Share This:
https://ntp.niehs.nih.gov/go/2770

TDMS Study 05019-04 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                 CI PIGMENT RED 3                                   DATE: 09/03/94       
EXPERIMENT: 05019 TEST: 04                                                                                     TIME: 16:44:25       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NOIES9565102          ROUTE: DOSED FEED                                                                  NTP C#: 60366        
PATHOLOGIST: H. GILES                        S. EUSTIS                                                         CAS: 2425-85-6       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               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 3                                   DATE: 09/03/94      
EXPERIMENT: 05019 TEST: 04                                                                                     TIME: 16:44:25      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NOIES9565102          ROUTE: DOSED FEED                                                                  NTP C#: 60366       
PATHOLOGIST: H. GILES                        S. EUSTIS                                                         CAS: 2425-85-6      
 
 
 
 
 
                                                    MICE(B6C3F1)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                 CI PIGMENT RED 3                                   DATE: 09/03/94       
EXPERIMENT: 05019 TEST: 04                                                                                     TIME: 16:44:25       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NOIES9565102          ROUTE: DOSED FEED                                                                  NTP C#: 60366        
PATHOLOGIST: H. GILES                        S. EUSTIS                                                         CAS: 2425-85-6       
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                        IN THE ANALYSIS OF THE STUDY OF CI PIGMENT RED 3
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Kidney                        Adenoma
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             Skin: Subcutaneous Tissue     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
                                                            Neurofibroma, or Fibroma
                             Thyroid Gland: Follicular Cell
                                                           Adenoma
                                                           Carcinoma or Adenoma
                             All Organs                    Malignant Lymphoma And Histiocytic Sarcoma
                                                           Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
                                                            NOS, or Undifferentiated Cell Type
                                                           Benign Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Liver                         Hepatocellular Carcinoma
                             Ovary                         Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                             All Organs                    Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
                                                            NOS, or Undifferentiated Cell Type
                                                           Benign Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 04                                                 PAGE   1
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.25%        2.5%         5.0%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    1/21 (5%)    0/18 (0%)    0/50 (0%)  |  1/50 (2%)    2/14 (14%)   0/18 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   2.6%       100.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/33 (0%)    0/0          0/0          0/33 (0%)  |  1/39 (3%)    1/1 (100%)   0/0          0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          576          ---          ---       |   729 (T)      540          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.594N     P=0.475        (e)          (e)      |  P=0.272N     P=0.043 *      (e)        P=0.589N   |
|INCIDENTAL TUMOR       |  P=0.406N     P=0.419        (e)          (e)      |  P=0.299N     P=0.016 *      (e)        P=0.589N   |
|LOGISTIC REGRESSION    |  P=0.534N     P=0.348        (e)          (e)      |  P=0.188N     P=0.113        (e)        P=0.589N   |
|COCHRAN-ARMITAGE       |  P=0.535N                                          |  P=0.188N                                          |
|FISHER EXACT           |               P=0.296        (e)          (e)      |               P=0.118      P=0.735N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    2/50 (4%)    1/50 (2%)    1/50 (2%)  |  3/50 (6%)    1/50 (2%)    1/50 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |   5.4%         6.7%         3.2%         3.0%      |   7.2%         2.4%         3.2%         2.6%      |
|TERMINAL (d)           |  1/33 (3%)    1/28 (4%)    1/31 (3%)    1/33 (3%)  |  2/39 (5%)    0/37 (0%)    1/31 (3%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   630          703          729 (T)      729 (T)   |   630          680          729 (T)      625       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.338N     P=0.642      P=0.520N     P=0.522N   |  P=0.364N     P=0.330N     P=0.385N     P=0.451N   |
|INCIDENTAL TUMOR       |  P=0.324N     P=0.639      P=0.481N     P=0.406N   |  P=0.118N     P=0.195N     P=0.214N     P=0.058N   |
