T)   |   584          430          715          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.071N     P=0.273N     P=0.053N     P=0.146N   |  P=0.179      P=0.225      P=0.457N     P=0.157    |
|INCIDENTAL TUMOR       |  P=0.069N     P=0.269N     P=0.065N     P=0.131N   |  P=0.309      P=0.250      P=0.486      P=0.307    |
|LOGISTIC REGRESSION    |  P=0.080N     P=0.326N     P=0.059N     P=0.172N   |  P=0.206      P=0.200      P=0.567N     P=0.159    |
|COCHRAN-ARMITAGE       |  P=0.087N                                          |  P=0.182                                           |
|FISHER EXACT           |               P=0.340N     P=0.059N     P=0.182N   |               P=0.197      P=0.500      P=0.146    |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05120 TEST: 03                                                 PAGE  10
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0%           0.3%         0.6%         1.2%      |   0%           0.3%         0.6%         1.2%      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    2/60 (3%)    1/60 (2%)  |  0/60 (0%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         5.4%         1.7%      |   0.0%         0.0%         2.7%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/27 (0%)    0/34 (0%)    1/30 (3%)    0/33 (0%)  |  0/30 (0%)    0/30 (0%)    1/37 (3%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          622          431       |   ---          ---          731 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.260        (e)        P=0.267      P=0.500    |  P=0.696        (e)        P=0.542        (e)      |
|INCIDENTAL TUMOR       |  P=0.254        (e)        P=0.234      P=0.455    |  P=0.696        (e)        P=0.542        (e)      |
|LOGISTIC REGRESSION    |  P=0.240        (e)        P=0.243      P=0.455    |  P=0.696        (e)        P=0.542        (e)      |
|COCHRAN-ARMITAGE       |  P=0.246                                           |  P=0.694                                           |
|FISHER EXACT           |                 (e)        P=0.248      P=0.500    |                 (e)        P=0.500        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    2/60 (3%)    2/60 (3%)  |  1/60 (2%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         5.4%         4.6%      |   3.3%         0.0%         2.7%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/27 (0%)    0/34 (0%)    1/30 (3%)    1/33 (3%)  |  1/30 (3%)    0/30 (0%)    1/37 (3%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          622          431       |   731 (T)      ---          731 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.097        (e)        P=0.267      P=0.262    |  P=0.410N     P=0.500N     P=0.715N     P=0.514N   |
|INCIDENTAL TUMOR       |  P=0.097        (e)        P=0.234      P=0.236    |  P=0.410N     P=0.500N     P=0.715N     P=0.514N   |
|LOGISTIC REGRESSION    |  P=0.085        (e)        P=0.243      P=0.231    |  P=0.410N     P=0.500N     P=0.715N     P=0.514N   |
|COCHRAN-ARMITAGE       |  P=0.086                                           |  P=0.405N                                          |
|FISHER EXACT           |                 (e)        P=0.248      P=0.248    |               P=0.500N     P=0.752N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05120 TEST: 03                                                 PAGE  11
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0%           0.3%         0.6%         1.2%      |   0%           0.3%         0.6%         1.2%      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    2/60 (3%)    3/60 (5%)    1/59 (2%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   3.7%         5.9%        10.0%         3.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/27 (4%)    2/34 (6%)    3/30 (10%)   1/33 (3%)  |  0/30 (0%)    0/30 (0%)    0/37 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      729 (T)      729 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.525N     P=0.581      P=0.342      P=0.717N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.525N     P=0.581      P=0.342      P=0.717N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.525N     P=0.581      P=0.342      P=0.717N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.584N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.500      P=0.309      P=0.748    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Pharynx                                                                                                                          |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    2/60 (3%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         5.4%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/27 (0%)    0/34 (0%)    1/30 (3%)    0/33 (0%)  |  0/30 (0%)    0/30 (0%)    0/37 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          622          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.615        (e)        P=0.267        (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.619        (e)        P=0.234        (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.598        (e)        P=0.243        (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.595                                           |    (e)                                             |
|FISHER EXACT           |                 (e)        P=0.248        (e)      |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05120 TEST: 03                                                 PAGE  12
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0%           0.3%         0.6%         1.2%      |   0%           0.3%         0.6%         1.2%      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 11/59 (19%)   9/60 (15%)  10/60 (17%)   6/58 (10%) | 38/60 (63%)  34/60 (57%)  31/60 (52%)  33/60 (55%) |
|ADJUSTED (b)           |  26.8%        25.7%        28.3%        16.2%      |  82.3%        78.6%        68.7%        76.2%      |
|INTERIM SACRIFICE 1 (c)|  3/10 (30%)   0/10 (0%)    1/10 (10%)   0/10 (0%)  |  2/10 (20%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/27 (11%)   8/34 (24%)   7/30 (23%)   3/33 (9%)  | 22/30 (73%)  21/30 (70%)  23/37 (62%)  18/28 (64%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      710          458 (I)      644       |   458 (I)      430          592          582       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.099N     P=0.286N     P=0.430N     P=0.116N   |  P=0.273N     P=0.303N     P=0.020N*    P=0.332N   |
|INCIDENTAL TUMOR       |  P=0.147N     P=0.425N     P=0.456N     P=0.251N   |  P=0.074N     P=0.248N     P=0.118N     P=0.075N   |
|LOGISTIC REGRESSION    |  P=0.133N     P=0.383N     P=0.479N     P=0.154N   |  P=0.094N     P=0.234N     P=0.039N*    P=0.130N   |
|COCHRAN-ARMITAGE       |  P=0.145N                                          |  P=0.214N                                          |
|FISHER EXACT           |               P=0.387N     P=0.483N     P=0.156N   |               P=0.288N     P=0.134N     P=0.229N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 11/59 (19%)   9/60 (15%)  10/60 (17%)   6/58 (10%) | 39/60 (65%)  35/60 (58%)  31/60 (52%)  33/60 (55%) |
|ADJUSTED (b)           |  26.8%        25.7%        28.3%        16.2%      |  84.5%        81.0%        68.7%        76.2%      |
|INTERIM SACRIFICE 1 (c)|  3/10 (30%)   0/10 (0%)    1/10 (10%)   0/10 (0%)  |  2/10 (20%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/27 (11%)   8/34 (24%)   7/30 (23%)   3/33 (9%)  | 23/30 (77%)  22/30 (73%)  23/37 (62%)  18/28 (64%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      710          458 (I)      644       |   458 (I)      430          592          582       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.099N     P=0.286N     P=0.430N     P=0.116N   |  P=0.212N     P=0.301N     P=0.013N*    P=0.280N   |
|INCIDENTAL TUMOR       |  P=0.147N     P=0.425N     P=0.456N     P=0.251N   |  P=0.044N*    P=0.243N     P=0.075N     P=0.048N*  |
|LOGISTIC REGRESSION    |  P=0.133N     P=0.383N     P=0.479N     P=0.154N   |  P=0.056N     P=0.226N     P=0.023N*    P=0.087N   |
|COCHRAN-ARMITAGE       |  P=0.145N                                          |  P=0.155N                                          |
|FISHER EXACT           |               P=0.387N     P=0.483N     P=0.156N   |               P=0.287N     P=0.097N     P=0.176N   |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05120 TEST: 03                                                 PAGE  13
