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TDMS Study 05021-03 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                 CI PIGMENT RED 23                                  DATE: 09/03/94       
EXPERIMENT: 05021 TEST: 03                                                                                     TIME: 21:21:19       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01ES9565102          ROUTE: DOSED FEED                                                                  NTP C#: 60377        
PATHOLOGIST: P. HILDEBRANDT                  S. EUSTIS                                                         CAS: 6471-49-4       
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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: Southern Research Inst                                 CI PIGMENT RED 23                                  DATE: 09/03/94      
EXPERIMENT: 05021 TEST: 03                                                                                     TIME: 21:21:19      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01ES9565102          ROUTE: DOSED FEED                                                                  NTP C#: 60377       
PATHOLOGIST: P. HILDEBRANDT                  S. EUSTIS                                                         CAS: 6471-49-4      
 
 
 
 
 
                                                    RATS(FISCHER344)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                 CI PIGMENT RED 23                                  DATE: 09/03/94       
EXPERIMENT: 05021 TEST: 03                                                                                     TIME: 21:21:19       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01ES9565102          ROUTE: DOSED FEED                                                                  NTP C#: 60377        
PATHOLOGIST: P. HILDEBRANDT                  S. EUSTIS                                                         CAS: 6471-49-4       
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                       IN THE ANALYSIS OF THE STUDY OF CI PIGMENT RED 23
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Benign
                                                           Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Brain                         Astrocytoma NOS
                             Clitoral/Preputial Gland      Adenoma
                                                           Carcinoma or Adenoma
                             Islets, Pancreatic            Carcinoma
                                                           Carcinoma or Adenoma
                             Kidney: Renal Tubule          Adenoma
                                                           Carcinoma or Adenoma
                             Mammary Gland                 Fibroma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                                                           Carcinoma or Adenoma
                             Skin                          Basal Cell Carcinoma
                             Skin: Subcutaneous Tissue     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
                                                            Neurofibroma, or Fibroma
                             Testes                        Adenoma
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Mesothelioma Benign, Malignant, NOS
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                 CI PIGMENT RED 23                                  DATE: 09/03/94       
EXPERIMENT: 05021 TEST: 03                                                                                     TIME: 21:21:19       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01ES9565102          ROUTE: DOSED FEED                                                                  NTP C#: 60377        
PATHOLOGIST: P. HILDEBRANDT                  S. EUSTIS                                                         CAS: 6471-49-4       
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                       IN THE ANALYSIS OF THE STUDY OF CI PIGMENT RED 23
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Clitoral/Preputial Gland      Carcinoma or Adenoma
                             Islets, Pancreatic            Carcinoma or Adenoma
                             Lung                          Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             Mammary Gland                 Fibroadenoma
                                                           Fibroma, Fibroadenoma or Adenoma
                                                           Fibroma, Fibroadenoma, Carcinoma, or Adenoma
                             Ovary                         Thecoma NOS
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                                                           Carcinoma or Adenoma
                             Thyroid Gland: Follicular Cell
                                                           Adenoma
                             Uterus                        Polyp Stromal
                                                           Sarcoma Stromal or Polyp Stromal
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE   1
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/48 (2%)    0/2 (0%)     0/0 (0%)     0/50 (0%)  |  2/50 (4%)    0/1 (0%)     0/0 (0%)     2/50 (4%)  |
|ADJUSTED (b)           |   4.0%         0.0%         0.0%         0.0%      |   6.9%         0.0%         0.0%         5.0%      |
|TERMINAL (d)           |  0/22 (0%)    0/0          0/0          0/35 (0%)  |  2/29 (7%)    0/1 (0%)     0/0          2/40 (5%)  |
|FIRST INCIDENCE (DAYS) |   707          ---          ---          ---       |   729 (T)      ---          ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.276N     P=0.445N     P=0.416N     P=0.422N   |  P=0.480N     P=0.959N       (e)        P=0.574N   |
|INCIDENTAL TUMOR       |  P=0.318N     P=0.892N       (e)        P=0.500N   |  P=0.480N     P=0.959N       (e)        P=0.574N   |
|LOGISTIC REGRESSION    |  P=0.318N     P=0.892N       (e)        P=0.500N   |  P=0.480N     P=0.959N       (e)        P=0.574N   |
|COCHRAN-ARMITAGE       |  P=0.304N                                          |  P=0.596                                           |
|FISHER EXACT           |               P=0.960N     P=1.000N     P=0.490N   |               P=0.961N     P=1.000N     P=0.691N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 30/48 (63%)   4/6 (67%)    3/5 (60%)   26/50 (52%) |  4/49 (8%)    0/1 (0%)     0/1 (0%)     6/50 (12%) |
|ADJUSTED (b)           |  77.8%        75.6%        67.4%        59.8%      |  10.9%         0.0%         0.0%        15.0%      |
|TERMINAL (d)           | 14/22 (64%)   3/4 (75%)    2/3 (67%)   18/35 (51%) |  2/29 (7%)    0/1 (0%)     0/0          6/40 (15%) |
|FIRST INCIDENCE (DAYS) |   502          592          617          513       |   378          ---          ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.034N*    P<0.001N**   P<0.001N**   P=0.014N*  |  P=0.419      P=0.216N     P=0.240N     P=0.545    |
|INCIDENTAL TUMOR       |  P=0.157N     P=0.650      P=0.603N     P=0.181N   |  P=0.421      P=0.959N     P=0.814N     P=0.502    |
|LOGISTIC REGRESSION    |  P=0.132N     P=0.653      P=0.603N     P=0.156N   |  P=0.288      P=0.974N     P=0.915N     P=0.356    |
|COCHRAN-ARMITAGE       |  P=0.157N                                          |  P=0.312                                           |
|FISHER EXACT           |               P=0.609      P=0.632N     P=0.199N   |               P=0.920N     P=0.920N     P=0.383    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE   2
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 30/48 (63%)   4/6 (67%)    5/5 (100%)  26/50 (52%) |  5/49 (10%)   1/1 (100%)   1/1 (100%)   6/50 (12%) |
|ADJUSTED (b)           |  77.8%        75.6%       100.0%        59.8%      |  14.2%       100.0%         0.0%        15.0%      |
|TERMINAL (d)           | 14/22 (64%)   3/4 (75%)    3/3 (100%)  18/35 (51%) |  3/29 (10%)   1/1 (100%)   0/0          6/40 (15%) |
|FIRST INCIDENCE (DAYS) |   502          592          617          513       |   378          729 (T)      595          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.033N*    P<0.001N**   P=0.001N**   P=0.014N*  |  P=0.476N     P=0.670N     P=0.492N     P=0.564N   |
|INCIDENTAL TUMOR       |  P=0.148N     P=0.650      P=0.143      P=0.181N   |  P=0.444N     P=0.140      P=0.362      P=0.606N   |
|LOGISTIC REGRESSION    |  P=0.121N     P=0.653      P=0.148      P=0.156N   |  P=0.496      P=0.096      P=0.151      P=0.503    |
|COCHRAN-ARMITAGE       |  P=0.157N                                          |  P=0.518                                           |
|FISHER EXACT           |               P=0.609      P=0.113      P=0.199N   |               P=0.120      P=0.120      P=0.514    |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Astrocytoma NOS                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    1/3 (33%)    0/4 (0%)     2/50 (4%)  |  0/50 (0%)    1/5 (20%)    0/3 (0%)     3/50 (6%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         5.5%      |   0.0%         0.0%         0.0%         7.2%      |
