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TDMS Study 05145-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Mason                                                    TRICAPRYLIN                                      DATE: 09/17/94       
EXPERIMENT: 05145 TEST: 01                                                                                     TIME: 20:57:29       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-55123          ROUTE: GAVAGE                                                                      NTP C#: 62215        
PATHOLOGIST: K. MURTHY                       S. EUSTIS                                                         CAS: 538-23-8        
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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                                                    TRICAPRYLIN                                      DATE: 09/17/94      
EXPERIMENT: 05145 TEST: 01                                                                                     TIME: 20:57:29      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-55123          ROUTE: GAVAGE                                                                      NTP C#: 62215       
PATHOLOGIST: K. MURTHY                       S. EUSTIS                                                         CAS: 538-23-8       
 
 
 
 
 
                                                    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                                                    TRICAPRYLIN                                      DATE: 09/17/94       
EXPERIMENT: 05145 TEST: 01                                                                                     TIME: 20:57:29       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55123          ROUTE: GAVAGE                                                                      NTP C#: 62215        
PATHOLOGIST: K. MURTHY                       S. EUSTIS                                                         CAS: 538-23-8        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                          IN THE ANALYSIS OF THE STUDY OF TRICAPRYLIN
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Pancreas                      Adenoma
                             Stomach, Forestomach          Squamous Cell Papilloma
 
              ====================================================================================================
         DATE: 09/17/94                     EXPERIMENT: 05145 TEST: 01                                                 PAGE   1
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Adrenal Medulla                                                               |
|     Pheochromocytoma Benign                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        11/60 (18%)         41/176 (23%)              |
|ADJUSTED (b)           |         31.9%               42.9%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         8/31 (26%)         29/82 (35%)               |
|FIRST INCIDENCE (DAYS) |          678                 597                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.163                  |
|INCIDENTAL TUMOR       |                             P=0.105                  |
|LOGISTIC REGRESSION    |                             P=0.124                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.271                  |
|==============================================================================|
|                                                                              |
|Adrenal Medulla                                                               |
|     Pheochromocytoma Malignant                                               |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/60 (3%)           1/176 (1%)               |
|ADJUSTED (b)           |          5.3%                1.1%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         1/31 (3%)           0/82 (0%)                |
|FIRST INCIDENCE (DAYS) |          576                 698                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.193N                 |
|INCIDENTAL TUMOR       |                             P=0.201N                 |
|LOGISTIC REGRESSION    |                             P=0.181N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.160N                 |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05145 TEST: 01                                                 PAGE   2
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Adrenal Medulla                                                               |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                        |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        14/60 (23%)         42/176 (24%)              |
|ADJUSTED (b)           |         39.1%               43.5%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |        10/31 (32%)         29/82 (35%)               |
|FIRST INCIDENCE (DAYS) |          576                 597                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.382                  |
|INCIDENTAL TUMOR       |                             P=0.295                  |
|LOGISTIC REGRESSION    |                             P=0.332                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.543                  |
|==============================================================================|
|                                                                              |
|Bone                                                                          |
|     Osteosarcoma                                                             |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/60 (0%)           2/180 (1%)               |
|ADJUSTED (b)           |          0.0%                2.0%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         0/31 (0%)           1/84 (1%)                |
|FIRST INCIDENCE (DAYS) |          ---                 569                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.470                  |
|INCIDENTAL TUMOR       |                             P=0.487                  |
|LOGISTIC REGRESSION    |                             P=0.487                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.562                  |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05145 TEST: 01                                                 PAGE   3
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Clitoral/Preputial Gland                                                      |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         7/60 (12%)         13/178 (7%)               |
|ADJUSTED (b)           |         20.0%               14.0%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         5/31 (16%)          8/83 (10%)               |
|FIRST INCIDENCE (DAYS) |          541                 608                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.297N                 |
|INCIDENTAL TUMOR       |                             P=0.288N                 |
|LOGISTIC REGRESSION    |                             P=0.300N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.212N                 |
|==============================================================================|
