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TDMS Study 05084-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Mason                                                 TURMERIC OLEORESIN                                  DATE: 09/10/94       
EXPERIMENT: 05084 TEST: 01                                                                                     TIME: 21:56:16       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01ES9561902          ROUTE: DOSED FEED                                                                  NTP C#: 60015        
PATHOLOGIST: R. FLEISCHMAN                                                                                     CAS: 458-37-7        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Mason                                                 TURMERIC OLEORESIN                                  DATE: 09/10/94      
EXPERIMENT: 05084 TEST: 01                                                                                     TIME: 21:56:16      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01ES9561902          ROUTE: DOSED FEED                                                                  NTP C#: 60015       
PATHOLOGIST: R. FLEISCHMAN                                                                                     CAS: 458-37-7       
 
 
 
 
 
                                                    RATS(FISCHER344)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal 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: Mason                                                 TURMERIC OLEORESIN                                  DATE: 09/10/94       
EXPERIMENT: 05084 TEST: 01                                                                                     TIME: 21:56:16       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01ES9561902          ROUTE: DOSED FEED                                                                  NTP C#: 60015        
PATHOLOGIST: R. FLEISCHMAN                                                                                     CAS: 458-37-7        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                       IN THE ANALYSIS OF THE STUDY OF TURMERIC OLEORESIN
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Benign
                                                           Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                                                           Carcinoma or Adenoma
                             Skin                          Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
                                                           Squamous Cell Papilloma
                                                           Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,
                                                            Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma
                             Testes                        Adenoma
                             All Organs                    Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Clitoral/Preputial Gland      Adenoma
                                                           Carcinoma or Adenoma
                             Mammary Gland                 Fibroadenoma
                                                           Fibroma, Fibroadenoma or Adenoma
                                                           Fibroma, Fibroadenoma, Carcinoma, or Adenoma
 
              ====================================================================================================
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 01                                                 PAGE   1
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        2,000PPM     10,000       50,000    |   0 PPM        2,000PPM     10,000       50,000    |
|                       |   MALE         MALE         PPM MALE     PPM MALE  |   FEMALE       FEMALE       PPM FEM      PPM FEM   |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    1/59 (2%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    3/60 (5%)    1/60 (2%)  |
|ADJUSTED (b)           |   3.1%         0.0%         5.0%         0.0%      |   0.0%         0.0%         9.0%         2.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/18 (0%)    0/17 (0%)    0/15 (0%)    0/17 (0%)  |  0/33 (0%)    0/27 (0%)    1/28 (4%)    1/34 (3%)  |
|FIRST INCIDENCE (DAYS) |   644          ---          707          ---       |   ---          ---          591          727 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.546N     P=0.461N     P=0.760      P=0.541N   |  P=0.549        (e)        P=0.104      P=0.506    |
|INCIDENTAL TUMOR       |  P=0.591N     P=0.500N     P=0.735N     P=0.557N   |  P=0.460        (e)        P=0.117      P=0.506    |
|LOGISTIC REGRESSION    |  P=0.525N     P=0.494N     P=0.757      P=0.518N   |  P=0.524        (e)        P=0.113      P=0.506    |
|COCHRAN-ARMITAGE       |  P=0.485N                                          |  P=0.520                                           |
|FISHER EXACT           |               P=0.500N     P=0.748      P=0.500N   |                 (e)        P=0.122      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 14/57 (25%)  20/60 (33%)  18/60 (30%)   9/59 (15%) |  3/60 (5%)    0/59 (0%)    2/60 (3%)    2/60 (3%)  |
|ADJUSTED (b)           |  49.6%        61.9%        62.9%        41.9%      |   9.1%         0.0%         6.4%         5.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  6/18 (33%)   6/17 (35%)   6/15 (40%)   5/16 (31%) |  3/33 (9%)    0/26 (0%)    1/28 (4%)    2/34 (6%)  |
|FIRST INCIDENCE (DAYS) |   609          588          634          615       |   727 (T)      ---          680          727 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.112N     P=0.259      P=0.210      P=0.299N   |  P=0.617      P=0.165N     P=0.570N     P=0.486N   |
|INCIDENTAL TUMOR       |  P=0.214N     P=0.520      P=0.515      P=0.320N   |  P=0.600      P=0.165N     P=0.537N     P=0.486N   |
|LOGISTIC REGRESSION    |  P=0.140N     P=0.458      P=0.545      P=0.258N   |  P=0.600      P=0.165N     P=0.552N     P=0.486N   |
|COCHRAN-ARMITAGE       |  P=0.029N*                                         |  P=0.567                                           |
|FISHER EXACT           |               P=0.200      P=0.326      P=0.153N   |               P=0.125N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 01                                                 PAGE   2
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        2,000PPM     10,000       50,000    |   0 PPM        2,000PPM     10,000       50,000    |
|                       |   MALE         MALE         PPM MALE     PPM MALE  |   FEMALE       FEMALE       PPM FEM      PPM FEM   |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/57 (0%)    1/60 (2%)    2/60 (3%)    1/59 (2%)  |  0/60 (0%)    0/59 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         5.9%        11.6%         6.3%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/18 (0%)    1/17 (6%)    1/15 (7%)    1/16 (6%)  |  0/33 (0%)    0/26 (0%)    0/28 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      715          729 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.568      P=0.489      P=0.214      P=0.477    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.539      P=0.489      P=0.272      P=0.477    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.534      P=0.489      P=0.224      P=0.477    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.600                                           |    (e)                                             |
|FISHER EXACT           |               P=0.513      P=0.261      P=0.509    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 14/57 (25%)  21/60 (35%)  19/60 (32%)   9/59 (15%) |  3/60 (5%)    0/59 (0%)    2/60 (3%)    2/60 (3%)  |
|ADJUSTED (b)           |  49.6%        65.3%        67.1%        41.9%      |   9.1%         0.0%         6.4%         5.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  6/18 (33%)   7/17 (41%)   7/15 (47%)   5/16 (31%) |  3/33 (9%)    0/26 (0%)    1/28 (4%)    2/34 (6%)  |
|FIRST INCIDENCE (DAYS) |   609          588          634          615       |   727 (T)      ---          680          727 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.091N     P=0.203      P=0.157      P=0.299N   |  P=0.617      P=0.165N     P=0.570N     P=0.486N   |
|INCIDENTAL TUMOR       |  P=0.172N     P=0.427      P=0.414      P=0.320N   |  P=0.600      P=0.165N     P=0.537N     P=0.486N   |