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0%           0.3%         0.6%         1.2%      |   0%           0.3%         0.6%         1.2%      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Intermedia                                                                                                 |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/59 (0%)    0/60 (0%)    0/60 (0%)    0/58 (0%)  |  1/60 (2%)    0/60 (0%)    2/60 (3%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   3.3%         0.0%         5.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/27 (0%)    0/34 (0%)    0/30 (0%)    0/33 (0%)  |  1/30 (3%)    0/30 (0%)    1/37 (3%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   731 (T)      ---          711          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.470N     P=0.500N     P=0.579      P=0.514N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.426N     P=0.500N     P=0.548      P=0.514N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.455N     P=0.500N     P=0.557      P=0.514N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.461N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.500N     P=0.500      P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/60 (8%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  15.3%         0.0%         2.9%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/27 (4%)    0/34 (0%)    0/30 (0%)    0/33 (0%)  |  0/30 (0%)    0/30 (0%)    0/37 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   705          ---          701          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.017N*    P=0.027N*    P=0.109N     P=0.028N*  |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.025N*    P=0.088N     P=0.073N     P=0.089N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.016N*    P=0.028N*    P=0.088N     P=0.028N*  |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.018N*                                         |    (e)                                             |
|FISHER EXACT           |               P=0.029N*    P=0.103N     P=0.029N*  |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05120 TEST: 03                                                 PAGE  14
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0%           0.3%         0.6%         1.2%      |   0%           0.3%         0.6%         1.2%      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/60 (8%)    1/60 (2%)    1/60 (2%)    1/60 (2%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  15.3%         2.9%         2.9%         2.7%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/27 (4%)    1/34 (3%)    0/30 (0%)    0/33 (0%)  |  0/30 (0%)    0/30 (0%)    0/37 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   705          729 (T)      701          686       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.067N     P=0.081N     P=0.109N     P=0.089N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.108N     P=0.212N     P=0.073N     P=0.274N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.065N     P=0.090N     P=0.088N     P=0.254N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.072N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.103N     P=0.103N     P=0.103N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/60 (7%)    2/60 (3%)    3/60 (5%)    3/60 (5%)  |  1/60 (2%)    0/60 (0%)    2/60 (3%)    0/60 (0%)  |
|ADJUSTED (b)           |  12.6%         5.2%         7.6%         8.7%      |   3.3%         0.0%         5.4%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/27 (0%)    1/34 (3%)    0/30 (0%)    2/33 (6%)  |  1/30 (3%)    0/30 (0%)    2/37 (5%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   705          600          641          715       |   731 (T)      ---          731 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.466N     P=0.294N     P=0.491N     P=0.434N   |  P=0.470N     P=0.500N     P=0.573      P=0.514N   |
|INCIDENTAL TUMOR       |  P=0.543      P=0.570N     P=0.469N     P=0.557    |  P=0.470N     P=0.500N     P=0.573      P=0.514N   |
|LOGISTIC REGRESSION    |  P=0.483N     P=0.325N     P=0.470N     P=0.467N   |  P=0.470N     P=0.500N     P=0.573      P=0.514N   |
|COCHRAN-ARMITAGE       |  P=0.500N                                          |  P=0.461N                                          |
|FISHER EXACT           |               P=0.340N     P=0.500N     P=0.500N   |               P=0.500N     P=0.500      P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05120 TEST: 03                                                 PAGE  15
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0%           0.3%         0.6%         1.2%      |   0%           0.3%         0.6%         1.2%      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    1/60 (2%)    0/60 (0%)    2/60 (3%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         2.9%         0.0%         5.1%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/27 (0%)    1/34 (3%)    0/30 (0%)    1/33 (3%)  |  0/30 (0%)    0/30 (0%)    0/37 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      ---          539       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.156      P=0.546        (e)        P=0.267    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.146      P=0.546        (e)        P=0.236    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.141      P=0.546        (e)        P=0.236    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.140                                           |    (e)                                             |
