National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/3078

TR 358 Rat Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                        OCHRATOXIN A                                     DATE: 09/05/94       
EXPERIMENT: 05036 TEST: 01                                                                                     TIME: 02:39:22       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-CP-95653          ROUTE: GAVAGE                                                                      NTP C#: 56586        
PATHOLOGIST: R. PERSING                      S. EUSTIS                                                         CAS: 303-47-9        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Battelle Columbus                                        OCHRATOXIN A                                     DATE: 09/05/94      
EXPERIMENT: 05036 TEST: 01                                                                                     TIME: 02:39:22      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-CP-95653          ROUTE: GAVAGE                                                                      NTP C#: 56586       
PATHOLOGIST: R. PERSING                      S. EUSTIS                                                         CAS: 303-47-9       
 
 
 
 
 
                                                    RATS(FISCHER344)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                        OCHRATOXIN A                                     DATE: 09/05/94       
EXPERIMENT: 05036 TEST: 01                                                                                     TIME: 02:39:22       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-CP-95653          ROUTE: GAVAGE                                                                      NTP C#: 56586        
PATHOLOGIST: R. PERSING                      S. EUSTIS                                                         CAS: 303-47-9        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                          IN THE ANALYSIS OF THE STUDY OF OCHRATOXIN A
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Malignant
                                                           Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Islets, Pancreatic            Adenoma
                                                           Carcinoma or Adenoma
                             Kidney: Renal Tubule          Adenoma
                                                           Carcinoma
                                                           Carcinoma or Adenoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             Pancreas                      Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                                                           Carcinoma
                                                           Carcinoma or Adenoma
                             Skin: Subcutaneous Tissue     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
                                                            Neurofibroma, or Fibroma
                             Testes                        Adenoma
                             Thyroid Gland: C-Cell         Adenoma
                                                           Carcinoma or Adenoma
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                        OCHRATOXIN A                                     DATE: 09/05/94       
EXPERIMENT: 05036 TEST: 01                                                                                     TIME: 02:39:22       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-CP-95653          ROUTE: GAVAGE                                                                      NTP C#: 56586        
PATHOLOGIST: R. PERSING                      S. EUSTIS                                                         CAS: 303-47-9        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                          IN THE ANALYSIS OF THE STUDY OF OCHRATOXIN A
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Kidney: Renal Tubule          Adenoma
                                                           Carcinoma
                                                           Carcinoma or Adenoma
                             Mammary Gland                 Fibroadenoma
                                                           Fibroma, Fibroadenoma or Adenoma
                                                           Fibroma, Fibroadenoma, Carcinoma, or Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                                                           Carcinoma or Adenoma
                             Thyroid Gland: C-Cell         Adenoma
                                                           Carcinoma or Adenoma
                             Thyroid Gland: Follicular Cell
                                                           Carcinoma or Adenoma
                             Uterus                        Polyp Stromal
                                                           Sarcoma Stromal or Polyp Stromal
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Benign Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/05/94                     EXPERIMENT: 05036 TEST: 01                                                 PAGE   1
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |
|                       |                                          KG        |                                          KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    0/25 (0%)    0/25 (0%)    0/50 (0%)  |  2/50 (4%)    0/29 (0%)    0/15 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   5.1%         0.0%         0.0%         0.0%      |   6.3%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  2/39 (5%)    0/1 (0%)     0/1 (0%)     0/23 (0%)  |  2/32 (6%)    0/1 (0%)     0/0          0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          ---       |   728 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.275N     P=0.981N     P=0.981N     P=0.361N   |  P=0.159N     P=0.967N       (e)        P=0.219N   |
|INCIDENTAL TUMOR       |  P=0.275N     P=0.981N     P=0.981N     P=0.361N   |  P=0.159N     P=0.967N       (e)        P=0.219N   |
|LOGISTIC REGRESSION    |  P=0.275N     P=0.981N     P=0.981N     P=0.361N   |  P=0.159N     P=0.967N       (e)        P=0.219N   |
|COCHRAN-ARMITAGE       |  P=0.218N                                          |  P=0.227N                                          |
|FISHER EXACT           |               P=0.441N     P=0.441N     P=0.247N   |               P=0.398N     P=0.589N     P=0.247N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 17/50 (34%)   4/25 (16%)   5/26 (19%)  11/50 (22%) |  3/50 (6%)    1/27 (4%)    2/16 (13%)   4/50 (8%)  |
|ADJUSTED (b)           |  42.3%        11.5%        54.6%        37.6%      |   8.9%         4.0%       100.0%        10.2%      |
|TERMINAL (d)           | 16/39 (41%)   0/1 (0%)     2/4 (50%)    6/23 (26%) |  2/32 (6%)    0/1 (0%)     1/1 (100%)   2/35 (6%)  |
|FIRST INCIDENCE (DAYS) |   495          627          669          408       |   675          718          697          415       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.523      P=0.248      P=0.234      P=0.547    |  P=0.512      P=0.719      P=0.309      P=0.537    |
|INCIDENTAL TUMOR       |  P=0.324N     P=0.637N     P=0.499      P=0.305N   |  P=0.362      P=0.680N     P=0.201      P=0.439    |
|LOGISTIC REGRESSION    |  P=0.360N     P=0.393N     P=0.568N     P=0.279N   |  P=0.451      P=0.658      P=0.094      P=0.500    |
|COCHRAN-ARMITAGE       |  P=0.246N                                          |  P=0.390                                           |
|FISHER EXACT           |               P=0.084N     P=0.140N     P=0.133N   |               P=0.561N     P=0.351      P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05036 TEST: 01                                                 PAGE   2
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |
|                       |                                          KG        |                                          KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/25 (0%)    2/26 (8%)    1/50 (2%)  |  0/50 (0%)    0/27 (0%)    0/16 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%        50.0%         4.3%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/39 (0%)    0/1 (0%)     2/4 (50%)    1/23 (4%)  |  0/32 (0%)    0/1 (0%)     0/1 (0%)     0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          729 (T)      729 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.382        (e)        P<0.001 **   P=0.395    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.382        (e)        P<0.001 **   P=0.395    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.382        (e)        P<0.001 **   P=0.395    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.436                                           |    (e)                                             |
|FISHER EXACT           |                 (e)        P=0.114      P=0.500    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 18/50 (36%)   4/25 (16%)   8/26 (31%)  13/50 (26%) |  3/50 (6%)    2/27 (7%)    2/16 (13%)   4/50 (8%)  |