|TERMINAL (d)           |  0/22 (0%)    0/0          0/2 (0%)     1/35 (3%)  |  0/29 (0%)    0/0          0/0          2/40 (5%)  |
|FIRST INCIDENCE (DAYS) |   ---          686          ---          718       |   ---          673          ---          627       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.294      P=0.559        (e)        P=0.348    |  P=0.146      P=0.531        (e)        P=0.172    |
|INCIDENTAL TUMOR       |  P=0.309      P=0.227        (e)        P=0.290    |  P=0.113      P=0.282        (e)        P=0.174    |
|LOGISTIC REGRESSION    |  P=0.357      P=0.014 *      (e)        P=0.321    |  P=0.150      P=0.065        (e)        P=0.124    |
|COCHRAN-ARMITAGE       |  P=0.283                                           |  P=0.146                                           |
|FISHER EXACT           |               P=0.057        (e)        P=0.247    |               P=0.091        (e)        P=0.121    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE   3
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Oligodendroglioma, Glioma, or Astrocytoma                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/3 (0%)     1/4 (25%)    0/50 (0%)  |  2/50 (4%)    1/5 (20%)    0/3 (0%)     0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         2.0%         0.0%      |   4.6%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/22 (0%)    0/0          0/2 (0%)     0/35 (0%)  |  0/29 (0%)    0/0          0/0          0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          479          ---       |   249          407          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.680        (e)        P=0.504        (e)      |  P=0.101N     P=0.483N     P=0.237N     P=0.231N   |
|INCIDENTAL TUMOR       |  P=0.657        (e)        P=0.227        (e)      |  P=0.485N     P=0.442      P=0.718N     P=0.909N   |
|LOGISTIC REGRESSION    |  P=0.612        (e)        P=0.226        (e)      |  P=0.427N     P=0.444      P=0.988N     P=0.582N   |
|COCHRAN-ARMITAGE       |  P=0.691                                           |  P=0.112N                                          |
|FISHER EXACT           |                 (e)        P=0.074        (e)      |               P=0.253      P=0.889N     P=0.247N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/49 (6%)    5/9 (56%)    8/8 (100%)   7/49 (14%) |  5/47 (11%)   4/48 (8%)    3/47 (6%)    2/49 (4%)  |
|ADJUSTED (b)           |   9.9%        80.5%       100.0%        17.6%      |  17.6%        11.2%         9.4%         5.1%      |
|TERMINAL (d)           |  1/22 (5%)    4/5 (80%)    6/6 (100%)   4/35 (11%) |  4/26 (15%)   3/33 (9%)    3/32 (9%)    2/39 (5%)  |
|FIRST INCIDENCE (DAYS) |   612          675          618          514       |   648          673          729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.494N     P=0.049 *    P=0.003 **   P=0.342    |  P=0.074N     P=0.364N     P=0.259N     P=0.099N   |
|INCIDENTAL TUMOR       |  P=0.423      P<0.001 **   P<0.001 **   P=0.129    |  P=0.112N     P=0.371N     P=0.284N     P=0.157N   |
|LOGISTIC REGRESSION    |  P=0.407      P=0.001 **   P<0.001 **   P=0.138    |  P=0.099N     P=0.397N     P=0.294N     P=0.132N   |
|COCHRAN-ARMITAGE       |  P=0.347                                           |  P=0.141N                                          |
|FISHER EXACT           |               P=0.001 **   P<0.001 **   P=0.159    |               P=0.486N     P=0.357N     P=0.201N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE   4
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/49 (4%)    0/9 (0%)     0/8 (0%)     1/49 (2%)  |  3/47 (6%)    0/48 (0%)    1/47 (2%)    0/49 (0%)  |
|ADJUSTED (b)           |   9.1%         0.0%         0.0%         2.9%      |   8.6%         0.0%         3.1%         0.0%      |
|TERMINAL (d)           |  2/22 (9%)    0/5 (0%)     0/6 (0%)     1/35 (3%)  |  1/26 (4%)    0/33 (0%)    1/32 (3%)    0/39 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          729 (T)   |   578          ---          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.274N     P=0.595N     P=0.550N     P=0.340N   |  P=0.081N     P=0.099N     P=0.271N     P=0.091N   |
|INCIDENTAL TUMOR       |  P=0.274N     P=0.595N     P=0.550N     P=0.340N   |  P=0.101N     P=0.156N     P=0.321N     P=0.166N   |
|LOGISTIC REGRESSION    |  P=0.274N     P=0.595N     P=0.550N     P=0.340N   |  P=0.101N     P=0.125N     P=0.305N     P=0.130N   |
|COCHRAN-ARMITAGE       |  P=0.411N                                          |  P=0.098N                                          |
|FISHER EXACT           |               P=0.711N     P=0.737N     P=0.500N   |               P=0.117N     P=0.308N     P=0.113N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/49 (10%)   5/9 (56%)    8/8 (100%)   8/49 (16%) |  7/47 (15%)   4/48 (8%)    4/47 (9%)    2/49 (4%)  |
|ADJUSTED (b)           |  18.5%        80.5%       100.0%        20.2%      |  21.7%        11.2%        12.5%         5.1%      |
|TERMINAL (d)           |  3/22 (14%)   4/5 (80%)    6/6 (100%)   5/35 (14%) |  4/26 (15%)   3/33 (9%)    4/32 (13%)   2/39 (5%)  |
|FIRST INCIDENCE (DAYS) |   612          675          618          514       |   578          673          729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.353N     P=0.103      P=0.011 *    P=0.552    |  P=0.031N*    P=0.165N     P=0.184N     P=0.032N*  |
|INCIDENTAL TUMOR       |  P=0.532N     P=0.002 **   P<0.001 **   P=0.312    |  P=0.055N     P=0.211N     P=0.227N     P=0.081N   |
|LOGISTIC REGRESSION    |  P=0.531      P=0.010 **   P<0.001 **   P=0.297    |  P=0.049N*    P=0.215N     P=0.227N     P=0.056N   |
|COCHRAN-ARMITAGE       |  P=0.432                                           |  P=0.065N                                          |
|FISHER EXACT           |               P=0.005 **   P<0.001 **   P=0.276    |               P=0.249N     P=0.261N     P=0.070N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE   5
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/0 (0%)     0/2 (0%)     3/49 (6%)  |  0/50 (0%)    2/49 (4%)    1/49 (2%)    3/50 (6%)  |
|ADJUSTED (b)           |   3.7%         0.0%         0.0%         7.7%      |   0.0%         5.9%         3.1%         7.5%      |
|TERMINAL (d)           |  0/22 (0%)    0/0          0/0          1/35 (3%)  |  0/29 (0%)    2/34 (6%)    1/32 (3%)    3/40 (8%)  |
|FIRST INCIDENCE (DAYS) |   681          ---          ---          648       |   ---          729 (T)      729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.187      P=0.443N     P=0.427N     P=0.466    |  P=0.177      P=0.274      P=0.520      P=0.183    |
|INCIDENTAL TUMOR       |  P=0.213        (e)        P=0.892N     P=0.302    |  P=0.177      P=0.274      P=0.520      P=0.183    |
|LOGISTIC REGRESSION    |  P=0.213        (e)        P=0.892N     P=0.302    |  P=0.177      P=0.274      P=0.520      P=0.183    |
|COCHRAN-ARMITAGE       |  P=0.214                                           |  P=0.115                                           |
|FISHER EXACT           |               P=1.000N     P=0.962N     P=0.301    |               P=0.242      P=0.495      P=0.121    |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/0 (0%)     2/2 (100%)   1/49 (2%)  |  0/50 (0%)    0/49 (0%)    0/49 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   4.5%         0.0%         0.0%         2.9%      |   0.0%         0.0%         0.0%         2.5%      |
|TERMINAL (d)           |  1/22 (5%)    0/0          0/0          1/35 (3%)  |  0/29 (0%)    0/34 (0%)    0/32 (0%)    1/40 (3%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          479          729 (T)   |   ---          ---          ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.560N       (e)        P=0.285      P=0.655N   |  P=0.230        (e)          (e)        P=0.564    |
|INCIDENTAL TUMOR       |  P=0.548N       (e)        P=0.010 **   P=0.655N   |  P=0.230        (e)          (e)        P=0.564    |
|LOGISTIC REGRESSION    |  P=0.548N       (e)        P=0.010 **   P=0.655N   |  P=0.230        (e)          (e)        P=0.564    |
|COCHRAN-ARMITAGE       |  P=0.594                                           |  P=0.195                                           |
|FISHER EXACT           |               P=1.000N     P=0.002 **   P=0.747    |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE   6
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    0/0 (0%)     2/2 (100%)   4/49 (8%)  |  0/50 (0%)    2/49 (4%)    1/49 (2%)    4/50 (8%)  |
|ADJUSTED (b)           |   8.1%         0.0%         0.0%        10.4%      |   0.0%         5.9%         3.1%        10.0%      |
|TERMINAL (d)           |  1/22 (5%)    0/0          0/0          2/35 (6%)  |  0/29 (0%)    2/34 (6%)    1/32 (3%)    4/40 (10%) |
|FIRST INCIDENCE (DAYS) |   681          ---          479          648       |   ---          729 (T)      729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.305      P=0.443N     P=0.589      P=0.549    |  P=0.081      P=0.274      P=0.520      P=0.111    |