|                                                                              |
|Clitoral/Preputial Gland                                                      |
|     Carcinoma or Adenoma                                                     |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         8/60 (13%)         14/178 (8%)               |
|ADJUSTED (b)           |         23.1%               14.9%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         6/31 (19%)          8/83 (10%)               |
|FIRST INCIDENCE (DAYS) |          541                 608                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.232N                 |
|INCIDENTAL TUMOR       |                             P=0.229N                 |
|LOGISTIC REGRESSION    |                             P=0.233N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.157N                 |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05145 TEST: 01                                                 PAGE   4
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Islets, Pancreatic                                                            |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         3/59 (5%)           6/173 (3%)               |
|ADJUSTED (b)           |         10.0%                6.7%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         3/30 (10%)          4/84 (5%)                |
|FIRST INCIDENCE (DAYS) |          729 (T)             632                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.465N                 |
|INCIDENTAL TUMOR       |                             P=0.488N                 |
|LOGISTIC REGRESSION    |                             P=0.489N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.412N                 |
|==============================================================================|
|                                                                              |
|Islets, Pancreatic                                                            |
|     Carcinoma                                                                |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/59 (3%)           0/173 (0%)               |
|ADJUSTED (b)           |          5.1%                0.0%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         0/30 (0%)           0/84 (0%)                |
|FIRST INCIDENCE (DAYS) |          625                 ---                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.070N                 |
|INCIDENTAL TUMOR       |                             P=0.087N                 |
|LOGISTIC REGRESSION    |                             P=0.059N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.064N                 |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05145 TEST: 01                                                 PAGE   5
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Islets, Pancreatic                                                            |
|     Carcinoma or Adenoma                                                     |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         5/59 (8%)           6/173 (3%)               |
|ADJUSTED (b)           |         14.6%                6.7%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         3/30 (10%)          4/84 (5%)                |
|FIRST INCIDENCE (DAYS) |          625                 632                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.141N                 |
|INCIDENTAL TUMOR       |                             P=0.163N                 |
|LOGISTIC REGRESSION    |                             P=0.150N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.116N                 |
|==============================================================================|
|                                                                              |
|Liver                                                                         |
|     Hepatocellular Adenoma                                                   |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         1/60 (2%)           7/178 (4%)               |
|ADJUSTED (b)           |          3.2%                8.2%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         1/31 (3%)           6/84 (7%)                |
|FIRST INCIDENCE (DAYS) |          729 (T)             715                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.300                  |
|INCIDENTAL TUMOR       |                             P=0.283                  |
|LOGISTIC REGRESSION    |                             P=0.299                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.358                  |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05145 TEST: 01                                                 PAGE   6
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Lung                                                                          |
|     Alveolar/Bronchiolar Adenoma                                             |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/60 (0%)           4/178 (2%)               |
|ADJUSTED (b)           |          0.0%                4.6%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         0/31 (0%)           3/84 (4%)                |
|FIRST INCIDENCE (DAYS) |          ---                 718                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.260                  |
|INCIDENTAL TUMOR       |                             P=0.240                  |
|LOGISTIC REGRESSION    |                             P=0.254                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.310                  |
|==============================================================================|
|                                                                              |
|Lung                                                                          |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma           |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/60 (0%)           5/178 (3%)               |
|ADJUSTED (b)           |          0.0%                5.2%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         0/31 (0%)           3/84 (4%)                |
|FIRST INCIDENCE (DAYS) |          ---                 426                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.199                  |
|INCIDENTAL TUMOR       |                             P=0.215                  |
|LOGISTIC REGRESSION    |                             P=0.198                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.231                  |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05145 TEST: 01                                                 PAGE   7
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Mammary Gland                                                                 |
|     Carcinoma or Adenoma                                                     |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         1/60 (2%)           2/180 (1%)               |
|ADJUSTED (b)           |          2.9%                2.1%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         0/31 (0%)           1/84 (1%)                |
|FIRST INCIDENCE (DAYS) |          704                 601                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.663N                 |