|ADJUSTED (b)           |  44.8%        11.5%       100.0%        44.9%      |   8.9%       100.0%       100.0%        10.2%      |
|TERMINAL (d)           | 17/39 (44%)   0/1 (0%)     4/4 (100%)   8/23 (35%) |  2/32 (6%)    1/1 (100%)   1/1 (100%)   2/35 (6%)  |
|FIRST INCIDENCE (DAYS) |   495          627          459          408       |   675          718          697          415       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.384      P=0.255      P=0.014 *    P=0.390    |  P=0.556N     P=0.238      P=0.309      P=0.537    |
|INCIDENTAL TUMOR       |  P=0.439N     P=0.627N     P=0.056      P=0.467N   |  P=0.487      P=0.339      P=0.201      P=0.439    |
|LOGISTIC REGRESSION    |  P=0.471N     P=0.347N     P=0.334      P=0.414N   |  P=0.553      P=0.201      P=0.094      P=0.500    |
|COCHRAN-ARMITAGE       |  P=0.338N                                          |  P=0.481                                           |
|FISHER EXACT           |               P=0.061N     P=0.424N     P=0.194N   |               P=0.578      P=0.351      P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05036 TEST: 01                                                 PAGE   3
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |
|                       |                                          KG        |                                          KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Astrocytoma Malignant                                                                                                       |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/25 (0%)    1/25 (4%)    0/50 (0%)  |  0/50 (0%)    2/28 (7%)    0/15 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   2.6%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/39 (3%)    0/1 (0%)     0/0          0/23 (0%)  |  0/32 (0%)    0/0          0/0          0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          297          ---       |   ---          538          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.459N     P=0.999N     P=0.508      P=0.605N   |  P=0.346N     P=0.209        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.629N     P=0.999N     P=0.500      P=0.605N   |  P=0.442N     P=0.293        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.441N     P=0.999N     P=0.642      P=0.605N   |  P=0.333N     P=0.116        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.408N                                          |  P=0.326N                                          |
|FISHER EXACT           |               P=0.667N     P=0.559      P=0.500N   |               P=0.126        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Oligodendroglioma, Glioma, or Astrocytoma                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/25 (0%)    1/25 (4%)    0/50 (0%)  |  0/50 (0%)    2/28 (7%)    1/15 (7%)    0/50 (0%)  |
|ADJUSTED (b)           |   2.6%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/39 (3%)    0/1 (0%)     0/0          0/23 (0%)  |  0/32 (0%)    0/0          0/0          0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          297          ---       |   ---          538          564          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.459N     P=0.999N     P=0.508      P=0.605N   |  P=0.361N     P=0.209      P=0.504        (e)      |
|INCIDENTAL TUMOR       |  P=0.629N     P=0.999N     P=0.500      P=0.605N   |  P=0.460N     P=0.293      P=0.557        (e)      |
|LOGISTIC REGRESSION    |  P=0.441N     P=0.999N     P=0.642      P=0.605N   |  P=0.342N     P=0.116      P=0.340        (e)      |
|COCHRAN-ARMITAGE       |  P=0.408N                                          |  P=0.323N                                          |
|FISHER EXACT           |               P=0.667N     P=0.559      P=0.500N   |               P=0.126      P=0.231        (e)      |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05036 TEST: 01                                                 PAGE   4
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |
|                       |                                          KG        |                                          KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/50 (12%)   3/28 (11%)   1/25 (4%)    3/48 (6%)  |  7/49 (14%)   4/29 (14%)   3/17 (18%)   3/47 (6%)  |
|ADJUSTED (b)           |  14.6%        75.0%         0.0%        12.5%      |  18.3%        54.4%        60.0%         9.1%      |
|TERMINAL (d)           |  4/39 (10%)   3/4 (75%)    0/0          2/23 (9%)  |  3/31 (10%)   1/2 (50%)    3/5 (60%)    3/33 (9%)  |
|FIRST INCIDENCE (DAYS) |   691          729 (T)      516          723       |   497          622          728 (T)      728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.376N     P=0.159      P=0.551N     P=0.541N   |  P=0.058N     P=0.505      P=0.610      P=0.150N   |
|INCIDENTAL TUMOR       |  P=0.272N     P=0.367      P=0.194N     P=0.247N   |  P=0.105N     P=0.573N     P=0.446      P=0.208N   |
|LOGISTIC REGRESSION    |  P=0.298N     P=0.281      P=0.359N     P=0.456N   |  P=0.098N     P=0.578      P=0.451      P=0.175N   |
|COCHRAN-ARMITAGE       |  P=0.224N                                          |  P=0.130N                                          |
|FISHER EXACT           |               P=0.589N     P=0.250N     P=0.264N   |               P=0.616N     P=0.505      P=0.176N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/50 (12%)   3/28 (11%)   1/25 (4%)    3/48 (6%)  |  7/49 (14%)   4/29 (14%)   4/17 (24%)   4/47 (9%)  |
|ADJUSTED (b)           |  14.6%        75.0%         0.0%        12.5%      |  18.3%        54.4%        80.0%        11.5%      |
|TERMINAL (d)           |  4/39 (10%)   3/4 (75%)    0/0          2/23 (9%)  |  3/31 (10%)   1/2 (50%)    4/5 (80%)    3/33 (9%)  |
|FIRST INCIDENCE (DAYS) |   691          729 (T)      516          723       |   497          622          728 (T)      699       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.376N     P=0.159      P=0.551N     P=0.541N   |  P=0.105N     P=0.505      P=0.348      P=0.242N   |
|INCIDENTAL TUMOR       |  P=0.272N     P=0.367      P=0.194N     P=0.247N   |  P=0.196N     P=0.573N     P=0.203      P=0.368N   |
|LOGISTIC REGRESSION    |  P=0.298N     P=0.281      P=0.359N     P=0.456N   |  P=0.167N     P=0.578      P=0.214      P=0.285N   |
|COCHRAN-ARMITAGE       |  P=0.224N                                          |  P=0.222N                                          |
|FISHER EXACT           |               P=0.589N     P=0.250N     P=0.264N   |               P=0.616N     P=0.297      P=0.287N   |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05036 TEST: 01                                                 PAGE   5
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |
|                       |                                          KG        |                                          KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/50 (10%)   2/26 (8%)    3/26 (12%)   1/50 (2%)  |  0/50 (0%)    0/28 (0%)    1/14 (7%)    0/50 (0%)  |
|ADJUSTED (b)           |  12.8%         6.1%       100.0%         3.4%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  5/39 (13%)   0/1 (0%)     2/2 (100%)   0/23 (0%)  |  0/32 (0%)    0/0          0/0          0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      633          544          649       |   ---          ---          637          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.176N     P=0.268      P=0.011 *    P=0.254N   |  P=0.785N       (e)        P=0.505        (e)      |
|INCIDENTAL TUMOR       |  P=0.104N     P=0.769      P=0.014 *    P=0.164N   |  P=0.809        (e)        P=0.557        (e)      |
|LOGISTIC REGRESSION    |  P=0.110N     P=0.488      P=0.300      P=0.176N   |  P=0.729N       (e)        P=0.261        (e)      |
|COCHRAN-ARMITAGE       |  P=0.085N                                          |  P=0.721N                                          |
|FISHER EXACT           |               P=0.550N     P=0.560      P=0.102N   |                 (e)        P=0.219        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/50 (12%)   2/26 (8%)    3/26 (12%)   2/50 (4%)  |  1/50 (2%)    0/28 (0%)    1/14 (7%)    0/50 (0%)  |
|ADJUSTED (b)           |  15.4%         6.1%       100.0%         7.6%      |   3.1%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  6/39 (15%)   0/1 (0%)     2/2 (100%)   1/23 (4%)  |  1/32 (3%)    0/0          0/0          0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      633          544          649       |   728 (T)      ---          637          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.247N     P=0.282      P=0.016 *    P=0.350N   |  P=0.367N       (e)        P=0.505      P=0.482N   |
|INCIDENTAL TUMOR       |  P=0.161N     P=0.776      P=0.019 *    P=0.256N   |  P=0.388N       (e)        P=0.557      P=0.482N   |
|LOGISTIC REGRESSION    |  P=0.169N     P=0.551      P=0.367      P=0.257N   |  P=0.389N       (e)        P=0.388      P=0.482N   |
|COCHRAN-ARMITAGE       |  P=0.127N                                          |  P=0.412N                                          |
