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TDMS Study 05084-02 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Mason                                                 TURMERIC OLEORESIN                                  DATE: 09/11/94       
EXPERIMENT: 05084 TEST: 02                                                                                     TIME: 00:39:08       
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        
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Mason                                                 TURMERIC OLEORESIN                                  DATE: 09/11/94      
EXPERIMENT: 05084 TEST: 02                                                                                     TIME: 00:39:08      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01ES9561902          ROUTE: DOSED FEED                                                                  NTP C#: 60015       
PATHOLOGIST: R. FLEISCHMAN                                                                                     CAS: 458-37-7       
 
 
 
 
 
                                                    MICE(B6C3F1)
                                              ----------------------------
             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
                                                    Gallbladder
                                                    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: 09/11/94       
EXPERIMENT: 05084 TEST: 02                                                                                     TIME: 00:39:08       
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 MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             All Organs                    Malignant Lymphoma And Histiocytic Sarcoma
                                                           Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
                                                            NOS, or Undifferentiated Cell Type
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                             Stomach, Forestomach          Squamous Cell Papilloma
                             All Organs                    Malignant Lymphoma And Histiocytic Sarcoma
                                                           Benign Tumors
 
              ====================================================================================================
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 02                                                 PAGE   1
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN
 
                                                 TERMINAL SACRIFICE AT 105 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   |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/60 (7%)    3/60 (5%)    1/60 (2%)    6/60 (10%) |  0/60 (0%)    2/60 (3%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   9.3%         7.0%         2.6%        13.4%      |   0.0%         4.9%         0.0%         2.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  4/43 (9%)    3/43 (7%)    0/37 (0%)    4/42 (10%) |  0/39 (0%)    2/41 (5%)    0/34 (0%)    1/42 (2%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      725          537       |   ---          729 (T)      ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.146      P=0.500N     P=0.228N     P=0.363    |  P=0.657      P=0.249        (e)        P=0.515    |
|INCIDENTAL TUMOR       |  P=0.147      P=0.500N     P=0.152N     P=0.444    |  P=0.657      P=0.249        (e)        P=0.515    |
|LOGISTIC REGRESSION    |  P=0.144      P=0.500N     P=0.205N     P=0.376    |  P=0.657      P=0.249        (e)        P=0.515    |
|COCHRAN-ARMITAGE       |  P=0.142                                           |  P=0.640                                           |
|FISHER EXACT           |               P=0.500N     P=0.182N     P=0.372    |               P=0.248        (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/60 (7%)    4/60 (7%)    1/60 (2%)    6/60 (10%) |  0/60 (0%)    2/60 (3%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   9.3%         9.1%         2.6%        13.4%      |   0.0%         4.9%         0.0%         2.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  4/43 (9%)    3/43 (7%)    0/37 (0%)    4/42 (10%) |  0/39 (0%)    2/41 (5%)    0/34 (0%)    1/42 (2%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      715          725          537       |   ---          729 (T)      ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.201      P=0.642      P=0.228N     P=0.363    |  P=0.657      P=0.249        (e)        P=0.515    |
|INCIDENTAL TUMOR       |  P=0.201      P=0.584N     P=0.152N     P=0.444    |  P=0.657      P=0.249        (e)        P=0.515    |
|LOGISTIC REGRESSION    |  P=0.198      P=0.633N     P=0.205N     P=0.376    |  P=0.657      P=0.249        (e)        P=0.515    |
|COCHRAN-ARMITAGE       |  P=0.194                                           |  P=0.640                                           |
|FISHER EXACT           |               P=0.641N     P=0.182N     P=0.372    |               P=0.248        (e)        P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 02                                                 PAGE   2
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN
 
                                                 TERMINAL SACRIFICE AT 105 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   |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    3/60 (5%)    3/60 (5%)    0/60 (0%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         7.0%         8.1%         0.0%      |   2.6%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/43 (0%)    3/43 (7%)    3/37 (8%)    0/42 (0%)  |  1/39 (3%)    0/41 (0%)    0/34 (0%)    0/42 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      729 (T)      ---       |   729 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.227N     P=0.121      P=0.096        (e)      |  P=0.573N     P=0.490N     P=0.527N     P=0.485N   |
|INCIDENTAL TUMOR       |  P=0.227N     P=0.121      P=0.096        (e)      |  P=0.573N     P=0.490N     P=0.527N     P=0.485N   |
|LOGISTIC REGRESSION    |  P=0.227N     P=0.121      P=0.096        (e)      |  P=0.573N     P=0.490N     P=0.527N     P=0.485N   |
|COCHRAN-ARMITAGE       |  P=0.225N                                          |  P=0.588N                                          |
|FISHER EXACT           |               P=0.122      P=0.122        (e)      |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Jejunum                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    2/60 (3%)    2/60 (3%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         4.7%         5.4%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/43 (0%)    2/43 (5%)    2/37 (5%)    0/42 (0%)  |  0/39 (0%)    0/41 (0%)    0/34 (0%)    0/42 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      729 (T)      ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.329N     P=0.238      P=0.206        (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.329N     P=0.238      P=0.206        (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.329N     P=0.238      P=0.206        (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.327N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.248      P=0.248        (e)      |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 02                                                 PAGE   3
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN
 