|LOGISTIC REGRESSION    |  P=0.357N     P=0.658      P=0.506N     P=0.526N   |  P=0.243N     P=0.305N     P=0.309N     P=0.306N   |
|COCHRAN-ARMITAGE       |  P=0.337N                                          |  P=0.242N                                          |
|FISHER EXACT           |               P=0.691N     P=0.500N     P=0.500N   |               P=0.309N     P=0.309N     P=0.309N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 04                                                 PAGE   2
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.25%        2.5%         5.0%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    2/50 (4%)    1/50 (2%)    1/50 (2%)  |  3/50 (6%)    2/50 (4%)    1/50 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |   5.4%         6.7%         3.2%         3.0%      |   7.2%         5.1%         3.2%         2.6%      |
|TERMINAL (d)           |  1/33 (3%)    1/28 (4%)    1/31 (3%)    1/33 (3%)  |  2/39 (5%)    1/37 (3%)    1/31 (3%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   630          703          729 (T)      729 (T)   |   630          680          729 (T)      625       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.338N     P=0.642      P=0.520N     P=0.522N   |  P=0.323N     P=0.527N     P=0.385N     P=0.451N   |
|INCIDENTAL TUMOR       |  P=0.324N     P=0.639      P=0.481N     P=0.406N   |  P=0.108N     P=0.391N     P=0.214N     P=0.058N   |
|LOGISTIC REGRESSION    |  P=0.357N     P=0.658      P=0.506N     P=0.526N   |  P=0.204N     P=0.497N     P=0.309N     P=0.306N   |
|COCHRAN-ARMITAGE       |  P=0.337N                                          |  P=0.199N                                          |
|FISHER EXACT           |               P=0.691N     P=0.500N     P=0.500N   |               P=0.500N     P=0.309N     P=0.309N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    0/50 (0%)    6/50 (12%) |  0/50 (0%)    0/49 (0%)    0/49 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%        18.2%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/33 (0%)    0/28 (0%)    0/31 (0%)    6/33 (18%) |  0/39 (0%)    0/37 (0%)    0/31 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          729 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **     (e)          (e)        P=0.017 *  |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P<0.001 **     (e)          (e)        P=0.017 *  |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P<0.001 **     (e)          (e)        P=0.016 *  |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |    (e)                                             |
|FISHER EXACT           |                 (e)          (e)        P=0.013 *  |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 04                                                 PAGE   3
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.25%        2.5%         5.0%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  8/50 (16%)  12/48 (25%)  11/50 (22%)  16/49 (33%) |  7/50 (14%)   8/50 (16%)   2/49 (4%)    8/50 (16%) |
|ADJUSTED (b)           |  23.3%        38.1%        30.7%        45.4%      |  17.3%        19.2%         6.5%        26.1%      |
|TERMINAL (d)           |  7/33 (21%)   9/28 (32%)   7/31 (23%)  14/33 (42%) |  6/39 (15%)   5/37 (14%)   2/31 (6%)    5/25 (20%) |
|FIRST INCIDENCE (DAYS) |   681          650          521          557       |   653          599          729 (T)      616       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.059      P=0.124      P=0.266      P=0.043 *  |  P=0.248      P=0.461      P=0.145N     P=0.209    |
|INCIDENTAL TUMOR       |  P=0.027 *    P=0.149      P=0.302      P=0.041 *  |  P=0.510N     P=0.608N     P=0.128N     P=0.510    |
|LOGISTIC REGRESSION    |  P=0.026 *    P=0.126      P=0.279      P=0.021 *  |  P=0.482      P=0.506      P=0.107N     P=0.406    |
|COCHRAN-ARMITAGE       |  P=0.046 *                                         |  P=0.541                                           |
|FISHER EXACT           |               P=0.197      P=0.306      P=0.044 *  |               P=0.500      P=0.085N     P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/50 (10%)  10/48 (21%)   8/50 (16%)   4/49 (8%)  |  4/50 (8%)    8/50 (16%)   2/49 (4%)    1/50 (2%)  |
|ADJUSTED (b)           |  12.9%        30.1%        25.0%        11.4%      |  10.3%        20.0%         6.5%         4.0%      |
|TERMINAL (d)           |  1/33 (3%)    6/28 (21%)   7/31 (23%)   3/33 (9%)  |  4/39 (10%)   6/37 (16%)   2/31 (6%)    1/25 (4%)  |
|FIRST INCIDENCE (DAYS) |   653          512          724          557       |   729 (T)      627          729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.280N     P=0.084      P=0.249      P=0.541N   |  P=0.138N     P=0.157      P=0.447N     P=0.334N   |
|INCIDENTAL TUMOR       |  P=0.507N     P=0.118      P=0.244      P=0.390    |  P=0.085N     P=0.210      P=0.447N     P=0.334N   |
|LOGISTIC REGRESSION    |  P=0.319N     P=0.091      P=0.254      P=0.451    |  P=0.086N     P=0.176      P=0.447N     P=0.334N   |
|COCHRAN-ARMITAGE       |  P=0.281N                                          |  P=0.047N*                                         |
|FISHER EXACT           |               P=0.113      P=0.277      P=0.513N   |               P=0.178      P=0.349N     P=0.181N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 04                                                 PAGE   4