|FISHER EXACT           |               P=0.440N     P=0.633N     P=0.134N   |               P=0.641N     P=0.392      P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05036 TEST: 01                                                 PAGE   6
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |
|                       |                                          KG        |                                          KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    1/51 (2%)    6/51 (12%)  10/50 (20%) |  0/50 (0%)    0/51 (0%)    1/50 (2%)    5/50 (10%) |
|ADJUSTED (b)           |   2.6%         3.8%        19.7%        33.1%      |   0.0%         0.0%         2.4%        14.3%      |
|TERMINAL (d)           |  1/39 (3%)    1/26 (4%)    4/26 (15%)   5/23 (22%) |  0/32 (0%)    0/23 (0%)    0/35 (0%)    5/35 (14%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      524          513       |   ---          ---          637          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.669      P=0.023 *    P<0.001 ** |  P=0.003 **     (e)        P=0.505      P=0.041 *  |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.669      P=0.042 *    P=0.007 ** |  P=0.002 **     (e)        P=0.557      P=0.041 *  |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.669      P=0.053      P=0.004 ** |  P=0.002 **     (e)        P=0.493      P=0.041 *  |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.001 **                                        |
|FISHER EXACT           |               P=0.748N     P=0.059      P=0.004 ** |                 (e)        P=0.500      P=0.028 *  |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/51 (0%)   16/51 (31%)  30/50 (60%) |  0/50 (0%)    0/51 (0%)    1/50 (2%)    3/50 (6%)  |
|ADJUSTED (b)           |   0.0%         0.0%        43.4%        77.2%      |   0.0%         0.0%         2.0%         8.6%      |
|TERMINAL (d)           |  0/39 (0%)    0/26 (0%)    7/26 (27%)  15/23 (65%) |  0/32 (0%)    0/23 (0%)    0/35 (0%)    3/35 (9%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          507          390       |   ---          ---          319          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **     (e)        P<0.001 **   P<0.001 ** |  P=0.031 *      (e)        P=0.504      P=0.137    |
|INCIDENTAL TUMOR       |  P<0.001 **     (e)        P<0.001 **   P<0.001 ** |  P=0.025 *      (e)        P=0.500      P=0.137    |
|LOGISTIC REGRESSION    |  P<0.001 **     (e)        P<0.001 **   P<0.001 ** |  P=0.017 *      (e)        P=0.357      P=0.137    |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.021 *                                         |
|FISHER EXACT           |                 (e)        P<0.001 **   P<0.001 ** |                 (e)        P=0.500      P=0.121    |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05036 TEST: 01                                                 PAGE   7
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |
|                       |                                          KG        |                                          KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    1/51 (2%)   20/51 (39%)  36/50 (72%) |  0/50 (0%)    0/51 (0%)    2/50 (4%)    8/50 (16%) |
|ADJUSTED (b)           |   2.6%         3.8%        53.4%        87.2%      |   0.0%         0.0%         4.3%        22.9%      |
|TERMINAL (d)           |  1/39 (3%)    1/26 (4%)   10/26 (38%)  18/23 (78%) |  0/32 (0%)    0/23 (0%)    0/35 (0%)    8/35 (23%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      507          390       |   ---          ---          319          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.669      P<0.001 **   P<0.001 ** |  P<0.001 **     (e)        P=0.245      P=0.006 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.669      P<0.001 **   P<0.001 ** |  P<0.001 **     (e)        P=0.271      P=0.006 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.669      P<0.001 **   P<0.001 ** |  P<0.001 **     (e)        P=0.180      P=0.006 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.748N     P<0.001 **   P<0.001 ** |                 (e)        P=0.247      P=0.003 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/26 (0%)    0/26 (0%)    2/50 (4%)  |  0/50 (0%)    0/29 (0%)    0/19 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   2.6%         0.0%         0.0%         7.2%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/39 (3%)    0/1 (0%)     0/1 (0%)     1/23 (4%)  |  0/32 (0%)    0/1 (0%)     0/4 (0%)     0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          589       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.215      P=0.999N     P=0.999N     P=0.356    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.252      P=0.999N     P=0.999N     P=0.639    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.256      P=0.999N     P=0.999N     P=0.471    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.268                                           |    (e)                                             |
|FISHER EXACT           |               P=0.658N     P=0.658N     P=0.500    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05036 TEST: 01                                                 PAGE   8
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |
|                       |                                          KG        |                                          KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/26 (0%)    0/26 (0%)    2/50 (4%)  |  0/50 (0%)    0/29 (0%)    0/19 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   2.6%         0.0%         0.0%         7.2%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/39 (3%)    0/1 (0%)     0/1 (0%)     1/23 (4%)  |  0/32 (0%)    0/1 (0%)     0/4 (0%)     0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          589       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.215      P=0.999N     P=0.999N     P=0.356    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.252      P=0.999N     P=0.999N     P=0.639    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.256      P=0.999N     P=0.999N     P=0.471    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.268                                           |    (e)                                             |
|FISHER EXACT           |               P=0.658N     P=0.658N     P=0.500    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    3/30 (10%)   0/27 (0%)    0/50 (0%)  |  0/50 (0%)    1/32 (3%)    0/18 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%        24.8%         0.0%         0.0%      |   0.0%         2.7%         0.0%         2.9%      |
|TERMINAL (d)           |  0/39 (0%)    1/5 (20%)    0/2 (0%)     0/23 (0%)  |  0/32 (0%)    0/4 (0%)     0/3 (0%)     1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          633          ---          ---       |   ---          637          ---          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.305N     P=0.027 *      (e)          (e)      |  P=0.557      P=0.480        (e)        P=0.518    |
|INCIDENTAL TUMOR       |  P=0.212N     P=0.121        (e)          (e)      |  P=0.533      P=0.695        (e)        P=0.518    |
|LOGISTIC REGRESSION    |  P=0.246N     P=0.019 *      (e)          (e)      |  P=0.536      P=0.413        (e)        P=0.518    |
|COCHRAN-ARMITAGE       |  P=0.222N                                          |  P=0.516                                           |
|FISHER EXACT           |               P=0.049 *      (e)          (e)      |               P=0.390        (e)        P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05036 TEST: 01                                                 PAGE   9
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |
|                       |                                          KG        |                                          KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    4/30 (13%)   0/27 (0%)    0/50 (0%)  |  0/50 (0%)    1/32 (3%)    0/18 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%        43.6%         0.0%         0.0%      |   0.0%         2.7%         0.0%         2.9%      |
|TERMINAL (d)           |  0/39 (0%)    2/5 (40%)    0/2 (0%)     0/23 (0%)  |  0/32 (0%)    0/4 (0%)     0/3 (0%)     1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          633          ---          ---       |   ---          637          ---          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.232N     P=0.002 **     (e)          (e)      |  P=0.557      P=0.480        (e)        P=0.518    |
|INCIDENTAL TUMOR       |  P=0.165N     P=0.007 **     (e)          (e)      |  P=0.533      P=0.695        (e)        P=0.518    |
|LOGISTIC REGRESSION    |  P=0.185N     P=0.003 **     (e)          (e)      |  P=0.536      P=0.413        (e)        P=0.518    |
|COCHRAN-ARMITAGE       |  P=0.155N                                          |  P=0.516                                           |
|FISHER EXACT           |               P=0.017 *      (e)          (e)      |               P=0.390        (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/51 (0%)    0/51 (0%)    0/50 (0%)  |  1/50 (2%)    2/51 (4%)    2/50 (4%)    2/50 (4%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   3.1%         7.9%         5.2%         5.2%      |