|FISHER EXACT           |               P=0.500        (e)        P=0.248    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/60 (8%)    3/60 (5%)    3/60 (5%)    5/60 (8%)  |  1/60 (2%)    0/60 (0%)    2/60 (3%)    0/60 (0%)  |
|ADJUSTED (b)           |  14.9%         8.1%         7.6%        13.5%      |   3.3%         0.0%         5.4%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/27 (0%)    2/34 (6%)    0/30 (0%)    3/33 (9%)  |  1/30 (3%)    0/30 (0%)    2/37 (5%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   654          600          641          539       |   731 (T)      ---          731 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.541      P=0.303N     P=0.347N     P=0.557N   |  P=0.470N     P=0.500N     P=0.573      P=0.514N   |
|INCIDENTAL TUMOR       |  P=0.372      P=0.603N     P=0.309N     P=0.347    |  P=0.470N     P=0.500N     P=0.573      P=0.514N   |
|LOGISTIC REGRESSION    |  P=0.515      P=0.343N     P=0.165N     P=0.611N   |  P=0.470N     P=0.500N     P=0.573      P=0.514N   |
|COCHRAN-ARMITAGE       |  P=0.500                                           |  P=0.461N                                          |
|FISHER EXACT           |               P=0.359N     P=0.359N     P=0.628N   |               P=0.500N     P=0.500      P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05120 TEST: 03                                                 PAGE  16
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0%           0.3%         0.6%         1.2%      |   0%           0.3%         0.6%         1.2%      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    1/60 (2%)    0/60 (0%)    2/60 (3%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   2.6%         2.9%         0.0%         5.1%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/27 (0%)    1/34 (3%)    0/30 (0%)    1/33 (3%)  |  0/30 (0%)    0/30 (0%)    0/37 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   654          729 (T)      ---          539       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.389      P=0.732N     P=0.480N     P=0.528    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.333      P=0.707      P=0.483N     P=0.409    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.368      P=0.758N     P=0.500N     P=0.499    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.367                                           |    (e)                                             |
|FISHER EXACT           |               P=0.752N     P=0.500N     P=0.500    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 57/60 (95%)  58/60 (97%)  60/60 (100%) 59/60 (98%) |                                                    |
|ADJUSTED (b)           |  98.2%        98.3%       100.0%       100.0%      |                                                    |
|INTERIM SACRIFICE 1 (c)| 10/10 (100%)  9/10 (90%)  10/10 (100%) 10/10 (100%)|                                                    |
|TERMINAL (d)           | 26/27 (96%)  33/34 (97%)  30/30 (100%) 33/33 (100%)|                                                    |
|FIRST INCIDENCE (DAYS) |   456 (I)      396          456 (I)      431       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.352N     P=0.199N     P=0.497N     P=0.271N   |                                                    |
|INCIDENTAL TUMOR       |  P=0.183      P=0.526      P=0.121      P=0.413    |                                                    |
|LOGISTIC REGRESSION    |  P=0.162      P=0.499      P=0.113      P=0.293    |                                                    |
|COCHRAN-ARMITAGE       |  P=0.164                                           |                                                    |
|FISHER EXACT           |               P=0.500      P=0.122      P=0.309    |                                                    |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05120 TEST: 03                                                 PAGE  17
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0%           0.3%         0.6%         1.2%      |   0%           0.3%         0.6%         1.2%      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  9/60 (15%)   4/59 (7%)    7/60 (12%)   7/58 (12%) |  4/60 (7%)    4/60 (7%)    9/60 (15%)   5/60 (8%)  |
