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TDMS Study 05144-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Mason                                                    SAFFLOWER OIL                                    DATE: 09/17/94       
EXPERIMENT: 05144 TEST: 01                                                                                     TIME: 19:56:57       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-55123          ROUTE: GAVAGE                                                                      NTP C#: 62204        
PATHOLOGIST: K. MURTHY                       S. EUSTIS                                                         CAS: 8001-23-8       
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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                                                    SAFFLOWER OIL                                    DATE: 09/17/94      
EXPERIMENT: 05144 TEST: 01                                                                                     TIME: 19:56:57      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-55123          ROUTE: GAVAGE                                                                      NTP C#: 62204       
PATHOLOGIST: K. MURTHY                       S. EUSTIS                                                         CAS: 8001-23-8      
 
 
 
 
 
                                                    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                                                    SAFFLOWER OIL                                    DATE: 09/17/94       
EXPERIMENT: 05144 TEST: 01                                                                                     TIME: 19:56:57       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55123          ROUTE: GAVAGE                                                                      NTP C#: 62204        
PATHOLOGIST: K. MURTHY                       S. EUSTIS                                                         CAS: 8001-23-8       
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                         IN THE ANALYSIS OF THE STUDY OF SAFFLOWER OIL
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Benign
                                                           Pheochromocytoma: Benign, Complex, Malignant, NOS
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Malignant Tumors
                             Mammary Gland                 Fibroadenoma
                             Pancreas                      Adenoma
                                                           Carcinoma or Adenoma
                             Testes                        Adenoma
 
              ====================================================================================================
         DATE: 09/17/94                     EXPERIMENT: 05144 TEST: 01                                                 PAGE   1
   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Adrenal Cortex                                                                |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/60 (0%)           2/177 (1%)               |
|ADJUSTED (b)           |          0.0%                1.8%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/29 (0%)                |
|TERMINAL (d)           |         0/30 (0%)           1/109 (1%)               |
|FIRST INCIDENCE (DAYS) |          ---                 722                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.551                  |
|INCIDENTAL TUMOR       |                             P=0.381                  |
|LOGISTIC REGRESSION    |                             P=0.525                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.557                  |
|==============================================================================|
|                                                                              |
|Adrenal Medulla                                                               |
|     Pheochromocytoma Benign                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        15/59 (25%)         31/175 (18%)              |
|ADJUSTED (b)           |         39.2%               26.5%                    |
|INTERIM SACRIFICE 1 (c)|         4/10 (40%)          2/29 (7%)                |
|TERMINAL (d)           |         9/29 (31%)         24/107 (22%)              |
|FIRST INCIDENCE (DAYS) |          462 (I)             462 (I)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.046N*                |
|INCIDENTAL TUMOR       |                             P=0.105N                 |
|LOGISTIC REGRESSION    |                             P=0.130N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.136N                 |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05144 TEST: 01                                                 PAGE   2
   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Adrenal Medulla                                                               |
|     Pheochromocytoma Malignant                                               |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/59 (3%)           1/175 (1%)               |
|ADJUSTED (b)           |          6.9%                0.8%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/29 (0%)                |
|TERMINAL (d)           |         2/29 (7%)           0/107 (0%)               |
|FIRST INCIDENCE (DAYS) |          729 (T)             672                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.123N                 |
|INCIDENTAL TUMOR       |                             P=0.218N                 |
|LOGISTIC REGRESSION    |                             P=0.150N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.157N                 |
|==============================================================================|
|                                                                              |
|Adrenal Medulla                                                               |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                        |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        17/59 (29%)         32/175 (18%)              |
|ADJUSTED (b)           |         45.3%               27.1%                    |
|INTERIM SACRIFICE 1 (c)|         4/10 (40%)          2/29 (7%)                |
|TERMINAL (d)           |        11/29 (38%)         24/107 (22%)              |
|FIRST INCIDENCE (DAYS) |          462 (I)             462 (I)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.016N*                |
|INCIDENTAL TUMOR       |                             P=0.051N                 |
|LOGISTIC REGRESSION    |                             P=0.058N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.065N                 |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05144 TEST: 01                                                 PAGE   3
   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Brain                                                                         |