|LOGISTIC REGRESSION    |  P=0.114N     P=0.375      P=0.440      P=0.258N   |  P=0.600      P=0.165N     P=0.552N     P=0.486N   |
|COCHRAN-ARMITAGE       |  P=0.022N*                                         |  P=0.567                                           |
|FISHER EXACT           |               P=0.151      P=0.259      P=0.153N   |               P=0.125N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 01                                                 PAGE   3
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        2,000PPM     10,000       50,000    |   0 PPM        2,000PPM     10,000       50,000    |
|                       |   MALE         MALE         PPM MALE     PPM MALE  |   FEMALE       FEMALE       PPM FEM      PPM FEM   |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Oligodendroglioma, Glioma, or Astrocytoma                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    2/60 (3%)    1/60 (2%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         3.9%         6.7%         0.0%      |   0.0%         0.0%         3.6%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/18 (0%)    0/17 (0%)    1/15 (7%)    0/17 (0%)  |  0/33 (0%)    0/27 (0%)    1/28 (4%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          337          729 (T)      ---       |   ---          ---          727 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.384N     P=0.262      P=0.464        (e)      |  P=0.737N       (e)        P=0.467        (e)      |
|INCIDENTAL TUMOR       |  P=0.367N     P=0.500      P=0.464        (e)      |  P=0.737N       (e)        P=0.467        (e)      |
|LOGISTIC REGRESSION    |  P=0.318N     P=0.209      P=0.464        (e)      |  P=0.737N       (e)        P=0.467        (e)      |
|COCHRAN-ARMITAGE       |  P=0.360N                                          |  P=0.763N                                          |
|FISHER EXACT           |               P=0.248      P=0.500        (e)      |                 (e)        P=0.500        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/58 (5%)    5/58 (9%)    2/59 (3%)    3/60 (5%)  |  7/60 (12%)  13/58 (22%)  16/57 (28%)  17/58 (29%) |
|ADJUSTED (b)           |  14.8%        14.6%        13.3%        10.5%      |  17.6%        40.4%        47.3%        47.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    1/10 (10%)   0/10 (0%)    0/9 (0%)   |  2/10 (20%)   1/10 (10%)   1/10 (10%)   1/9 (11%)  |
|TERMINAL (d)           |  2/17 (12%)   1/17 (6%)    2/15 (13%)   1/17 (6%)  |  4/33 (12%)   9/26 (35%)  11/28 (39%)  15/33 (45%) |
|FIRST INCIDENCE (DAYS) |   671          459 (I)      729 (T)      374       |   455 (I)      457 (I)      455 (I)      457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.549N     P=0.413      P=0.550N     P=0.635    |  P=0.121      P=0.054      P=0.015 *    P=0.017 *  |
|INCIDENTAL TUMOR       |  P=0.520N     P=0.464      P=0.500N     P=0.655    |  P=0.067      P=0.076      P=0.014 *    P=0.016 *  |
|LOGISTIC REGRESSION    |  P=0.525N     P=0.390      P=0.490N     P=0.649    |  P=0.066      P=0.092      P=0.015 *    P=0.015 *  |
|COCHRAN-ARMITAGE       |  P=0.472N                                          |  P=0.061                                           |
|FISHER EXACT           |               P=0.358      P=0.492N     P=0.644N   |               P=0.095      P=0.022 *    P=0.015 *  |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 01                                                 PAGE   4
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        2,000PPM     10,000       50,000    |   0 PPM        2,000PPM     10,000       50,000    |
|                       |   MALE         MALE         PPM MALE     PPM MALE  |   FEMALE       FEMALE       PPM FEM      PPM FEM   |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/58 (3%)    2/58 (3%)    1/59 (2%)    1/60 (2%)  |  1/60 (2%)    4/58 (7%)    0/57 (0%)    0/58 (0%)  |
|ADJUSTED (b)           |   8.1%         5.7%         2.2%         5.9%      |   3.0%        13.8%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    1/10 (10%)   0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/17 (6%)    0/17 (0%)    0/15 (0%)    1/17 (6%)  |  1/33 (3%)    3/26 (12%)   0/28 (0%)    0/33 (0%)  |
|FIRST INCIDENCE (DAYS) |   529          459 (I)      467          729 (T)   |   727 (T)      654          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.473N     P=0.667N     P=0.514N     P=0.531N   |  P=0.121N     P=0.128      P=0.533N     P=0.500N   |
|INCIDENTAL TUMOR       |  P=0.298N     P=0.623      P=0.738N     P=0.443N   |  P=0.131N     P=0.157      P=0.533N     P=0.500N   |
|LOGISTIC REGRESSION    |  P=0.406N     P=0.681      P=0.486N     P=0.523N   |  P=0.130N     P=0.155      P=0.533N     P=0.500N   |
|COCHRAN-ARMITAGE       |  P=0.415N                                          |  P=0.137N                                          |
|FISHER EXACT           |               P=0.691N     P=0.494N     P=0.487N   |               P=0.172      P=0.513N     P=0.508N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/58 (9%)    7/58 (12%)   3/59 (5%)    4/60 (7%)  |  8/60 (13%)  17/58 (29%)  16/57 (28%)  17/58 (29%) |
|ADJUSTED (b)           |  22.3%        19.5%        15.2%        16.0%      |  20.5%        52.2%        47.3%        47.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    2/10 (20%)   0/10 (0%)    0/9 (0%)   |  2/10 (20%)   1/10 (10%)   1/10 (10%)   1/9 (11%)  |
|TERMINAL (d)           |  3/17 (18%)   1/17 (6%)    2/15 (13%)   2/17 (12%) |  5/33 (15%)  12/26 (46%)  11/28 (39%)  15/33 (45%) |
|FIRST INCIDENCE (DAYS) |   529          459 (I)      467          374       |   455 (I)      457 (I)      455 (I)      457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.431N     P=0.445      P=0.402N     P=0.541N   |  P=0.278      P=0.012 *    P=0.026 *    P=0.030 *  |
|INCIDENTAL TUMOR       |  P=0.303N     P=0.418      P=0.499N     P=0.473N   |  P=0.181      P=0.020 *    P=0.026 *    P=0.029 *  |
|LOGISTIC REGRESSION    |  P=0.373N     P=0.397      P=0.337N     P=0.528N   |  P=0.176      P=0.026 *    P=0.027 *    P=0.027 *  |
|COCHRAN-ARMITAGE       |  P=0.338N                                          |  P=0.163                                           |
|FISHER EXACT           |               P=0.381      P=0.349N     P=0.478N   |               P=0.028 *    P=0.040 *    P=0.028 *  |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 01                                                 PAGE   5
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        2,000PPM     10,000       50,000    |   0 PPM        2,000PPM     10,000       50,000    |
|                       |   MALE         MALE         PPM MALE     PPM MALE  |   FEMALE       FEMALE       PPM FEM      PPM FEM   |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/57 (4%)    1/60 (2%)    1/58 (2%)    3/58 (5%)  |  2/59 (3%)    0/60 (0%)    0/60 (0%)    1/59 (2%)  |
|ADJUSTED (b)           |   9.0%         3.2%         2.4%         9.5%      |   6.1%         0.0%         0.0%         2.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/17 (6%)    0/17 (0%)    0/15 (0%)    0/17 (0%)  |  2/33 (6%)    0/27 (0%)    0/28 (0%)    1/34 (3%)  |
|FIRST INCIDENCE (DAYS) |   662          696          568          522       |   727 (T)      ---          ---          727 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.190      P=0.456N     P=0.499N     P=0.448    |  P=0.710N     P=0.283N     P=0.275N     P=0.490N   |
|INCIDENTAL TUMOR       |  P=0.210      P=0.380N     P=0.481N     P=0.459    |  P=0.710N     P=0.283N     P=0.275N     P=0.490N   |
|LOGISTIC REGRESSION    |  P=0.169      P=0.439N     P=0.494N     P=0.480    |  P=0.710N     P=0.283N     P=0.275N     P=0.490N   |
|COCHRAN-ARMITAGE       |  P=0.260                                           |  P=0.680                                           |
|FISHER EXACT           |               P=0.481N     P=0.493N     P=0.508    |               P=0.244N     P=0.244N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/57 (4%)    1/60 (2%)    2/58 (3%)    3/58 (5%)  |  3/59 (5%)    0/60 (0%)    0/60 (0%)    2/59 (3%)  |
|ADJUSTED (b)           |   9.0%         3.2%         8.9%         9.5%      |   9.1%         0.0%         0.0%         5.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/17 (6%)    0/17 (0%)    1/15 (7%)    0/17 (0%)  |  3/33 (9%)    0/27 (0%)    0/28 (0%)    2/34 (6%)  |
|FIRST INCIDENCE (DAYS) |   662          696          568          522       |   727 (T)      ---          ---          727 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.238      P=0.456N     P=0.682      P=0.448    |  P=0.529      P=0.158N     P=0.151N     P=0.486N   |