|INCIDENTAL TUMOR       |  P=0.321        (e)        P=0.031 *    P=0.411    |  P=0.081      P=0.274      P=0.520      P=0.111    |
|LOGISTIC REGRESSION    |  P=0.321        (e)        P=0.031 *    P=0.411    |  P=0.081      P=0.274      P=0.520      P=0.111    |
|COCHRAN-ARMITAGE       |  P=0.278                                           |  P=0.045 *                                         |
|FISHER EXACT           |               P=1.000N     P=0.005 **   P=0.329    |               P=0.242      P=0.495      P=0.059    |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/48 (0%)    0/50 (0%)    2/50 (4%)  |  0/50 (0%)    0/45 (0%)    0/44 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         5.7%      |   0.0%         0.0%         0.0%         2.5%      |
|TERMINAL (d)           |  0/22 (0%)    0/28 (0%)    0/36 (0%)    2/35 (6%)  |  0/29 (0%)    0/32 (0%)    0/32 (0%)    1/40 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          729 (T)   |   ---          ---          ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.068        (e)          (e)        P=0.345    |  P=0.234        (e)          (e)        P=0.564    |
|INCIDENTAL TUMOR       |  P=0.068        (e)          (e)        P=0.345    |  P=0.234        (e)          (e)        P=0.564    |
|LOGISTIC REGRESSION    |  P=0.068        (e)          (e)        P=0.345    |  P=0.234        (e)          (e)        P=0.564    |
|COCHRAN-ARMITAGE       |  P=0.046 *                                         |  P=0.202                                           |
|FISHER EXACT           |                 (e)          (e)        P=0.247    |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE   7
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/48 (0%)    1/50 (2%)    3/50 (6%)  |  0/50 (0%)    0/45 (0%)    0/44 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         2.8%         8.6%      |   0.0%         0.0%         0.0%         2.5%      |
|TERMINAL (d)           |  0/22 (0%)    0/28 (0%)    1/36 (3%)    3/35 (9%)  |  0/29 (0%)    0/32 (0%)    0/32 (0%)    1/40 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          729 (T)      729 (T)   |   ---          ---          ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.037 *      (e)        P=0.598      P=0.213    |  P=0.234        (e)          (e)        P=0.564    |
|INCIDENTAL TUMOR       |  P=0.037 *      (e)        P=0.598      P=0.213    |  P=0.234        (e)          (e)        P=0.564    |
|LOGISTIC REGRESSION    |  P=0.037 *      (e)        P=0.598      P=0.213    |  P=0.234        (e)          (e)        P=0.564    |
|COCHRAN-ARMITAGE       |  P=0.020 *                                         |  P=0.202                                           |
|FISHER EXACT           |                 (e)        P=0.500      P=0.121    |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    1/50 (2%)    1/50 (2%)    2/50 (4%)  |  1/50 (2%)    0/50 (0%)    1/50 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |   8.1%         2.2%         2.3%         5.7%      |   3.4%         0.0%         3.0%         2.5%      |
|TERMINAL (d)           |  1/22 (5%)    0/29 (0%)    0/36 (0%)    2/35 (6%)  |  1/29 (3%)    0/34 (0%)    1/33 (3%)    1/40 (3%)  |
|FIRST INCIDENCE (DAYS) |   681          557          620          729 (T)   |   729 (T)      ---          729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.566N     P=0.432N     P=0.370N     P=0.525N   |  P=0.588      P=0.468N     P=0.733N     P=0.688N   |
|INCIDENTAL TUMOR       |  P=0.454      P=0.534N     P=0.585N     P=0.565N   |  P=0.588      P=0.468N     P=0.733N     P=0.688N   |
|LOGISTIC REGRESSION    |  P=0.517      P=0.511N     P=0.520N     P=0.586N   |  P=0.588      P=0.468N     P=0.733N     P=0.688N   |
|COCHRAN-ARMITAGE       |  P=0.544                                           |  P=0.515                                           |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.691N   |               P=0.500N     P=0.753N     P=0.753N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE   8
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    1/50 (2%)    1/50 (2%)    3/50 (6%)  |  1/50 (2%)    0/50 (0%)    1/50 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |  10.4%         2.2%         2.3%         8.6%      |   3.4%         0.0%         3.0%         2.5%      |
|TERMINAL (d)           |  1/22 (5%)    0/29 (0%)    0/36 (0%)    3/35 (9%)  |  1/29 (3%)    0/34 (0%)    1/33 (3%)    1/40 (3%)  |
|FIRST INCIDENCE (DAYS) |   612          557          620          729 (T)   |   729 (T)      ---          729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.581N     P=0.256N     P=0.202N     P=0.466N   |  P=0.588      P=0.468N     P=0.733N     P=0.688N   |
|INCIDENTAL TUMOR       |  P=0.354      P=0.403N     P=0.472N     P=0.618N   |  P=0.588      P=0.468N     P=0.733N     P=0.688N   |
|LOGISTIC REGRESSION    |  P=0.447      P=0.319N     P=0.363N     P=0.596N   |  P=0.588      P=0.468N     P=0.733N     P=0.688N   |
|COCHRAN-ARMITAGE       |  P=0.481                                           |  P=0.515                                           |
|FISHER EXACT           |               P=0.309N     P=0.309N     P=0.661N   |               P=0.500N     P=0.753N     P=0.753N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    1/50 (2%)    1/50 (2%)    3/50 (6%)  |  1/50 (2%)    0/50 (0%)    1/50 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |  10.4%         2.2%         2.3%         8.6%      |   3.4%         0.0%         3.0%         2.5%      |
|TERMINAL (d)           |  1/22 (5%)    0/29 (0%)    0/36 (0%)    3/35 (9%)  |  1/29 (3%)    0/34 (0%)    1/33 (3%)    1/40 (3%)  |
|FIRST INCIDENCE (DAYS) |   612          557          620          729 (T)   |   729 (T)      ---          729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.581N     P=0.256N     P=0.202N     P=0.466N   |  P=0.588      P=0.468N     P=0.733N     P=0.688N   |
|INCIDENTAL TUMOR       |  P=0.354      P=0.403N     P=0.472N     P=0.618N   |  P=0.588      P=0.468N     P=0.733N     P=0.688N   |
|LOGISTIC REGRESSION    |  P=0.447      P=0.319N     P=0.363N     P=0.596N   |  P=0.588      P=0.468N     P=0.733N     P=0.688N   |
|COCHRAN-ARMITAGE       |  P=0.481                                           |  P=0.515                                           |
|FISHER EXACT           |               P=0.309N     P=0.309N     P=0.661N   |               P=0.500N     P=0.753N     P=0.753N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE   9
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    1/6 (17%)    0/3 (0%)     2/50 (4%)  |  1/50 (2%)    2/4 (50%)    1/8 (13%)    0/50 (0%)  |
|ADJUSTED (b)           |   3.7%         2.3%         0.0%         5.7%      |   3.4%       100.0%        33.3%         0.0%      |
|TERMINAL (d)           |  0/22 (0%)    0/1 (0%)     0/1 (0%)     2/35 (6%)  |  1/29 (3%)    2/2 (100%)   1/3 (33%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   681          592          ---          729 (T)   |   729 (T)      729 (T)      729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.580      P=0.723N     P=0.422N     P=0.651    |  P=0.118N     P<0.001 **   P=0.220      P=0.436N   |
|INCIDENTAL TUMOR       |  P=0.475      P=0.266      P=0.892N     P=0.606    |  P=0.118N     P<0.001 **   P=0.220      P=0.436N   |
|LOGISTIC REGRESSION    |  P=0.513      P=0.286      P=0.979N     P=0.591    |  P=0.118N     P<0.001 **   P=0.220      P=0.436N   |
|COCHRAN-ARMITAGE       |  P=0.493                                           |  P=0.194N                                          |
|FISHER EXACT           |               P=0.205      P=0.943N     P=0.500    |               P=0.012 *    P=0.259      P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |  0/50 (0%)    2/50 (4%)    2/50 (4%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         5.9%         6.1%         2.5%      |
|TERMINAL (d)           |  0/22 (0%)    0/29 (0%)    0/36 (0%)    0/35 (0%)  |  0/29 (0%)    2/34 (6%)    2/33 (6%)    1/40 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          729 (T)      729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.583      P=0.274      P=0.267      P=0.564    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.583      P=0.274      P=0.267      P=0.564    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.583      P=0.274      P=0.267      P=0.564    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.488                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.247      P=0.247      P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE  10