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.25%        2.5%         5.0%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 12/50 (24%)  16/48 (33%)  16/50 (32%)  19/49 (39%) | 10/50 (20%)  14/50 (28%)   4/49 (8%)    9/50 (18%) |
|ADJUSTED (b)           |  32.0%        49.2%        45.2%        52.4%      |  24.8%        33.5%        12.9%        29.8%      |
|TERMINAL (d)           |  8/33 (24%)  12/28 (43%)  12/31 (39%)  16/33 (48%) |  9/39 (23%)  10/37 (27%)   4/31 (13%)   6/25 (24%) |
|FIRST INCIDENCE (DAYS) |   653          512          521          557       |   653          599          729 (T)      616       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.116      P=0.129      P=0.212      P=0.087    |  P=0.475      P=0.207      P=0.156N     P=0.325    |
|INCIDENTAL TUMOR       |  P=0.043 *    P=0.175      P=0.232      P=0.031 *  |  P=0.299N     P=0.304      P=0.141N     P=0.589N   |
|LOGISTIC REGRESSION    |  P=0.050 *    P=0.137      P=0.219      P=0.043 *  |  P=0.354N     P=0.246      P=0.119N     P=0.550    |
|COCHRAN-ARMITAGE       |  P=0.090                                           |  P=0.242N                                          |
|FISHER EXACT           |               P=0.212      P=0.252      P=0.085    |               P=0.241      P=0.080N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 12/50 (24%)  16/48 (33%)  16/50 (32%)  19/49 (39%) | 10/50 (20%)  14/50 (28%)   4/49 (8%)    9/50 (18%) |
|ADJUSTED (b)           |  32.0%        49.2%        45.2%        52.4%      |  24.8%        33.5%        12.9%        29.8%      |
|TERMINAL (d)           |  8/33 (24%)  12/28 (43%)  12/31 (39%)  16/33 (48%) |  9/39 (23%)  10/37 (27%)   4/31 (13%)   6/25 (24%) |
|FIRST INCIDENCE (DAYS) |   653          512          521          557       |   653          599          729 (T)      616       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.116      P=0.129      P=0.212      P=0.087    |  P=0.475      P=0.207      P=0.156N     P=0.325    |
|INCIDENTAL TUMOR       |  P=0.043 *    P=0.175      P=0.232      P=0.031 *  |  P=0.299N     P=0.304      P=0.141N     P=0.589N   |
|LOGISTIC REGRESSION    |  P=0.050 *    P=0.137      P=0.219      P=0.043 *  |  P=0.354N     P=0.246      P=0.119N     P=0.550    |
|COCHRAN-ARMITAGE       |  P=0.090                                           |  P=0.242N                                          |
|FISHER EXACT           |               P=0.212      P=0.252      P=0.085    |               P=0.241      P=0.080N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 04                                                 PAGE   5
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.25%        2.5%         5.0%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    5/25 (20%)   7/26 (27%)   5/50 (10%) |  3/50 (6%)    0/13 (0%)    0/21 (0%)    3/50 (6%)  |
|ADJUSTED (b)           |   5.7%        69.7%        73.0%        14.3%      |   7.7%         0.0%         0.0%        10.8%      |
|TERMINAL (d)           |  1/33 (3%)    2/3 (67%)    5/7 (71%)    4/33 (12%) |  3/39 (8%)    0/0          0/2 (0%)     2/25 (8%)  |
|FIRST INCIDENCE (DAYS) |   697          650          541          557       |   729 (T)      ---          ---          627       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.370      P=0.015 *    P<0.001 **   P=0.211    |  P=0.362        (e)        P=0.835N     P=0.456    |
|INCIDENTAL TUMOR       |  P=0.222      P=0.017 *    P<0.001 **   P=0.168    |  P=0.480        (e)        P=0.835N     P=0.645    |
|LOGISTIC REGRESSION    |  P=0.313      P<0.001 **   P<0.001 **   P=0.184    |  P=0.425        (e)        P=0.835N     P=0.565    |
|COCHRAN-ARMITAGE       |  P=0.322                                           |  P=0.540                                           |
|FISHER EXACT           |               P=0.037 *    P=0.006 **   P=0.218    |               P=0.494N     P=0.343N     P=0.661N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    2/25 (8%)    0/26 (0%)    0/50 (0%)  |  1/50 (2%)    0/13 (0%)    1/21 (5%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%        35.6%         0.0%         0.0%      |   2.6%         0.0%        50.0%         0.0%      |
|TERMINAL (d)           |  0/33 (0%)    1/3 (33%)    0/7 (0%)     0/33 (0%)  |  1/39 (3%)    0/0          1/2 (50%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          710          ---          ---       |   729 (T)      ---          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.382N     P=0.047 *      (e)          (e)      |  P=0.478N       (e)        P=0.090      P=0.589N   |
|INCIDENTAL TUMOR       |  P=0.483N     P=0.061        (e)          (e)      |  P=0.478N       (e)        P=0.090      P=0.589N   |
|LOGISTIC REGRESSION    |  P=0.393N     P=0.007 **     (e)          (e)      |  P=0.478N       (e)        P=0.090      P=0.589N   |
|COCHRAN-ARMITAGE       |  P=0.388N                                          |  P=0.372N                                          |
|FISHER EXACT           |               P=0.108        (e)          (e)      |               P=0.794N     P=0.507      P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 04                                                 PAGE   6
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.25%        2.5%         5.0%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    5/25 (20%)   7/26 (27%)   5/50 (10%) |  4/50 (8%)    0/13 (0%)    1/21 (5%)    3/50 (6%)  |
|ADJUSTED (b)           |   5.7%        69.7%        73.0%        14.3%      |  10.3%         0.0%        50.0%        10.8%      |
|TERMINAL (d)           |  1/33 (3%)    2/3 (67%)    5/7 (71%)    4/33 (12%) |  4/39 (10%)   0/0          1/2 (50%)    2/25 (8%)  |