                                                 TERMINAL SACRIFICE AT 105 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                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    3/60 (5%)    1/60 (2%)    1/60 (2%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   2.2%         7.0%         2.7%         2.1%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/43 (0%)    3/43 (7%)    1/37 (3%)    0/42 (0%)  |  0/39 (0%)    0/41 (0%)    0/34 (0%)    0/42 (0%)  |
|FIRST INCIDENCE (DAYS) |   634          729 (T)      729 (T)      627       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.445N     P=0.311      P=0.741      P=0.758N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.430N     P=0.121      P=0.744      P=0.691    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.441N     P=0.312      P=0.759      P=0.757    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.443N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.309      P=0.752N     P=0.752N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatoblastoma                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    3/60 (5%)    1/60 (2%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         7.6%         2.4%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/43 (0%)    0/43 (0%)    1/37 (3%)    1/42 (2%)  |  0/39 (0%)    0/41 (0%)    0/34 (0%)    0/42 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          713          729 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.520        (e)        P=0.105      P=0.495    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.528        (e)        P=0.238      P=0.495    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.523        (e)        P=0.111      P=0.495    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.520                                           |    (e)                                             |
|FISHER EXACT           |                 (e)        P=0.122      P=0.500    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 02                                                 PAGE   4
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN
 
                                                 TERMINAL SACRIFICE AT 105 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)            | 25/60 (42%)  29/60 (48%)  37/60 (62%)  31/60 (52%) |  7/60 (12%)   8/60 (13%)  20/60 (33%)  14/60 (23%) |
|ADJUSTED (b)           |  55.5%        64.2%        83.8%        64.4%      |  17.0%        19.5%        51.8%        33.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    1/10 (10%)   2/10 (20%)   1/10 (10%) |  0/10 (0%)    0/10 (0%)    1/9 (11%)    0/10 (0%)  |
|TERMINAL (d)           | 23/43 (53%)  27/43 (63%)  30/37 (81%)  25/42 (60%) |  5/39 (13%)   8/41 (20%)  16/34 (47%)  14/42 (33%) |
|FIRST INCIDENCE (DAYS) |   634          455 (I)      455 (I)      457 (I)   |   701          729 (T)      450 (I)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.330      P=0.276      P=0.002 **   P=0.153    |  P=0.204      P=0.539      P=0.002 **   P=0.100    |
|INCIDENTAL TUMOR       |  P=0.338      P=0.259      P=0.007 **   P=0.172    |  P=0.189      P=0.511      P=0.003 **   P=0.096    |
|LOGISTIC REGRESSION    |  P=0.336      P=0.319      P=0.006 **   P=0.174    |  P=0.177      P=0.524      P=0.002 **   P=0.091    |
|COCHRAN-ARMITAGE       |  P=0.335                                           |  P=0.140                                           |
|FISHER EXACT           |               P=0.291      P=0.022 *    P=0.180    |               P=0.500      P=0.004 **   P=0.074    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 12/60 (20%)  18/60 (30%)  18/60 (30%)  18/60 (30%) |  7/60 (12%)   5/60 (8%)   10/60 (17%)   7/60 (12%) |
|ADJUSTED (b)           |  25.0%        38.0%        37.2%        37.4%      |  16.3%        12.2%        25.2%        14.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    2/10 (20%)   0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     1/10 (10%) |
|TERMINAL (d)           |  7/43 (16%)  14/43 (33%)   8/37 (22%)  12/42 (29%) |  4/39 (10%)   5/41 (12%)   5/34 (15%)   3/42 (7%)  |
|FIRST INCIDENCE (DAYS) |   479          507          455 (I)      537       |   536          729 (T)      524          453 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.320      P=0.165      P=0.108      P=0.156    |  P=0.550N     P=0.354N     P=0.237      P=0.562N   |
|INCIDENTAL TUMOR       |  P=0.328      P=0.154      P=0.350      P=0.224    |  P=0.529      P=0.439N     P=0.432      P=0.591    |
|LOGISTIC REGRESSION    |  P=0.275      P=0.145      P=0.206      P=0.138    |  P=0.521      P=0.374N     P=0.280      P=0.523    |
|COCHRAN-ARMITAGE       |  P=0.301                                           |  P=0.537                                           |
|FISHER EXACT           |               P=0.146      P=0.146      P=0.146    |               P=0.381N     P=0.301      P=0.611N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 02                                                 PAGE   5
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN
 