|TERMINAL (d)           |  0/39 (0%)    0/26 (0%)    0/26 (0%)    0/23 (0%)  |  1/32 (3%)    1/23 (4%)    1/35 (3%)    1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   728 (T)      716          659          626       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.561      P=0.401      P=0.530      P=0.524    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.448      P=0.457      P=0.474      P=0.554    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.508      P=0.427      P=0.508      P=0.503    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.487                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.508      P=0.500      P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05036 TEST: 01                                                 PAGE  10
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |
|                       |                                          KG        |                                          KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/51 (0%)    1/51 (2%)    0/50 (0%)  |  1/50 (2%)    2/51 (4%)    3/50 (6%)    2/50 (4%)  |
|ADJUSTED (b)           |   0.0%         0.0%         3.6%         0.0%      |   3.1%         7.9%         8.0%         5.2%      |
|TERMINAL (d)           |  0/39 (0%)    0/26 (0%)    0/26 (0%)    0/23 (0%)  |  1/32 (3%)    1/23 (4%)    2/35 (6%)    1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          717          ---       |   728 (T)      716          659          626       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.791        (e)        P=0.434        (e)      |  P=0.578      P=0.401      P=0.338      P=0.524    |
|INCIDENTAL TUMOR       |  P=0.750N       (e)        P=0.757        (e)      |  P=0.473      P=0.457      P=0.294      P=0.554    |
|LOGISTIC REGRESSION    |  P=0.805        (e)        P=0.474        (e)      |  P=0.522      P=0.427      P=0.315      P=0.503    |
|COCHRAN-ARMITAGE       |  P=0.789N                                          |  P=0.496                                           |
|FISHER EXACT           |                 (e)        P=0.505        (e)      |               P=0.508      P=0.309      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    2/51 (4%)    1/51 (2%)    3/50 (6%)  | 17/50 (34%)  23/51 (45%)  22/50 (44%)  28/50 (56%) |
|ADJUSTED (b)           |   7.2%         7.7%         3.8%        10.8%      |  46.6%        70.5%        56.3%        69.9%      |
|TERMINAL (d)           |  2/39 (5%)    2/26 (8%)    1/26 (4%)    2/23 (9%)  | 13/32 (41%)  14/23 (61%)  18/35 (51%)  23/35 (66%) |
|FIRST INCIDENCE (DAYS) |   516          729 (T)      729 (T)      513       |   525          436          659          630       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.361      P=0.650N     P=0.416N     P=0.483    |  P=0.205      P=0.021 *    P=0.313      P=0.052    |
|INCIDENTAL TUMOR       |  P=0.472      P=0.645N     P=0.390N     P=0.633    |  P=0.037 *    P=0.058      P=0.188      P=0.015 *  |
|LOGISTIC REGRESSION    |  P=0.473      P=0.512N     P=0.301N     P=0.661    |  P=0.046 *    P=0.096      P=0.234      P=0.020 *  |
|COCHRAN-ARMITAGE       |  P=0.504                                           |  P=0.030 *                                         |
|FISHER EXACT           |               P=0.491N     P=0.301N     P=0.661N   |               P=0.174      P=0.206      P=0.022 *  |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05036 TEST: 01                                                 PAGE  11
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |
|                       |                                          KG        |                                          KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    2/51 (4%)    2/51 (4%)    3/50 (6%)  | 17/50 (34%)  23/51 (45%)  22/50 (44%)  28/50 (56%) |
|ADJUSTED (b)           |   7.2%         7.7%         7.3%        10.8%      |  46.6%        70.5%        56.3%        69.9%      |
|TERMINAL (d)           |  2/39 (5%)    2/26 (8%)    1/26 (4%)    2/23 (9%)  | 13/32 (41%)  14/23 (61%)  18/35 (51%)  23/35 (66%) |
|FIRST INCIDENCE (DAYS) |   516          729 (T)      717          513       |   525          436          659          630       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.358      P=0.650N     P=0.635N     P=0.483    |  P=0.205      P=0.021 *    P=0.313      P=0.052    |
|INCIDENTAL TUMOR       |  P=0.500      P=0.645N     P=0.478N     P=0.633    |  P=0.037 *    P=0.058      P=0.188      P=0.015 *  |
|LOGISTIC REGRESSION    |  P=0.473      P=0.512N     P=0.502N     P=0.661    |  P=0.046 *    P=0.096      P=0.234      P=0.020 *  |
|COCHRAN-ARMITAGE       |  P=0.511                                           |  P=0.030 *                                         |
|FISHER EXACT           |               P=0.491N     P=0.491N     P=0.661N   |               P=0.174      P=0.206      P=0.022 *  |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    2/51 (4%)    2/51 (4%)    3/50 (6%)  | 17/50 (34%)  24/51 (47%)  22/50 (44%)  30/50 (60%) |
|ADJUSTED (b)           |   7.2%         7.7%         7.3%        10.8%      |  46.6%        73.8%        56.3%        73.1%      |
|TERMINAL (d)           |  2/39 (5%)    2/26 (8%)    1/26 (4%)    2/23 (9%)  | 13/32 (41%)  15/23 (65%)  18/35 (51%)  24/35 (69%) |
|FIRST INCIDENCE (DAYS) |   516          729 (T)      717          513       |   525          436          659          626       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.358      P=0.650N     P=0.635N     P=0.483    |  P=0.127      P=0.012 *    P=0.313      P=0.024 *  |
|INCIDENTAL TUMOR       |  P=0.500      P=0.645N     P=0.478N     P=0.633    |  P=0.015 *    P=0.034 *    P=0.188      P=0.006 ** |
|LOGISTIC REGRESSION    |  P=0.473      P=0.512N     P=0.502N     P=0.661    |  P=0.019 *    P=0.063      P=0.234      P=0.007 ** |
|COCHRAN-ARMITAGE       |  P=0.511                                           |  P=0.012 *                                         |
|FISHER EXACT           |               P=0.491N     P=0.491N     P=0.661N   |               P=0.128      P=0.206      P=0.008 ** |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05036 TEST: 01                                                 PAGE  12
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |
|                       |                                          KG        |                                          KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Papilloma Squamous or Papilloma                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    2/51 (4%)    2/51 (4%)    0/50 (0%)  |  0/50 (0%)    0/51 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   2.6%         7.7%         6.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/39 (3%)    2/26 (8%)    0/26 (0%)    0/23 (0%)  |  0/32 (0%)    0/23 (0%)    0/35 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      589          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.343N     P=0.360      P=0.408      P=0.605N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.258N     P=0.360      P=0.689N     P=0.605N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.279N     P=0.360      P=0.502      P=0.605N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.247N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.508      P=0.508      P=0.500N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    2/51 (4%)    2/51 (4%)    0/50 (0%)  |  1/50 (2%)    0/51 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   2.6%         7.7%         6.0%         0.0%      |   2.5%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/39 (3%)    2/26 (8%)    0/26 (0%)    0/23 (0%)  |  0/32 (0%)    0/23 (0%)    0/35 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      589          ---       |   654          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.343N     P=0.360      P=0.408      P=0.605N   |  P=0.468N     P=0.538N     P=0.495N     P=0.505N   |
|INCIDENTAL TUMOR       |  P=0.258N     P=0.360      P=0.689N     P=0.605N   |  P=0.592N     P=0.443N     P=0.581N     P=0.617N   |
|LOGISTIC REGRESSION    |  P=0.279N     P=0.360      P=0.502      P=0.605N   |  P=0.480N     P=0.494N     P=0.504N     P=0.501N   |
|COCHRAN-ARMITAGE       |  P=0.247N                                          |  P=0.477N                                          |
|FISHER EXACT           |               P=0.508      P=0.508      P=0.500N   |               P=0.495N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05036 TEST: 01                                                 PAGE  13
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |
|                       |                                          KG        |                                          KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    3/26 (12%)   0/24 (0%)    3/50 (6%)  |  0/50 (0%)    0/29 (0%)    0/14 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |  10.3%       100.0%         0.0%        13.0%      |   0.0%         0.0%         0.0%         2.9%      |
