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TDMS Study 05143-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Mason                                                 CORN OIL / CORN OIL                                 DATE: 09/17/94       
EXPERIMENT: 05143 TEST: 01                                                                                     TIME: 18:53:54       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-55123          ROUTE: GAVAGE                                                                      NTP C#: 00577        
PATHOLOGIST: K. MURTHY                       S. EUSTIS                                                         CAS: 8001-30-7       
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Mason                                                 CORN OIL / CORN OIL                                 DATE: 09/17/94      
EXPERIMENT: 05143 TEST: 01                                                                                     TIME: 18:53:54      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-55123          ROUTE: GAVAGE                                                                      NTP C#: 00577       
PATHOLOGIST: K. MURTHY                       S. EUSTIS                                                         CAS: 8001-30-7      
 
 
 
 
 
                                                    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 Cortex
                                                    Adrenal Medulla
                                                    Bone Marrow
                                                    Brain
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    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: Mason                                                 CORN OIL / CORN OIL                                 DATE: 09/17/94       
EXPERIMENT: 05143 TEST: 01                                                                                     TIME: 18:53:54       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55123          ROUTE: GAVAGE                                                                      NTP C#: 00577        
PATHOLOGIST: K. MURTHY                       S. EUSTIS                                                         CAS: 8001-30-7       
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                      IN THE ANALYSIS OF THE STUDY OF CORN OIL / CORN OIL
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Benign
                                                           Pheochromocytoma: Benign, Complex, Malignant, NOS
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
                             Clitoral/Preputial Gland      Adenoma
                             Pancreas                      Adenoma
                                                           Carcinoma or Adenoma
                             Skin                          Squamous Cell Carcinoma
                             Testes                        Adenoma
 
              ====================================================================================================
         DATE: 09/17/94                     EXPERIMENT: 05143 TEST: 01                                                 PAGE   1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          10                  10.0                    |
|                       |          ML/KG               ML/KG                   |
|==============================================================================|
|                                                                              |
|Adrenal Medulla                                                               |
|     Pheochromocytoma Benign                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        35/98 (36%)         30/150 (20%)              |
|ADJUSTED (b)           |         48.4%               25.1%                    |
|TERMINAL (d)           |        21/56 (38%)         23/111 (21%)              |
|FIRST INCIDENCE (DAYS) |          600                 586                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P<0.001N**               |
|INCIDENTAL TUMOR       |                             P=0.006N**               |
|LOGISTIC REGRESSION    |                             P=0.003N**               |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.005N**               |
|==============================================================================|
|                                                                              |
|Adrenal Medulla                                                               |
|     Pheochromocytoma Malignant                                               |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         4/98 (4%)           4/150 (3%)               |
|ADJUSTED (b)           |          6.2%                3.2%                    |
|TERMINAL (d)           |         2/56 (4%)           2/111 (2%)               |
|FIRST INCIDENCE (DAYS) |          635                 576                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.328N                 |
|INCIDENTAL TUMOR       |                             P=0.390N                 |
|LOGISTIC REGRESSION    |                             P=0.417N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.394N                 |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05143 TEST: 01                                                 PAGE   2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          10                  10.0                    |
|                       |          ML/KG               ML/KG                   |
|==============================================================================|
|                                                                              |
|Adrenal Medulla                                                               |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                        |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        38/98 (39%)         35/150 (23%)              |
|ADJUSTED (b)           |         51.2%               28.3%                    |
|TERMINAL (d)           |        22/56 (39%)         25/111 (23%)              |
|FIRST INCIDENCE (DAYS) |          600                 520                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P<0.001N**               |
|INCIDENTAL TUMOR       |                             P=0.008N**               |
|LOGISTIC REGRESSION    |                             P=0.005N**               |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.007N**               |
|==============================================================================|
|                                                                              |
|Clitoral/Preputial Gland                                                      |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        14/100 (14%)        10/148 (7%)               |
|ADJUSTED (b)           |         19.6%                8.7%                    |
|TERMINAL (d)           |         7/58 (12%)          8/110 (7%)               |
|FIRST INCIDENCE (DAYS) |          591                 576                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.017N*                |
|INCIDENTAL TUMOR       |                             P=0.058N                 |
|LOGISTIC REGRESSION    |                             P=0.044N*                |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.048N*                |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05143 TEST: 01                                                 PAGE   3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          10                  10.0                    |
|                       |          ML/KG               ML/KG                   |
|==============================================================================|
|                                                                              |