|FIRST INCIDENCE (DAYS) |   697          650          541          557       |   729 (T)      ---          729 (T)      627       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.370      P=0.015 *    P<0.001 **   P=0.211    |  P=0.469        (e)        P=0.288      P=0.583    |
|INCIDENTAL TUMOR       |  P=0.222      P=0.017 *    P<0.001 **   P=0.168    |  P=0.574        (e)        P=0.288      P=0.571N   |
|LOGISTIC REGRESSION    |  P=0.313      P<0.001 **   P<0.001 **   P=0.184    |  P=0.526        (e)        P=0.288      P=0.636N   |
|COCHRAN-ARMITAGE       |  P=0.322                                           |  P=0.481N                                          |
|FISHER EXACT           |               P=0.037 *    P=0.006 **   P=0.218    |               P=0.387N     P=0.534N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/50 (0%)    0/49 (0%)    1/50 (2%)    2/50 (4%)  |
|ADJUSTED (b)           |                                                    |   0.0%         0.0%         3.2%         8.0%      |
|TERMINAL (d)           |                                                    |  0/39 (0%)    0/37 (0%)    1/31 (3%)    2/25 (8%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          ---          729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.032 *      (e)        P=0.454      P=0.147    |
|INCIDENTAL TUMOR       |                                                    |  P=0.032 *      (e)        P=0.454      P=0.147    |
|LOGISTIC REGRESSION    |                                                    |  P=0.032 *      (e)        P=0.454      P=0.147    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.071                                           |
|FISHER EXACT           |                                                    |                 (e)        P=0.500      P=0.247    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 04                                                 PAGE   7
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.25%        2.5%         5.0%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/46 (0%)    0/20 (0%)    0/18 (0%)    0/49 (0%)  |  8/49 (16%)   2/14 (14%)   0/17 (0%)    2/50 (4%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |  19.9%       100.0%         0.0%         8.0%      |
|TERMINAL (d)           |  0/30 (0%)    0/0          0/0          0/33 (0%)  |  7/39 (18%)   2/2 (100%)   0/0          2/25 (8%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   703          729 (T)      ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.107N     P=0.224      P=0.542N     P=0.166N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.104N     P=0.231      P=0.443N     P=0.165N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.100N     P=0.257      P=0.402N     P=0.154N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.021N*                                         |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.610N     P=0.079N     P=0.043N*  |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/50 (10%)   1/50 (2%)    3/50 (6%)    1/50 (2%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |  15.2%         3.6%         9.7%         3.0%      |   0.0%         0.0%         0.0%         2.3%      |
|TERMINAL (d)           |  5/33 (15%)   1/28 (4%)    3/31 (10%)   1/33 (3%)  |  0/39 (0%)    0/37 (0%)    0/31 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      729 (T)      729 (T)   |   ---          ---          ---          599       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.105N     P=0.142N     P=0.389N     P=0.101N   |  P=0.190        (e)          (e)        P=0.487    |
|INCIDENTAL TUMOR       |  P=0.105N     P=0.142N     P=0.389N     P=0.101N   |  P=0.471        (e)          (e)        P=0.977    |
|LOGISTIC REGRESSION    |  P=0.105N     P=0.142N     P=0.389N     P=0.100N   |  P=0.193        (e)          (e)        P=0.494    |
|COCHRAN-ARMITAGE       |  P=0.114N                                          |  P=0.198                                           |
|FISHER EXACT           |               P=0.102N     P=0.357N     P=0.102N   |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 04                                                 PAGE   8
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.25%        2.5%         5.0%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 12/50 (24%)   7/50 (14%)   8/50 (16%)   5/50 (10%) |  2/50 (4%)    0/50 (0%)    1/50 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |  30.0%        21.8%        21.7%        13.2%      |   4.5%         0.0%         3.0%         2.5%      |
|TERMINAL (d)           |  6/33 (18%)   4/28 (14%)   3/31 (10%)   3/33 (9%)  |  0/39 (0%)    0/37 (0%)    0/31 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   450          648          541          294       |   508          ---          724          616       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.072N     P=0.272N     P=0.282N     P=0.080N   |  P=0.580N     P=0.243N     P=0.544N     P=0.570N   |
|INCIDENTAL TUMOR       |  P=0.138N     P=0.193N     P=0.182N     P=0.087N   |  P=0.402N     P=0.314N     P=0.385N     P=0.400N   |
|LOGISTIC REGRESSION    |  P=0.066N     P=0.204N     P=0.233N     P=0.059N   |  P=0.496N     P=0.261N     P=0.515N     P=0.501N   |
|COCHRAN-ARMITAGE       |  P=0.059N                                          |  P=0.500N                                          |