|TERMINAL (d)           |  4/39 (10%)   1/1 (100%)   0/0          3/23 (13%) |  0/32 (0%)    0/1 (0%)     0/0          1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      627          ---          729 (T)   |   ---          ---          ---          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.516N     P=0.031 *      (e)        P=0.532    |  P=0.381        (e)          (e)        P=0.518    |
|INCIDENTAL TUMOR       |  P=0.457N     P=0.129        (e)        P=0.532    |  P=0.381        (e)          (e)        P=0.518    |
|LOGISTIC REGRESSION    |  P=0.471N     P=0.180        (e)        P=0.532    |  P=0.381        (e)          (e)        P=0.518    |
|COCHRAN-ARMITAGE       |  P=0.378N                                          |  P=0.277                                           |
|FISHER EXACT           |               P=0.450      P=0.200N     P=0.500N   |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Parathyroid Gland                                                                                                                |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/41 (5%)    0/21 (0%)    0/21 (0%)    0/47 (0%)  |  0/39 (0%)    0/17 (0%)    0/13 (0%)    1/42 (2%)  |
|ADJUSTED (b)           |   5.7%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         3.2%      |
|TERMINAL (d)           |  2/35 (6%)    0/1 (0%)     0/0          0/22 (0%)  |  0/26 (0%)    0/0          0/0          1/31 (3%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          ---       |   ---          ---          ---          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.264N     P=0.974N       (e)        P=0.345N   |  P=0.403        (e)          (e)        P=0.535    |
|INCIDENTAL TUMOR       |  P=0.264N     P=0.974N       (e)        P=0.345N   |  P=0.403        (e)          (e)        P=0.535    |
|LOGISTIC REGRESSION    |  P=0.264N     P=0.974N       (e)        P=0.345N   |  P=0.403        (e)          (e)        P=0.535    |
|COCHRAN-ARMITAGE       |  P=0.197N                                          |  P=0.302                                           |
|FISHER EXACT           |               P=0.434N     P=0.434N     P=0.214N   |                 (e)          (e)        P=0.519    |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05036 TEST: 01                                                 PAGE  14
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |
|                       |                                          KG        |                                          KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 14/50 (28%)  16/33 (48%)   7/27 (26%)  11/49 (22%) | 16/49 (33%)  19/41 (46%)  15/35 (43%)  22/49 (45%) |
|ADJUSTED (b)           |  34.1%        90.2%        77.9%        40.4%      |  40.0%        73.1%        66.7%        53.4%      |
|TERMINAL (d)           | 12/39 (31%)   7/8 (88%)    3/4 (75%)    8/23 (35%) |  9/32 (28%)   8/13 (62%)  13/20 (65%)  16/35 (46%) |
|FIRST INCIDENCE (DAYS) |   704          409          540          540       |   466          585          589          520       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.387N     P<0.001 **   P=0.056      P=0.318    |  P=0.466N     P=0.020 *    P=0.263      P=0.246    |
|INCIDENTAL TUMOR       |  P=0.133N     P=0.013 *    P=0.311      P=0.540N   |  P=0.252      P=0.100      P=0.177      P=0.107    |
|LOGISTIC REGRESSION    |  P=0.150N     P=0.007 **   P=0.241      P=0.560    |  P=0.359      P=0.046 *    P=0.173      P=0.149    |
|COCHRAN-ARMITAGE       |  P=0.092N                                          |  P=0.255                                           |
|FISHER EXACT           |               P=0.048 *    P=0.534N     P=0.343N   |               P=0.134      P=0.234      P=0.150    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    2/33 (6%)    2/27 (7%)    0/49 (0%)  |  1/49 (2%)    2/41 (5%)    1/35 (3%)    0/49 (0%)  |
|ADJUSTED (b)           |   0.0%        15.6%        27.6%         0.0%      |   3.1%         6.9%         2.6%         0.0%      |
|TERMINAL (d)           |  0/39 (0%)    1/8 (13%)    1/4 (25%)    0/23 (0%)  |  1/32 (3%)    0/13 (0%)    0/20 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          722          716          ---       |   728 (T)      658          667          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.457N     P=0.071      P=0.044 *      (e)      |  P=0.193N     P=0.353      P=0.716      P=0.482N   |
|INCIDENTAL TUMOR       |  P=0.367N     P=0.160      P=0.108        (e)      |  P=0.320N     P=0.467      P=0.660      P=0.482N   |
|LOGISTIC REGRESSION    |  P=0.427N     P=0.039 *    P=0.025 *      (e)      |  P=0.208N     P=0.360      P=0.675      P=0.482N   |
|COCHRAN-ARMITAGE       |  P=0.340N                                          |  P=0.220N                                          |
|FISHER EXACT           |               P=0.155      P=0.120        (e)      |               P=0.433      P=0.663      P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05036 TEST: 01                                                 PAGE  15
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |
|                       |                                          KG        |                                          KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 14/50 (28%)  18/33 (55%)   9/27 (33%)  11/49 (22%) | 17/49 (35%)  20/41 (49%)  16/35 (46%)  22/49 (45%) |
|ADJUSTED (b)           |  34.1%       100.0%       100.0%        40.4%      |  42.6%        73.9%        67.6%        53.4%      |
|TERMINAL (d)           | 12/39 (31%)   8/8 (100%)   4/4 (100%)   8/23 (35%) | 10/32 (31%)   8/13 (62%)  13/20 (65%)  16/35 (46%) |
|FIRST INCIDENCE (DAYS) |   704          409          540          540       |   466          585          589          520       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.328N     P<0.001 **   P=0.008 **   P=0.318    |  P=0.370N     P=0.017 *    P=0.254      P=0.312    |
|INCIDENTAL TUMOR       |  P=0.089N     P=0.002 **   P=0.091      P=0.540N   |  P=0.320      P=0.088      P=0.154      P=0.154    |
|LOGISTIC REGRESSION    |  P=0.106N     P<0.001 **   P=0.050 *    P=0.560    |  P=0.463      P=0.040 *    P=0.153      P=0.204    |
|COCHRAN-ARMITAGE       |  P=0.058N                                          |  P=0.345                                           |
|FISHER EXACT           |               P=0.014 *    P=0.406      P=0.343N   |               P=0.128      P=0.214      P=0.205    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Intermedia                                                                                                 |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/33 (0%)    0/27 (0%)    0/49 (0%)  |  0/49 (0%)    0/41 (0%)    2/35 (6%)    0/49 (0%)  |
|ADJUSTED (b)           |   2.6%         0.0%         0.0%         0.0%      |   0.0%         0.0%         7.3%         0.0%      |
|TERMINAL (d)           |  1/39 (3%)    0/8 (0%)     0/4 (0%)     0/23 (0%)  |  0/32 (0%)    0/13 (0%)    1/20 (5%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          ---       |   ---          ---          637          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.495N     P=0.810N     P=0.919N     P=0.605N   |  P=0.641N       (e)        P=0.191        (e)      |
|INCIDENTAL TUMOR       |  P=0.495N     P=0.810N     P=0.919N     P=0.605N   |  P=0.699N       (e)        P=0.217        (e)      |
|LOGISTIC REGRESSION    |  P=0.495N     P=0.810N     P=0.919N     P=0.605N   |  P=0.664N       (e)        P=0.162        (e)      |
|COCHRAN-ARMITAGE       |  P=0.452N                                          |  P=0.672N                                          |
|FISHER EXACT           |               P=0.602N     P=0.649N     P=0.505N   |                 (e)        P=0.171        (e)      |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05036 TEST: 01                                                 PAGE  16
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |
|                       |                                          KG        |                                          KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    1/51 (2%)    4/51 (8%)    2/50 (4%)  |  0/50 (0%)    0/51 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   2.6%         3.8%        13.2%         7.3%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/39 (3%)    1/26 (4%)    2/26 (8%)    1/23 (4%)  |  0/32 (0%)    0/23 (0%)    0/35 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      589          647       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.268      P=0.669      P=0.100      P=0.349    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.369      P=0.669      P=0.290      P=0.496    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.345      P=0.669      P=0.165      P=0.433    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.409                                           |    (e)                                             |
|FISHER EXACT           |               P=0.748N     P=0.187      P=0.500    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    1/51 (2%)    4/51 (8%)    1/50 (2%)  |  0/50 (0%)    2/51 (4%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   5.1%         3.8%        11.2%         4.3%      |   0.0%         8.7%         0.0%         2.9%      |