|Islets, Pancreatic                                                            |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        14/99 (14%)         14/147 (10%)              |
|ADJUSTED (b)           |         20.0%               12.2%                    |
|TERMINAL (d)           |         7/58 (12%)         11/110 (10%)              |
|FIRST INCIDENCE (DAYS) |          591                 599                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.077N                 |
|INCIDENTAL TUMOR       |                             P=0.215N                 |
|LOGISTIC REGRESSION    |                             P=0.159N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.180N                 |
|==============================================================================|
|                                                                              |
|Liver                                                                         |
|     Hepatocellular Adenoma                                                   |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         4/100 (4%)          3/150 (2%)               |
|ADJUSTED (b)           |          5.7%                2.6%                    |
|TERMINAL (d)           |         1/58 (2%)           2/111 (2%)               |
|FIRST INCIDENCE (DAYS) |          610                 695                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.220N                 |
|INCIDENTAL TUMOR       |                             P=0.403N                 |
|LOGISTIC REGRESSION    |                             P=0.288N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.287N                 |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05143 TEST: 01                                                 PAGE   4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          10                  10.0                    |
|                       |          ML/KG               ML/KG                   |
|==============================================================================|
|                                                                              |
|Lung                                                                          |
|     Alveolar/Bronchiolar Adenoma                                             |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/98 (2%)           4/148 (3%)               |
|ADJUSTED (b)           |          3.3%                3.6%                    |
|TERMINAL (d)           |         1/56 (2%)           3/110 (3%)               |
|FIRST INCIDENCE (DAYS) |          710                 706                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.650                  |
|INCIDENTAL TUMOR       |                             P=0.483                  |
|LOGISTIC REGRESSION    |                             P=0.584                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.548                  |
|==============================================================================|
|                                                                              |
|Lung                                                                          |
|     Alveolar/Bronchiolar Carcinoma                                           |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         1/98 (1%)           2/148 (1%)               |
|ADJUSTED (b)           |          1.3%                1.8%                    |
|TERMINAL (d)           |         0/56 (0%)           2/110 (2%)               |
|FIRST INCIDENCE (DAYS) |          685                 729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.704                  |
|INCIDENTAL TUMOR       |                             P=0.607                  |
|LOGISTIC REGRESSION    |                             P=0.658                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.651                  |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05143 TEST: 01                                                 PAGE   5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          10                  10.0                    |
|                       |          ML/KG               ML/KG                   |
|==============================================================================|
|                                                                              |
|Lung                                                                          |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma           |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         3/98 (3%)           6/148 (4%)               |
|ADJUSTED (b)           |          4.6%                5.4%                    |
|TERMINAL (d)           |         1/56 (2%)           5/110 (5%)               |
|FIRST INCIDENCE (DAYS) |          685                 706                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.608                  |
|INCIDENTAL TUMOR       |                             P=0.409                  |
|LOGISTIC REGRESSION    |                             P=0.521                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.486                  |
|==============================================================================|
|                                                                              |
|Mammary Gland                                                                 |
|     Fibroadenoma                                                             |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         6/100 (6%)          5/150 (3%)               |
|ADJUSTED (b)           |          8.7%                4.3%                    |
|TERMINAL (d)           |         3/58 (5%)           4/111 (4%)               |
|FIRST INCIDENCE (DAYS) |          216                 622                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.162N                 |
|INCIDENTAL TUMOR       |                             P=0.363N                 |
|LOGISTIC REGRESSION    |                             P=0.278N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.242N                 |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05143 TEST: 01                                                 PAGE   6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          10                  10.0                    |
|                       |          ML/KG               ML/KG                   |
|==============================================================================|
|                                                                              |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                        |
|     Papilloma Squamous or Papilloma                                          |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/100 (0%)          2/150 (1%)               |
|ADJUSTED (b)           |          0.0%                1.8%                    |
|TERMINAL (d)           |         0/58 (0%)           2/111 (2%)               |
|FIRST INCIDENCE (DAYS) |          ---                 729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.390                  |
|INCIDENTAL TUMOR       |                             P=0.390                  |
|LOGISTIC REGRESSION    |                             P=0.390                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.359                  |
|==============================================================================|
|                                                                              |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                        |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/100 (0%)          2/150 (1%)               |
|ADJUSTED (b)           |          0.0%                1.8%                    |
|TERMINAL (d)           |         0/58 (0%)           2/111 (2%)               |
|FIRST INCIDENCE (DAYS) |          ---                 729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.390                  |
|INCIDENTAL TUMOR       |                             P=0.390                  |