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |  1/50 (2%)    2/50 (4%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   3.4%         5.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/22 (0%)    0/29 (0%)    0/36 (0%)    0/35 (0%)  |  1/29 (3%)    1/34 (3%)    0/33 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   729 (T)      514          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.140N     P=0.544      P=0.474N     P=0.436N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.169N     P=0.436      P=0.474N     P=0.436N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.180N     P=0.481      P=0.474N     P=0.436N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.167N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.500      P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |  1/50 (2%)    4/50 (8%)    2/50 (4%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   3.4%        10.7%         6.1%         2.5%      |
|TERMINAL (d)           |  0/22 (0%)    0/29 (0%)    0/36 (0%)    0/35 (0%)  |  1/29 (3%)    3/34 (9%)    2/33 (6%)    1/40 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   729 (T)      514          729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.273N     P=0.225      P=0.545      P=0.688N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.302N     P=0.162      P=0.545      P=0.688N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.345N     P=0.182      P=0.545      P=0.688N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.369N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.181      P=0.500      P=0.753N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE  11
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    2/50 (4%)    2/50 (4%)    3/50 (6%)  | 23/50 (46%)  24/50 (48%)  14/50 (28%)  19/50 (38%) |
|ADJUSTED (b)           |   9.1%         6.9%         5.6%         8.1%      |  64.7%        62.8%        35.1%        41.7%      |
|TERMINAL (d)           |  2/22 (9%)    2/29 (7%)    2/36 (6%)    2/35 (6%)  | 17/29 (59%)  20/34 (59%)   8/33 (24%)  14/40 (35%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      729 (T)      687       |   507          651          491          535       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.567      P=0.593N     P=0.507N     P=0.659N   |  P=0.022N*    P=0.373N     P=0.028N*    P=0.048N*  |
|INCIDENTAL TUMOR       |  P=0.542      P=0.593N     P=0.507N     P=0.665    |  P=0.069N     P=0.533N     P=0.044N*    P=0.101N   |
|LOGISTIC REGRESSION    |  P=0.525      P=0.593N     P=0.507N     P=0.654    |  P=0.083N     P=0.474N     P=0.039N*    P=0.199N   |
|COCHRAN-ARMITAGE       |  P=0.384                                           |  P=0.129N                                          |
|FISHER EXACT           |               P=0.691N     P=0.691N     P=0.500    |               P=0.500      P=0.048N*    P=0.272N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         5.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/22 (0%)    0/29 (0%)    0/36 (0%)    1/35 (3%)  |  0/29 (0%)    0/34 (0%)    0/33 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          618       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.064        (e)          (e)        P=0.327    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.021 *      (e)          (e)        P=0.138    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.039 *      (e)          (e)        P=0.220    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.045 *                                         |    (e)                                             |
|FISHER EXACT           |                 (e)          (e)        P=0.247    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE  12
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    2/50 (4%)    2/50 (4%)    5/50 (10%) | 23/50 (46%)  25/50 (50%)  15/50 (30%)  20/50 (40%) |
|ADJUSTED (b)           |   9.1%         6.9%         5.6%        12.8%      |  64.7%        65.5%        37.7%        44.0%      |
|TERMINAL (d)           |  2/22 (9%)    2/29 (7%)    2/36 (6%)    3/35 (9%)  | 17/29 (59%)  21/34 (62%)   9/33 (27%)  15/40 (38%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      729 (T)      618       |   507          651          491          535       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.234      P=0.593N     P=0.507N     P=0.422    |  P=0.028N*    P=0.444N     P=0.042N*    P=0.066N   |
|INCIDENTAL TUMOR       |  P=0.165      P=0.593N     P=0.507N     P=0.276    |  P=0.087N     P=0.558      P=0.066N     P=0.137N   |
|LOGISTIC REGRESSION    |  P=0.169      P=0.593N     P=0.507N     P=0.297    |  P=0.107N     P=0.551N     P=0.060N     P=0.255N   |
|COCHRAN-ARMITAGE       |  P=0.112                                           |  P=0.168N                                          |
|FISHER EXACT           |               P=0.691N     P=0.691N     P=0.218    |               P=0.421      P=0.074N     P=0.343N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    2/50 (4%)    2/50 (4%)    5/50 (10%) | 23/50 (46%)  27/50 (54%)  15/50 (30%)  20/50 (40%) |
|ADJUSTED (b)           |   9.1%         6.9%         5.6%        12.8%      |  64.7%        68.8%        37.7%        44.0%      |
|TERMINAL (d)           |  2/22 (9%)    2/29 (7%)    2/36 (6%)    3/35 (9%)  | 17/29 (59%)  22/34 (65%)   9/33 (27%)  15/40 (38%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      729 (T)      618       |   507          514          491          535       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.234      P=0.593N     P=0.507N     P=0.422    |  P=0.020N*    P=0.564      P=0.042N*    P=0.066N   |
|INCIDENTAL TUMOR       |  P=0.165      P=0.593N     P=0.507N     P=0.276    |  P=0.066N     P=0.363      P=0.066N     P=0.137N   |
|LOGISTIC REGRESSION    |  P=0.169      P=0.593N     P=0.507N     P=0.297    |  P=0.083N     P=0.424      P=0.060N     P=0.255N   |
|COCHRAN-ARMITAGE       |  P=0.112                                           |  P=0.129N                                          |
|FISHER EXACT           |               P=0.691N     P=0.691N     P=0.218    |               P=0.274      P=0.074N     P=0.343N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE  13
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Thecoma NOS                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/50 (0%)    2/4 (50%)    0/1 (0%)     0/50 (0%)  |
|ADJUSTED (b)           |                                                    |   0.0%       100.0%         0.0%         0.0%      |
|TERMINAL (d)           |                                                    |  0/29 (0%)    1/1 (100%)   0/0          0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          514          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.282N     P=0.037 *      (e)          (e)      |
|INCIDENTAL TUMOR       |                                                    |  P=0.379N     P<0.001 **     (e)          (e)      |
|LOGISTIC REGRESSION    |                                                    |  P=0.389N     P<0.001 **     (e)          (e)      |
|COCHRAN-ARMITAGE       |                                                    |  P=0.317N                                          |
|FISHER EXACT           |                                                    |               P=0.004 **     (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    0/0 (0%)     1/2 (50%)    1/49 (2%)  |  0/50 (0%)    2/50 (4%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   9.1%         0.0%       100.0%         2.9%      |   0.0%         5.9%         0.0%         0.0%      |
|TERMINAL (d)           |  2/22 (9%)    0/0          1/1 (100%)   1/35 (3%)  |  0/29 (0%)    2/34 (6%)    0/33 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          729 (T)      729 (T)   |   ---          729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.229N       (e)        P=0.136      P=0.340N   |  P=0.302N     P=0.274        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.229N       (e)        P=0.136      P=0.340N   |  P=0.302N     P=0.274        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.229N       (e)        P=0.136      P=0.340N   |  P=0.302N     P=0.274        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.406N                                          |  P=0.353N                                          |
|FISHER EXACT           |               P=1.000N     P=0.113      P=0.508N   |               P=0.247        (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE  14
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Parathyroid Gland                                                                                                                |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/49 (4%)    0/1 (0%)     0/1 (0%)     2/49 (4%)  |  0/50 (0%)    0/1 (0%)     0/0 (0%)     0/50 (0%)  |
|ADJUSTED (b)           |   9.1%         0.0%         0.0%         5.2%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  2/22 (9%)    0/0          0/0          1/35 (3%)  |  0/29 (0%)    0/0          0/0          0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          676       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.475N       (e)          (e)        P=0.530N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.481N       (e)          (e)        P=0.578N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.497N       (e)          (e)        P=0.595N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.597                                           |    (e)                                             |