|INCIDENTAL TUMOR       |  P=0.261      P=0.380N     P=0.691N     P=0.459    |  P=0.529      P=0.158N     P=0.151N     P=0.486N   |
|LOGISTIC REGRESSION    |  P=0.269      P=0.439N     P=0.687N     P=0.480    |  P=0.529      P=0.158N     P=0.151N     P=0.486N   |
|COCHRAN-ARMITAGE       |  P=0.307                                           |  P=0.474                                           |
|FISHER EXACT           |               P=0.481N     P=0.684N     P=0.508    |               P=0.119N     P=0.119N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 01                                                 PAGE   6
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        2,000PPM     10,000       50,000    |   0 PPM        2,000PPM     10,000       50,000    |
|                       |   MALE         MALE         PPM MALE     PPM MALE  |   FEMALE       FEMALE       PPM FEM      PPM FEM   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    1/60 (2%)    4/60 (7%)    3/60 (5%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         2.9%        15.8%         9.3%      |   3.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    1/10 (10%)   1/9 (11%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/18 (0%)    0/17 (0%)    0/15 (0%)    1/17 (6%)  |  1/33 (3%)    0/27 (0%)    0/28 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          660          459 (I)      374       |   727 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.149      P=0.531      P=0.058      P=0.111    |  P=0.563N     P=0.540N     P=0.533N     P=0.494N   |
|INCIDENTAL TUMOR       |  P=0.137      P=0.605      P=0.109      P=0.142    |  P=0.563N     P=0.540N     P=0.533N     P=0.494N   |
|LOGISTIC REGRESSION    |  P=0.208      P=0.513      P=0.062      P=0.157    |  P=0.563N     P=0.540N     P=0.533N     P=0.494N   |
|COCHRAN-ARMITAGE       |  P=0.197                                           |  P=0.588N                                          |
|FISHER EXACT           |               P=0.500      P=0.059      P=0.122    |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    1/60 (2%)    5/60 (8%)    4/60 (7%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   5.6%         2.9%        19.4%        15.0%      |   3.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    1/10 (10%)   1/9 (11%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/18 (6%)    0/17 (0%)    0/15 (0%)    2/17 (12%) |  1/33 (3%)    0/27 (0%)    0/28 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      660          459 (I)      374       |   727 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.129      P=0.750N     P=0.089      P=0.161    |  P=0.563N     P=0.540N     P=0.533N     P=0.494N   |
|INCIDENTAL TUMOR       |  P=0.109      P=0.711N     P=0.168      P=0.192    |  P=0.563N     P=0.540N     P=0.533N     P=0.494N   |
|LOGISTIC REGRESSION    |  P=0.150      P=0.733N     P=0.102      P=0.175    |  P=0.563N     P=0.540N     P=0.533N     P=0.494N   |
|COCHRAN-ARMITAGE       |  P=0.174                                           |  P=0.588N                                          |
|FISHER EXACT           |               P=0.752N     P=0.103      P=0.182    |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 01                                                 PAGE   7
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        2,000PPM     10,000       50,000    |   0 PPM        2,000PPM     10,000       50,000    |
|                       |   MALE         MALE         PPM MALE     PPM MALE  |   FEMALE       FEMALE       PPM FEM      PPM FEM   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    1/60 (2%)    5/60 (8%)    4/60 (7%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   5.6%         2.9%        19.4%        15.0%      |   3.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    1/10 (10%)   1/9 (11%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/18 (6%)    0/17 (0%)    0/15 (0%)    2/17 (12%) |  1/33 (3%)    0/27 (0%)    0/28 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      660          459 (I)      374       |   727 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.129      P=0.750N     P=0.089      P=0.161    |  P=0.563N     P=0.540N     P=0.533N     P=0.494N   |
|INCIDENTAL TUMOR       |  P=0.109      P=0.711N     P=0.168      P=0.192    |  P=0.563N     P=0.540N     P=0.533N     P=0.494N   |
|LOGISTIC REGRESSION    |  P=0.150      P=0.733N     P=0.102      P=0.175    |  P=0.563N     P=0.540N     P=0.533N     P=0.494N   |
|COCHRAN-ARMITAGE       |  P=0.174                                           |  P=0.588N                                          |
|FISHER EXACT           |               P=0.752N     P=0.103      P=0.182    |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/59 (3%)    2/60 (3%)    5/60 (8%)    2/60 (3%)  |  1/60 (2%)    0/60 (0%)    2/60 (3%)    1/60 (2%)  |
|ADJUSTED (b)           |   8.2%         6.3%        18.6%        11.8%      |   3.0%         0.0%         6.8%         2.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    1/10 (10%)   0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/17 (6%)    0/17 (0%)    2/15 (13%)   2/17 (12%) |  1/33 (3%)    0/27 (0%)    1/28 (4%)    1/34 (3%)  |
|FIRST INCIDENCE (DAYS) |   543          611          456 (I)      729 (T)   |   727 (T)      ---          708          727 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.579N     P=0.651N     P=0.205      P=0.673    |  P=0.658      P=0.540N     P=0.448      P=0.755N   |
|INCIDENTAL TUMOR       |  P=0.369N     P=0.619      P=0.089      P=0.652N   |  P=0.625      P=0.540N     P=0.491      P=0.755N   |
|LOGISTIC REGRESSION    |  P=0.552N     P=0.673N     P=0.227      P=0.656    |  P=0.642      P=0.540N     P=0.457      P=0.755N   |
|COCHRAN-ARMITAGE       |  P=0.517N                                          |  P=0.617                                           |
|FISHER EXACT           |               P=0.684N     P=0.226      P=0.684N   |               P=0.500N     P=0.500      P=0.752N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 01                                                 PAGE   8
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        2,000PPM     10,000       50,000    |   0 PPM        2,000PPM     10,000       50,000    |
|                       |   MALE         MALE         PPM MALE     PPM MALE  |   FEMALE       FEMALE       PPM FEM      PPM FEM   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/59 (5%)    3/60 (5%)    5/60 (8%)    2/60 (3%)  |  1/60 (2%)    1/60 (2%)    2/60 (3%)    1/60 (2%)  |
|ADJUSTED (b)           |  13.9%        11.9%        18.6%        11.8%      |   3.0%         3.7%         6.8%         2.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    1/10 (10%)   0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  2/17 (12%)   1/17 (6%)    2/15 (13%)   2/17 (12%) |  1/33 (3%)    1/27 (4%)    1/28 (4%)    1/34 (3%)  |
|FIRST INCIDENCE (DAYS) |   543          611          456 (I)      729 (T)   |   727 (T)      727 (T)      708          727 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.407N     P=0.626N     P=0.330      P=0.523N   |  P=0.571N     P=0.717      P=0.448      P=0.755N   |
|INCIDENTAL TUMOR       |  P=0.238N     P=0.597      P=0.182      P=0.455N   |  P=0.607N     P=0.717      P=0.491      P=0.755N   |
|LOGISTIC REGRESSION    |  P=0.411N     P=0.606N     P=0.366      P=0.554N   |  P=0.592N     P=0.717      P=0.457      P=0.755N   |
|COCHRAN-ARMITAGE       |  P=0.356N                                          |  P=0.627N                                          |
|FISHER EXACT           |               P=0.652N     P=0.368      P=0.492N   |               P=0.752N     P=0.500      P=0.752N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |  2/60 (3%)    1/60 (2%)    2/60 (3%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         1.7%         0.0%      |   6.1%         3.7%         6.8%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/18 (0%)    0/17 (0%)    0/15 (0%)    0/17 (0%)  |  2/33 (6%)    1/27 (4%)    1/28 (4%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          337          ---       |   727 (T)      727 (T)      708          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.764N       (e)        P=0.493        (e)      |  P=0.186N     P=0.570N     P=0.637      P=0.232N   |
|INCIDENTAL TUMOR       |  P=0.787N       (e)          (e)          (e)      |  P=0.204N     P=0.570N     P=0.673      P=0.232N   |