|LOGISTIC REGRESSION    |                             P=0.390                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.359                  |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05143 TEST: 01                                                 PAGE   7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          10                  10.0                    |
|                       |          ML/KG               ML/KG                   |
|==============================================================================|
|                                                                              |
|Pancreas                                                                      |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/100 (2%)         41/147 (28%)              |
|ADJUSTED (b)           |          3.4%               35.3%                    |
|TERMINAL (d)           |         2/58 (3%)          36/110 (33%)              |
|FIRST INCIDENCE (DAYS) |          729 (T)             569                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P<0.001 **               |
|INCIDENTAL TUMOR       |                             P<0.001 **               |
|LOGISTIC REGRESSION    |                             P<0.001 **               |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P<0.001 **               |
|==============================================================================|
|                                                                              |
|Pancreas                                                                      |
|     Carcinoma or Adenoma                                                     |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/100 (2%)         42/147 (29%)              |
|ADJUSTED (b)           |          3.4%               36.2%                    |
|TERMINAL (d)           |         2/58 (3%)          37/110 (34%)              |
|FIRST INCIDENCE (DAYS) |          729 (T)             569                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P<0.001 **               |
|INCIDENTAL TUMOR       |                             P<0.001 **               |
|LOGISTIC REGRESSION    |                             P<0.001 **               |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P<0.001 **               |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05143 TEST: 01                                                 PAGE   8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          10                  10.0                    |
|                       |          ML/KG               ML/KG                   |
|==============================================================================|
|                                                                              |
|Pituitary Gland: Pars Distalis or Unspecified Site                            |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        11/99 (11%)         23/149 (15%)              |
|ADJUSTED (b)           |         17.8%               18.8%                    |
|TERMINAL (d)           |         9/58 (16%)         15/110 (14%)              |
|FIRST INCIDENCE (DAYS) |          620                 409                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.409                  |
|INCIDENTAL TUMOR       |                             P=0.282                  |
|LOGISTIC REGRESSION    |                             P=0.220                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.219                  |
|==============================================================================|
|                                                                              |
|Prostate                                                                      |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/99 (0%)           2/148 (1%)               |
|ADJUSTED (b)           |          0.0%                1.8%                    |
|TERMINAL (d)           |         0/57 (0%)           2/110 (2%)               |
|FIRST INCIDENCE (DAYS) |          ---                 729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.392                  |
|INCIDENTAL TUMOR       |                             P=0.392                  |
|LOGISTIC REGRESSION    |                             P=0.392                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.358                  |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05143 TEST: 01                                                 PAGE   9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          10                  10.0                    |
|                       |          ML/KG               ML/KG                   |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Keratoacanthoma                                                          |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         1/100 (1%)          2/150 (1%)               |
|ADJUSTED (b)           |          1.7%                1.8%                    |
|TERMINAL (d)           |         1/58 (2%)           2/111 (2%)               |
|FIRST INCIDENCE (DAYS) |          729 (T)             729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.718                  |
|INCIDENTAL TUMOR       |                             P=0.718                  |
|LOGISTIC REGRESSION    |                             P=0.718                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.649                  |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Squamous Cell Carcinoma                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         3/100 (3%)          0/150 (0%)               |
|ADJUSTED (b)           |          4.7%                0.0%                    |
|TERMINAL (d)           |         2/58 (3%)           0/111 (0%)               |
|FIRST INCIDENCE (DAYS) |          685                 ---                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.042N*                |
|INCIDENTAL TUMOR       |                             P=0.070N                 |
|LOGISTIC REGRESSION    |                             P=0.056N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.063N                 |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05143 TEST: 01                                                 PAGE  10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          10                  10.0                    |
|                       |          ML/KG               ML/KG                   |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         4/100 (4%)          7/150 (5%)               |
|ADJUSTED (b)           |          6.4%                6.3%                    |
|TERMINAL (d)           |         3/58 (5%)           7/111 (6%)               |
|FIRST INCIDENCE (DAYS) |          685                 729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.581N                 |
|INCIDENTAL TUMOR       |                             P=0.623                  |
|LOGISTIC REGRESSION    |                             P=0.609                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.533                  |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Squamous Cell Papilloma                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         1/100 (1%)          7/150 (5%)               |
|ADJUSTED (b)           |          1.7%                6.3%                    |
|TERMINAL (d)           |         1/58 (2%)           7/111 (6%)               |
|FIRST INCIDENCE (DAYS) |          729 (T)             729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.172                  |
|INCIDENTAL TUMOR       |                             P=0.172                  |
|LOGISTIC REGRESSION    |                             P=0.172                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.103                  |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05143 TEST: 01                                                 PAGE  11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          10                  10.0                    |