|FISHER EXACT           |               P=0.960N     P=0.960N     P=0.691N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 12/50 (24%)  12/16 (75%)   8/9 (89%)    8/49 (16%) | 29/50 (58%)  23/50 (46%)  28/50 (56%)  18/50 (36%) |
|ADJUSTED (b)           |  38.3%        75.8%        86.4%        22.3%      |  74.2%        56.5%        66.3%        41.6%      |
|TERMINAL (d)           |  6/22 (27%)   8/11 (73%)   6/7 (86%)    7/34 (21%) | 19/29 (66%)  17/34 (50%)  19/33 (58%)  15/40 (38%) |
|FIRST INCIDENCE (DAYS) |   502          686          591          618       |   582          612          501          592       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.006N**   P=0.247      P=0.448      P=0.058N   |  P=0.004N**   P=0.053N     P=0.306N     P=0.001N** |
|INCIDENTAL TUMOR       |  P=0.031N*    P=0.001 **   P<0.001 **   P=0.208N   |  P=0.026N*    P=0.068N     P=0.505N     P=0.013N*  |
|LOGISTIC REGRESSION    |  P=0.038N*    P<0.001 **   P<0.001 **   P=0.231N   |  P=0.019N*    P=0.062N     P=0.426N     P=0.005N** |
|COCHRAN-ARMITAGE       |  P=0.063N                                          |  P=0.036N*                                         |
|FISHER EXACT           |               P<0.001 **   P<0.001 **   P=0.242N   |               P=0.158N     P=0.500N     P=0.022N*  |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE  15
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/16 (0%)    0/9 (0%)     0/49 (0%)  |  0/50 (0%)    2/50 (4%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         5.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/22 (0%)    0/11 (0%)    0/7 (0%)     0/34 (0%)  |  0/29 (0%)    1/34 (3%)    0/33 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          592          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.316N     P=0.276        (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.289N     P=0.141        (e)          (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.370N     P=0.226        (e)          (e)      |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.353N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.247        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 12/50 (24%)  12/16 (75%)   8/9 (89%)    8/49 (16%) | 29/50 (58%)  25/50 (50%)  28/50 (56%)  18/50 (36%) |
|ADJUSTED (b)           |  38.3%        75.8%        86.4%        22.3%      |  74.2%        59.9%        66.3%        41.6%      |
|TERMINAL (d)           |  6/22 (27%)   8/11 (73%)   6/7 (86%)    7/34 (21%) | 19/29 (66%)  18/34 (53%)  19/33 (58%)  15/40 (38%) |
|FIRST INCIDENCE (DAYS) |   502          686          591          618       |   582          592          501          592       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.006N**   P=0.247      P=0.448      P=0.058N   |  P=0.002N**   P=0.102N     P=0.306N     P=0.001N** |
|INCIDENTAL TUMOR       |  P=0.031N*    P=0.001 **   P<0.001 **   P=0.208N   |  P=0.015N*    P=0.162N     P=0.505N     P=0.013N*  |
|LOGISTIC REGRESSION    |  P=0.038N*    P<0.001 **   P<0.001 **   P=0.231N   |  P=0.012N*    P=0.138N     P=0.426N     P=0.005N** |
|COCHRAN-ARMITAGE       |  P=0.063N                                          |  P=0.024N*                                         |
|FISHER EXACT           |               P<0.001 **   P<0.001 **   P=0.242N   |               P=0.274N     P=0.500N     P=0.022N*  |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE  16
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Carcinoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)  |  0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         5.7%      |   0.0%         2.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/22 (0%)    0/29 (0%)    0/36 (0%)    2/35 (6%)  |  0/29 (0%)    0/34 (0%)    0/33 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          729 (T)   |   ---          407          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.066        (e)          (e)        P=0.345    |  P=0.521N     P=0.504        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.066        (e)          (e)        P=0.345    |  P=0.625N     P=0.318        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.066        (e)          (e)        P=0.345    |  P=0.781N     P=0.451        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.045 *                                         |  P=0.527N                                          |
|FISHER EXACT           |                 (e)          (e)        P=0.247    |               P=0.500        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/50 (0%)    3/50 (6%)    3/50 (6%)  |  1/50 (2%)    0/50 (0%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   4.5%         0.0%         8.3%         8.6%      |   2.7%         0.0%         0.0%         2.0%      |
|TERMINAL (d)           |  1/22 (5%)    0/29 (0%)    3/36 (8%)    3/35 (9%)  |  0/29 (0%)    0/34 (0%)    0/33 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          729 (T)      729 (T)   |   655          ---          ---          505       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.180      P=0.445N     P=0.493      P=0.482    |  P=0.586      P=0.470N     P=0.495N     P=0.740N   |
|INCIDENTAL TUMOR       |  P=0.180      P=0.445N     P=0.493      P=0.482    |  P=0.333      P=0.460N     P=0.581N     P=0.417    |
|LOGISTIC REGRESSION    |  P=0.180      P=0.445N     P=0.493      P=0.482    |  P=0.481      P=0.512N     P=0.505N     P=0.652    |
|COCHRAN-ARMITAGE       |  P=0.096                                           |  P=0.575                                           |
|FISHER EXACT           |               P=0.500N     P=0.309      P=0.309    |               P=0.500N     P=0.500N     P=0.753N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE  17
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    2/50 (4%)    1/50 (2%)    1/50 (2%)  |  0/50 (0%)    2/50 (4%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   9.1%         6.9%         2.5%         2.5%      |   0.0%         5.9%         0.0%         0.0%      |
|TERMINAL (d)           |  2/22 (9%)    2/29 (7%)    0/36 (0%)    0/35 (0%)  |  0/29 (0%)    2/34 (6%)    0/33 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      681          687       |   ---          729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.212N     P=0.593N     P=0.343N     P=0.345N   |  P=0.302N     P=0.274        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.254N     P=0.593N     P=0.403N     P=0.394N   |  P=0.302N     P=0.274        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.261N     P=0.593N     P=0.406N     P=0.402N   |  P=0.302N     P=0.274        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.330N                                          |  P=0.353N                                          |
|FISHER EXACT           |               P=0.691N     P=0.500N     P=0.500N   |               P=0.247        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    2/50 (4%)    0/50 (0%)    1/50 (2%)  |  0/50 (0%)    2/50 (4%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   4.5%         6.9%         0.0%         2.5%      |   0.0%         5.9%         0.0%         0.0%      |
|TERMINAL (d)           |  1/22 (5%)    2/29 (7%)    0/36 (0%)    0/35 (0%)  |  0/29 (0%)    2/34 (6%)    0/33 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      ---          687       |   ---          729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.356N     P=0.597      P=0.402N     P=0.658N   |  P=0.302N     P=0.274        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.391N     P=0.597      P=0.402N     P=0.710N   |  P=0.302N     P=0.274        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.398N     P=0.597      P=0.402N     P=0.721N   |  P=0.302N     P=0.274        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.473N                                          |  P=0.353N                                          |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.753N   |               P=0.247        (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE  18
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/50 (0%)    1/50 (2%)    2/50 (4%)  |  0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   2.6%         0.0%         2.8%         5.7%      |   0.0%         2.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/22 (0%)    0/29 (0%)    1/36 (3%)    2/35 (6%)  |  0/29 (0%)    0/34 (0%)    0/33 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   612          ---          729 (T)      729 (T)   |   ---          407          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.318      P=0.495N     P=0.687N     P=0.627    |  P=0.521N     P=0.504        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.220      P=0.665N     P=0.711      P=0.464    |  P=0.625N     P=0.318        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.247      P=0.503N     P=0.749      P=0.520    |  P=0.781N     P=0.451        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.230                                           |  P=0.527N                                          |