|ADJUSTED (b)           |  26.2%        10.7%        23.3%        20.5%      |  11.1%        11.0%        21.9%        16.7%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    1/10 (10%)   0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  5/27 (19%)   2/34 (6%)    7/30 (23%)   6/33 (18%) |  2/30 (7%)    2/30 (7%)    6/37 (16%)   4/28 (14%) |
|FIRST INCIDENCE (DAYS) |   457 (I)      618          729 (T)      715       |   606          458 (I)      700          704       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.397N     P=0.082N     P=0.320N     P=0.277N   |  P=0.332      P=0.635N     P=0.221      P=0.474    |
|INCIDENTAL TUMOR       |  P=0.479N     P=0.147N     P=0.328N     P=0.423N   |  P=0.415      P=0.640      P=0.118      P=0.520    |
|LOGISTIC REGRESSION    |  P=0.479N     P=0.117N     P=0.348N     P=0.391N   |  P=0.374      P=0.641N     P=0.162      P=0.517    |
|COCHRAN-ARMITAGE       |  P=0.510N                                          |  P=0.353                                           |
|FISHER EXACT           |               P=0.126N     P=0.395N     P=0.423N   |               P=0.641N     P=0.120      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    1/59 (2%)    5/60 (8%)    1/58 (2%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    2/60 (3%)  |
|ADJUSTED (b)           |   3.7%         2.9%        15.4%         3.0%      |   0.0%         0.0%         0.0%         7.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/27 (4%)    1/34 (3%)    4/30 (13%)   1/33 (3%)  |  0/30 (0%)    0/30 (0%)    0/37 (0%)    2/28 (7%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      668          729 (T)   |   ---          ---          ---          731 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.551      P=0.710N     P=0.129      P=0.717N   |  P=0.038 *      (e)          (e)        P=0.223    |
|INCIDENTAL TUMOR       |  P=0.516      P=0.710N     P=0.128      P=0.717N   |  P=0.038 *      (e)          (e)        P=0.223    |
|LOGISTIC REGRESSION    |  P=0.513      P=0.710N     P=0.116      P=0.717N   |  P=0.038 *      (e)          (e)        P=0.223    |
|COCHRAN-ARMITAGE       |  P=0.488                                           |  P=0.046 *                                         |
|FISHER EXACT           |               P=0.748      P=0.103      P=0.744    |                 (e)          (e)        P=0.248    |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05120 TEST: 03                                                 PAGE  18
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0%           0.3%         0.6%         1.2%      |   0%           0.3%         0.6%         1.2%      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 10/60 (17%)   5/59 (8%)   12/60 (20%)   8/58 (14%) |  4/60 (7%)    4/60 (7%)    9/60 (15%)   7/60 (12%) |
|ADJUSTED (b)           |  29.6%        13.5%        38.2%        23.4%      |  11.1%        11.0%        21.9%        23.6%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    1/10 (10%)   0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  6/27 (22%)   3/34 (9%)   11/30 (37%)   7/33 (21%) |  2/30 (7%)    2/30 (7%)    6/37 (16%)   6/28 (21%) |
|FIRST INCIDENCE (DAYS) |   457 (I)      618          668          715       |   606          458 (I)      700          704       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.430N     P=0.084N     P=0.504      P=0.268N   |  P=0.137      P=0.635N     P=0.221      P=0.238    |
|INCIDENTAL TUMOR       |  P=0.524N     P=0.147N     P=0.495      P=0.406N   |  P=0.191      P=0.640      P=0.118      P=0.269    |
|LOGISTIC REGRESSION    |  P=0.528N     P=0.129N     P=0.466      P=0.393N   |  P=0.166      P=0.641N     P=0.162      P=0.275    |
|COCHRAN-ARMITAGE       |  P=0.534                                           |  P=0.154                                           |
|FISHER EXACT           |               P=0.142N     P=0.407      P=0.430N   |               P=0.641N     P=0.120      P=0.264    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/59 (0%)    0/60 (0%)    0/58 (0%)  |  1/60 (2%)    0/60 (0%)    2/60 (3%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   3.3%         0.0%         5.4%         3.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/27 (0%)    0/34 (0%)    0/30 (0%)    0/33 (0%)  |  1/30 (3%)    0/30 (0%)    2/37 (5%)    1/28 (4%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   731 (T)      ---          731 (T)      731 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.488      P=0.500N     P=0.573      P=0.747    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.488      P=0.500N     P=0.573      P=0.747    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.488      P=0.500N     P=0.573      P=0.747    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.500                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.500N     P=0.500      P=0.752N   |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05120 TEST: 03                                                 PAGE  19