                                                 TERMINAL SACRIFICE AT 105 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 or Hepatoblastoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 12/60 (20%)  18/60 (30%)  20/60 (33%)  19/60 (32%) |  7/60 (12%)   5/60 (8%)   10/60 (17%)   7/60 (12%) |
|ADJUSTED (b)           |  25.0%        38.0%        41.0%        39.5%      |  16.3%        12.2%        25.2%        14.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    2/10 (20%)   0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     1/10 (10%) |
|TERMINAL (d)           |  7/43 (16%)  14/43 (33%)   9/37 (24%)  13/42 (31%) |  4/39 (10%)   5/41 (12%)   5/34 (15%)   3/42 (7%)  |
|FIRST INCIDENCE (DAYS) |   479          507          455 (I)      537       |   536          729 (T)      524          453 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.271      P=0.165      P=0.055      P=0.116    |  P=0.550N     P=0.354N     P=0.237      P=0.562N   |
|INCIDENTAL TUMOR       |  P=0.268      P=0.154      P=0.225      P=0.162    |  P=0.529      P=0.439N     P=0.432      P=0.591    |
|LOGISTIC REGRESSION    |  P=0.221      P=0.145      P=0.103      P=0.096    |  P=0.521      P=0.374N     P=0.280      P=0.523    |
|COCHRAN-ARMITAGE       |  P=0.249                                           |  P=0.537                                           |
|FISHER EXACT           |               P=0.146      P=0.074      P=0.105    |               P=0.381N     P=0.301      P=0.611N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 30/60 (50%)  39/60 (65%)  45/60 (75%)  38/60 (63%) | 13/60 (22%)  12/60 (20%)  26/60 (43%)  20/60 (33%) |
|ADJUSTED (b)           |  62.5%        79.5%        88.1%        76.0%      |  30.0%        29.3%        61.4%        43.2%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    1/10 (10%)   4/10 (40%)   1/10 (10%) |  0/10 (0%)    0/10 (0%)    1/9 (11%)    1/10 (10%) |
|TERMINAL (d)           | 25/43 (58%)  33/43 (77%)  31/37 (84%)  30/42 (71%) |  9/39 (23%)  12/41 (29%)  18/34 (53%)  16/42 (38%) |
|FIRST INCIDENCE (DAYS) |   479          455 (I)      455 (I)      457 (I)   |   536          729 (T)      450 (I)      453 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.379      P=0.076      P<0.001 **   P=0.093    |  P=0.212      P=0.450N     P=0.004 **   P=0.167    |
|INCIDENTAL TUMOR       |  P=0.397      P=0.069      P=0.004 **   P=0.111    |  P=0.152      P=0.528N     P=0.011 *    P=0.117    |
|LOGISTIC REGRESSION    |  P=0.356      P=0.070      P=0.001 **   P=0.083    |  P=0.160      P=0.484N     P=0.004 **   P=0.125    |
|COCHRAN-ARMITAGE       |  P=0.366                                           |  P=0.127                                           |
|FISHER EXACT           |               P=0.070      P=0.004 **   P=0.099    |               P=0.500N     P=0.009 **   P=0.110    |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 02                                                 PAGE   6
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN
 
                                                 TERMINAL SACRIFICE AT 105 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)            | 30/60 (50%)  39/60 (65%)  45/60 (75%)  39/60 (65%) | 13/60 (22%)  12/60 (20%)  26/60 (43%)  20/60 (33%) |
|ADJUSTED (b)           |  62.5%        79.5%        88.1%        78.0%      |  30.0%        29.3%        61.4%        43.2%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    1/10 (10%)   4/10 (40%)   1/10 (10%) |  0/10 (0%)    0/10 (0%)    1/9 (11%)    1/10 (10%) |
|TERMINAL (d)           | 25/43 (58%)  33/43 (77%)  31/37 (84%)  31/42 (74%) |  9/39 (23%)  12/41 (29%)  18/34 (53%)  16/42 (38%) |
|FIRST INCIDENCE (DAYS) |   479          455 (I)      455 (I)      457 (I)   |   536          729 (T)      450 (I)      453 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.302      P=0.076      P<0.001 **   P=0.066    |  P=0.212      P=0.450N     P=0.004 **   P=0.167    |
|INCIDENTAL TUMOR       |  P=0.301      P=0.069      P=0.004 **   P=0.075    |  P=0.152      P=0.528N     P=0.011 *    P=0.117    |
|LOGISTIC REGRESSION    |  P=0.264      P=0.070      P=0.001 **   P=0.054    |  P=0.160      P=0.484N     P=0.004 **   P=0.125    |
|COCHRAN-ARMITAGE       |  P=0.283                                           |  P=0.127                                           |
|FISHER EXACT           |               P=0.070      P=0.004 **   P=0.070    |               P=0.500N     P=0.009 **   P=0.110    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 11/60 (18%)   9/60 (15%)   7/60 (12%)  11/60 (18%) |  4/60 (7%)    3/60 (5%)    4/60 (7%)    1/60 (2%)  |
|ADJUSTED (b)           |  25.0%        20.9%        17.2%        24.1%      |  10.3%         7.3%        10.8%         2.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/10 (0%)    0/10 (0%)    1/9 (11%)    0/10 (0%)  |
|TERMINAL (d)           | 10/43 (23%)   9/43 (21%)   5/37 (14%)   8/42 (19%) |  4/39 (10%)   3/41 (7%)    3/34 (9%)    1/42 (2%)  |
|FIRST INCIDENCE (DAYS) |   664          729 (T)      541          457 (I)   |   729 (T)      729 (T)      453 (I)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.403      P=0.399N     P=0.320N     P=0.576    |  P=0.134N     P=0.473N     P=0.568      P=0.158N   |
|INCIDENTAL TUMOR       |  P=0.410      P=0.360N     P=0.227N     P=0.521N   |  P=0.134N     P=0.473N     P=0.568      P=0.158N   |
|LOGISTIC REGRESSION    |  P=0.407      P=0.377N     P=0.244N     P=0.585N   |  P=0.141N     P=0.473N     P=0.618      P=0.158N   |
|COCHRAN-ARMITAGE       |  P=0.400                                           |  P=0.153N                                          |
|FISHER EXACT           |               P=0.404N     P=0.222N     P=0.593N   |               P=0.500N     P=0.641N     P=0.182N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 02                                                 PAGE   7
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN
 