|FISHER EXACT           |               P=0.500N     P=0.753N     P=0.500    |               P=0.500        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    2/50 (4%)    5/50 (10%)   6/50 (12%) |  1/50 (2%)    3/50 (6%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |  15.9%         6.9%        13.3%        16.4%      |   2.7%         7.8%         0.0%         2.0%      |
|TERMINAL (d)           |  3/22 (14%)   2/29 (7%)    4/36 (11%)   5/35 (14%) |  0/29 (0%)    2/34 (6%)    0/33 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   612          729 (T)      681          687       |   655          407          ---          505       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.365      P=0.235N     P=0.505N     P=0.617N   |  P=0.329N     P=0.352      P=0.495N     P=0.740N   |
|INCIDENTAL TUMOR       |  P=0.282      P=0.288N     P=0.628N     P=0.531    |  P=0.507N     P=0.273      P=0.581N     P=0.417    |
|LOGISTIC REGRESSION    |  P=0.274      P=0.262N     P=0.632N     P=0.537    |  P=0.477N     P=0.267      P=0.505N     P=0.652    |
|COCHRAN-ARMITAGE       |  P=0.169                                           |  P=0.370N                                          |
|FISHER EXACT           |               P=0.339N     P=0.500      P=0.370    |               P=0.309      P=0.500N     P=0.753N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE  19
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    3/50 (6%)    4/50 (8%)    2/50 (4%)  |  0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         7.8%        10.2%         5.6%      |   0.0%         2.9%         0.0%         0.0%      |
|TERMINAL (d)           |  0/22 (0%)    1/29 (3%)    3/36 (8%)    1/35 (3%)  |  0/29 (0%)    1/34 (3%)    0/33 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          592          535          727       |   ---          729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.448      P=0.150      P=0.121      P=0.344    |  P=0.484N     P=0.532        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.273      P=0.050      P=0.085      P=0.290    |  P=0.484N     P=0.532        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.294      P=0.113      P=0.053      P=0.336    |  P=0.484N     P=0.532        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.317                                           |  P=0.527N                                          |
|FISHER EXACT           |               P=0.121      P=0.059      P=0.247    |               P=0.500        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    2/50 (4%)    0/50 (0%)    0/50 (0%)  |  1/50 (2%)    0/50 (0%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         6.4%         0.0%         0.0%      |   3.1%         0.0%         0.0%         2.5%      |
|TERMINAL (d)           |  0/22 (0%)    1/29 (3%)    0/36 (0%)    0/35 (0%)  |  0/29 (0%)    0/34 (0%)    0/33 (0%)    1/40 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          711          ---          ---       |   693          ---          ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.277N     P=0.312        (e)          (e)      |  P=0.621      P=0.466N     P=0.488N     P=0.696N   |
|INCIDENTAL TUMOR       |  P=0.324N     P=0.296        (e)          (e)      |  P=0.452      P=0.460N     P=0.581N     P=0.622    |
|LOGISTIC REGRESSION    |  P=0.300N     P=0.289        (e)          (e)      |  P=0.594      P=0.493N     P=0.495N     P=0.736N   |
|COCHRAN-ARMITAGE       |  P=0.353N                                          |  P=0.575                                           |
|FISHER EXACT           |               P=0.247        (e)          (e)      |               P=0.500N     P=0.500N     P=0.753N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE  20
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    5/50 (10%)   4/50 (8%)    2/50 (4%)  |  1/50 (2%)    1/50 (2%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%        13.8%        10.2%         5.6%      |   3.1%         2.9%         0.0%         2.5%      |
|TERMINAL (d)           |  0/22 (0%)    2/29 (7%)    3/36 (8%)    1/35 (3%)  |  0/29 (0%)    1/34 (3%)    0/33 (0%)    1/40 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          592          535          727       |   693          729 (T)      ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.527N     P=0.058      P=0.121      P=0.344    |  P=0.540N     P=0.723N     P=0.488N     P=0.696N   |
|INCIDENTAL TUMOR       |  P=0.446      P=0.019 *    P=0.085      P=0.290    |  P=0.639      P=0.720N     P=0.581N     P=0.622    |
|LOGISTIC REGRESSION    |  P=0.471      P=0.032 *    P=0.053      P=0.336    |  P=0.576N     P=0.741N     P=0.495N     P=0.736N   |
|COCHRAN-ARMITAGE       |  P=0.475                                           |  P=0.607N                                          |
|FISHER EXACT           |               P=0.028 *    P=0.059      P=0.247    |               P=0.753N     P=0.500N     P=0.753N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 48/50 (96%)  44/44 (100%) 44/44 (100%) 46/49 (94%) |                                                    |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%        97.9%      |                                                    |
|TERMINAL (d)           | 22/22 (100%) 26/26 (100%) 33/33 (100%) 34/35 (97%) |                                                    |
|FIRST INCIDENCE (DAYS) |   448          513          479          513       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001N**   P=0.059N     P<0.001N**   P=0.001N** |                                                    |
|INCIDENTAL TUMOR       |  P=0.150N     P=0.390      P=0.581      P=0.335N   |                                                    |
|LOGISTIC REGRESSION    |  P=0.147N     P=0.459      P=0.520      P=0.291N   |                                                    |
|COCHRAN-ARMITAGE       |  P=0.234N                                          |                                                    |
|FISHER EXACT           |               P=0.280      P=0.280      P=0.490N   |                                                    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE  21
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    6/50 (12%)   5/49 (10%)   7/50 (14%) |  5/50 (10%)   5/50 (10%)   5/50 (10%)   2/50 (4%)  |
|ADJUSTED (b)           |   9.1%        18.7%        12.5%        19.1%      |  15.9%        14.1%        13.6%         4.9%      |
|TERMINAL (d)           |  1/22 (5%)    4/29 (14%)   3/36 (8%)    6/35 (17%) |  4/29 (14%)   4/34 (12%)   2/33 (6%)    1/40 (3%)  |
|FIRST INCIDENCE (DAYS) |   564          675          620          648       |   606          693          651          707       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.383      P=0.365      P=0.557      P=0.355    |  P=0.091N     P=0.528N     P=0.561N     P=0.119N   |
|INCIDENTAL TUMOR       |  P=0.202      P=0.254      P=0.247      P=0.181    |  P=0.232N     P=0.602N     P=0.604      P=0.197N   |
|LOGISTIC REGRESSION    |  P=0.219      P=0.270      P=0.297      P=0.184    |  P=0.129N     P=0.559N     P=0.611N     P=0.172N   |
|COCHRAN-ARMITAGE       |  P=0.174                                           |  P=0.160N                                          |
|FISHER EXACT           |               P=0.243      P=0.346      P=0.159    |               P=0.630N     P=0.630N     P=0.218N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    3/50 (6%)    1/49 (2%)    3/50 (6%)  |  1/50 (2%)    0/50 (0%)    4/50 (8%)    3/50 (6%)  |
|ADJUSTED (b)           |   4.3%         9.0%         2.8%         7.9%      |   3.4%         0.0%        12.1%         7.5%      |
|TERMINAL (d)           |  0/22 (0%)    2/29 (7%)    1/36 (3%)    2/35 (6%)  |  1/29 (3%)    0/34 (0%)    4/33 (12%)   3/40 (8%)  |
|FIRST INCIDENCE (DAYS) |   728          592          729 (T)      648       |   729 (T)      ---          729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.479      P=0.391      P=0.652N     P=0.467    |  P=0.166      P=0.468N     P=0.218      P=0.426    |
|INCIDENTAL TUMOR       |  P=0.356      P=0.302      P=0.742N     P=0.389    |  P=0.166      P=0.468N     P=0.218      P=0.426    |
|LOGISTIC REGRESSION    |  P=0.371      P=0.331      P=0.663N     P=0.380    |  P=0.166      P=0.468N     P=0.218      P=0.426    |
|COCHRAN-ARMITAGE       |  P=0.333                                           |  P=0.098                                           |
|FISHER EXACT           |               P=0.309      P=0.747      P=0.309    |               P=0.500N     P=0.181      P=0.309    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE  22
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    9/50 (18%)   6/49 (12%)   9/50 (18%) |  5/50 (10%)   5/50 (10%)   8/50 (16%)   5/50 (10%) |