|INCIDENTAL TUMOR       |                             P=0.671N                 |
|LOGISTIC REGRESSION    |                             P=0.656N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.580N                 |
|==============================================================================|
|                                                                              |
|Mammary Gland                                                                 |
|     Fibroadenoma                                                             |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         5/60 (8%)           7/180 (4%)               |
|ADJUSTED (b)           |         16.1%                8.0%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         5/31 (16%)          6/84 (7%)                |
|FIRST INCIDENCE (DAYS) |          729 (T)             670                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.199N                 |
|INCIDENTAL TUMOR       |                             P=0.207N                 |
|LOGISTIC REGRESSION    |                             P=0.202N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.152N                 |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05145 TEST: 01                                                 PAGE   8
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Mammary Gland                                                                 |
|     Fibroma, Fibroadenoma or Adenoma                                         |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         6/60 (10%)          8/180 (4%)               |
|ADJUSTED (b)           |         18.6%                9.2%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         5/31 (16%)          7/84 (8%)                |
|FIRST INCIDENCE (DAYS) |          704                 670                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.142N                 |
|INCIDENTAL TUMOR       |                             P=0.156N                 |
|LOGISTIC REGRESSION    |                             P=0.146N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.105N                 |
|==============================================================================|
|                                                                              |
|Mammary Gland                                                                 |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                             |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         6/60 (10%)          9/180 (5%)               |
|ADJUSTED (b)           |         18.6%               10.0%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         5/31 (16%)          7/84 (8%)                |
|FIRST INCIDENCE (DAYS) |          704                 601                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.195N                 |
|INCIDENTAL TUMOR       |                             P=0.205N                 |
|LOGISTIC REGRESSION    |                             P=0.203N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.141N                 |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05145 TEST: 01                                                 PAGE   9
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                        |
|     Papilloma Squamous or Papilloma                                          |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/60 (3%)           0/180 (0%)               |
|ADJUSTED (b)           |          6.5%                0.0%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         2/31 (6%)           0/84 (0%)                |
|FIRST INCIDENCE (DAYS) |          729 (T)             ---                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.062N                 |
|INCIDENTAL TUMOR       |                             P=0.062N                 |
|LOGISTIC REGRESSION    |                             P=0.062N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.062N                 |
|==============================================================================|
|                                                                              |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                        |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/60 (3%)           1/180 (1%)               |
|ADJUSTED (b)           |          6.5%                1.2%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         2/31 (6%)           1/84 (1%)                |
|FIRST INCIDENCE (DAYS) |          729 (T)             729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.182N                 |
|INCIDENTAL TUMOR       |                             P=0.182N                 |
|LOGISTIC REGRESSION    |                             P=0.182N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.155N                 |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05145 TEST: 01                                                 PAGE  10
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Pancreas                                                                      |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/59 (3%)          38/175 (22%)              |
|ADJUSTED (b)           |          6.7%               41.8%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           1/27 (4%)                |
|TERMINAL (d)           |         2/30 (7%)          33/84 (39%)               |
|FIRST INCIDENCE (DAYS) |          729 (T)             464 (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 **               |
|==============================================================================|
|                                                                              |
|Pituitary Gland: Pars Distalis or Unspecified Site                            |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         8/60 (13%)         17/174 (10%)              |
|ADJUSTED (b)           |         21.7%               18.9%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         4/31 (13%)         13/82 (16%)               |
|FIRST INCIDENCE (DAYS) |          593                 518                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.389N                 |
|INCIDENTAL TUMOR       |                             P=0.375N                 |
|LOGISTIC REGRESSION    |                             P=0.404N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.291N                 |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05145 TEST: 01                                                 PAGE  11
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Keratoacanthoma                                                          |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/60 (3%)           4/180 (2%)               |
|ADJUSTED (b)           |          6.5%                4.6%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         2/31 (6%)           3/84 (4%)                |
|FIRST INCIDENCE (DAYS) |          729 (T)             687                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.547N                 |
|INCIDENTAL TUMOR       |                             P=0.563N                 |