                                                 TERMINAL SACRIFICE AT 105 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                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/60 (7%)    7/60 (12%)   0/60 (0%)    4/60 (7%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   8.9%        15.8%         0.0%         9.5%      |   2.6%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  3/43 (7%)    6/43 (14%)   0/37 (0%)    4/42 (10%) |  1/39 (3%)    0/41 (0%)    0/34 (0%)    0/42 (0%)  |
|FIRST INCIDENCE (DAYS) |   609          691          ---          729 (T)   |   729 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.509N     P=0.267      P=0.083N     P=0.630    |  P=0.573N     P=0.490N     P=0.527N     P=0.485N   |
|INCIDENTAL TUMOR       |  P=0.503N     P=0.195      P=0.080N     P=0.604    |  P=0.573N     P=0.490N     P=0.527N     P=0.485N   |
|LOGISTIC REGRESSION    |  P=0.503N     P=0.275      P=0.067N     P=0.638N   |  P=0.573N     P=0.490N     P=0.527N     P=0.485N   |
|COCHRAN-ARMITAGE       |  P=0.508N                                          |  P=0.588N                                          |
|FISHER EXACT           |               P=0.264      P=0.059N     P=0.641N   |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 14/60 (23%)  16/60 (27%)   7/60 (12%)  14/60 (23%) |  5/60 (8%)    3/60 (5%)    4/60 (7%)    1/60 (2%)  |
|ADJUSTED (b)           |  31.0%        36.3%        17.2%        30.8%      |  12.8%         7.3%        10.8%         2.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/10 (0%)    0/10 (0%)    1/9 (11%)    0/10 (0%)  |
|TERMINAL (d)           | 12/43 (28%)  15/43 (35%)   5/37 (14%)  11/42 (26%) |  5/39 (13%)   3/41 (7%)    3/34 (9%)    1/42 (2%)  |
|FIRST INCIDENCE (DAYS) |   609          691          541          457 (I)   |   729 (T)      729 (T)      453 (I)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.527      P=0.419      P=0.133N     P=0.564    |  P=0.098N     P=0.328N     P=0.583N     P=0.087N   |
|INCIDENTAL TUMOR       |  P=0.539      P=0.399      P=0.080N     P=0.541N   |  P=0.098N     P=0.328N     P=0.583N     P=0.087N   |
|LOGISTIC REGRESSION    |  P=0.537      P=0.445      P=0.063N     P=0.576N   |  P=0.104N     P=0.328N     P=0.530N     P=0.087N   |
|COCHRAN-ARMITAGE       |  P=0.526                                           |  P=0.114N                                          |
|FISHER EXACT           |               P=0.417      P=0.074N     P=0.585N   |               P=0.359N     P=0.500N     P=0.103N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 02                                                 PAGE   8
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN
 