|TERMINAL (d)           |  2/39 (5%)    1/26 (4%)    1/26 (4%)    1/23 (4%)  |  0/32 (0%)    2/23 (9%)    0/35 (0%)    1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      459          729 (T)   |   ---          728 (T)      ---          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.608N     P=0.640N     P=0.233      P=0.681N   |  P=0.677      P=0.168        (e)        P=0.518    |
|INCIDENTAL TUMOR       |  P=0.471N     P=0.640N     P=0.522      P=0.681N   |  P=0.677      P=0.168        (e)        P=0.518    |
|LOGISTIC REGRESSION    |  P=0.489N     P=0.640N     P=0.348      P=0.681N   |  P=0.677      P=0.168        (e)        P=0.518    |
|COCHRAN-ARMITAGE       |  P=0.469N                                          |  P=0.623                                           |
|FISHER EXACT           |               P=0.492N     P=0.348      P=0.500N   |               P=0.252        (e)        P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05036 TEST: 01                                                 PAGE  17
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |
|                       |                                          KG        |                                          KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    2/51 (4%)    7/51 (14%)   3/50 (6%)  |  0/50 (0%)    2/51 (4%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |  10.3%         7.7%        21.1%        11.5%      |   0.0%         8.7%         0.0%         2.9%      |
|TERMINAL (d)           |  4/39 (10%)   2/26 (8%)    3/26 (12%)   2/23 (9%)  |  0/32 (0%)    2/23 (9%)    0/35 (0%)    1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      459          647       |   ---          728 (T)      ---          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.419      P=0.535N     P=0.122      P=0.551    |  P=0.677      P=0.168        (e)        P=0.518    |
|INCIDENTAL TUMOR       |  P=0.574      P=0.535N     P=0.350      P=0.652    |  P=0.677      P=0.168        (e)        P=0.518    |
|LOGISTIC REGRESSION    |  P=0.557      P=0.535N     P=0.252      P=0.646    |  P=0.677      P=0.168        (e)        P=0.518    |
|COCHRAN-ARMITAGE       |  P=0.544N                                          |  P=0.623                                           |
|FISHER EXACT           |               P=0.329N     P=0.274      P=0.500N   |               P=0.252        (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    4/51 (8%)    1/51 (2%)    2/50 (4%)  |  0/50 (0%)    1/51 (2%)    1/50 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |   9.7%        14.2%         3.8%         6.1%      |   0.0%         2.5%         2.3%         0.0%      |
|TERMINAL (d)           |  2/39 (5%)    2/26 (8%)    1/26 (4%)    0/23 (0%)  |  0/32 (0%)    0/23 (0%)    0/35 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   540          717          729 (T)      425       |   ---          624          622          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.387N     P=0.459      P=0.278N     P=0.507N   |  P=0.528N     P=0.495      P=0.510        (e)      |
|INCIDENTAL TUMOR       |  P=0.185N     P=0.529N     P=0.158N     P=0.148N   |  P=0.594N     P=0.695      P=0.557        (e)      |
|LOGISTIC REGRESSION    |  P=0.265N     P=0.607      P=0.181N     P=0.328N   |  P=0.551N     P=0.518      P=0.491        (e)      |
|COCHRAN-ARMITAGE       |  P=0.245N                                          |  P=0.536N                                          |
|FISHER EXACT           |               P=0.631N     P=0.175N     P=0.339N   |               P=0.505      P=0.500        (e)      |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05036 TEST: 01                                                 PAGE  18
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |
|                       |                                          KG        |                                          KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/51 (0%)    2/51 (4%)    0/50 (0%)  |  1/50 (2%)    2/51 (4%)    0/50 (0%)    2/50 (4%)  |
|ADJUSTED (b)           |   2.6%         0.0%         5.7%         0.0%      |   3.1%         6.5%         0.0%         5.3%      |
|TERMINAL (d)           |  1/39 (3%)    0/26 (0%)    1/26 (4%)    0/23 (0%)  |  1/32 (3%)    1/23 (4%)    0/35 (0%)    1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          290          ---       |   728 (T)      525          ---          645       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.523N     P=0.581N     P=0.414      P=0.605N   |  P=0.514      P=0.424      P=0.482N     P=0.518    |
|INCIDENTAL TUMOR       |  P=0.688N     P=0.581N     P=0.407      P=0.605N   |  P=0.461      P=0.445      P=0.482N     P=0.454    |
|LOGISTIC REGRESSION    |  P=0.460N     P=0.581N     P=0.494      P=0.605N   |  P=0.464      P=0.507      P=0.482N     P=0.504    |
|COCHRAN-ARMITAGE       |  P=0.460N                                          |  P=0.464                                           |
|FISHER EXACT           |               P=0.495N     P=0.508      P=0.500N   |               P=0.508      P=0.500N     P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/50 (12%)   4/51 (8%)    4/51 (8%)    2/50 (4%)  |  1/50 (2%)    3/51 (6%)    1/50 (2%)    2/50 (4%)  |
|ADJUSTED (b)           |  14.1%        14.2%        11.8%         6.1%      |   3.1%         8.8%         2.3%         5.3%      |
|TERMINAL (d)           |  3/39 (8%)    2/26 (8%)    2/26 (8%)    0/23 (0%)  |  1/32 (3%)    1/23 (4%)    0/35 (0%)    1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |   526          717          290          425       |   728 (T)      525          622          645       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.251N     P=0.566N     P=0.514N     P=0.273N   |  P=0.623      P=0.249      P=0.745N     P=0.518    |
|INCIDENTAL TUMOR       |  P=0.111N     P=0.285N     P=0.255N     P=0.039N*  |  P=0.551      P=0.342      P=0.718N     P=0.454    |
|LOGISTIC REGRESSION    |  P=0.132N     P=0.385N     P=0.354N     P=0.127N   |  P=0.574      P=0.317      P=0.762      P=0.504    |
|COCHRAN-ARMITAGE       |  P=0.135N                                          |  P=0.580                                           |
|FISHER EXACT           |               P=0.358N     P=0.358N     P=0.134N   |               P=0.316      P=0.753N     P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05036 TEST: 01                                                 PAGE  19
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |
|                       |                                          KG        |                                          KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    0/51 (0%)    3/51 (6%)    0/50 (0%)  |  1/50 (2%)    2/51 (4%)    0/50 (0%)    2/50 (4%)  |
|ADJUSTED (b)           |   4.8%         0.0%         8.1%         0.0%      |   3.1%         6.5%         0.0%         5.3%      |
|TERMINAL (d)           |  1/39 (3%)    0/26 (0%)    1/26 (4%)    0/23 (0%)  |  1/32 (3%)    1/23 (4%)    0/35 (0%)    1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |   526          ---          290          ---       |   728 (T)      525          ---          645       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.356N     P=0.289N     P=0.429      P=0.306N   |  P=0.514      P=0.424      P=0.482N     P=0.518    |
|INCIDENTAL TUMOR       |  P=0.337N     P=0.284N     P=0.647      P=0.196N   |  P=0.461      P=0.445      P=0.482N     P=0.454    |
|LOGISTIC REGRESSION    |  P=0.306N     P=0.229N     P=0.487      P=0.232N   |  P=0.464      P=0.507      P=0.482N     P=0.504    |
|COCHRAN-ARMITAGE       |  P=0.302N                                          |  P=0.464                                           |
|FISHER EXACT           |               P=0.243N     P=0.509      P=0.247N   |               P=0.508      P=0.500N     P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 44/50 (88%)  39/50 (78%)  42/48 (88%)  40/50 (80%) |                                                    |
|ADJUSTED (b)           |  97.8%       100.0%       100.0%        97.5%      |                                                    |
|TERMINAL (d)           | 38/39 (97%)  25/25 (100%) 23/23 (100%) 22/23 (96%) |                                                    |
|FIRST INCIDENCE (DAYS) |   516          428          507          425       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.011 *    P=0.018 *    P=0.002 **   P=0.004 ** |                                                    |
|INCIDENTAL TUMOR       |  P=0.568N     P=0.476N     P=0.470      P=0.588N   |                                                    |
|LOGISTIC REGRESSION    |  P=0.547      P=0.376N     P=0.459      P=0.573N   |                                                    |
|COCHRAN-ARMITAGE       |  P=0.327N                                          |                                                    |
|FISHER EXACT           |               P=0.143N     P=0.591N     P=0.207N   |                                                    |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05036 TEST: 01                                                 PAGE  20