|LOGISTIC REGRESSION    |  P=0.727N       (e)        P=0.732        (e)      |  P=0.194N     P=0.570N     P=0.650      P=0.232N   |
|COCHRAN-ARMITAGE       |  P=0.763N                                          |  P=0.214N                                          |
|FISHER EXACT           |                 (e)        P=0.500        (e)      |               P=0.500N     P=0.691N     P=0.248N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 01                                                 PAGE   9
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        2,000PPM     10,000       50,000    |   0 PPM        2,000PPM     10,000       50,000    |
|                       |   MALE         MALE         PPM MALE     PPM MALE  |   FEMALE       FEMALE       PPM FEM      PPM FEM   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |  3/60 (5%)    1/60 (2%)    2/60 (3%)    0/60 (0%)  |
|ADJUSTED (b)           |   3.6%         0.0%         1.7%         0.0%      |   9.1%         3.7%         6.8%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/18 (0%)    0/17 (0%)    0/15 (0%)    0/17 (0%)  |  3/33 (9%)    1/27 (4%)    1/28 (4%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   676          ---          337          ---       |   727 (T)      727 (T)      708          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.514N     P=0.461N     P=0.752      P=0.531N   |  P=0.126N     P=0.378N     P=0.571N     P=0.115N   |
|INCIDENTAL TUMOR       |  P=0.546N     P=0.395N     P=0.414N     P=0.573N   |  P=0.138N     P=0.378N     P=0.537N     P=0.115N   |
|LOGISTIC REGRESSION    |  P=0.423N     P=0.480N     P=0.729N     P=0.527N   |  P=0.131N     P=0.378N     P=0.560N     P=0.115N   |
|COCHRAN-ARMITAGE       |  P=0.486N                                          |  P=0.149N                                          |
|FISHER EXACT           |               P=0.500N     P=0.752N     P=0.500N   |               P=0.309N     P=0.500N     P=0.122N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    1/60 (2%)    1/60 (2%)  | 13/60 (22%)  22/60 (37%)  19/60 (32%)  16/60 (27%) |
|ADJUSTED (b)           |   0.0%         0.0%         3.3%         5.9%      |  36.5%        61.4%        52.1%        42.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/18 (0%)    0/17 (0%)    0/15 (0%)    1/17 (6%)  | 11/33 (33%)  14/27 (52%)  11/28 (39%)  13/34 (38%) |
|FIRST INCIDENCE (DAYS) |   ---          ---          662          729 (T)   |   517          552          489          598       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.353        (e)        P=0.500      P=0.489    |  P=0.252N     P=0.016 *    P=0.071      P=0.361    |
|INCIDENTAL TUMOR       |  P=0.300        (e)        P=0.586      P=0.489    |  P=0.407N     P=0.035 *    P=0.121      P=0.339    |
|LOGISTIC REGRESSION    |  P=0.324        (e)        P=0.499      P=0.489    |  P=0.364N     P=0.036 *    P=0.084      P=0.334    |
|COCHRAN-ARMITAGE       |  P=0.376                                           |  P=0.414N                                          |
|FISHER EXACT           |                 (e)        P=0.500      P=0.500    |               P=0.054      P=0.151      P=0.335    |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 01                                                 PAGE  10
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        2,000PPM     10,000       50,000    |   0 PPM        2,000PPM     10,000       50,000    |
|                       |   MALE         MALE         PPM MALE     PPM MALE  |   FEMALE       FEMALE       PPM FEM      PPM FEM   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    1/60 (2%)    1/60 (2%)  | 13/60 (22%)  22/60 (37%)  19/60 (32%)  16/60 (27%) |
|ADJUSTED (b)           |   3.6%         0.0%         3.3%         5.9%      |  36.5%        61.4%        52.1%        42.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/18 (0%)    0/17 (0%)    0/15 (0%)    1/17 (6%)  | 11/33 (33%)  14/27 (52%)  11/28 (39%)  13/34 (38%) |
|FIRST INCIDENCE (DAYS) |   676          ---          662          729 (T)   |   517          552          489          598       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.534      P=0.461N     P=0.756      P=0.737    |  P=0.252N     P=0.016 *    P=0.071      P=0.361    |
|INCIDENTAL TUMOR       |  P=0.463      P=0.395N     P=0.664N     P=0.713    |  P=0.407N     P=0.035 *    P=0.121      P=0.339    |
|LOGISTIC REGRESSION    |  P=0.520      P=0.480N     P=0.761      P=0.729    |  P=0.364N     P=0.036 *    P=0.084      P=0.334    |
|COCHRAN-ARMITAGE       |  P=0.574                                           |  P=0.414N                                          |
|FISHER EXACT           |               P=0.500N     P=0.752N     P=0.752N   |               P=0.054      P=0.151      P=0.335    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    2/60 (3%)    1/60 (2%)  | 14/60 (23%)  23/60 (38%)  20/60 (33%)  16/60 (27%) |
|ADJUSTED (b)           |   3.6%         0.0%         5.0%         5.9%      |  39.4%        64.4%        54.9%        42.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/18 (0%)    0/17 (0%)    0/15 (0%)    1/17 (6%)  | 12/33 (36%)  15/27 (56%)  12/28 (43%)  13/34 (38%) |
|FIRST INCIDENCE (DAYS) |   676          ---          337          729 (T)   |   517          552          489          598       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.583      P=0.461N     P=0.492      P=0.737    |  P=0.179N     P=0.015 *    P=0.068      P=0.448    |
|INCIDENTAL TUMOR       |  P=0.540      P=0.395N     P=0.664N     P=0.713    |  P=0.302N     P=0.033 *    P=0.117      P=0.425    |
|LOGISTIC REGRESSION    |  P=0.627      P=0.480N     P=0.521      P=0.729    |  P=0.271N     P=0.036 *    P=0.082      P=0.421    |
|COCHRAN-ARMITAGE       |  P=0.617                                           |  P=0.325N                                          |
|FISHER EXACT           |               P=0.500N     P=0.500      P=0.752N   |               P=0.057      P=0.156      P=0.417    |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 01                                                 PAGE  11
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        2,000PPM     10,000       50,000    |   0 PPM        2,000PPM     10,000       50,000    |
|                       |   MALE         MALE         PPM MALE     PPM MALE  |   FEMALE       FEMALE       PPM FEM      PPM FEM   |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    2/60 (3%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         5.9%      |   2.1%         0.0%         0.0%         5.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/18 (0%)    0/17 (0%)    0/15 (0%)    1/17 (6%)  |  0/33 (0%)    0/27 (0%)    0/28 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          729 (T)   |   517          ---          ---          661       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.238        (e)          (e)        P=0.489    |  P=0.176      P=0.500N     P=0.513N     P=0.498    |
|INCIDENTAL TUMOR       |  P=0.238        (e)          (e)        P=0.489    |  P=0.131      P=0.638N     P=0.362N     P=0.526    |
|LOGISTIC REGRESSION    |  P=0.238        (e)          (e)        P=0.489    |  P=0.097      P=0.504N     P=0.467N     P=0.426    |
|COCHRAN-ARMITAGE       |  P=0.237                                           |  P=0.168                                           |
|FISHER EXACT           |                 (e)          (e)        P=0.500    |               P=0.500N     P=0.500N     P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Granulosa Cell Tumor Benign                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  2/60 (3%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |                                                    |   5.7%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |                                                    |  1/33 (3%)    0/27 (0%)    0/28 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   692          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.335N     P=0.262N     P=0.271N     P=0.233N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.366N     P=0.192N     P=0.229N     P=0.236N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.343N     P=0.246N     P=0.259N     P=0.236N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.350N                                          |
|FISHER EXACT           |                                                    |               P=0.248N     P=0.248N     P=0.248N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 01                                                 PAGE  12