|ADJUSTED (b)           |  13.0%        26.9%        15.2%        24.7%      |  15.9%        14.1%        22.0%        12.2%      |
|TERMINAL (d)           |  1/22 (5%)    6/29 (21%)   4/36 (11%)   8/35 (23%) |  4/29 (14%)   4/34 (12%)   5/33 (15%)   4/40 (10%) |
|FIRST INCIDENCE (DAYS) |   564          592          620          648       |   606          693          651          707       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.444      P=0.231      P=0.610      P=0.333    |  P=0.420N     P=0.528N     P=0.355      P=0.434N   |
|INCIDENTAL TUMOR       |  P=0.223      P=0.121      P=0.282      P=0.164    |  P=0.452      P=0.602N     P=0.274      P=0.562N   |
|LOGISTIC REGRESSION    |  P=0.251      P=0.140      P=0.356      P=0.171    |  P=0.531N     P=0.559N     P=0.300      P=0.538N   |
|COCHRAN-ARMITAGE       |  P=0.185                                           |  P=0.506                                           |
|FISHER EXACT           |               P=0.117      P=0.357      P=0.117    |               P=0.630N     P=0.277      P=0.630N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    2/50 (4%)    0/49 (0%)    1/50 (2%)  |  0/50 (0%)    1/50 (2%)    0/50 (0%)    3/50 (6%)  |
|ADJUSTED (b)           |   7.4%         5.3%         0.0%         2.9%      |   0.0%         2.9%         0.0%         7.1%      |
|TERMINAL (d)           |  1/22 (5%)    0/29 (0%)    0/36 (0%)    1/35 (3%)  |  0/29 (0%)    1/34 (3%)    0/33 (0%)    2/40 (5%)  |
|FIRST INCIDENCE (DAYS) |   630          675          ---          729 (T)   |   ---          729 (T)      ---          618       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.199N     P=0.597N     P=0.164N     P=0.367N   |  P=0.072      P=0.532        (e)        P=0.173    |
|INCIDENTAL TUMOR       |  P=0.324N     P=0.693      P=0.289N     P=0.536N   |  P=0.086      P=0.532        (e)        P=0.174    |
|LOGISTIC REGRESSION    |  P=0.277N     P=0.690N     P=0.240N     P=0.463N   |  P=0.051      P=0.532        (e)        P=0.121    |
|COCHRAN-ARMITAGE       |  P=0.285N                                          |  P=0.047 *                                         |
|FISHER EXACT           |               P=0.691N     P=0.253N     P=0.500N   |               P=0.500        (e)        P=0.121    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE  23
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    2/50 (4%)    1/49 (2%)    3/50 (6%)  |  1/50 (2%)    0/50 (0%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   4.5%         6.9%         2.8%         8.6%      |   3.4%         0.0%         0.0%         2.5%      |
|TERMINAL (d)           |  1/22 (5%)    2/29 (7%)    1/36 (3%)    3/35 (9%)  |  1/29 (3%)    0/34 (0%)    0/33 (0%)    1/40 (3%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      729 (T)      729 (T)   |   729 (T)      ---          ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.387      P=0.597      P=0.648N     P=0.482    |  P=0.631      P=0.468N     P=0.474N     P=0.688N   |
|INCIDENTAL TUMOR       |  P=0.387      P=0.597      P=0.648N     P=0.482    |  P=0.631      P=0.468N     P=0.474N     P=0.688N   |
|LOGISTIC REGRESSION    |  P=0.387      P=0.597      P=0.648N     P=0.482    |  P=0.631      P=0.468N     P=0.474N     P=0.688N   |
|COCHRAN-ARMITAGE       |  P=0.245                                           |  P=0.575                                           |
|FISHER EXACT           |               P=0.500      P=0.747      P=0.309    |               P=0.500N     P=0.500N     P=0.753N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    4/50 (8%)    1/49 (2%)    4/50 (8%)  |  1/50 (2%)    1/50 (2%)    0/50 (0%)    4/50 (8%)  |
|ADJUSTED (b)           |  11.8%        11.9%         2.8%        11.4%      |   3.4%         2.9%         0.0%         9.6%      |
|TERMINAL (d)           |  2/22 (9%)    2/29 (7%)    1/36 (3%)    4/35 (11%) |  1/29 (3%)    1/34 (3%)    0/33 (0%)    3/40 (8%)  |
|FIRST INCIDENCE (DAYS) |   630          675          729 (T)      729 (T)   |   729 (T)      729 (T)      ---          618       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.444N     P=0.640      P=0.170N     P=0.582N   |  P=0.101      P=0.726N     P=0.474N     P=0.276    |
|INCIDENTAL TUMOR       |  P=0.549N     P=0.560      P=0.259N     P=0.625    |  P=0.115      P=0.726N     P=0.474N     P=0.277    |
|LOGISTIC REGRESSION    |  P=0.541N     P=0.561      P=0.244N     P=0.651    |  P=0.073      P=0.726N     P=0.474N     P=0.209    |
|COCHRAN-ARMITAGE       |  P=0.514                                           |  P=0.062                                           |
|FISHER EXACT           |               P=0.500      P=0.316N     P=0.500    |               P=0.753N     P=0.500N     P=0.181    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE  24
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Tissue NOS                                                                                                                       |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   8.2%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/22 (5%)    0/29 (0%)    0/36 (0%)    0/35 (0%)  |  0/29 (0%)    0/34 (0%)    0/33 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   700          ---          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.092N     P=0.185N     P=0.150N     P=0.156N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.112N     P=0.187N     P=0.199N     P=0.189N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.103N     P=0.193N     P=0.173N     P=0.175N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.129N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.247N     P=0.247N     P=0.247N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  7/50 (14%)   4/50 (8%)    8/50 (16%)  13/50 (26%) |
|ADJUSTED (b)           |                                                    |  22.1%        10.2%        22.3%        30.0%      |
|TERMINAL (d)           |                                                    |  5/29 (17%)   2/34 (6%)    6/33 (18%)  10/40 (25%) |
|FIRST INCIDENCE (DAYS) |                                                    |   655          592          546          535       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.082      P=0.184N     P=0.588      P=0.300    |
|INCIDENTAL TUMOR       |                                                    |  P=0.017 *    P=0.225N     P=0.500      P=0.078    |
|LOGISTIC REGRESSION    |                                                    |  P=0.030 *    P=0.221N     P=0.533      P=0.158    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.022 *                                         |
|FISHER EXACT           |                                                    |               P=0.262N     P=0.500      P=0.105    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE  25
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  1/50 (2%)    2/50 (4%)    1/50 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |                                                    |   3.3%         5.6%         3.0%         0.0%      |
|TERMINAL (d)           |                                                    |  0/29 (0%)    1/34 (3%)    1/33 (3%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   718          703          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.180N     P=0.557      P=0.735N     P=0.443N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.352N     P=0.565      P=0.732      P=0.909N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.171N     P=0.546      P=0.748N     P=0.467N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.230N                                          |
|FISHER EXACT           |                                                    |               P=0.500      P=0.753N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  8/50 (16%)   6/50 (12%)   8/50 (16%)  13/50 (26%) |
|ADJUSTED (b)           |                                                    |  24.7%        15.5%        22.3%        30.0%      |
|TERMINAL (d)           |                                                    |  5/29 (17%)   3/34 (9%)    6/33 (18%)  10/40 (25%) |
|FIRST INCIDENCE (DAYS) |                                                    |   655          592          546          535       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.193      P=0.277N     P=0.515N     P=0.406    |
|INCIDENTAL TUMOR       |                                                    |  P=0.036 *    P=0.316N     P=0.587      P=0.087    |
|LOGISTIC REGRESSION    |                                                    |  P=0.087      P=0.323N     P=0.575N     P=0.237    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.064                                           |
|FISHER EXACT           |                                                    |               P=0.387N     P=0.607N     P=0.163    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE  26
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |  0/50 (0%)    2/50 (4%)    1/50 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         5.1%         3.0%         0.0%      |