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |
|                       |                                          KG        |                                          KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  9/50 (18%)   5/29 (17%)   6/26 (23%)   5/50 (10%) |  7/50 (14%)   7/32 (22%)   5/18 (28%)   3/50 (6%)  |
|ADJUSTED (b)           |  22.5%        62.4%       100.0%        19.3%      |  18.9%       100.0%       100.0%         8.0%      |
|TERMINAL (d)           |  8/39 (21%)   3/5 (60%)    2/2 (100%)   4/23 (17%) |  4/32 (13%)   4/4 (100%)   3/3 (100%)   1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |   704          675          516          513       |   568          637          669          659       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.363N     P=0.062      P=0.017 *    P=0.546N   |  P=0.024N*    P=0.028 *    P=0.150      P=0.144N   |
|INCIDENTAL TUMOR       |  P=0.191N     P=0.204      P=0.082      P=0.403N   |  P=0.050N     P=0.113      P=0.100      P=0.184N   |
|LOGISTIC REGRESSION    |  P=0.208N     P=0.209      P=0.144      P=0.358N   |  P=0.034N*    P=0.112      P=0.053      P=0.157N   |
|COCHRAN-ARMITAGE       |  P=0.144N                                          |  P=0.058N                                          |
|FISHER EXACT           |               P=0.594N     P=0.404      P=0.194N   |               P=0.264      P=0.169      P=0.159N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  9/50 (18%)   6/29 (21%)   7/26 (27%)   6/50 (12%) |  8/50 (16%)   7/32 (22%)   5/18 (28%)   3/50 (6%)  |
|ADJUSTED (b)           |  22.5%        81.2%       100.0%        22.4%      |  21.8%       100.0%       100.0%         8.0%      |
|TERMINAL (d)           |  8/39 (21%)   4/5 (80%)    2/2 (100%)   4/23 (17%) |  5/32 (16%)   4/4 (100%)   3/3 (100%)   1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |   704          675          516          513       |   568          637          669          659       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.459N     P=0.014 *    P=0.008 **   P=0.544    |  P=0.014N*    P=0.035 *    P=0.169      P=0.090N   |
|INCIDENTAL TUMOR       |  P=0.235N     P=0.057      P=0.061      P=0.464N   |  P=0.031N*    P=0.134      P=0.117      P=0.115N   |
|LOGISTIC REGRESSION    |  P=0.268N     P=0.084      P=0.057      P=0.481N   |  P=0.022N*    P=0.152      P=0.072      P=0.098N   |
|COCHRAN-ARMITAGE       |  P=0.184N                                          |  P=0.041N*                                         |
|FISHER EXACT           |               P=0.495      P=0.268      P=0.288N   |               P=0.349      P=0.225      P=0.100N   |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05036 TEST: 01                                                 PAGE  21
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |
|                       |                                          KG        |                                          KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    1/29 (3%)    0/26 (0%)    0/50 (0%)  |  0/50 (0%)    1/32 (3%)    1/18 (6%)    0/50 (0%)  |
|ADJUSTED (b)           |   5.1%        20.0%         0.0%         0.0%      |   0.0%        25.0%         2.5%         0.0%      |
|TERMINAL (d)           |  2/39 (5%)    1/5 (20%)    0/2 (0%)     0/23 (0%)  |  0/32 (0%)    1/4 (25%)    0/3 (0%)     0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      ---          ---       |   ---          728 (T)      665          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.216N     P=0.383      P=0.910N     P=0.361N   |  P=0.435N     P=0.108      P=0.516        (e)      |
|INCIDENTAL TUMOR       |  P=0.216N     P=0.383      P=0.910N     P=0.361N   |  P=0.511N     P=0.108      P=0.419        (e)      |
|LOGISTIC REGRESSION    |  P=0.216N     P=0.383      P=0.910N     P=0.361N   |  P=0.452N     P=0.108      P=0.274        (e)      |
|COCHRAN-ARMITAGE       |  P=0.152N                                          |  P=0.484N                                          |
|FISHER EXACT           |               P=0.697N     P=0.430N     P=0.247N   |               P=0.390      P=0.265        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    1/29 (3%)    1/26 (4%)    1/50 (2%)  |  0/50 (0%)    2/32 (6%)    1/18 (6%)    0/50 (0%)  |
|ADJUSTED (b)           |   7.7%        20.0%         3.0%         4.3%      |   0.0%        28.0%         2.5%         0.0%      |
|TERMINAL (d)           |  3/39 (8%)    1/5 (20%)    0/2 (0%)     1/23 (4%)  |  0/32 (0%)    1/4 (25%)    0/3 (0%)     0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      706          729 (T)   |   ---          718          665          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.395N     P=0.470      P=0.563      P=0.507N   |  P=0.298N     P=0.051      P=0.516        (e)      |
|INCIDENTAL TUMOR       |  P=0.354N     P=0.470      P=0.772      P=0.507N   |  P=0.416N     P=0.082      P=0.419        (e)      |
|LOGISTIC REGRESSION    |  P=0.380N     P=0.470      P=0.610      P=0.507N   |  P=0.294N     P=0.020 *    P=0.274        (e)      |
|COCHRAN-ARMITAGE       |  P=0.276N                                          |  P=0.334N                                          |
|FISHER EXACT           |               P=0.532N     P=0.577N     P=0.309N   |               P=0.149      P=0.265        (e)      |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05036 TEST: 01                                                 PAGE  22
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |
|                       |                                          KG        |                                          KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Tongue                                                                                                                           |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    2/51 (4%)    2/51 (4%)    0/50 (0%)  |  0/50 (0%)    0/51 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         7.7%         6.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/39 (0%)    2/26 (8%)    0/26 (0%)    0/23 (0%)  |  0/32 (0%)    0/23 (0%)    0/35 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      589          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.481N     P=0.154      P=0.197        (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.373N     P=0.154      P=0.757        (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.409N     P=0.154      P=0.243        (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.381N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.252      P=0.252        (e)      |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  2/50 (4%)    7/51 (14%)   2/50 (4%)    7/50 (14%) |
|ADJUSTED (b)           |                                                    |   5.7%        23.6%         5.4%        17.8%      |
|TERMINAL (d)           |                                                    |  1/32 (3%)    4/23 (17%)   1/35 (3%)    4/35 (11%) |
|FIRST INCIDENCE (DAYS) |                                                    |   673          624          669          305       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.247      P=0.043 *    P=0.674N     P=0.105    |
|INCIDENTAL TUMOR       |                                                    |  P=0.122      P=0.112      P=0.639      P=0.051    |
|LOGISTIC REGRESSION    |                                                    |  P=0.160      P=0.071      P=0.689N     P=0.080    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.156                                           |
|FISHER EXACT           |                                                    |               P=0.085      P=0.691N     P=0.080    |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05036 TEST: 01                                                 PAGE  23
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |
|                       |                                          KG        |                                          KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  2/50 (4%)    7/51 (14%)   3/50 (6%)    7/50 (14%) |
|ADJUSTED (b)           |                                                    |   5.7%        23.6%         7.4%        17.8%      |
|TERMINAL (d)           |                                                    |  1/32 (3%)    4/23 (17%)   1/35 (3%)    4/35 (11%) |
|FIRST INCIDENCE (DAYS) |                                                    |   673          624          506          305       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.258      P=0.043 *    P=0.522      P=0.105    |
|INCIDENTAL TUMOR       |                                                    |  P=0.131      P=0.112      P=0.423      P=0.051    |
|LOGISTIC REGRESSION    |                                                    |  P=0.164      P=0.071      P=0.494      P=0.080    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.165                                           |