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        2,000PPM     10,000       50,000    |   0 PPM        2,000PPM     10,000       50,000    |
|                       |   MALE         MALE         PPM MALE     PPM MALE  |   FEMALE       FEMALE       PPM FEM      PPM FEM   |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Granulosa Cell Tumor, Benign, Malignant, NOS                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  2/60 (3%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |                                                    |   5.7%         0.0%         3.6%         0.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |                                                    |  1/33 (3%)    0/27 (0%)    1/28 (4%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   692          ---          727 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.297N     P=0.262N     P=0.552N     P=0.233N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.321N     P=0.192N     P=0.509N     P=0.236N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.307N     P=0.246N     P=0.538N     P=0.236N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.318N                                          |
|FISHER EXACT           |                                                    |               P=0.248N     P=0.500N     P=0.248N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 26/60 (43%)  18/60 (30%)  17/59 (29%)  14/58 (24%) | 28/60 (47%)  27/58 (47%)  25/60 (42%)  25/60 (42%) |
|ADJUSTED (b)           |  60.8%        59.5%        61.1%        49.4%      |  64.2%        64.9%        59.8%        60.1%      |
|INTERIM SACRIFICE 1 (c)|  3/10 (30%)   1/10 (10%)   1/10 (10%)   1/9 (11%)  |  2/10 (20%)   1/10 (10%)   1/10 (10%)   1/9 (11%)  |
|TERMINAL (d)           |  5/18 (28%)   7/17 (41%)   6/14 (43%)   5/17 (29%) | 18/33 (55%)  13/26 (50%)  12/28 (43%)  18/34 (53%) |
|FIRST INCIDENCE (DAYS) |   435          459 (I)      456 (I)      456 (I)   |   455 (I)      444          455          367       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.183N     P=0.082N     P=0.150N     P=0.088N   |  P=0.210N     P=0.376      P=0.538      P=0.334N   |
|INCIDENTAL TUMOR       |  P=0.086N     P=0.119N     P=0.113N     P=0.045N*  |  P=0.393N     P=0.551N     P=0.365N     P=0.404N   |
|LOGISTIC REGRESSION    |  P=0.163N     P=0.074N     P=0.077N     P=0.052N   |  P=0.324N     P=0.559      P=0.433N     P=0.365N   |
|COCHRAN-ARMITAGE       |  P=0.067N                                          |  P=0.337N                                          |
|FISHER EXACT           |               P=0.092N     P=0.072N     P=0.022N*  |               P=0.568N     P=0.357N     P=0.357N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 01                                                 PAGE  13
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        2,000PPM     10,000       50,000    |   0 PPM        2,000PPM     10,000       50,000    |
|                       |   MALE         MALE         PPM MALE     PPM MALE  |   FEMALE       FEMALE       PPM FEM      PPM FEM   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/59 (0%)    0/58 (0%)  |  2/60 (3%)    0/58 (0%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   5.5%         0.0%         2.3%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/18 (0%)    0/17 (0%)    0/14 (0%)    0/17 (0%)  |  1/33 (3%)    0/26 (0%)    0/28 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   676          ---          526          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.313N     P=0.272N     P=0.536N     P=0.242N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.304N     P=0.204N     P=0.412N     P=0.236N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.315N     P=0.254N     P=0.502N     P=0.237N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.315N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.256N     P=0.500N     P=0.248N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 26/60 (43%)  18/60 (30%)  17/59 (29%)  14/58 (24%) | 30/60 (50%)  27/58 (47%)  26/60 (43%)  25/60 (42%) |
|ADJUSTED (b)           |  60.8%        59.5%        61.1%        49.4%      |  67.4%        64.9%        60.8%        60.1%      |
|INTERIM SACRIFICE 1 (c)|  3/10 (30%)   1/10 (10%)   1/10 (10%)   1/9 (11%)  |  2/10 (20%)   1/10 (10%)   1/10 (10%)   1/9 (11%)  |
|TERMINAL (d)           |  5/18 (28%)   7/17 (41%)   6/14 (43%)   5/17 (29%) | 19/33 (58%)  13/26 (50%)  12/28 (43%)  18/34 (53%) |
|FIRST INCIDENCE (DAYS) |   435          459 (I)      456 (I)      456 (I)   |   455 (I)      444          455          367       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.183N     P=0.082N     P=0.150N     P=0.088N   |  P=0.158N     P=0.493      P=0.536N     P=0.223N   |
|INCIDENTAL TUMOR       |  P=0.086N     P=0.119N     P=0.113N     P=0.045N*  |  P=0.298N     P=0.387N     P=0.271N     P=0.263N   |
|LOGISTIC REGRESSION    |  P=0.163N     P=0.074N     P=0.077N     P=0.052N   |  P=0.242N     P=0.445N     P=0.360N     P=0.232N   |
|COCHRAN-ARMITAGE       |  P=0.067N                                          |  P=0.256N                                          |
|FISHER EXACT           |               P=0.092N     P=0.072N     P=0.022N*  |               P=0.425N     P=0.292N     P=0.232N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 01                                                 PAGE  14
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        2,000PPM     10,000       50,000    |   0 PPM        2,000PPM     10,000       50,000    |
|                       |   MALE         MALE         PPM MALE     PPM MALE  |   FEMALE       FEMALE       PPM FEM      PPM FEM   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    3/60 (5%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%        10.7%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/18 (0%)    0/17 (0%)    0/15 (0%)    0/17 (0%)  |  0/33 (0%)    0/27 (0%)    0/28 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          634          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.613N       (e)        P=0.127        (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.692N       (e)        P=0.165        (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.585N       (e)        P=0.119        (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.540N                                          |    (e)                                             |
|FISHER EXACT           |                 (e)        P=0.122        (e)      |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/60 (8%)    0/60 (0%)    2/60 (3%)    1/60 (2%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  19.3%         0.0%        10.0%         3.6%      |   3.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  2/18 (11%)   0/17 (0%)    1/15 (7%)    0/17 (0%)  |  1/33 (3%)    0/27 (0%)    0/28 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   589          ---          674          633       |   727 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.334N     P=0.029N*    P=0.254N     P=0.145N   |  P=0.563N     P=0.540N     P=0.533N     P=0.494N   |
|INCIDENTAL TUMOR       |  P=0.367N     P=0.027N*    P=0.214N     P=0.158N   |  P=0.563N     P=0.540N     P=0.533N     P=0.494N   |
|LOGISTIC REGRESSION    |  P=0.333N     P=0.026N*    P=0.218N     P=0.131N   |  P=0.563N     P=0.540N     P=0.533N     P=0.494N   |
|COCHRAN-ARMITAGE       |  P=0.273N                                          |  P=0.588N                                          |
|FISHER EXACT           |               P=0.029N*    P=0.219N     P=0.103N   |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 01                                                 PAGE  15
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        2,000PPM     10,000       50,000    |   0 PPM        2,000PPM     10,000       50,000    |
|                       |   MALE         MALE         PPM MALE     PPM MALE  |   FEMALE       FEMALE       PPM FEM      PPM FEM   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/60 (7%)    0/60 (0%)    2/60 (3%)    1/60 (2%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  17.0%         0.0%        10.0%         3.6%      |   3.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  2/18 (11%)   0/17 (0%)    1/15 (7%)    0/17 (0%)  |  1/33 (3%)    0/27 (0%)    0/28 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   609          ---          674          633       |   727 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.422N     P=0.058N     P=0.386N     P=0.227N   |  P=0.563N     P=0.540N     P=0.533N     P=0.494N   |