|     Oligodendroglioma, Glioma, or Astrocytoma                                |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/60 (0%)           3/180 (2%)               |
|ADJUSTED (b)           |          0.0%                1.9%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/29 (0%)                |
|TERMINAL (d)           |         0/30 (0%)           0/109 (0%)               |
|FIRST INCIDENCE (DAYS) |          ---                 329                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.364                  |
|INCIDENTAL TUMOR       |                             P=0.707                  |
|LOGISTIC REGRESSION    |                             P=0.475                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.420                  |
|==============================================================================|
|                                                                              |
|Clitoral/Preputial Gland                                                      |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         8/60 (13%)         14/177 (8%)               |
|ADJUSTED (b)           |         24.7%               11.8%                    |
|INTERIM SACRIFICE 1 (c)|         1/10 (10%)          2/29 (7%)                |
|TERMINAL (d)           |         7/30 (23%)         10/107 (9%)               |
|FIRST INCIDENCE (DAYS) |          462 (I)             461 (I)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.089N                 |
|INCIDENTAL TUMOR       |                             P=0.111N                 |
|LOGISTIC REGRESSION    |                             P=0.159N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.160N                 |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05144 TEST: 01                                                 PAGE   4
   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Islets, Pancreatic                                                            |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         7/59 (12%)         11/177 (6%)               |
|ADJUSTED (b)           |         18.1%               10.1%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/29 (0%)                |
|TERMINAL (d)           |         3/30 (10%)         11/109 (10%)              |
|FIRST INCIDENCE (DAYS) |          476                 729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.072N                 |
|INCIDENTAL TUMOR       |                             P=0.092N                 |
|LOGISTIC REGRESSION    |                             P=0.118N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.130N                 |
|==============================================================================|
|                                                                              |
|Liver                                                                         |
|     Hepatocellular Adenoma                                                   |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/60 (3%)           3/180 (2%)               |
|ADJUSTED (b)           |          6.7%                2.6%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/29 (0%)                |
|TERMINAL (d)           |         2/30 (7%)           2/109 (2%)               |
|FIRST INCIDENCE (DAYS) |          729 (T)             624                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.341N                 |
|INCIDENTAL TUMOR       |                             P=0.342N                 |
|LOGISTIC REGRESSION    |                             P=0.384N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.367N                 |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05144 TEST: 01                                                 PAGE   5
   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Liver                                                                         |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                       |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         3/60 (5%)           4/180 (2%)               |
|ADJUSTED (b)           |         10.0%                3.5%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/29 (0%)                |
|TERMINAL (d)           |         3/30 (10%)          3/109 (3%)               |
|FIRST INCIDENCE (DAYS) |          729 (T)             624                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.190N                 |
|INCIDENTAL TUMOR       |                             P=0.192N                 |
|LOGISTIC REGRESSION    |                             P=0.233N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.241N                 |
|==============================================================================|
|                                                                              |
|Liver                                                                         |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma      |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         3/60 (5%)           4/180 (2%)               |
|ADJUSTED (b)           |         10.0%                3.5%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/29 (0%)                |
|TERMINAL (d)           |         3/30 (10%)          3/109 (3%)               |
|FIRST INCIDENCE (DAYS) |          729 (T)             624                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.190N                 |
|INCIDENTAL TUMOR       |                             P=0.192N                 |
|LOGISTIC REGRESSION    |                             P=0.233N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.241N                 |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05144 TEST: 01                                                 PAGE   6
   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Mammary Gland                                                                 |
|     Fibroadenoma                                                             |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         7/60 (12%)          5/180 (3%)               |
|ADJUSTED (b)           |         22.2%                4.6%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/29 (0%)                |
|TERMINAL (d)           |         6/30 (20%)          5/109 (5%)               |
|FIRST INCIDENCE (DAYS) |          691                 729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.002N**               |
|INCIDENTAL TUMOR       |                             P=0.004N**               |
|LOGISTIC REGRESSION    |                             P=0.003N**               |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.012N*                |
|==============================================================================|
|                                                                              |