|TERMINAL (d)           |  0/22 (0%)    0/29 (0%)    0/36 (0%)    0/35 (0%)  |  0/29 (0%)    1/34 (3%)    1/33 (3%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          612          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.371N     P=0.276      P=0.526        (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.342N     P=0.141      P=0.526        (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.420N     P=0.230      P=0.526        (e)      |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.423N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.247      P=0.500        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |  0/50 (0%)    2/50 (4%)    1/50 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |   3.7%         0.0%         0.0%         0.0%      |   0.0%         5.1%         3.0%         0.0%      |
|TERMINAL (d)           |  0/22 (0%)    0/29 (0%)    0/36 (0%)    0/35 (0%)  |  0/29 (0%)    1/34 (3%)    1/33 (3%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   681          ---          ---          ---       |   ---          612          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.279N     P=0.437N     P=0.422N     P=0.422N   |  P=0.371N     P=0.276      P=0.526        (e)      |
|INCIDENTAL TUMOR       |  P=0.335N     P=0.455N     P=0.527N     P=0.500N   |  P=0.342N     P=0.141      P=0.526        (e)      |
|LOGISTIC REGRESSION    |  P=0.323N     P=0.495N     P=0.504N     P=0.501N   |  P=0.420N     P=0.230      P=0.526        (e)      |
|COCHRAN-ARMITAGE       |  P=0.321N                                          |  P=0.423N                                          |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.500N   |               P=0.247      P=0.500        (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE  27
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 28/50 (56%)  22/50 (44%)  10/50 (20%)   4/50 (8%)  | 14/50 (28%)   7/50 (14%)   3/50 (6%)    3/50 (6%)  |
|ADJUSTED (b)           |  63.7%        53.5%        25.3%        10.4%      |  41.2%        18.3%         7.8%         6.9%      |
|TERMINAL (d)           |  8/22 (36%)  11/29 (38%)   7/36 (19%)   3/35 (9%)  | 10/29 (34%)   4/34 (12%)   1/33 (3%)    1/40 (3%)  |
|FIRST INCIDENCE (DAYS) |   502          301          617          412       |   507          242          572          610       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001N**   P=0.072N     P<0.001N**   P<0.001N** |  P<0.001N**   P=0.038N*    P=0.003N**   P<0.001N** |
|INCIDENTAL TUMOR       |  P<0.001N**   P=0.273N     P=0.004N**   P<0.001N** |  P=0.003N**   P=0.055N     P=0.004N**   P=0.005N** |
|LOGISTIC REGRESSION    |  P<0.001N**   P=0.232N     P=0.001N**   P<0.001N** |  P=0.002N**   P=0.065N     P=0.003N**   P=0.002N** |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |  P=0.002N**                                        |
|FISHER EXACT           |               P=0.159N     P<0.001N**   P<0.001N** |               P=0.070N     P=0.003N**   P=0.003N** |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma Benign, Malignant, NOS                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    0/50 (0%)    3/50 (6%)    3/50 (6%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |  12.2%         0.0%         7.7%         7.6%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/22 (5%)    0/29 (0%)    2/36 (6%)    2/35 (6%)  |  0/29 (0%)    0/34 (0%)    0/33 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   585          ---          620          513       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.533N     P=0.049N*    P=0.324N     P=0.348N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.393      P=0.096N     P=0.649N     P=0.607N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.437      P=0.068N     P=0.578N     P=0.594N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.500                                           |    (e)                                             |
|FISHER EXACT           |               P=0.059N     P=0.500N     P=0.500N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE  28
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 50/50 (100%) 48/50 (96%)  48/50 (96%)  49/50 (98%) | 43/50 (86%)  43/50 (86%)  41/50 (82%)  41/50 (82%) |
|ADJUSTED (b)           | 100.0%       100.0%        96.0%       100.0%      |  95.5%        93.4%        87.2%        83.6%      |
|TERMINAL (d)           | 22/22 (100%) 29/29 (100%) 34/36 (94%)  35/35 (100%)| 27/29 (93%)  31/34 (91%)  27/33 (82%)  32/40 (80%) |
|FIRST INCIDENCE (DAYS) |   448          513          479          513       |   378          592          325          505       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.003N**   P=0.046N*    P=0.001N**   P=0.002N** |  P=0.018N*    P=0.162N     P=0.199N     P=0.016N*  |
|INCIDENTAL TUMOR       |  P=0.384N     P=0.443N     P=0.352N     P=0.443N   |  P=0.279N     P=0.340N     P=0.398N     P=0.328N   |
|LOGISTIC REGRESSION    |  P=0.306N     P=0.338N     P=0.352N     P=0.443N   |  P=0.146N     P=0.348N     P=0.315N     P=0.195N   |
|COCHRAN-ARMITAGE       |  P=0.488N                                          |  P=0.295N                                          |
|FISHER EXACT           |               P=0.247N     P=0.247N     P=0.500N   |               P=0.613N     P=0.393N     P=0.393N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 33/50 (66%)  30/50 (60%)  22/50 (44%)  22/50 (44%) | 22/50 (44%)  15/50 (30%)  14/50 (28%)  10/50 (20%) |
|ADJUSTED (b)           |  71.8%        67.4%        48.4%        51.4%      |  53.9%        36.1%        34.0%        23.6%      |
|TERMINAL (d)           | 10/22 (45%)  15/29 (52%)  13/36 (36%)  15/35 (43%) | 11/29 (38%)   9/34 (26%)   8/33 (24%)   8/40 (20%) |
|FIRST INCIDENCE (DAYS) |   448          301          479          412       |   494          242          325          610       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001N**   P=0.132N     P=0.002N**   P=0.002N** |  P=0.003N**   P=0.063N     P=0.061N     P=0.002N** |
|INCIDENTAL TUMOR       |  P=0.054N     P=0.524N     P=0.155N     P=0.123N   |  P=0.022N*    P=0.160N     P=0.096N     P=0.044N*  |
|LOGISTIC REGRESSION    |  P=0.034N*    P=0.482N     P=0.109N     P=0.086N   |  P=0.017N*    P=0.134N     P=0.079N     P=0.007N** |
|COCHRAN-ARMITAGE       |  P=0.010N**                                        |  P=0.010N*                                         |
|FISHER EXACT           |               P=0.339N     P=0.022N*    P=0.022N*  |               P=0.107N     P=0.072N     P=0.009N** |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05021 TEST: 03                                                 PAGE  29
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 50/50 (100%) 50/50 (100%) 48/50 (96%)  50/50 (100%)| 48/50 (96%)  48/50 (96%)  44/50 (88%)  44/50 (88%) |
|ADJUSTED (b)           | 100.0%       100.0%        96.0%       100.0%      |  98.0%        96.0%        89.7%        88.0%      |
|TERMINAL (d)           | 22/22 (100%) 29/29 (100%) 34/36 (94%)  35/35 (100%)| 28/29 (97%)  32/34 (94%)  28/33 (85%)  34/40 (85%) |
|FIRST INCIDENCE (DAYS) |   448          301          479          412       |   249          242          325          505       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.003N**   P=0.087N     P=0.001N**   P=0.004N** |  P=0.006N**   P=0.169N     P=0.128N     P=0.006N** |
|INCIDENTAL TUMOR       |  P=0.659N       (e)        P=0.352N       (e)      |  P=0.110N     P=0.663N     P=0.160N     P=0.192N   |
|LOGISTIC REGRESSION    |  P=0.659N       (e)        P=0.352N       (e)      |  P=0.063N     P=0.672N     P=0.135N     P=0.135N   |
|COCHRAN-ARMITAGE       |  P=0.575N                                          |  P=0.052N                                          |
|FISHER EXACT           |               P=1.000N     P=0.247N     P=1.000N   |               P=0.691N     P=0.134N     P=0.134N   |
|=================================================================================================================================|
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (d)  Observed incidence at terminal kill.
 (f)  Beneath the control incidence are the P-values associated with the trend 
      test.  Beneath the dosed group incidence are the P-values corresponding to 
      pairwise comparisons between the controls and that dosed group.  The life
      table analysis regards tumors in animals dying  prior to terminal kill as
      being (directly or indirectly) the cause of death.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's exact tests compare directly the overall incidence rates.  
      For all tests, a negative trend is indicated by "N".
 (e)  Value of Statistic cannot be computed. 
 (I)  Interim sacrifice
 (T)  Terminal sacrifice
  #   Tumor rates based on number of animals necropsied.
 
  *   To the right of any statistical result, indicates significance at (P<=0.05).
  **  To the right of any statistical result, indicates significance at (P<=0.01).
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.