|LOGISTIC REGRESSION    |                             P=0.553N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.467N                 |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Squamous Cell Papilloma                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         4/60 (7%)           5/180 (3%)               |
|ADJUSTED (b)           |         12.2%                5.2%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         3/31 (10%)          2/84 (2%)                |
|FIRST INCIDENCE (DAYS) |          691                 628                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.218N                 |
|INCIDENTAL TUMOR       |                             P=0.241N                 |
|LOGISTIC REGRESSION    |                             P=0.214N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.162N                 |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05145 TEST: 01                                                 PAGE  12
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,             |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma        |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         7/60 (12%)          9/180 (5%)               |
|ADJUSTED (b)           |         21.6%                9.6%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         6/31 (19%)          5/84 (6%)                |
|FIRST INCIDENCE (DAYS) |          691                 628                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.108N                 |
|INCIDENTAL TUMOR       |                             P=0.124N                 |
|LOGISTIC REGRESSION    |                             P=0.108N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.072N                 |
|==============================================================================|
|                                                                              |
|Skin: Subcutaneous Tissue                                                     |
|     Fibroma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         3/60 (5%)           7/180 (4%)               |
|ADJUSTED (b)           |          8.1%                7.2%                    |
|INTERIM SACRIFICE 1 (c)|         1/10 (10%)          0/27 (0%)                |
|TERMINAL (d)           |         2/31 (6%)           4/84 (5%)                |
|FIRST INCIDENCE (DAYS) |          463 (I)             446                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.555N                 |
|INCIDENTAL TUMOR       |                             P=0.484N                 |
|LOGISTIC REGRESSION    |                             P=0.532N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.476N                 |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05145 TEST: 01                                                 PAGE  13
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Skin: Subcutaneous Tissue                                                     |
|     Neurofibroma or Fibroma                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         3/60 (5%)           8/180 (4%)               |
|ADJUSTED (b)           |          8.1%                8.3%                    |
|INTERIM SACRIFICE 1 (c)|         1/10 (10%)          0/27 (0%)                |
|TERMINAL (d)           |         2/31 (6%)           5/84 (6%)                |
|FIRST INCIDENCE (DAYS) |          463 (I)             446                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.625N                 |
|INCIDENTAL TUMOR       |                             P=0.562N                 |
|LOGISTIC REGRESSION    |                             P=0.609N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.548N                 |
|==============================================================================|
|                                                                              |
|Skin: Subcutaneous Tissue                                                     |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                |
|     Neurofibroma, or Fibroma                                                 |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         3/60 (5%)          12/180 (7%)               |
|ADJUSTED (b)           |          8.1%               11.6%                    |
|INTERIM SACRIFICE 1 (c)|         1/10 (10%)          0/27 (0%)                |
|TERMINAL (d)           |         2/31 (6%)           5/84 (6%)                |
|FIRST INCIDENCE (DAYS) |          463 (I)             386                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.372                  |
|INCIDENTAL TUMOR       |                             P=0.461                  |
|LOGISTIC REGRESSION    |                             P=0.416                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.457                  |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05145 TEST: 01                                                 PAGE  14
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Skin: Subcutaneous Tissue                                                     |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                              |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/60 (0%)           4/180 (2%)               |
|ADJUSTED (b)           |          0.0%                3.5%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         0/31 (0%)           0/84 (0%)                |
|FIRST INCIDENCE (DAYS) |          ---                 386                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.253                  |
|INCIDENTAL TUMOR       |                             P=0.296                  |
|LOGISTIC REGRESSION    |                             P=0.297                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.314                  |
|==============================================================================|
|                                                                              |
|Skin: Subcutaneous Tissue                                                     |
|     Sarcoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/60 (0%)           3/180 (2%)               |
|ADJUSTED (b)           |          0.0%                2.4%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         0/31 (0%)           0/84 (0%)                |
|FIRST INCIDENCE (DAYS) |          ---                 386                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.337                  |
|INCIDENTAL TUMOR       |                             P=0.431                  |
|LOGISTIC REGRESSION    |                             P=0.416                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.420                  |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05145 TEST: 01                                                 PAGE  15
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Stomach, Forestomach                                                          |
|     Squamous Cell Papilloma                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/60 (0%)          13/180 (7%)               |
|ADJUSTED (b)           |          0.0%               14.7%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         0/31 (0%)          11/84 (13%)               |