|FISHER EXACT           |               P=0.154N     P=0.227N     P=0.054N   |               P=0.247N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibroma or Fibroma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/50 (10%)   2/50 (4%)    3/50 (6%)    1/50 (2%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |  15.2%         7.1%         9.7%         3.0%      |   0.0%         0.0%         0.0%         2.3%      |
|TERMINAL (d)           |  5/33 (15%)   2/28 (7%)    3/31 (10%)   1/33 (3%)  |  0/39 (0%)    0/37 (0%)    0/31 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      729 (T)      729 (T)   |   ---          ---          ---          599       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.087N     P=0.284N     P=0.389N     P=0.101N   |  P=0.190        (e)          (e)        P=0.487    |
|INCIDENTAL TUMOR       |  P=0.087N     P=0.284N     P=0.389N     P=0.101N   |  P=0.471        (e)          (e)        P=0.977    |
|LOGISTIC REGRESSION    |  P=0.087N     P=0.284N     P=0.389N     P=0.100N   |  P=0.193        (e)          (e)        P=0.494    |
|COCHRAN-ARMITAGE       |  P=0.095N                                          |  P=0.198                                           |
|FISHER EXACT           |               P=0.218N     P=0.357N     P=0.102N   |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 04                                                 PAGE   9
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.25%        2.5%         5.0%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 15/50 (30%)   8/50 (16%)  10/50 (20%)   7/50 (14%) |  3/50 (6%)    0/50 (0%)    2/50 (4%)    2/50 (4%)  |
|ADJUSTED (b)           |  37.8%        25.1%        27.3%        18.3%      |   7.0%         0.0%         5.7%         4.8%      |
|TERMINAL (d)           |  9/33 (27%)   5/28 (18%)   5/31 (16%)   4/33 (12%) |  1/39 (3%)    0/37 (0%)    0/31 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   450          648          541          294       |   508          ---          679          599       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.072N     P=0.173N     P=0.238N     P=0.069N   |  P=0.517      P=0.129N     P=0.570N     P=0.599N   |
|INCIDENTAL TUMOR       |  P=0.115N     P=0.114N     P=0.153N     P=0.058N   |  P=0.426N     P=0.167N     P=0.404N     P=0.280N   |
|LOGISTIC REGRESSION    |  P=0.070N     P=0.117N     P=0.186N     P=0.052N   |  P=0.567N     P=0.127N     P=0.505N     P=0.494N   |
|COCHRAN-ARMITAGE       |  P=0.060N                                          |  P=0.577N                                          |
|FISHER EXACT           |               P=0.077N     P=0.178N     P=0.045N*  |               P=0.121N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 12/50 (24%)   7/50 (14%)   8/50 (16%)   6/50 (12%) |  3/50 (6%)    0/50 (0%)    2/50 (4%)    1/50 (2%)  |
|ADJUSTED (b)           |  30.0%        21.8%        21.7%        15.5%      |   7.0%         0.0%         5.7%         2.5%      |
|TERMINAL (d)           |  6/33 (18%)   4/28 (14%)   3/31 (10%)   3/33 (9%)  |  1/39 (3%)    0/37 (0%)    0/31 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   450          648          541          294       |   508          ---          679          616       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.122N     P=0.272N     P=0.282N     P=0.133N   |  P=0.448N     P=0.129N     P=0.570N     P=0.404N   |
|INCIDENTAL TUMOR       |  P=0.200N     P=0.193N     P=0.182N     P=0.120N   |  P=0.293N     P=0.167N     P=0.404N     P=0.255N   |
|LOGISTIC REGRESSION    |  P=0.105N     P=0.204N     P=0.233N     P=0.099N   |  P=0.330N     P=0.127N     P=0.505N     P=0.300N   |
|COCHRAN-ARMITAGE       |  P=0.105N                                          |  P=0.337N                                          |
|FISHER EXACT           |               P=0.154N     P=0.227N     P=0.096N   |               P=0.121N     P=0.500N     P=0.309N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 04                                                 PAGE  10
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.25%        2.5%         5.0%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Schwannoma Malignant                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    2/50 (4%)    0/50 (0%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         6.2%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/33 (0%)    1/28 (4%)    0/31 (0%)    0/33 (0%)  |  0/39 (0%)    0/37 (0%)    0/31 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          588          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.419N     P=0.208        (e)          (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.299N     P=0.180        (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.408N     P=0.228        (e)          (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.405N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.247        (e)          (e)      |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/48 (0%)    0/47 (0%)    1/49 (2%)    0/48 (0%)  |  1/50 (2%)    2/49 (4%)    2/49 (4%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         3.2%         0.0%      |   2.2%         5.4%         6.5%         0.0%      |
|TERMINAL (d)           |  0/33 (0%)    0/28 (0%)    1/31 (3%)    0/32 (0%)  |  0/39 (0%)    2/37 (5%)    2/31 (6%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          729 (T)      ---       |   653          729 (T)      729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.693        (e)        P=0.488        (e)      |  P=0.430N     P=0.483      P=0.431      P=0.588N   |