|INCIDENTAL TUMOR       |  P=0.463N     P=0.052N     P=0.324N     P=0.248N   |  P=0.563N     P=0.540N     P=0.533N     P=0.494N   |
|LOGISTIC REGRESSION    |  P=0.440N     P=0.047N*    P=0.339N     P=0.221N   |  P=0.563N     P=0.540N     P=0.533N     P=0.494N   |
|COCHRAN-ARMITAGE       |  P=0.363N                                          |  P=0.588N                                          |
|FISHER EXACT           |               P=0.059N     P=0.340N     P=0.182N   |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/60 (8%)    0/60 (0%)    5/60 (8%)    2/60 (3%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  19.3%         0.0%        19.6%         9.2%      |   3.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  2/18 (11%)   0/17 (0%)    1/15 (7%)    1/17 (6%)  |  1/33 (3%)    0/27 (0%)    0/28 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   589          ---          634          633       |   727 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.503N     P=0.029N*    P=0.594      P=0.277N   |  P=0.563N     P=0.540N     P=0.533N     P=0.494N   |
|INCIDENTAL TUMOR       |  P=0.574N     P=0.027N*    P=0.583N     P=0.301N   |  P=0.563N     P=0.540N     P=0.533N     P=0.494N   |
|LOGISTIC REGRESSION    |  P=0.506N     P=0.026N*    P=0.628      P=0.270N   |  P=0.563N     P=0.540N     P=0.533N     P=0.494N   |
|COCHRAN-ARMITAGE       |  P=0.408N                                          |  P=0.588N                                          |
|FISHER EXACT           |               P=0.029N*    P=0.628N     P=0.219N   |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 01                                                 PAGE  16
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        2,000PPM     10,000       50,000    |   0 PPM        2,000PPM     10,000       50,000    |
|                       |   MALE         MALE         PPM MALE     PPM MALE  |   FEMALE       FEMALE       PPM FEM      PPM FEM   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    1/60 (2%)    1/60 (2%)    3/60 (5%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  12.7%         2.4%         3.7%        14.5%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/18 (6%)    0/17 (0%)    0/15 (0%)    2/17 (12%) |  0/33 (0%)    0/27 (0%)    0/28 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   676          611          676          569       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.302      P=0.259N     P=0.338N     P=0.608    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.241      P=0.223N     P=0.210N     P=0.568    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.293      P=0.269N     P=0.306N     P=0.595    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.375                                           |    (e)                                             |
|FISHER EXACT           |               P=0.309N     P=0.309N     P=0.660N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/60 (8%)    2/60 (3%)    1/60 (2%)    4/60 (7%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  19.1%         5.6%         3.7%        20.2%      |   2.3%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/18 (6%)    0/17 (0%)    0/15 (0%)    3/17 (18%) |  0/33 (0%)    0/27 (0%)    0/28 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   563          611          676          569       |   603          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.354      P=0.163N     P=0.124N     P=0.572N   |  P=0.582N     P=0.505N     P=0.525N     P=0.500N   |
|INCIDENTAL TUMOR       |  P=0.270      P=0.115N     P=0.057N     P=0.630N   |  P=0.733N     P=0.443N     P=0.536N     P=0.638N   |
|LOGISTIC REGRESSION    |  P=0.351      P=0.184N     P=0.104N     P=0.588N   |  P=0.585N     P=0.500N     P=0.490N     P=0.494N   |
|COCHRAN-ARMITAGE       |  P=0.453                                           |  P=0.588N                                          |
|FISHER EXACT           |               P=0.219N     P=0.103N     P=0.500N   |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 01                                                 PAGE  17
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        2,000PPM     10,000       50,000    |   0 PPM        2,000PPM     10,000       50,000    |
|                       |   MALE         MALE         PPM MALE     PPM MALE  |   FEMALE       FEMALE       PPM FEM      PPM FEM   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    1/60 (2%)    0/60 (0%)    1/60 (2%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   7.3%         3.2%         0.0%         5.9%      |   2.3%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/18 (0%)    0/17 (0%)    0/15 (0%)    1/17 (6%)  |  0/33 (0%)    0/27 (0%)    0/28 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   563          696          ---          729 (T)   |   603          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.664N     P=0.433N     P=0.242N     P=0.544N   |  P=0.582N     P=0.505N     P=0.525N     P=0.500N   |
|INCIDENTAL TUMOR       |  P=0.695      P=0.380N     P=0.206N     P=0.582N   |  P=0.733N     P=0.443N     P=0.536N     P=0.638N   |
|LOGISTIC REGRESSION    |  P=0.657N     P=0.479N     P=0.239N     P=0.544N   |  P=0.585N     P=0.500N     P=0.490N     P=0.494N   |
|COCHRAN-ARMITAGE       |  P=0.598N                                          |  P=0.588N                                          |
|FISHER EXACT           |               P=0.500N     P=0.248N     P=0.500N   |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Schwannoma Malignant                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |  0/60 (0%)    2/60 (3%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   2.4%         0.0%         6.7%         0.0%      |   0.0%         6.1%         0.0%         2.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/18 (0%)    0/17 (0%)    1/15 (7%)    0/17 (0%)  |  0/33 (0%)    1/27 (4%)    0/28 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   543          ---          729 (T)      ---       |   ---          622          ---          659       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.522N     P=0.473N     P=0.743      P=0.549N   |  P=0.659      P=0.215        (e)        P=0.510    |
|INCIDENTAL TUMOR       |  P=0.352N     P=0.831N     P=0.653      P=0.402N   |  P=0.566      P=0.248        (e)        P=0.500    |
|LOGISTIC REGRESSION    |  P=0.502N     P=0.526N     P=0.761      P=0.469N   |  P=0.640      P=0.236        (e)        P=0.499    |
|COCHRAN-ARMITAGE       |  P=0.486N                                          |  P=0.640                                           |
|FISHER EXACT           |               P=0.500N     P=0.752N     P=0.500N   |               P=0.248        (e)        P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 01                                                 PAGE  18
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        2,000PPM     10,000       50,000    |   0 PPM        2,000PPM     10,000       50,000    |
|                       |   MALE         MALE         PPM MALE     PPM MALE  |   FEMALE       FEMALE       PPM FEM      PPM FEM   |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 40/60 (67%)  47/60 (78%)  44/60 (73%)  43/60 (72%) |                                                    |
|ADJUSTED (b)           | 100.0%        95.8%       100.0%       100.0%      |                                                    |
|INTERIM SACRIFICE 1 (c)|  3/10 (30%)   3/10 (30%)   4/10 (40%)   3/9 (33%)  |                                                    |
|TERMINAL (d)           | 18/18 (100%) 15/17 (88%)  15/15 (100%) 17/17 (100%)|                                                    |
|FIRST INCIDENCE (DAYS) |   456 (I)      459 (I)      456 (I)      456       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.203      P=0.348      P=0.188      P=0.155    |                                                    |
|INCIDENTAL TUMOR       |  P=0.065      P=0.320      P=0.266      P=0.069    |                                                    |
|LOGISTIC REGRESSION    |  P=0.037 *    P=0.272      P=0.218      P=0.023 *  |                                                    |
|COCHRAN-ARMITAGE       |  P=0.520N                                          |                                                    |
|FISHER EXACT           |               P=0.110      P=0.275      P=0.346    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/60 (7%)    8/60 (13%)   5/60 (8%)    6/60 (10%) |  6/60 (10%)   2/60 (3%)    3/60 (5%)    3/60 (5%)  |