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0%           0.3%         0.6%         1.2%      |   0%           0.3%         0.6%         1.2%      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  2/60 (3%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |                                                    |   6.2%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |                                                    |  1/30 (3%)    0/30 (0%)    0/37 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   710          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.111N     P=0.237N     P=0.190N     P=0.261N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.096N     P=0.211N     P=0.217N     P=0.189N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.108N     P=0.234N     P=0.206N     P=0.234N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.115N                                          |
|FISHER EXACT           |                                                    |               P=0.248N     P=0.248N     P=0.248N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    | 15/60 (25%)  18/60 (30%)   4/60 (7%)   11/60 (18%) |
|ADJUSTED (b)           |                                                    |  41.1%        44.7%        10.2%        28.1%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  2/10 (20%)   3/10 (30%)   0/10 (0%)    1/10 (10%) |
|TERMINAL (d)           |                                                    | 10/30 (33%)  10/30 (33%)   3/37 (8%)    4/28 (14%) |
|FIRST INCIDENCE (DAYS) |                                                    |   457 (I)      456 (I)      711          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.088N     P=0.351      P=0.002N**   P=0.303N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.045N*    P=0.389      P=0.002N**   P=0.161N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.069N     P=0.347      P=0.004N**   P=0.235N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.078N                                          |
|FISHER EXACT           |                                                    |               P=0.342      P=0.005N**   P=0.253N   |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05120 TEST: 03                                                 PAGE  20
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0%           0.3%         0.6%         1.2%      |   0%           0.3%         0.6%         1.2%      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/60 (0%)    0/60 (0%)    1/60 (2%)    2/60 (3%)  |
|ADJUSTED (b)           |                                                    |   0.0%         0.0%         1.7%         5.6%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |                                                    |  0/30 (0%)    0/30 (0%)    0/37 (0%)    1/28 (4%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          ---          367          631       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.071        (e)        P=0.500      P=0.244    |
|INCIDENTAL TUMOR       |                                                    |  P=0.019 *      (e)        P=0.419      P=0.196    |
|LOGISTIC REGRESSION    |                                                    |  P=0.062        (e)        P=0.419      P=0.242    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.070                                           |
|FISHER EXACT           |                                                    |                 (e)        P=0.500      P=0.248    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    | 15/60 (25%)  18/60 (30%)   5/60 (8%)   12/60 (20%) |
|ADJUSTED (b)           |                                                    |  41.1%        44.7%        11.7%        29.6%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  2/10 (20%)   3/10 (30%)   0/10 (0%)    1/10 (10%) |
|TERMINAL (d)           |                                                    | 10/30 (33%)  10/30 (33%)   3/37 (8%)    4/28 (14%) |