|                       |          ML/KG               ML/KG                   |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,             |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma        |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         6/100 (6%)         10/150 (7%)               |
|ADJUSTED (b)           |          9.8%                9.0%                    |
|TERMINAL (d)           |         5/58 (9%)          10/111 (9%)               |
|FIRST INCIDENCE (DAYS) |          685                 729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.507N                 |
|INCIDENTAL TUMOR       |                             P=0.551N                 |
|LOGISTIC REGRESSION    |                             P=0.573N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.527                  |
|==============================================================================|
|                                                                              |
|Skin: Subcutaneous Tissue                                                     |
|     Fibroma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         4/100 (4%)          7/150 (5%)               |
|ADJUSTED (b)           |          5.8%                6.0%                    |
|TERMINAL (d)           |         1/58 (2%)           5/111 (5%)               |
|FIRST INCIDENCE (DAYS) |          658                 619                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.615N                 |
|INCIDENTAL TUMOR       |                             P=0.422                  |
|LOGISTIC REGRESSION    |                             P=0.534                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.533                  |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05143 TEST: 01                                                 PAGE  12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          10                  10.0                    |
|                       |          ML/KG               ML/KG                   |
|==============================================================================|
|                                                                              |
|Testes                                                                        |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        95/100 (95%)       141/149 (95%)              |
|ADJUSTED (b)           |         99.0%              100.0%                    |
|TERMINAL (d)           |        57/58 (98%)        111/111 (100%)             |
|FIRST INCIDENCE (DAYS) |          483                 432                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.004N**               |
|INCIDENTAL TUMOR       |                             P=0.141N                 |
|LOGISTIC REGRESSION    |                             P=0.388N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.571N                 |
|==============================================================================|
|                                                                              |
|Thyroid Gland: C-Cell                                                         |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         7/99 (7%)          19/147 (13%)              |
|ADJUSTED (b)           |         11.0%               16.9%                    |
|TERMINAL (d)           |         5/58 (9%)          18/111 (16%)              |
|FIRST INCIDENCE (DAYS) |          620                 653                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.249                  |
|INCIDENTAL TUMOR       |                             P=0.190                  |
|LOGISTIC REGRESSION    |                             P=0.149                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.104                  |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05143 TEST: 01                                                 PAGE  13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          10                  10.0                    |
|                       |          ML/KG               ML/KG                   |
|==============================================================================|
|                                                                              |
|Thyroid Gland: C-Cell                                                         |
|     Carcinoma                                                                |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         1/99 (1%)           2/147 (1%)               |
|ADJUSTED (b)           |          1.1%                1.7%                    |
|TERMINAL (d)           |         0/58 (0%)           1/111 (1%)               |
|FIRST INCIDENCE (DAYS) |          635                 669                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.669                  |
|INCIDENTAL TUMOR       |                             P=0.562                  |
|LOGISTIC REGRESSION    |                             P=0.621                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.645                  |
|==============================================================================|
|                                                                              |
|Thyroid Gland: C-Cell                                                         |
|     Carcinoma or Adenoma                                                     |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         8/99 (8%)          21/147 (14%)              |
|ADJUSTED (b)           |         12.0%               18.4%                    |
|TERMINAL (d)           |         5/58 (9%)          19/111 (17%)              |
|FIRST INCIDENCE (DAYS) |          620                 653                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.244                  |
|INCIDENTAL TUMOR       |                             P=0.162                  |
|LOGISTIC REGRESSION    |                             P=0.130                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.099                  |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05143 TEST: 01                                                 PAGE  14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          10                  10.0                    |
|                       |          ML/KG               ML/KG                   |
|==============================================================================|
|                                                                              |
|Thyroid Gland: Follicular Cell                                                |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/99 (2%)           0/147 (0%)               |
|ADJUSTED (b)           |          3.4%                0.0%                    |
|TERMINAL (d)           |         2/58 (3%)           0/111 (0%)               |
|FIRST INCIDENCE (DAYS) |          729 (T)             ---                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.112N                 |
|INCIDENTAL TUMOR       |                             P=0.112N                 |
|LOGISTIC REGRESSION    |                             P=0.112N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.161N                 |
|==============================================================================|
|                                                                              |
|Thyroid Gland: Follicular Cell                                                |
|     Carcinoma or Adenoma                                                     |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/99 (2%)           1/147 (1%)               |
|ADJUSTED (b)           |          3.4%                0.9%                    |
|TERMINAL (d)           |         2/58 (3%)           1/111 (1%)               |
|FIRST INCIDENCE (DAYS) |          729 (T)             729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.282N                 |
|INCIDENTAL TUMOR       |                             P=0.282N                 |