|ADJUSTED (b)           |  14.2%        24.9%        19.0%        23.3%      |  18.2%         6.5%        10.7%         8.8%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  2/18 (11%)   1/17 (6%)    1/15 (7%)    2/17 (12%) |  6/33 (18%)   1/27 (4%)    3/28 (11%)   3/34 (9%)  |
|FIRST INCIDENCE (DAYS) |   456 (I)      602          467          538       |   727 (T)      700          727 (T)      727 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.412      P=0.246      P=0.458      P=0.310    |  P=0.350N     P=0.196N     P=0.325N     P=0.224N   |
|INCIDENTAL TUMOR       |  P=0.408      P=0.317      P=0.460      P=0.317    |  P=0.365N     P=0.165N     P=0.325N     P=0.224N   |
|LOGISTIC REGRESSION    |  P=0.461      P=0.203      P=0.499      P=0.334    |  P=0.361N     P=0.170N     P=0.325N     P=0.224N   |
|COCHRAN-ARMITAGE       |  P=0.545                                           |  P=0.430N                                          |
|FISHER EXACT           |               P=0.181      P=0.500      P=0.372    |               P=0.136N     P=0.245N     P=0.245N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 01                                                 PAGE  19
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        2,000PPM     10,000       50,000    |   0 PPM        2,000PPM     10,000       50,000    |
|                       |   MALE         MALE         PPM MALE     PPM MALE  |   FEMALE       FEMALE       PPM FEM      PPM FEM   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |  2/60 (3%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   8.3%         0.0%         0.0%         0.0%      |   5.8%         0.0%         2.6%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  1/18 (6%)    0/17 (0%)    0/15 (0%)    0/17 (0%)  |  1/33 (3%)    0/27 (0%)    0/28 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   633          ---          ---          ---       |   707          ---          591          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.376N     P=0.231N     P=0.253N     P=0.268N   |  P=0.298N     P=0.292N     P=0.548N     P=0.233N   |
|INCIDENTAL TUMOR       |  P=0.377N     P=0.246N     P=0.275N     P=0.278N   |  P=0.386N     P=0.192N     P=0.511N     P=0.236N   |
|LOGISTIC REGRESSION    |  P=0.384N     P=0.213N     P=0.238N     P=0.268N   |  P=0.317N     P=0.251N     P=0.517N     P=0.234N   |
|COCHRAN-ARMITAGE       |  P=0.350N                                          |  P=0.318N                                          |
|FISHER EXACT           |               P=0.248N     P=0.248N     P=0.248N   |               P=0.248N     P=0.500N     P=0.248N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/60 (10%)   8/60 (13%)   5/60 (8%)    6/60 (10%) |  8/60 (13%)   2/60 (3%)    4/60 (7%)    3/60 (5%)  |
|ADJUSTED (b)           |  22.0%        24.9%        19.0%        23.3%      |  23.5%         6.5%        13.0%         8.8%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  3/18 (17%)   1/17 (6%)    1/15 (7%)    2/17 (12%) |  7/33 (21%)   1/27 (4%)    3/28 (11%)   3/34 (9%)  |
|FIRST INCIDENCE (DAYS) |   456 (I)      602          467          538       |   707          700          591          727 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.535      P=0.468      P=0.546N     P=0.541    |  P=0.205N     P=0.087N     P=0.262N     P=0.090N   |
|INCIDENTAL TUMOR       |  P=0.537      P=0.549      P=0.556N     P=0.547    |  P=0.247N     P=0.052N     P=0.246N     P=0.091N   |
|LOGISTIC REGRESSION    |  P=0.581      P=0.432      P=0.504N     P=0.568    |  P=0.237N     P=0.062N     P=0.229N     P=0.087N   |
|COCHRAN-ARMITAGE       |  P=0.494N                                          |  P=0.269N                                          |
|FISHER EXACT           |               P=0.389      P=0.500N     P=0.619N   |               P=0.047N*    P=0.181N     P=0.102N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 01                                                 PAGE  20
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        2,000PPM     10,000       50,000    |   0 PPM        2,000PPM     10,000       50,000    |
|                       |   MALE         MALE         PPM MALE     PPM MALE  |   FEMALE       FEMALE       PPM FEM      PPM FEM   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    2/60 (3%)    0/60 (0%)    1/60 (2%)  |  0/60 (0%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   2.6%        11.8%         0.0%         5.9%      |   0.0%         0.0%         3.6%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/18 (0%)    2/17 (12%)   0/15 (0%)    1/17 (6%)  |  0/33 (0%)    0/27 (0%)    1/28 (4%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   553          729 (T)      ---          729 (T)   |   ---          ---          727 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.642N     P=0.506      P=0.485N     P=0.732    |  P=0.737N       (e)        P=0.467        (e)      |
|INCIDENTAL TUMOR       |  P=0.641N     P=0.487      P=0.527N     P=0.722    |  P=0.737N       (e)        P=0.467        (e)      |
|LOGISTIC REGRESSION    |  P=0.683N     P=0.530      P=0.486N     P=0.745    |  P=0.737N       (e)        P=0.467        (e)      |
|COCHRAN-ARMITAGE       |  P=0.617N                                          |  P=0.763N                                          |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.752N   |                 (e)        P=0.500        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    3/60 (5%)    0/60 (0%)    1/60 (2%)  |  0/60 (0%)    1/60 (2%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   2.6%        13.7%         0.0%         5.9%      |   0.0%         2.9%         3.6%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/18 (0%)    2/17 (12%)   0/15 (0%)    1/17 (6%)  |  0/33 (0%)    0/27 (0%)    1/28 (4%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   553          582          ---          729 (T)   |   ---          700          727 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.530N     P=0.333      P=0.485N     P=0.732    |  P=0.489N     P=0.500      P=0.467        (e)      |
|INCIDENTAL TUMOR       |  P=0.528N     P=0.294      P=0.527N     P=0.722    |  P=0.534N     P=0.623      P=0.467        (e)      |
|LOGISTIC REGRESSION    |  P=0.541N     P=0.319      P=0.486N     P=0.745    |  P=0.502N     P=0.494      P=0.467        (e)      |
|COCHRAN-ARMITAGE       |  P=0.487N                                          |  P=0.514N                                          |
|FISHER EXACT           |               P=0.309      P=0.500N     P=0.752N   |               P=0.500      P=0.500        (e)      |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 01                                                 PAGE  21
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        2,000PPM     10,000       50,000    |   0 PPM        2,000PPM     10,000       50,000    |
|                       |   MALE         MALE         PPM MALE     PPM MALE  |   FEMALE       FEMALE       PPM FEM      PPM FEM   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    | 10/60 (17%)  10/60 (17%)  11/60 (18%)   9/60 (15%) |
|ADJUSTED (b)           |                                                    |  24.2%        31.3%        33.3%        22.2%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  1/10 (10%)   0/10 (0%)    0/10 (0%)    1/9 (11%)  |
|TERMINAL (d)           |                                                    |  5/33 (15%)   7/27 (26%)   8/28 (29%)   5/34 (15%) |
|FIRST INCIDENCE (DAYS) |                                                    |   457 (I)      552          462          457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.340N     P=0.475      P=0.378      P=0.495N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.414N     P=0.531      P=0.521      P=0.529N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.431N     P=0.593      P=0.482      P=0.500N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.432N                                          |
|FISHER EXACT           |                                                    |               P=0.596N     P=0.500      P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |  2/60 (3%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         4.8%      |   5.2%         0.0%         2.4%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/18 (0%)    0/17 (0%)    0/15 (0%)    0/17 (0%)  |  1/33 (3%)    0/27 (0%)    0/28 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          695       |   574          ---          576          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.192        (e)          (e)        P=0.457    |  P=0.309N     P=0.259N     P=0.533N     P=0.236N   |