|INCIDENTAL TUMOR       |  P=0.693        (e)        P=0.488        (e)      |  P=0.421N     P=0.488      P=0.480      P=0.581N   |
|LOGISTIC REGRESSION    |  P=0.693        (e)        P=0.488        (e)      |  P=0.354N     P=0.497      P=0.492      P=0.497N   |
|COCHRAN-ARMITAGE       |  P=0.696                                           |  P=0.295N                                          |
|FISHER EXACT           |                 (e)        P=0.505        (e)      |               P=0.492      P=0.492      P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 04                                                 PAGE  11
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.25%        2.5%         5.0%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/49 (0%)    1/50 (2%)    5/50 (10%) |  4/50 (8%)    1/50 (2%)    0/49 (0%)    3/50 (6%)  |
|ADJUSTED (b)           |   0.0%         0.0%         2.6%        14.3%      |   9.9%         2.7%         0.0%        12.0%      |
|TERMINAL (d)           |  0/33 (0%)    0/28 (0%)    0/31 (0%)    4/33 (12%) |  3/39 (8%)    1/37 (3%)    0/31 (0%)    3/25 (12%) |
|FIRST INCIDENCE (DAYS) |   ---          ---          658          557       |   703          729 (T)      ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.002 **     (e)        P=0.495      P=0.033 *  |  P=0.507      P=0.199N     P=0.097N     P=0.575    |
|INCIDENTAL TUMOR       |  P=0.002 **     (e)        P=0.500      P=0.048 *  |  P=0.514      P=0.194N     P=0.077N     P=0.577    |
|LOGISTIC REGRESSION    |  P=0.001 **     (e)        P=0.500      P=0.027 *  |  P=0.525      P=0.190N     P=0.079N     P=0.596    |
|COCHRAN-ARMITAGE       |  P=0.002 **                                        |  P=0.501N                                          |
|FISHER EXACT           |                 (e)        P=0.500      P=0.028 *  |               P=0.181N     P=0.061N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/49 (0%)    1/50 (2%)    5/50 (10%) |  4/50 (8%)    2/50 (4%)    0/49 (0%)    3/50 (6%)  |
|ADJUSTED (b)           |   0.0%         0.0%         2.6%        14.3%      |   9.9%         5.4%         0.0%        12.0%      |
|TERMINAL (d)           |  0/33 (0%)    0/28 (0%)    0/31 (0%)    4/33 (12%) |  3/39 (8%)    2/37 (5%)    0/31 (0%)    3/25 (12%) |
|FIRST INCIDENCE (DAYS) |   ---          ---          658          557       |   703          729 (T)      ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.002 **     (e)        P=0.495      P=0.033 *  |  P=0.555      P=0.364N     P=0.097N     P=0.575    |
|INCIDENTAL TUMOR       |  P=0.002 **     (e)        P=0.500      P=0.048 *  |  P=0.563      P=0.358N     P=0.077N     P=0.577    |
|LOGISTIC REGRESSION    |  P=0.001 **     (e)        P=0.500      P=0.027 *  |  P=0.573      P=0.357N     P=0.079N     P=0.596    |
|COCHRAN-ARMITAGE       |  P=0.002 **                                        |  P=0.433N                                          |
|FISHER EXACT           |                 (e)        P=0.500      P=0.028 *  |               P=0.339N     P=0.061N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 04                                                 PAGE  12
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.25%        2.5%         5.0%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  2/50 (4%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |                                                    |   5.1%         2.7%         0.0%         0.0%      |
|TERMINAL (d)           |                                                    |  2/39 (5%)    1/37 (3%)    0/31 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   729 (T)      729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.148N     P=0.518N     P=0.290N     P=0.341N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.148N     P=0.518N     P=0.290N     P=0.341N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.148N     P=0.518N     P=0.290N     P=0.341N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.101N                                          |
|FISHER EXACT           |                                                    |               P=0.500N     P=0.247N     P=0.247N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |  2/50 (4%)    1/50 (2%)    0/50 (0%)    2/50 (4%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   5.1%         2.7%         0.0%         8.0%      |
|TERMINAL (d)           |  0/33 (0%)    0/28 (0%)    0/31 (0%)    0/33 (0%)  |  2/39 (5%)    1/37 (3%)    0/31 (0%)    2/25 (8%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   729 (T)      729 (T)      ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.441      P=0.518N     P=0.290N     P=0.526    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.441      P=0.518N     P=0.290N     P=0.526    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.441      P=0.518N     P=0.290N     P=0.526    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.591                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.500N     P=0.247N     P=0.691N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 04                                                 PAGE  13
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.25%        2.5%         5.0%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    1/50 (2%)    1/50 (2%)    0/50 (0%)  |  2/50 (4%)    3/50 (6%)    2/50 (4%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         3.4%         3.2%         0.0%      |   4.7%         7.8%         6.5%         0.0%      |