|FIRST INCIDENCE (DAYS) |          ---                 623                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.025 *                |
|INCIDENTAL TUMOR       |                             P=0.026 *                |
|LOGISTIC REGRESSION    |                             P=0.023 *                |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.021 *                |
|==============================================================================|
|                                                                              |
|Testes                                                                        |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        57/59 (97%)        161/179 (90%)              |
|ADJUSTED (b)           |        100.0%               99.4%                    |
|INTERIM SACRIFICE 1 (c)|         9/10 (90%)         25/27 (93%)               |
|TERMINAL (d)           |        30/30 (100%)        83/84 (99%)               |
|FIRST INCIDENCE (DAYS) |          390                 322                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.400                  |
|INCIDENTAL TUMOR       |                             P=0.525N                 |
|LOGISTIC REGRESSION    |                             P=0.475N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.085N                 |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05145 TEST: 01                                                 PAGE  16
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Thyroid Gland: C-Cell                                                         |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         6/57 (11%)         18/169 (11%)              |
|ADJUSTED (b)           |         19.8%               19.5%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           1/27 (4%)                |
|TERMINAL (d)           |         5/29 (17%)         13/83 (16%)               |
|FIRST INCIDENCE (DAYS) |          707                 463 (I)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.537                  |
|INCIDENTAL TUMOR       |                             P=0.483                  |
|LOGISTIC REGRESSION    |                             P=0.498                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.600                  |
|==============================================================================|
|                                                                              |
|Thyroid Gland: C-Cell                                                         |
|     Carcinoma or Adenoma                                                     |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         6/57 (11%)         19/169 (11%)              |
|ADJUSTED (b)           |         19.8%               20.6%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           1/27 (4%)                |
|TERMINAL (d)           |         5/29 (17%)         14/83 (17%)               |
|FIRST INCIDENCE (DAYS) |          707                 463 (I)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.486                  |
|INCIDENTAL TUMOR       |                             P=0.434                  |
|LOGISTIC REGRESSION    |                             P=0.445                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.550                  |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05145 TEST: 01                                                 PAGE  17
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Thyroid Gland: Follicular Cell                                                |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/57 (0%)           3/169 (2%)               |
|ADJUSTED (b)           |          0.0%                3.5%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         0/29 (0%)           2/83 (2%)                |
|FIRST INCIDENCE (DAYS) |          ---                 698                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.350                  |
|INCIDENTAL TUMOR       |                             P=0.317                  |
|LOGISTIC REGRESSION    |                             P=0.341                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.416                  |
|==============================================================================|
|                                                                              |
|Thyroid Gland: Follicular Cell                                                |
|     Carcinoma or Adenoma                                                     |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/57 (0%)           4/169 (2%)               |
|ADJUSTED (b)           |          0.0%                4.7%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         0/29 (0%)           3/83 (4%)                |
|FIRST INCIDENCE (DAYS) |          ---                 698                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.264                  |
|INCIDENTAL TUMOR       |                             P=0.239                  |
|LOGISTIC REGRESSION    |                             P=0.254                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.310                  |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05145 TEST: 01                                                 PAGE  18
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|Tongue                                                                        |
|     Squamous Cell Papilloma                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/60 (3%)           0/180 (0%)               |
|ADJUSTED (b)           |          6.5%                0.0%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         2/31 (6%)           0/84 (0%)                |
|FIRST INCIDENCE (DAYS) |          729 (T)             ---                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.062N                 |
|INCIDENTAL TUMOR       |                             P=0.062N                 |
|LOGISTIC REGRESSION    |                             P=0.062N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.062N                 |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                           |
|     or Undifferentiated                                                      |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |        23/60 (38%)         61/180 (34%)              |
|ADJUSTED (b)           |         54.9%               55.1%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           2/27 (7%)                |
|TERMINAL (d)           |        13/31 (42%)         37/84 (44%)               |
|FIRST INCIDENCE (DAYS) |          593                 446                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.546N                 |
|INCIDENTAL TUMOR       |                             P=0.558N                 |
|LOGISTIC REGRESSION    |                             P=0.518                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.318N                 |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05145 TEST: 01                                                 PAGE  19
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Malignant Lymphoma And Histiocytic Sarcoma                               |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/60 (0%)           2/180 (1%)               |