                                                 TERMINAL SACRIFICE AT 105 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                                                                                                                            |
|     Cystadenoma                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  1/60 (2%)    2/58 (3%)    1/59 (2%)    0/58 (0%)  |
|ADJUSTED (b)           |                                                    |   2.6%         5.1%         2.4%         0.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |                                                    |  1/39 (3%)    2/39 (5%)    0/34 (0%)    0/42 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   729 (T)      729 (T)      667          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.228N     P=0.500      P=0.740      P=0.485N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.248N     P=0.500      P=0.714N     P=0.485N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.235N     P=0.500      P=0.749      P=0.485N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.247N                                          |
|FISHER EXACT           |                                                    |               P=0.487      P=0.748      P=0.508N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/59 (0%)    0/60 (0%)    0/60 (0%)  |  0/56 (0%)    2/59 (3%)    4/59 (7%)    5/60 (8%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         5.0%        11.8%        11.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/43 (0%)    0/42 (0%)    0/37 (0%)    0/42 (0%)  |  0/37 (0%)    2/40 (5%)    4/34 (12%)   4/42 (10%) |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          729 (T)      729 (T)      621       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.084      P=0.256      P=0.053      P=0.045 *  |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.070      P=0.256      P=0.053      P=0.030 *  |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.076      P=0.256      P=0.053      P=0.041 *  |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.066                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.261      P=0.066      P=0.034 *  |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 02                                                 PAGE   9
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN
 
                                                 TERMINAL SACRIFICE AT 105 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                                                                                                        |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    2/60 (3%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         5.4%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/43 (0%)    0/43 (0%)    2/37 (5%)    0/42 (0%)  |  0/39 (0%)    0/41 (0%)    0/34 (0%)    0/42 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          729 (T)      ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.623N       (e)        P=0.206        (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.623N       (e)        P=0.206        (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.623N       (e)        P=0.206        (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.624N                                          |    (e)                                             |
|FISHER EXACT           |                 (e)        P=0.248        (e)      |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    1/60 (2%)    1/60 (2%)    1/59 (2%)  |  1/59 (2%)    1/60 (2%)    2/59 (3%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         2.3%         2.2%         2.1%      |   2.1%         2.4%         5.5%         2.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/43 (0%)    1/43 (2%)    0/37 (0%)    0/41 (0%)  |  0/38 (0%)    1/41 (2%)    1/34 (3%)    1/42 (2%)  |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      639          627       |   522          729 (T)      704          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.549      P=0.500      P=0.500      P=0.504    |  P=0.600N     P=0.754N     P=0.479      P=0.749N   |
|INCIDENTAL TUMOR       |  P=0.569      P=0.500      P=0.500      P=0.419    |  P=0.660N     P=0.658      P=0.587      P=0.661    |
|LOGISTIC REGRESSION    |  P=0.547      P=0.500      P=0.502      P=0.491    |  P=0.614N     P=0.759N     P=0.498      P=0.761    |
|COCHRAN-ARMITAGE       |  P=0.547                                           |  P=0.623N                                          |
|FISHER EXACT           |               P=0.500      P=0.500      P=0.496    |               P=0.748N     P=0.500      P=0.748N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 02                                                 PAGE  10
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN
 
                                                 TERMINAL SACRIFICE AT 105 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   |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    2/60 (3%)    3/60 (5%)  |
|ADJUSTED (b)           |   4.5%         0.0%         0.0%         0.0%      |   0.0%         0.0%         5.9%         7.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  1/43 (2%)    0/43 (0%)    0/37 (0%)    0/42 (0%)  |  0/39 (0%)    0/41 (0%)    2/34 (6%)    3/42 (7%)  |
|FIRST INCIDENCE (DAYS) |   717          ---          ---          ---       |   ---          ---          729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.349N     P=0.242N     P=0.273N     P=0.242N   |  P=0.066        (e)        P=0.209      P=0.135    |
|INCIDENTAL TUMOR       |  P=0.343N     P=0.145N     P=0.140N     P=0.168N   |  P=0.066        (e)        P=0.209      P=0.135    |
|LOGISTIC REGRESSION    |  P=0.349N     P=0.232N     P=0.250N     P=0.235N   |  P=0.066        (e)        P=0.209      P=0.135    |
|COCHRAN-ARMITAGE       |  P=0.350N                                          |  P=0.053                                           |
|FISHER EXACT           |               P=0.248N     P=0.248N     P=0.248N   |                 (e)        P=0.248      P=0.122    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    1/60 (2%)    3/60 (5%)  |
|ADJUSTED (b)           |   4.5%         0.0%         0.0%         0.0%      |   0.0%         0.0%         2.9%         7.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  1/43 (2%)    0/43 (0%)    0/37 (0%)    0/42 (0%)  |  0/39 (0%)    0/41 (0%)    1/34 (3%)    3/42 (7%)  |
|FIRST INCIDENCE (DAYS) |   717          ---          ---          ---       |   ---          ---          729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.349N     P=0.242N     P=0.273N     P=0.242N   |  P=0.034 *      (e)        P=0.473      P=0.135    |
|INCIDENTAL TUMOR       |  P=0.343N     P=0.145N     P=0.140N     P=0.168N   |  P=0.034 *      (e)        P=0.473      P=0.135    |
|LOGISTIC REGRESSION    |  P=0.349N     P=0.232N     P=0.250N     P=0.235N   |  P=0.034 *      (e)        P=0.473      P=0.135    |
|COCHRAN-ARMITAGE       |  P=0.350N                                          |  P=0.026 *                                         |
|FISHER EXACT           |               P=0.248N     P=0.248N     P=0.248N   |                 (e)        P=0.500      P=0.122    |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 02                                                 PAGE  11
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN
 