|Pancreas                                                                      |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         1/60 (2%)          51/178 (29%)              |
|ADJUSTED (b)           |          3.3%               44.0%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           1/29 (3%)                |
|TERMINAL (d)           |         1/30 (3%)          45/109 (41%)              |
|FIRST INCIDENCE (DAYS) |          729 (T)             461 (I)                 |
|-----------------------|                                                      |
|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: 05144 TEST: 01                                                 PAGE   7
   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Pancreas                                                                      |
|     Carcinoma                                                                |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/60 (0%)           2/178 (1%)               |
|ADJUSTED (b)           |          0.0%                1.7%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/29 (0%)                |
|TERMINAL (d)           |         0/30 (0%)           1/109 (1%)               |
|FIRST INCIDENCE (DAYS) |          ---                 633                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.519                  |
|INCIDENTAL TUMOR       |                             P=0.515                  |
|LOGISTIC REGRESSION    |                             P=0.499                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.559                  |
|==============================================================================|
|                                                                              |
|Pancreas                                                                      |
|     Carcinoma or Adenoma                                                     |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         1/60 (2%)          52/178 (29%)              |
|ADJUSTED (b)           |          3.3%               44.4%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           1/29 (3%)                |
|TERMINAL (d)           |         1/30 (3%)          45/109 (41%)              |
|FIRST INCIDENCE (DAYS) |          729 (T)             461 (I)                 |
|-----------------------|                                                      |
|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: 05144 TEST: 01                                                 PAGE   8
   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Pituitary Gland: Pars Distalis or Unspecified Site                            |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         8/60 (13%)         22/176 (13%)              |
|ADJUSTED (b)           |         21.5%               19.1%                    |
|INTERIM SACRIFICE 1 (c)|         1/10 (10%)          0/29 (0%)                |
|TERMINAL (d)           |         4/30 (13%)         17/107 (16%)              |
|FIRST INCIDENCE (DAYS) |          461 (I)             485                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.369N                 |
|INCIDENTAL TUMOR       |                             P=0.538N                 |
|LOGISTIC REGRESSION    |                             P=0.510N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.512N                 |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Keratoacanthoma                                                          |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/60 (0%)           5/180 (3%)               |
|ADJUSTED (b)           |          0.0%                4.6%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/29 (0%)                |
|TERMINAL (d)           |         0/30 (0%)           5/109 (5%)               |
|FIRST INCIDENCE (DAYS) |          ---                 729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.261                  |
|INCIDENTAL TUMOR       |                             P=0.261                  |
|LOGISTIC REGRESSION    |                             P=0.261                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.234                  |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05144 TEST: 01                                                 PAGE   9
   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Squamous Cell Carcinoma                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/60 (0%)           3/180 (2%)               |
|ADJUSTED (b)           |          0.0%                2.5%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/29 (0%)                |
|TERMINAL (d)           |         0/30 (0%)           2/109 (2%)               |
|FIRST INCIDENCE (DAYS) |          ---                 547                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.400                  |
|INCIDENTAL TUMOR       |                             P=0.396                  |
|LOGISTIC REGRESSION    |                             P=0.369                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.420                  |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/60 (3%)          10/180 (6%)               |
|ADJUSTED (b)           |          5.5%                8.7%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/29 (0%)                |
|TERMINAL (d)           |         1/30 (3%)           8/109 (7%)               |
|FIRST INCIDENCE (DAYS) |          635                 547                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.440                  |
|INCIDENTAL TUMOR       |                             P=0.436                  |
|LOGISTIC REGRESSION    |                             P=0.375                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.386                  |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05144 TEST: 01                                                 PAGE  10
   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Squamous Cell Papilloma                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/60 (3%)           7/180 (4%)               |
|ADJUSTED (b)           |          5.5%                6.2%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/29 (0%)                |
|TERMINAL (d)           |         1/30 (3%)           6/109 (6%)               |
|FIRST INCIDENCE (DAYS) |          635                 634                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.649                  |
|INCIDENTAL TUMOR       |                             P=0.649                  |
|LOGISTIC REGRESSION    |                             P=0.595                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.601                  |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,             |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma        |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/60 (3%)          16/180 (9%)               |