|FISHER EXACT           |                                                    |               P=0.085      P=0.500      P=0.080    |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    2/51 (4%)    0/51 (0%)    3/50 (6%)  |  0/50 (0%)    1/51 (2%)    2/50 (4%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         4.4%         0.0%         8.2%      |   0.0%         2.3%         4.2%         0.0%      |
|TERMINAL (d)           |  0/39 (0%)    0/26 (0%)    0/26 (0%)    0/23 (0%)  |  0/32 (0%)    0/23 (0%)    0/35 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          409          ---          540       |   ---          577          466          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.088      P=0.242        (e)        P=0.097    |  P=0.516N     P=0.500      P=0.245        (e)      |
|INCIDENTAL TUMOR       |  P=0.287      P=0.500        (e)        P=0.324    |  P=0.551N     P=0.695      P=0.176        (e)      |
|LOGISTIC REGRESSION    |  P=0.092      P=0.215        (e)        P=0.120    |  P=0.585N     P=0.537      P=0.183        (e)      |
|COCHRAN-ARMITAGE       |  P=0.105                                           |  P=0.516N                                          |
|FISHER EXACT           |               P=0.252        (e)        P=0.121    |               P=0.505      P=0.247        (e)      |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05036 TEST: 01                                                 PAGE  24
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |
|                       |                                          KG        |                                          KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 12/50 (24%)   7/51 (14%)   7/51 (14%)   7/50 (14%) | 10/50 (20%)   8/51 (16%)   2/50 (4%)    3/50 (6%)  |
|ADJUSTED (b)           |  29.8%        18.7%        19.3%        22.5%      |  23.8%        21.0%         5.1%         7.9%      |
|TERMINAL (d)           | 11/39 (28%)   1/26 (4%)    2/26 (8%)    3/23 (13%) |  3/32 (9%)    0/23 (0%)    0/35 (0%)    2/35 (6%)  |
|FIRST INCIDENCE (DAYS) |   516          418          544          408       |   495          585          667          568       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.503N     P=0.392N     P=0.387N     P=0.504N   |  P=0.022N*    P=0.531N     P=0.018N*    P=0.039N*  |
|INCIDENTAL TUMOR       |  P=0.168N     P=0.128N     P=0.092N     P=0.244N   |  P=0.062N     P=0.099N     P=0.023N*    P=0.039N*  |
|LOGISTIC REGRESSION    |  P=0.251N     P=0.151N     P=0.042N*    P=0.198N   |  P=0.057N     P=0.160N     P=0.017N*    P=0.053N   |
|COCHRAN-ARMITAGE       |  P=0.246N                                          |  P=0.026N*                                         |
|FISHER EXACT           |               P=0.143N     P=0.143N     P=0.154N   |               P=0.380N     P=0.014N*    P=0.036N*  |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma Benign, Malignant, NOS                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    4/51 (8%)    0/51 (0%)    0/50 (0%)  |  0/50 (0%)    0/51 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   2.6%        11.4%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/39 (3%)    1/26 (4%)    0/26 (0%)    0/23 (0%)  |  0/32 (0%)    0/23 (0%)    0/35 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      487          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.155N     P=0.118      P=0.581N     P=0.605N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.078N     P=0.259      P=0.581N     P=0.605N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.108N     P=0.184      P=0.581N     P=0.605N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.108N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.187      P=0.495N     P=0.500N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05036 TEST: 01                                                 PAGE  25
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |
|                       |                                          KG        |                                          KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 47/50 (94%)  46/51 (90%)  48/51 (94%)  44/50 (88%) | 34/50 (68%)  38/51 (75%)  34/50 (68%)  42/50 (84%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  75.3%        90.2%        79.0%        93.3%      |
|TERMINAL (d)           | 39/39 (100%) 26/26 (100%) 26/26 (100%) 23/23 (100%)| 21/32 (66%)  19/23 (83%)  26/35 (74%)  32/35 (91%) |
|FIRST INCIDENCE (DAYS) |   377          409          459          408       |   466          436          589          305       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.015 *    P=0.006 **   P=0.004 **   P=0.002 ** |  P=0.516      P=0.037 *    P=0.402N     P=0.225    |
|INCIDENTAL TUMOR       |  P=0.153N     P=0.500N     P=0.702      P=0.378N   |  P=0.041 *    P=0.283      P=0.579      P=0.033 *  |
|LOGISTIC REGRESSION    |  P=0.134N     P=0.746N     P=0.809      P=0.345N   |  P=0.066      P=0.187      P=0.547N     P=0.048 *  |
|COCHRAN-ARMITAGE       |  P=0.238N                                          |  P=0.052                                           |
|FISHER EXACT           |               P=0.369N     P=0.652      P=0.243N   |               P=0.308      P=0.585N     P=0.050    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 22/50 (44%)  18/51 (35%)  28/51 (55%)  39/50 (78%) | 14/50 (28%)  19/51 (37%)  13/50 (26%)  10/50 (20%) |
|ADJUSTED (b)           |  52.1%        43.5%        65.0%        82.3%      |  33.4%        47.7%        27.6%        24.0%      |
|TERMINAL (d)           | 19/39 (49%)   5/26 (19%)  12/26 (46%)  15/23 (65%) |  6/32 (19%)   4/23 (17%)   3/35 (9%)    5/35 (14%) |
|FIRST INCIDENCE (DAYS) |   495          409          290          390       |   495          525          319          305       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.444      P=0.021 *    P<0.001 ** |  P=0.060N     P=0.103      P=0.445N     P=0.224N   |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.163N     P=0.314      P=0.007 ** |  P=0.225N     P=0.465      P=0.578      P=0.287N   |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.256N     P=0.181      P<0.001 ** |  P=0.143N     P=0.348      P=0.593N     P=0.245N   |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.082N                                          |
|FISHER EXACT           |               P=0.245N     P=0.185      P<0.001 ** |               P=0.218      P=0.500N     P=0.241N   |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05036 TEST: 01                                                 PAGE  26
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |   0 UG/KG      21 UG/KG     70 UG/KG     210 UG/   |
|                       |                                          KG        |                                          KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 47/50 (94%)  47/51 (92%)  50/51 (98%)  50/50 (100%)| 39/50 (78%)  44/51 (86%)  40/50 (80%)  45/50 (90%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  81.2%        93.6%        81.6%        95.7%      |
|TERMINAL (d)           | 39/39 (100%) 26/26 (100%) 26/26 (100%) 23/23 (100%)| 23/32 (72%)  20/23 (87%)  26/35 (74%)  33/35 (94%) |
|FIRST INCIDENCE (DAYS) |   377          409          290          390       |   466          436          319          305       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.001 **   P=0.004 **   P=0.002 **   P<0.001 ** |  P=0.365N     P=0.027 *    P=0.457N     P=0.356    |
|INCIDENTAL TUMOR       |  P=0.059      P=0.771      P=0.234      P=0.331    |  P=0.067      P=0.250      P=0.442      P=0.064    |
|LOGISTIC REGRESSION    |  P=0.098      P=0.696      P=0.479      P=0.290    |  P=0.094      P=0.111      P=0.442      P=0.084    |
|COCHRAN-ARMITAGE       |  P=0.048 *                                         |  P=0.120                                           |
|FISHER EXACT           |               P=0.511N     P=0.301      P=0.121    |               P=0.205      P=0.500      P=0.086    |
|=================================================================================================================================|
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (d)  Observed incidence at terminal kill.
 (f)  Beneath the control incidence are the P-values associated with the trend 
      test.  Beneath the dosed group incidence are the P-values corresponding to 
      pairwise comparisons between the controls and that dosed group.  The life
      table analysis regards tumors in animals dying  prior to terminal kill as
      being (directly or indirectly) the cause of death.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's exact tests compare directly the overall incidence rates.  
      For all tests, a negative trend is indicated by "N".
 (e)  Value of Statistic cannot be computed. 
 (I)  Interim sacrifice
 (T)  Terminal sacrifice
  #   Tumor rates based on number of animals necropsied.
 
  *   To the right of any statistical result, indicates significance at (P<=0.05).
  **  To the right of any statistical result, indicates significance at (P<=0.01).

--multipart-boundary
Content-type: text/plain
Range: bytes 183829-183829/183829


--multipart-boundary--
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.