|FIRST INCIDENCE (DAYS) |                                                    |   457 (I)      456 (I)      367          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.144N     P=0.351      P=0.005N**   P=0.378N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.101N     P=0.389      P=0.007N**   P=0.237N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.121N     P=0.347      P=0.003N**   P=0.311N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.130N                                          |
|FISHER EXACT           |                                                    |               P=0.342      P=0.013N*    P=0.331N   |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05120 TEST: 03                                                 PAGE  21
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0%           0.3%         0.6%         1.2%      |   0%           0.3%         0.6%         1.2%      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    1/60 (2%)    1/60 (2%)  |  1/60 (2%)    2/60 (3%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   3.7%         0.0%         1.7%         2.4%      |   2.1%         4.1%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/27 (4%)    0/34 (0%)    0/30 (0%)    0/33 (0%)  |  0/30 (0%)    0/30 (0%)    0/37 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          456 (I)      631       |   525          487          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.554      P=0.454N     P=0.749N     P=0.735N   |  P=0.184N     P=0.500      P=0.500N     P=0.492N   |
|INCIDENTAL TUMOR       |  P=0.560      P=0.454N     P=0.749N     P=0.723N   |  P=0.444N     P=0.432      P=0.581N       (e)      |
|LOGISTIC REGRESSION    |  P=0.533      P=0.454N     P=0.750      P=0.758N   |  P=0.308N     P=0.494      P=0.511N     P=0.527N   |
|COCHRAN-ARMITAGE       |  P=0.539                                           |  P=0.188N                                          |
|FISHER EXACT           |               P=0.500N     P=0.752N     P=0.752N   |               P=0.500      P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 16/60 (27%)  19/60 (32%)  18/60 (30%)  15/60 (25%) |  9/60 (15%)   6/60 (10%)  12/60 (20%)  12/60 (20%) |
|ADJUSTED (b)           |  40.4%        42.6%        41.3%        34.4%      |  24.3%        14.8%        27.1%        30.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  6/27 (22%)  10/34 (29%)   6/30 (20%)   6/33 (18%) |  5/30 (17%)   1/30 (3%)    6/37 (16%)   4/28 (14%) |
|FIRST INCIDENCE (DAYS) |   542          396          457          431       |   420          584          521          593       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.303N     P=0.503      P=0.525      P=0.375N   |  P=0.159      P=0.288N     P=0.502      P=0.319    |
|INCIDENTAL TUMOR       |  P=0.483N     P=0.267      P=0.385      P=0.480    |  P=0.190      P=0.265N     P=0.376      P=0.369    |
|LOGISTIC REGRESSION    |  P=0.378N     P=0.280      P=0.462      P=0.510N   |  P=0.197      P=0.286N     P=0.364      P=0.332    |
|COCHRAN-ARMITAGE       |  P=0.386N                                          |  P=0.150                                           |
|FISHER EXACT           |               P=0.344      P=0.420      P=0.500N   |               P=0.291N     P=0.316      P=0.316    |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05120 TEST: 03                                                 PAGE  22
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0%           0.3%         0.6%         1.2%      |   0%           0.3%         0.6%         1.2%      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma Benign, Malignant, NOS                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    3/60 (5%)    2/60 (3%)    0/60 (0%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   3.7%         7.8%         5.8%         0.0%      |   2.1%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/27 (4%)    1/34 (3%)    1/30 (3%)    0/33 (0%)  |  0/30 (0%)    0/30 (0%)    0/37 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      600          674          ---       |   560          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.222N     P=0.352      P=0.537      P=0.460N   |  P=0.301N     P=0.500N     P=0.496N     P=0.492N   |
|INCIDENTAL TUMOR       |  P=0.260N     P=0.278      P=0.534      P=0.460N   |  P=0.377N     P=0.612N     P=0.872N     P=0.567N   |
|LOGISTIC REGRESSION    |  P=0.234N     P=0.311      P=0.521      P=0.460N   |  P=0.317N     P=0.503N     P=0.513N     P=0.519N   |
|COCHRAN-ARMITAGE       |  P=0.242N                                          |  P=0.306N                                          |