|TERMINAL (d)           |  0/33 (0%)    0/28 (0%)    1/31 (3%)    0/33 (0%)  |  1/39 (3%)    2/37 (5%)    2/31 (6%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          710          729 (T)      ---       |   653          719          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.587N     P=0.468      P=0.488        (e)      |  P=0.244N     P=0.477      P=0.617      P=0.341N   |
|INCIDENTAL TUMOR       |  P=0.692      P=0.527      P=0.488        (e)      |  P=0.226N     P=0.486      P=0.658      P=0.337N   |
|LOGISTIC REGRESSION    |  P=0.678      P=0.475      P=0.488        (e)      |  P=0.186N     P=0.501      P=0.684      P=0.243N   |
|COCHRAN-ARMITAGE       |  P=0.595N                                          |  P=0.134N                                          |
|FISHER EXACT           |               P=0.500      P=0.500        (e)      |               P=0.500      P=0.691N     P=0.247N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    1/50 (2%)    1/50 (2%)    0/50 (0%)  |  3/50 (6%)    4/50 (8%)    2/50 (4%)    2/50 (4%)  |
|ADJUSTED (b)           |   0.0%         3.4%         3.2%         0.0%      |   7.2%        10.5%         6.5%         8.0%      |
|TERMINAL (d)           |  0/33 (0%)    0/28 (0%)    1/31 (3%)    0/33 (0%)  |  2/39 (5%)    3/37 (8%)    2/31 (6%)    2/25 (8%)  |
|FIRST INCIDENCE (DAYS) |   ---          710          729 (T)      ---       |   653          719          729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.587N     P=0.468      P=0.488        (e)      |  P=0.538N     P=0.472      P=0.596N     P=0.664    |
|INCIDENTAL TUMOR       |  P=0.692      P=0.527      P=0.488        (e)      |  P=0.524N     P=0.479      P=0.557N     P=0.667    |
|LOGISTIC REGRESSION    |  P=0.678      P=0.475      P=0.488        (e)      |  P=0.474N     P=0.495      P=0.527N     P=0.610N   |
|COCHRAN-ARMITAGE       |  P=0.595N                                          |  P=0.319N                                          |
|FISHER EXACT           |               P=0.500      P=0.500        (e)      |               P=0.500      P=0.500N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 04                                                 PAGE  14
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.25%        2.5%         5.0%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Histiocytic Sarcoma                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)  |  0/50 (0%)    2/50 (4%)    2/50 (4%)    3/50 (6%)  |
|ADJUSTED (b)           |   0.0%         0.0%         4.8%         0.0%      |   0.0%         4.5%         4.6%         7.6%      |
|TERMINAL (d)           |  0/33 (0%)    0/28 (0%)    0/31 (0%)    0/33 (0%)  |  0/39 (0%)    0/37 (0%)    0/31 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          553          ---       |   ---          568          568          358       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.576        (e)        P=0.229        (e)      |  P=0.077      P=0.234      P=0.224      P=0.097    |
|INCIDENTAL TUMOR       |  P=0.546N       (e)        P=0.288        (e)      |  P=0.455      P=0.395      P=0.748      P=0.187    |
|LOGISTIC REGRESSION    |  P=0.604        (e)        P=0.243        (e)      |  P=0.094      P=0.204      P=0.194      P=0.094    |
|COCHRAN-ARMITAGE       |  P=0.595                                           |  P=0.108                                           |
|FISHER EXACT           |                 (e)        P=0.247        (e)      |               P=0.247      P=0.247      P=0.121    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    2/50 (4%)    8/50 (16%)   7/50 (14%) | 15/50 (30%)  11/50 (22%)  10/50 (20%)  10/50 (20%) |
|ADJUSTED (b)           |   6.1%         7.1%        22.1%        19.2%      |  36.3%        25.8%        24.8%        29.2%      |
|TERMINAL (d)           |  2/33 (6%)    2/28 (7%)    5/31 (16%)   4/33 (12%) | 13/39 (33%)   7/37 (19%)   4/31 (13%)   4/25 (16%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      553          555       |   528          540          474          358       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.032 *    P=0.635      P=0.042 *    P=0.075    |  P=0.509N     P=0.295N     P=0.352N     P=0.551N   |
|INCIDENTAL TUMOR       |  P=0.071      P=0.635      P=0.048 *    P=0.074    |  P=0.128N     P=0.233N     P=0.107N     P=0.310N   |
|LOGISTIC REGRESSION    |  P=0.024 *    P=0.635      P=0.046 *    P=0.067    |  P=0.157N     P=0.241N     P=0.177N     P=0.194N   |
|COCHRAN-ARMITAGE       |  P=0.028 *                                         |  P=0.167N                                          |
|FISHER EXACT           |               P=0.691N     P=0.046 *    P=0.080    |               P=0.247N     P=0.178N     P=0.178N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 04                                                 PAGE  15
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.25%        2.5%         5.0%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    2/50 (4%)    6/50 (12%)   7/50 (14%) | 15/50 (30%)   9/50 (18%)   8/50 (16%)   7/50 (14%) |
|ADJUSTED (b)           |   6.1%         7.1%        18.2%        19.2%      |  36.3%        22.3%        21.2%        23.2%      |
|TERMINAL (d)           |  2/33 (6%)    2/28 (7%)    5/31 (16%)   4/33 (12%) | 13/39 (33%)   7/37 (19%)   4/31 (13%)   4/25 (16%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      556          555       |   528          540          474          599       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.032 *    P=0.635      P=0.115      P=0.075    |  P=0.222N     P=0.151N     P=0.190N     P=0.259N   |