|LOGISTIC REGRESSION    |                             P=0.282N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.355N                 |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05143 TEST: 01                                                 PAGE  15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          10                  10.0                    |
|                       |          ML/KG               ML/KG                   |
|==============================================================================|
|                                                                              |
|Zymbal's Gland                                                                |
|     Carcinoma or Adenoma                                                     |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/100 (2%)          1/150 (1%)               |
|ADJUSTED (b)           |          2.5%                0.8%                    |
|TERMINAL (d)           |         0/58 (0%)           0/111 (0%)               |
|FIRST INCIDENCE (DAYS) |          670                 692                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.334N                 |
|INCIDENTAL TUMOR       |                             P=0.623N                 |
|LOGISTIC REGRESSION    |                             P=0.370N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.351N                 |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Hemangioma                                                               |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/100 (0%)          2/150 (1%)               |
|ADJUSTED (b)           |          0.0%                1.8%                    |
|TERMINAL (d)           |         0/58 (0%)           2/111 (2%)               |
|FIRST INCIDENCE (DAYS) |          ---                 729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.390                  |
|INCIDENTAL TUMOR       |                             P=0.390                  |
|LOGISTIC REGRESSION    |                             P=0.390                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.359                  |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05143 TEST: 01                                                 PAGE  16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          10                  10.0                    |
|                       |          ML/KG               ML/KG                   |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Hemangiosarcoma or Hemangioma                                            |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/100 (0%)          2/150 (1%)               |
|ADJUSTED (b)           |          0.0%                1.8%                    |
|TERMINAL (d)           |         0/58 (0%)           2/111 (2%)               |
|FIRST INCIDENCE (DAYS) |          ---                 729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.390                  |
|INCIDENTAL TUMOR       |                             P=0.390                  |
|LOGISTIC REGRESSION    |                             P=0.390                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.359                  |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                           |
|     or Undifferentiated                                                      |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |        57/100 (57%)        34/150 (23%)              |
|ADJUSTED (b)           |         62.6%               26.6%                    |
|TERMINAL (d)           |        25/58 (43%)         19/111 (17%)              |
|FIRST INCIDENCE (DAYS) |          483                 555                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P<0.001N**               |
|INCIDENTAL TUMOR       |                             P<0.001N**               |
|LOGISTIC REGRESSION    |                             P<0.001N**               |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P<0.001N**               |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05143 TEST: 01                                                 PAGE  17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          10                  10.0                    |
|                       |          ML/KG               ML/KG                   |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Mesothelioma Benign, Malignant, NOS                                      |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         3/100 (3%)          5/150 (3%)               |
|ADJUSTED (b)           |          4.6%                4.0%                    |
|TERMINAL (d)           |         2/58 (3%)           2/111 (2%)               |
|FIRST INCIDENCE (DAYS) |          635                 562                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.627N                 |
|INCIDENTAL TUMOR       |                             P=0.600                  |
|LOGISTIC REGRESSION    |                             P=0.559                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.595                  |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Benign Tumors                                                            |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |        98/100 (98%)       147/150 (98%)              |
|ADJUSTED (b)           |        100.0%              100.0%                    |
|TERMINAL (d)           |        58/58 (100%)       111/111 (100%)             |
|FIRST INCIDENCE (DAYS) |          216                 409                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.007N**               |
|INCIDENTAL TUMOR       |                             P=0.268N                 |
|LOGISTIC REGRESSION    |                             P=0.296N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.684N                 |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05143 TEST: 01                                                 PAGE  18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          10                  10.0                    |
|                       |          ML/KG               ML/KG                   |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Malignant Tumors                                                         |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |        64/100 (64%)        53/150 (35%)              |
|ADJUSTED (b)           |         68.4%               38.8%                    |
|TERMINAL (d)           |        29/58 (50%)         29/111 (26%)              |
|FIRST INCIDENCE (DAYS) |          483                 432                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P<0.001N**               |
|INCIDENTAL TUMOR       |                             P<0.001N**               |
|LOGISTIC REGRESSION    |                             P<0.001N**               |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P<0.001N**               |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Malignant and Benign Tumors                                              |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |        98/100 (98%)       147/150 (98%)              |
|ADJUSTED (b)           |        100.0%              100.0%                    |
|TERMINAL (d)           |        58/58 (100%)       111/111 (100%)             |
|FIRST INCIDENCE (DAYS) |          216                 409                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.007N**               |
|INCIDENTAL TUMOR       |                             P=0.268N                 |
|LOGISTIC REGRESSION    |                             P=0.296N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.684N                 |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05143 TEST: 01                                                 PAGE  19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
 
                       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.
 (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).