|FISHER EXACT           |               P=0.309      P=0.500      P=0.500N   |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 60/60 (100%) 59/60 (98%)  60/60 (100%) 60/60 (100%)| 47/60 (78%)  45/60 (75%)  39/60 (65%)  47/60 (78%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  92.1%        91.7%        84.7%        93.9%      |
|INTERIM SACRIFICE 1 (c)| 10/10 (100%)  9/10 (90%)  10/10 (100%) 10/10 (100%)|  4/10 (40%)   4/10 (40%)   0/10 (0%)    3/10 (30%) |
|TERMINAL (d)           | 27/27 (100%) 34/34 (100%) 30/30 (100%) 33/33 (100%)| 26/30 (87%)  26/30 (87%)  30/37 (81%)  25/28 (89%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      396          456 (I)      431       |   457 (I)      430          592          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.247N     P=0.115N     P=0.316N     P=0.173N   |  P=0.493      P=0.418N     P=0.007N**   P=0.471    |
|INCIDENTAL TUMOR       |  P=0.567      P=0.500N       (e)          (e)      |  P=0.240N     P=0.361N     P=0.036N*    P=0.266N   |
|LOGISTIC REGRESSION    |  P=0.577      P=0.542N       (e)          (e)      |  P=0.371N     P=0.378N     P=0.012N*    P=0.466N   |
|COCHRAN-ARMITAGE       |  P=0.567                                           |  P=0.520N                                          |
|FISHER EXACT           |               P=0.500N     P=1.000N     P=1.000N   |               P=0.415N     P=0.078N     P=0.588N   |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05120 TEST: 03                                                 PAGE  23
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0%           0.3%         0.6%         1.2%      |   0%           0.3%         0.6%         1.2%      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 20/60 (33%)  29/60 (48%)  29/60 (48%)  24/60 (40%) | 15/60 (25%)  14/60 (23%)  18/60 (30%)  18/60 (30%) |
|ADJUSTED (b)           |  49.0%        60.1%        59.5%        50.2%      |  37.9%        31.4%        39.0%        44.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  8/27 (30%)  15/34 (44%)  11/30 (37%)  10/33 (30%) |  8/30 (27%)   3/30 (10%)  10/37 (27%)   8/28 (29%) |
|FIRST INCIDENCE (DAYS) |   542          396          456 (I)      431       |   420          487          367          593       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.529      P=0.215      P=0.178      P=0.466    |  P=0.247      P=0.489N     P=0.573      P=0.330    |
|INCIDENTAL TUMOR       |  P=0.242      P=0.018 *    P=0.044 *    P=0.153    |  P=0.207      P=0.456N     P=0.419      P=0.349    |
|LOGISTIC REGRESSION    |  P=0.356      P=0.036 *    P=0.051      P=0.240    |  P=0.282      P=0.519N     P=0.377      P=0.365    |
|COCHRAN-ARMITAGE       |  P=0.379                                           |  P=0.238                                           |
|FISHER EXACT           |               P=0.068      P=0.068      P=0.285    |               P=0.500N     P=0.342      P=0.342    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 60/60 (100%) 59/60 (98%)  60/60 (100%) 60/60 (100%)| 53/60 (88%)  51/60 (85%)  45/60 (75%)  52/60 (87%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  98.1%        94.4%        90.0%        98.1%      |
|INTERIM SACRIFICE 1 (c)| 10/10 (100%)  9/10 (90%)  10/10 (100%) 10/10 (100%)|  5/10 (50%)   4/10 (40%)   0/10 (0%)    3/10 (30%) |
|TERMINAL (d)           | 27/27 (100%) 34/34 (100%) 30/30 (100%) 33/33 (100%)| 29/30 (97%)  27/30 (90%)  32/37 (86%)  27/28 (96%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      396          456 (I)      431       |   420          430          367          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.247N     P=0.115N     P=0.316N     P=0.173N   |  P=0.497N     P=0.419N     P=0.006N**   P=0.526    |
|INCIDENTAL TUMOR       |  P=0.567      P=0.500N       (e)          (e)      |  P=0.323N     P=0.376N     P=0.021N*    P=0.343N   |
|LOGISTIC REGRESSION    |  P=0.577      P=0.542N       (e)          (e)      |  P=0.259N     P=0.364N     P=0.009N**   P=0.337N   |
|COCHRAN-ARMITAGE       |  P=0.567                                           |  P=0.418N                                          |
|FISHER EXACT           |               P=0.500N     P=1.000N     P=1.000N   |               P=0.395N     P=0.049N*    P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05120 TEST: 03                                                 PAGE  24
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (c)  Observed incidence at interim kill.
          Male interim sacrifices(days):   456
          Female interim sacrifices(days): 456
 (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).