                                                 TERMINAL SACRIFICE AT 105 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%)    1/59 (2%)    0/59 (0%)    2/60 (3%)  |  1/60 (2%)    1/60 (2%)    2/59 (3%)    0/59 (0%)  |
|ADJUSTED (b)           |   2.3%         2.3%         0.0%         4.5%      |   2.6%         2.4%         5.9%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  1/43 (2%)    0/42 (0%)    0/37 (0%)    1/42 (2%)  |  1/39 (3%)    1/41 (2%)    2/34 (6%)    0/41 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      715          ---          678       |   729 (T)      729 (T)      729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.317      P=0.758      P=0.530N     P=0.500    |  P=0.298N     P=0.751N     P=0.452      P=0.490N   |
|INCIDENTAL TUMOR       |  P=0.313      P=0.667N     P=0.530N     P=0.573    |  P=0.298N     P=0.751N     P=0.452      P=0.490N   |
|LOGISTIC REGRESSION    |  P=0.316      P=0.762N     P=0.530N     P=0.504    |  P=0.298N     P=0.751N     P=0.452      P=0.490N   |
|COCHRAN-ARMITAGE       |  P=0.313                                           |  P=0.313N                                          |
|FISHER EXACT           |               P=0.748      P=0.504N     P=0.500    |               P=0.752N     P=0.494      P=0.504N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  2/60 (3%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |                                                    |   4.4%         2.4%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  1/10 (10%)   0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |                                                    |  1/39 (3%)    1/41 (2%)    0/34 (0%)    0/42 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   453 (I)      729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.234N     P=0.488N     P=0.267N     P=0.232N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.234N     P=0.488N     P=0.267N     P=0.232N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.242N     P=0.500N     P=0.220N     P=0.248N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.241N                                          |
|FISHER EXACT           |                                                    |               P=0.500N     P=0.248N     P=0.248N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 02                                                 PAGE  12
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN
 
                                                 TERMINAL SACRIFICE AT 105 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                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    1/60 (2%)    2/60 (3%)    0/60 (0%)  |  0/60 (0%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         2.3%         5.4%         0.0%      |   0.0%         2.3%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/43 (0%)    1/43 (2%)    2/37 (5%)    0/42 (0%)  |  0/39 (0%)    0/41 (0%)    0/34 (0%)    0/42 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      729 (T)      ---       |   ---          681          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.450N     P=0.500      P=0.206        (e)      |  P=0.615N     P=0.505        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.450N     P=0.500      P=0.206        (e)      |  P=0.642N     P=0.455        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.450N     P=0.500      P=0.206        (e)      |  P=0.622N     P=0.500        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.449N                                          |  P=0.626N                                          |
|FISHER EXACT           |               P=0.500      P=0.248        (e)      |               P=0.500        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    4/60 (7%)    2/60 (3%)    1/60 (2%)  |  1/60 (2%)    1/60 (2%)    2/60 (3%)    1/60 (2%)  |
|ADJUSTED (b)           |   4.4%         9.3%         4.9%         2.1%      |   2.1%         2.4%         5.5%         2.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  1/43 (2%)    4/43 (9%)    1/37 (3%)    0/42 (0%)  |  0/39 (0%)    1/41 (2%)    1/34 (3%)    1/42 (2%)  |
|FIRST INCIDENCE (DAYS) |   634          729 (T)      639          627       |   522          729 (T)      704          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.248N     P=0.342      P=0.663      P=0.500N   |  P=0.602N     P=0.757N     P=0.476      P=0.752N   |
|INCIDENTAL TUMOR       |  P=0.223N     P=0.180      P=0.674      P=0.604N   |  P=0.663N     P=0.654      P=0.584      P=0.658    |
|LOGISTIC REGRESSION    |  P=0.241N     P=0.347      P=0.690      P=0.501N   |  P=0.618N     P=0.762      P=0.496      P=0.758    |
|COCHRAN-ARMITAGE       |  P=0.243N                                          |  P=0.627N                                          |
|FISHER EXACT           |               P=0.340      P=0.691N     P=0.500N   |               P=0.752N     P=0.500      P=0.752N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 02                                                 PAGE  13
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN
 