|ADJUSTED (b)           |          0.0%                2.2%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         0/31 (0%)           1/84 (1%)                |
|FIRST INCIDENCE (DAYS) |          ---                 686                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.470                  |
|INCIDENTAL TUMOR       |                             P=0.443                  |
|LOGISTIC REGRESSION    |                             P=0.469                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.562                  |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                     |
|     NOS, or Undifferentiated Cell Type                                       |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/60 (0%)           2/180 (1%)               |
|ADJUSTED (b)           |          0.0%                2.2%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         0/31 (0%)           1/84 (1%)                |
|FIRST INCIDENCE (DAYS) |          ---                 686                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.470                  |
|INCIDENTAL TUMOR       |                             P=0.443                  |
|LOGISTIC REGRESSION    |                             P=0.469                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.562                  |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05145 TEST: 01                                                 PAGE  20
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Mesothelioma Benign, Malignant, NOS                                      |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         5/60 (8%)           7/180 (4%)               |
|ADJUSTED (b)           |         11.9%                7.6%                    |
|INTERIM SACRIFICE 1 (c)|         1/10 (10%)          0/27 (0%)                |
|TERMINAL (d)           |         2/31 (6%)           4/84 (5%)                |
|FIRST INCIDENCE (DAYS) |          390                 593                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.211N                 |
|INCIDENTAL TUMOR       |                             P=0.182N                 |
|LOGISTIC REGRESSION    |                             P=0.176N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.152N                 |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Osteosarcoma                                                             |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/60 (0%)           2/180 (1%)               |
|ADJUSTED (b)           |          0.0%                2.0%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         0/31 (0%)           1/84 (1%)                |
|FIRST INCIDENCE (DAYS) |          ---                 569                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.470                  |
|INCIDENTAL TUMOR       |                             P=0.487                  |
|LOGISTIC REGRESSION    |                             P=0.487                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.562                  |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05145 TEST: 01                                                 PAGE  21
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Osteosarcoma or Osteoma                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/60 (0%)           2/180 (1%)               |
|ADJUSTED (b)           |          0.0%                2.0%                    |
|INTERIM SACRIFICE 1 (c)|         0/10 (0%)           0/27 (0%)                |
|TERMINAL (d)           |         0/31 (0%)           1/84 (1%)                |
|FIRST INCIDENCE (DAYS) |          ---                 569                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.470                  |
|INCIDENTAL TUMOR       |                             P=0.487                  |
|LOGISTIC REGRESSION    |                             P=0.487                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.562                  |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Benign Tumors                                                            |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |        57/60 (95%)        162/180 (90%)              |
|ADJUSTED (b)           |         98.3%              100.0%                    |
|INTERIM SACRIFICE 1 (c)|         9/10 (90%)         25/27 (93%)               |
|TERMINAL (d)           |        30/31 (97%)         84/84 (100%)              |
|FIRST INCIDENCE (DAYS) |          390                 322                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.305                  |
|INCIDENTAL TUMOR       |                             P=0.482                  |
|LOGISTIC REGRESSION    |                             P=0.482                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.180N                 |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05145 TEST: 01                                                 PAGE  22
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |          0 ML/KG             10.0                    |
|                       |                              ML/KG                   |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Malignant Tumors                                                         |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |        34/60 (57%)         85/180 (47%)              |
|ADJUSTED (b)           |         71.7%               66.9%                    |
|INTERIM SACRIFICE 1 (c)|         1/10 (10%)          2/27 (7%)                |
|TERMINAL (d)           |        18/31 (58%)         44/84 (52%)               |
|FIRST INCIDENCE (DAYS) |          390                 324                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.400N                 |
|INCIDENTAL TUMOR       |                             P=0.252N                 |
|LOGISTIC REGRESSION    |                             P=0.347N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.132N                 |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Malignant and Benign Tumors                                              |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |        58/60 (97%)        165/180 (92%)              |
|ADJUSTED (b)           |        100.0%              100.0%                    |
|INTERIM SACRIFICE 1 (c)|         9/10 (90%)         25/27 (93%)               |
|TERMINAL (d)           |        31/31 (100%)        84/84 (100%)              |
|FIRST INCIDENCE (DAYS) |          390                 322                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.300                  |
|INCIDENTAL TUMOR       |                             P=0.583                  |
|LOGISTIC REGRESSION    |                             P=0.540                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.154N                 |
|==============================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05145 TEST: 01                                                 PAGE  23
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (c)  Observed incidence at interim kill.
          Male interim sacrifices(days):   463
          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.