|INCIDENTAL TUMOR       |  P=0.050 *    P=0.635      P=0.128      P=0.074    |  P=0.079N     P=0.142N     P=0.086N     P=0.132N   |
|LOGISTIC REGRESSION    |  P=0.022 *    P=0.635      P=0.125      P=0.067    |  P=0.051N     P=0.116N     P=0.078N     P=0.079N   |
|COCHRAN-ARMITAGE       |  P=0.027 *                                         |  P=0.043N*                                         |
|FISHER EXACT           |               P=0.691N     P=0.134      P=0.080    |               P=0.121N     P=0.077N     P=0.045N*  |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 16/50 (32%)  17/50 (34%)  20/50 (40%)  28/50 (56%) | 21/50 (42%)  15/50 (30%)   6/50 (12%)  23/50 (46%) |
|ADJUSTED (b)           |  42.8%        52.8%        53.3%        75.5%      |  49.7%        34.9%        19.4%        67.5%      |
|TERMINAL (d)           | 12/33 (36%)  13/28 (46%)  14/31 (45%)  24/33 (73%) | 18/39 (46%)  10/37 (27%)   6/31 (19%)  15/25 (60%) |
|FIRST INCIDENCE (DAYS) |   630          650          521          557       |   630          540          729 (T)      557       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.008 **   P=0.288      P=0.218      P=0.010 *  |  P=0.031 *    P=0.209N     P=0.006N**   P=0.032 *  |
|INCIDENTAL TUMOR       |  P=0.002 **   P=0.345      P=0.262      P=0.006 ** |  P=0.319      P=0.107N     P=0.002N**   P=0.447    |
|LOGISTIC REGRESSION    |  P=0.001 **   P=0.302      P=0.230      P=0.002 ** |  P=0.213      P=0.140N     P=0.002N**   P=0.244    |
|COCHRAN-ARMITAGE       |  P=0.005 **                                        |  P=0.332                                           |
|FISHER EXACT           |               P=0.500      P=0.266      P=0.013 *  |               P=0.149N     P<0.001N**   P=0.420    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 04                                                 PAGE  16
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.25%        2.5%         5.0%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 18/50 (36%)  23/50 (46%)  25/50 (50%)  17/50 (34%) | 21/50 (42%)  20/50 (40%)  19/50 (38%)  15/50 (30%) |
|ADJUSTED (b)           |  42.6%        60.3%        60.5%        42.0%      |  46.4%        43.7%        46.6%        40.1%      |
|TERMINAL (d)           |  9/33 (27%)  13/28 (46%)  15/31 (48%)  10/33 (30%) | 15/39 (38%)  12/37 (32%)  10/31 (32%)   5/25 (20%) |
|FIRST INCIDENCE (DAYS) |   450          512          521          294       |   508          540          474          358       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.396N     P=0.106      P=0.112      P=0.563N   |  P=0.480      P=0.559N     P=0.449      P=0.545    |
|INCIDENTAL TUMOR       |  P=0.543      P=0.103      P=0.127      P=0.442    |  P=0.068N     P=0.419N     P=0.307N     P=0.179N   |
|LOGISTIC REGRESSION    |  P=0.422N     P=0.111      P=0.133      P=0.557N   |  P=0.112N     P=0.497N     P=0.419N     P=0.158N   |
|COCHRAN-ARMITAGE       |  P=0.376N                                          |  P=0.113N                                          |
|FISHER EXACT           |               P=0.208      P=0.113      P=0.500N   |               P=0.500N     P=0.419N     P=0.149N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 25/50 (50%)  27/50 (54%)  33/50 (66%)  35/50 (70%) | 36/50 (72%)  29/50 (58%)  23/50 (46%)  33/50 (66%) |
|ADJUSTED (b)           |  59.4%        70.9%        78.3%        83.3%      |  76.6%        61.3%        56.8%        79.7%      |
|TERMINAL (d)           | 16/33 (48%)  17/28 (61%)  22/31 (71%)  26/33 (79%) | 28/39 (72%)  19/37 (51%)  14/31 (45%)  17/25 (68%) |
|FIRST INCIDENCE (DAYS) |   450          512          521          294       |   508          540          474          358       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.041 *    P=0.193      P=0.076      P=0.042 *  |  P=0.060      P=0.224N     P=0.144N     P=0.071    |
|INCIDENTAL TUMOR       |  P=0.004 **   P=0.225      P=0.076      P=0.006 ** |  P=0.279N     P=0.044N*    P=0.004N**   P=0.358N   |
|LOGISTIC REGRESSION    |  P=0.003 **   P=0.227      P=0.077      P=0.007 ** |  P=0.415N     P=0.091N     P=0.007N**   P=0.407N   |
|COCHRAN-ARMITAGE       |  P=0.016 *                                         |  P=0.357N                                          |
|FISHER EXACT           |               P=0.421      P=0.078      P=0.033 *  |               P=0.104N     P=0.007N**   P=0.333N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 04                                                 PAGE  17
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (d)  Observed incidence at terminal kill.
 (f)  Beneath the control incidence are the P-values associated with the trend 
      test.  Beneath the dosed group incidence are the P-values corresponding to 
      pairwise comparisons between the controls and that dosed group.  The life
      table analysis regards tumors in animals dying  prior to terminal kill as
      being (directly or indirectly) the cause of death.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's exact tests compare directly the overall incidence rates.  
      For all tests, a negative trend is indicated by "N".
 (e)  Value of Statistic cannot be computed. 
 (I)  Interim sacrifice
 (T)  Terminal sacrifice
  #   Tumor rates based on number of animals necropsied.
 
  *   To the right of any statistical result, indicates significance at (P<=0.05).
  **  To the right of any statistical result, indicates significance at (P<=0.01).

--multipart-boundary
Content-type: text/plain
Range: bytes 116749-116749/116749


--multipart-boundary--