|ADJUSTED (b)           |          5.5%               13.9%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/29 (0%)                |
|TERMINAL (d)           |         1/30 (3%)          13/109 (12%)              |
|FIRST INCIDENCE (DAYS) |          635                 547                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.182                  |
|INCIDENTAL TUMOR       |                             P=0.175                  |
|LOGISTIC REGRESSION    |                             P=0.135                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.125                  |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05144 TEST: 01                                                 PAGE  11
   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Skin: Subcutaneous Tissue                                                     |
|     Fibroma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/60 (3%)           7/180 (4%)               |
|ADJUSTED (b)           |          6.7%                5.2%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           1/29 (3%)                |
|TERMINAL (d)           |         2/30 (7%)           2/109 (2%)               |
|FIRST INCIDENCE (DAYS) |          729 (T)             398                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.612                  |
|INCIDENTAL TUMOR       |                             P=0.598                  |
|LOGISTIC REGRESSION    |                             P=0.586                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.601                  |
|==============================================================================|
|                                                                              |
|Skin: Subcutaneous Tissue                                                     |
|     Fibrosarcoma                                                             |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/60 (0%)           3/180 (2%)               |
|ADJUSTED (b)           |          0.0%                2.8%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/29 (0%)                |
|TERMINAL (d)           |         0/30 (0%)           3/109 (3%)               |
|FIRST INCIDENCE (DAYS) |          ---                 729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.417                  |
|INCIDENTAL TUMOR       |                             P=0.417                  |
|LOGISTIC REGRESSION    |                             P=0.417                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.420                  |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05144 TEST: 01                                                 PAGE  12
   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Skin: Subcutaneous Tissue                                                     |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                |
|     Neurofibroma, or Fibroma                                                 |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/60 (3%)          10/180 (6%)               |
|ADJUSTED (b)           |          6.7%                7.8%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           1/29 (3%)                |
|TERMINAL (d)           |         2/30 (7%)           5/109 (5%)               |
|FIRST INCIDENCE (DAYS) |          729 (T)             398                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.422                  |
|INCIDENTAL TUMOR       |                             P=0.407                  |
|LOGISTIC REGRESSION    |                             P=0.367                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.386                  |
|==============================================================================|
|                                                                              |
|Stomach, Forestomach                                                          |
|     Squamous Cell Papilloma                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         1/60 (2%)           3/180 (2%)               |
|ADJUSTED (b)           |          3.3%                2.7%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/29 (0%)                |
|TERMINAL (d)           |         1/30 (3%)           2/109 (2%)               |
|FIRST INCIDENCE (DAYS) |          729 (T)             721                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.669N                 |
|INCIDENTAL TUMOR       |                             P=0.688                  |
|LOGISTIC REGRESSION    |                             P=0.685N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.686N                 |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05144 TEST: 01                                                 PAGE  13
   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Testes                                                                        |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        57/60 (95%)        166/179 (93%)              |
|ADJUSTED (b)           |        100.0%              100.0%                    |
|INTERIM SACRIFICE 1 (c)|         7/10 (70%)         24/29 (83%)               |
|TERMINAL (d)           |        30/30 (100%)       108/108 (100%)             |
|FIRST INCIDENCE (DAYS) |          457                 461 (I)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.047N*                |
|INCIDENTAL TUMOR       |                             P=0.596N                 |
|LOGISTIC REGRESSION    |                             P=0.634N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.395N                 |
|==============================================================================|
|                                                                              |
|Thyroid Gland: C-Cell                                                         |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         5/58 (9%)          16/175 (9%)               |
|ADJUSTED (b)           |         13.2%               14.0%                    |
|INTERIM SACRIFICE 1 (c)|         1/10 (10%)          1/29 (3%)                |
|TERMINAL (d)           |         2/29 (7%)          13/109 (12%)              |
|FIRST INCIDENCE (DAYS) |          461 (I)             462 (I)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.522N                 |
|INCIDENTAL TUMOR       |                             P=0.465                  |
|LOGISTIC REGRESSION    |                             P=0.571                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.571                  |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05144 TEST: 01                                                 PAGE  14
   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Thyroid Gland: Follicular Cell                                                |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/58 (3%)           3/175 (2%)               |