|INCIDENTAL TUMOR       |  P=0.120        (e)          (e)        P=0.427    |  P=0.419N     P=0.229N     P=0.563N     P=0.310N   |
|LOGISTIC REGRESSION    |  P=0.200        (e)          (e)        P=0.470    |  P=0.317N     P=0.238N     P=0.494N     P=0.238N   |
|COCHRAN-ARMITAGE       |  P=0.237                                           |  P=0.318N                                          |
|FISHER EXACT           |                 (e)          (e)        P=0.500    |               P=0.248N     P=0.500N     P=0.248N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 01                                                 PAGE  22
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        2,000PPM     10,000       50,000    |   0 PPM        2,000PPM     10,000       50,000    |
|                       |   MALE         MALE         PPM MALE     PPM MALE  |   FEMALE       FEMALE       PPM FEM      PPM FEM   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 27/60 (45%)  29/60 (48%)  35/60 (58%)  23/60 (38%) | 15/60 (25%)  19/60 (32%)  18/60 (30%)  21/60 (35%) |
|ADJUSTED (b)           |  76.8%        71.0%        83.0%        65.8%      |  38.7%        47.2%        44.4%        49.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    1/10 (10%)   0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           | 11/18 (61%)   7/17 (41%)   8/15 (53%)   6/17 (35%) | 10/33 (30%)   8/27 (30%)   8/28 (29%)  13/34 (38%) |
|FIRST INCIDENCE (DAYS) |   465          456 (I)      464          400       |   553          444          414          367       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.440N     P=0.524N     P=0.103      P=0.524N   |  P=0.350      P=0.178      P=0.217      P=0.193    |
|INCIDENTAL TUMOR       |  P=0.269N     P=0.542      P=0.076      P=0.444N   |  P=0.119      P=0.380      P=0.348      P=0.102    |
|LOGISTIC REGRESSION    |  P=0.475N     P=0.550N     P=0.083      P=0.581N   |  P=0.154      P=0.330      P=0.292      P=0.147    |
|COCHRAN-ARMITAGE       |  P=0.114N                                          |  P=0.210                                           |
|FISHER EXACT           |               P=0.427      P=0.100      P=0.289N   |               P=0.272      P=0.342      P=0.160    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma Benign, Malignant, NOS                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    2/60 (3%)    1/60 (2%)    1/60 (2%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         7.4%         4.3%         5.9%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/18 (0%)    0/17 (0%)    0/15 (0%)    1/17 (6%)  |  0/33 (0%)    0/27 (0%)    0/28 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          612          695          729 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.628      P=0.263      P=0.476      P=0.489    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.571      P=0.297      P=0.586      P=0.489    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.619      P=0.254      P=0.498      P=0.489    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.673                                           |    (e)                                             |
|FISHER EXACT           |               P=0.248      P=0.500      P=0.500    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 01                                                 PAGE  23
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        2,000PPM     10,000       50,000    |   0 PPM        2,000PPM     10,000       50,000    |
|                       |   MALE         MALE         PPM MALE     PPM MALE  |   FEMALE       FEMALE       PPM FEM      PPM FEM   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 54/60 (90%)  53/60 (88%)  53/60 (88%)  48/60 (80%) | 46/60 (77%)  47/60 (78%)  44/60 (73%)  44/60 (73%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  91.7%        97.8%        95.5%        97.7%      |
|INTERIM SACRIFICE 1 (c)|  7/10 (70%)   4/10 (40%)   7/10 (70%)   5/9 (56%)  |  5/10 (50%)   2/10 (20%)   2/10 (20%)   3/9 (33%)  |
|TERMINAL (d)           | 18/18 (100%) 17/17 (100%) 15/15 (100%) 17/17 (100%)| 29/33 (88%)  26/27 (96%)  26/28 (93%)  33/34 (97%) |
|FIRST INCIDENCE (DAYS) |   435          459 (I)      456 (I)      374       |   455 (I)      444          455          367       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.427      P=0.311N     P=0.441      P=0.534    |  P=0.133N     P=0.181      P=0.331      P=0.385N   |
|INCIDENTAL TUMOR       |  P=0.266N     P=0.337N     P=0.574      P=0.278N   |  P=0.375N     P=0.408      P=0.526N     P=0.494N   |
|LOGISTIC REGRESSION    |  P=0.496      P=0.289N     P=0.554      P=0.588N   |  P=0.377N     P=0.504      P=0.565N     P=0.468N   |
|COCHRAN-ARMITAGE       |  P=0.058N                                          |  P=0.352N                                          |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.100N   |               P=0.500      P=0.417N     P=0.417N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 34/60 (57%)  36/60 (60%)  40/60 (67%)  26/60 (43%) | 25/60 (42%)  25/60 (42%)  24/60 (40%)  24/60 (40%) |
|ADJUSTED (b)           |  85.8%        79.0%        88.6%        73.2%      |  56.2%        58.8%        55.2%        53.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    3/10 (30%)   0/10 (0%)    0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           | 13/18 (72%)   9/17 (53%)  10/15 (67%)   8/17 (47%) | 14/33 (42%)  11/27 (41%)  10/28 (36%)  14/34 (41%) |
|FIRST INCIDENCE (DAYS) |   465          337          337          400       |   517          444          414          367       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.257N     P=0.497N     P=0.168      P=0.335N   |  P=0.333N     P=0.390      P=0.432      P=0.472N   |
|INCIDENTAL TUMOR       |  P=0.051N     P=0.522      P=0.116      P=0.173N   |  P=0.413      P=0.405N     P=0.462N     P=0.507    |
|LOGISTIC REGRESSION    |  P=0.151N     P=0.551      P=0.131      P=0.314N   |  P=0.481      P=0.426N     P=0.523N     P=0.575    |
|COCHRAN-ARMITAGE       |  P=0.021N*                                         |  P=0.477N                                          |
|FISHER EXACT           |               P=0.427      P=0.174      P=0.101N   |               P=0.573N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 01                                                 PAGE  24
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        2,000PPM     10,000       50,000    |   0 PPM        2,000PPM     10,000       50,000    |
|                       |   MALE         MALE         PPM MALE     PPM MALE  |   FEMALE       FEMALE       PPM FEM      PPM FEM   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 56/60 (93%)  55/60 (92%)  55/60 (92%)  49/60 (82%) | 53/60 (88%)  50/60 (83%)  49/60 (82%)  49/60 (82%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  96.3%        98.0%        96.0%        98.0%      |
|INTERIM SACRIFICE 1 (c)|  7/10 (70%)   5/10 (50%)   7/10 (70%)   5/9 (56%)  |  5/10 (50%)   2/10 (20%)   2/10 (20%)   3/9 (33%)  |
|TERMINAL (d)           | 18/18 (100%) 17/17 (100%) 15/15 (100%) 17/17 (100%)| 31/33 (94%)  26/27 (96%)  26/28 (93%)  33/34 (97%) |
|FIRST INCIDENCE (DAYS) |   435          337          337          374       |   455 (I)      444          414          367       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.480      P=0.313N     P=0.439      P=0.528N   |  P=0.145N     P=0.379      P=0.426      P=0.282N   |
|INCIDENTAL TUMOR       |  P=0.057N     P=0.385N     P=0.565      P=0.120N   |  P=0.487N     P=0.231N     P=0.165N     P=0.335N   |
|LOGISTIC REGRESSION    |  P=0.317N     P=0.365N     P=0.509      P=0.394N   |  P=0.395N     P=0.248N     P=0.321N     P=0.277N   |
|COCHRAN-ARMITAGE       |  P=0.017N*                                         |  P=0.316N                                          |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.048N*  |               P=0.301N     P=0.222N     P=0.222N   |
|=================================================================================================================================|
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (c)  Observed incidence at interim kill.
          Male interim sacrifices(days):   456
          Female interim sacrifices(days): 455
 (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).