                                                 TERMINAL SACRIFICE AT 105 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                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    5/60 (8%)    3/60 (5%)    1/60 (2%)  |  1/60 (2%)    2/60 (3%)    2/60 (3%)    1/60 (2%)  |
|ADJUSTED (b)           |   4.4%        11.6%         7.5%         2.1%      |   2.1%         4.7%         5.5%         2.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  1/43 (2%)    5/43 (12%)   2/37 (5%)    0/42 (0%)  |  0/39 (0%)    1/41 (2%)    1/34 (3%)    1/42 (2%)  |
|FIRST INCIDENCE (DAYS) |   634          729 (T)      639          627       |   522          681          704          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.183N     P=0.221      P=0.458      P=0.500N   |  P=0.484N     P=0.506      P=0.476      P=0.752N   |
|INCIDENTAL TUMOR       |  P=0.163N     P=0.103      P=0.458      P=0.604N   |  P=0.543N     P=0.362      P=0.584      P=0.658    |
|LOGISTIC REGRESSION    |  P=0.176N     P=0.226      P=0.491      P=0.501N   |  P=0.499N     P=0.416      P=0.496      P=0.758    |
|COCHRAN-ARMITAGE       |  P=0.178N                                          |  P=0.508N                                          |
|FISHER EXACT           |               P=0.219      P=0.500      P=0.500N   |               P=0.500      P=0.500      P=0.752N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Histiocytic Sarcoma                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |  0/60 (0%)    2/60 (3%)    2/60 (3%)    3/60 (5%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         4.3%         5.2%         7.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/43 (0%)    0/43 (0%)    0/37 (0%)    0/42 (0%)  |  0/39 (0%)    0/41 (0%)    1/34 (3%)    3/42 (7%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          599          662          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.224      P=0.245      P=0.222      P=0.135    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.176      P=0.215      P=0.286      P=0.135    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.206      P=0.238      P=0.227      P=0.135    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.195                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.248      P=0.248      P=0.122    |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 02                                                 PAGE  14
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN
 
                                                 TERMINAL SACRIFICE AT 105 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 Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    3/60 (5%)    2/60 (3%)    7/60 (12%) |  9/60 (15%)  18/60 (30%)  14/60 (23%)   9/60 (15%) |
|ADJUSTED (b)           |   2.3%         6.7%         3.9%        15.8%      |  21.7%        38.1%        35.6%        19.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  1/43 (2%)    2/43 (5%)    0/37 (0%)    6/42 (14%) |  7/39 (18%)  12/41 (29%)  10/34 (29%)   6/42 (14%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      691          224          457 (I)   |   628          467          437          662       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.016 *    P=0.311      P=0.482      P=0.032 *  |  P=0.120N     P=0.059      P=0.114      P=0.537N   |
|INCIDENTAL TUMOR       |  P=0.009 **   P=0.384      P=0.483      P=0.032 *  |  P=0.164N     P=0.026 *    P=0.123      P=0.588N   |
|LOGISTIC REGRESSION    |  P=0.015 *    P=0.313      P=0.504      P=0.034 *  |  P=0.157N     P=0.019 *    P=0.139      P=0.566N   |
|COCHRAN-ARMITAGE       |  P=0.015 *                                         |  P=0.156N                                          |
|FISHER EXACT           |               P=0.309      P=0.500      P=0.031 *  |               P=0.040 *    P=0.177      P=0.601N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    3/60 (5%)    2/60 (3%)    7/60 (12%) |  9/60 (15%)  16/60 (27%)  12/60 (20%)   7/60 (12%) |
|ADJUSTED (b)           |   2.3%         6.7%         3.9%        15.8%      |  21.7%        35.3%        31.3%        15.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  1/43 (2%)    2/43 (5%)    0/37 (0%)    6/42 (14%) |  7/39 (18%)  12/41 (29%)   9/34 (26%)   4/42 (10%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      691          224          457 (I)   |   628          467          437          662       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.016 *    P=0.311      P=0.482      P=0.032 *  |  P=0.072N     P=0.115      P=0.223      P=0.342N   |
|INCIDENTAL TUMOR       |  P=0.009 **   P=0.384      P=0.483      P=0.032 *  |  P=0.096N     P=0.072      P=0.224      P=0.384N   |
|LOGISTIC REGRESSION    |  P=0.015 *    P=0.313      P=0.504      P=0.034 *  |  P=0.087N     P=0.087      P=0.268      P=0.361N   |
|COCHRAN-ARMITAGE       |  P=0.015 *                                         |  P=0.094N                                          |
|FISHER EXACT           |               P=0.309      P=0.500      P=0.031 *  |               P=0.088      P=0.316      P=0.395N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 02                                                 PAGE  15
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN
 