|ADJUSTED (b)           |          5.0%                2.6%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/29 (0%)                |
|TERMINAL (d)           |         0/29 (0%)           2/109 (2%)               |
|FIRST INCIDENCE (DAYS) |          635                 672                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.356N                 |
|INCIDENTAL TUMOR       |                             P=0.559N                 |
|LOGISTIC REGRESSION    |                             P=0.389N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.365N                 |
|==============================================================================|
|                                                                              |
|Zymbal's Gland                                                                |
|     Carcinoma                                                                |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/60 (0%)           2/180 (1%)               |
|ADJUSTED (b)           |          0.0%                1.8%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/29 (0%)                |
|TERMINAL (d)           |         0/30 (0%)           1/109 (1%)               |
|FIRST INCIDENCE (DAYS) |          ---                 708                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.545                  |
|INCIDENTAL TUMOR       |                             P=0.411                  |
|LOGISTIC REGRESSION    |                             P=0.515                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.562                  |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05144 TEST: 01                                                 PAGE  15
   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                           |
|     or Undifferentiated                                                      |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |        35/60 (58%)         44/180 (24%)              |
|ADJUSTED (b)           |         74.9%               36.0%                    |
|INTERIM SACRIFICE 1 (c)|         2/10 (20%)          0/29 (0%)                |
|TERMINAL (d)           |        19/30 (63%)         33/109 (30%)              |
|FIRST INCIDENCE (DAYS) |          457                 491                     |
|-----------------------|                                                      |
|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                                                                    |
|     Mesothelioma Benign, Malignant, NOS                                      |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/60 (0%)           4/180 (2%)               |
|ADJUSTED (b)           |          0.0%                3.7%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/29 (0%)                |
|TERMINAL (d)           |         0/30 (0%)           4/109 (4%)               |
|FIRST INCIDENCE (DAYS) |          ---                 729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.328                  |
|INCIDENTAL TUMOR       |                             P=0.328                  |
|LOGISTIC REGRESSION    |                             P=0.328                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.314                  |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05144 TEST: 01                                                 PAGE  16
   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Benign Tumors                                                            |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |        58/60 (97%)        171/180 (95%)              |
|ADJUSTED (b)           |        100.0%               99.4%                    |
|INTERIM SACRIFICE 1 (c)|         8/10 (80%)         26/29 (90%)               |
|TERMINAL (d)           |        30/30 (100%)       108/109 (99%)              |
|FIRST INCIDENCE (DAYS) |          457                 398                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.060N                 |
|INCIDENTAL TUMOR       |                             P=0.601                  |
|LOGISTIC REGRESSION    |                             P=0.665                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.452N                 |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Malignant Tumors                                                         |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |        38/60 (63%)         68/180 (38%)              |
|ADJUSTED (b)           |         80.1%               50.2%                    |
|INTERIM SACRIFICE 1 (c)|         2/10 (20%)          0/29 (0%)                |
|TERMINAL (d)           |        21/30 (70%)         44/109 (40%)              |
|FIRST INCIDENCE (DAYS) |          457                 302                     |
|-----------------------|                                                      |
|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: 05144 TEST: 01                                                 PAGE  17
   STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Malignant and Benign Tumors                                              |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |        59/60 (98%)        175/180 (97%)              |
|ADJUSTED (b)           |        100.0%               99.4%                    |
|INTERIM SACRIFICE 1 (c)|         9/10 (90%)         26/29 (90%)               |
|TERMINAL (d)           |        30/30 (100%)       108/109 (99%)              |
|FIRST INCIDENCE (DAYS) |          457                 302                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.075N                 |
|INCIDENTAL TUMOR       |                             P=0.609N                 |
|LOGISTIC REGRESSION    |                             P=0.634N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.533N                 |
|==============================================================================|
 
 (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):   461
          Female interim sacrifices(days):
 (d)  Observed incidence at terminal kill.
 (f)  Beneath the control incidence are the P-values associated with the trend 
      test.  Beneath the dosed group incidence are the P-values corresponding to 
      pairwise comparisons between the controls and that dosed group.  The life
      table analysis regards tumors in animals dying  prior to terminal kill as
      being (directly or indirectly) the cause of death.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's exact tests compare directly the overall incidence rates.  
      For all tests, a negative trend is indicated by "N".
 (e)  Value of Statistic cannot be computed. 
 (I)  Interim sacrifice
 (T)  Terminal sacrifice
  #   Tumor rates based on number of animals necropsied.
 
  *   To the right of any statistical result, indicates significance at (P<=0.05).
  **  To the right of any statistical result, indicates significance at (P<=0.01).
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.