                                                 TERMINAL SACRIFICE AT 105 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)            | 34/60 (57%)  33/60 (55%)  42/60 (70%)  37/60 (62%) | 14/60 (23%)  18/60 (30%)  24/60 (40%)  21/60 (35%) |
|ADJUSTED (b)           |  72.3%        73.2%        91.1%        72.5%      |  33.2%        42.8%        60.7%        48.7%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   1/10 (10%)   2/10 (20%)   2/10 (20%) |  0/10 (0%)    0/10 (0%)    2/9 (22%)    0/10 (0%)  |
|TERMINAL (d)           | 30/43 (70%)  31/43 (72%)  33/37 (89%)  28/42 (67%) | 11/39 (28%)  17/41 (41%)  19/34 (56%)  20/42 (48%) |
|FIRST INCIDENCE (DAYS) |   457 (I)      455 (I)      399          457 (I)   |   681          681          450 (I)      621       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.366      P=0.497N     P=0.009 **   P=0.321    |  P=0.331      P=0.317      P=0.013 *    P=0.164    |
|INCIDENTAL TUMOR       |  P=0.377      P=0.475N     P=0.042 *    P=0.423    |  P=0.296      P=0.274      P=0.025 *    P=0.138    |
|LOGISTIC REGRESSION    |  P=0.369      P=0.431N     P=0.036 *    P=0.368    |  P=0.282      P=0.283      P=0.019 *    P=0.140    |
|COCHRAN-ARMITAGE       |  P=0.365                                           |  P=0.221                                           |
|FISHER EXACT           |               P=0.500N     P=0.092      P=0.355    |               P=0.268      P=0.038 *    P=0.114    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 18/60 (30%)  28/60 (47%)  27/60 (45%)  30/60 (50%) | 22/60 (37%)  25/60 (42%)  23/60 (38%)  17/60 (28%) |
|ADJUSTED (b)           |  35.8%        57.1%        53.4%        59.9%      |  46.4%        53.1%        52.8%        33.4%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   0/10 (0%)    2/10 (20%)   1/10 (10%) |  1/10 (10%)   0/10 (0%)    0/9 (0%)     1/10 (10%) |
|TERMINAL (d)           | 11/43 (26%)  22/43 (51%)  14/37 (38%)  22/42 (52%) | 14/39 (36%)  19/41 (46%)  14/34 (41%)   9/42 (21%) |
|FIRST INCIDENCE (DAYS) |   455 (I)      507          224          457 (I)   |   453 (I)      467          437          233       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.118      P=0.063      P=0.045 *    P=0.028 *  |  P=0.071N     P=0.426      P=0.341      P=0.183N   |
|INCIDENTAL TUMOR       |  P=0.076      P=0.037 *    P=0.152      P=0.022 *  |  P=0.104N     P=0.241      P=0.564      P=0.261N   |
|LOGISTIC REGRESSION    |  P=0.086      P=0.052      P=0.063      P=0.020 *  |  P=0.073N     P=0.212      P=0.428      P=0.208N   |
|COCHRAN-ARMITAGE       |  P=0.089                                           |  P=0.094N                                          |
|FISHER EXACT           |               P=0.045 *    P=0.066      P=0.020 *  |               P=0.354      P=0.500      P=0.218N   |
|=================================================================================================================================|
 
         DATE: 09/11/94                     EXPERIMENT: 05084 TEST: 02                                                 PAGE  16
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN
 
                                                 TERMINAL SACRIFICE AT 105 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)            | 40/60 (67%)  43/60 (72%)  51/60 (85%)  45/60 (75%) | 32/60 (53%)  33/60 (55%)  37/60 (62%)  34/60 (57%) |
|ADJUSTED (b)           |  78.3%        85.9%        94.4%        86.5%      |  66.6%        70.1%        80.1%        66.4%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   1/10 (10%)   4/10 (40%)   3/10 (30%) |  1/10 (10%)   0/10 (0%)    2/9 (22%)    1/10 (10%) |
|TERMINAL (d)           | 32/43 (74%)  36/43 (84%)  34/37 (92%)  35/42 (83%) | 23/39 (59%)  27/41 (66%)  25/34 (74%)  25/42 (60%) |
|FIRST INCIDENCE (DAYS) |   455 (I)      455 (I)      224          457 (I)   |   453 (I)      467          437          233       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.377      P=0.366      P=0.005 **   P=0.200    |  P=0.425N     P=0.544N     P=0.097      P=0.555N   |
|INCIDENTAL TUMOR       |  P=0.359      P=0.368      P=0.015 *    P=0.238    |  P=0.478      P=0.406      P=0.200      P=0.389    |
|LOGISTIC REGRESSION    |  P=0.368      P=0.399      P=0.007 **   P=0.214    |  P=0.535N     P=0.374      P=0.119      P=0.474    |
|COCHRAN-ARMITAGE       |  P=0.353                                           |  P=0.479                                           |
|FISHER EXACT           |               P=0.346      P=0.016 *    P=0.211    |               P=0.500      P=0.230      P=0.427    |
|=================================================================================================================================|
 
 (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):   455
          Female interim sacrifices(days): 450
 (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).