Share This:
https://ntp.niehs.nih.gov/go/2892

TDMS Study 05021-04 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                 CI PIGMENT RED 23                                  DATE: 09/03/94       
EXPERIMENT: 05021 TEST: 04                                                                                     TIME: 23:16:48       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01ES9565102          ROUTE: DOSED FEED                                                                  NTP C#: 60377        
PATHOLOGIST: S. EUSTIS                       J. SEALY                                                          CAS: 6471-49-4       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Southern Research Inst                                 CI PIGMENT RED 23                                  DATE: 09/03/94      
EXPERIMENT: 05021 TEST: 04                                                                                     TIME: 23:16:48      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01ES9565102          ROUTE: DOSED FEED                                                                  NTP C#: 60377       
PATHOLOGIST: S. EUSTIS                       J. SEALY                                                          CAS: 6471-49-4      
 
 
 
 
 
                                                    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 23                                  DATE: 09/03/94       
EXPERIMENT: 05021 TEST: 04                                                                                     TIME: 23:16:48       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01ES9565102          ROUTE: DOSED FEED                                                                  NTP C#: 60377        
PATHOLOGIST: S. EUSTIS                       J. SEALY                                                          CAS: 6471-49-4       
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                       IN THE ANALYSIS OF THE STUDY OF CI PIGMENT RED 23
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             All Organs                    Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
                                                            NOS, or Undifferentiated Cell Type
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Lung                          Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Carcinoma or Adenoma
 
              ====================================================================================================
         DATE: 09/04/94                     EXPERIMENT: 05021 TEST: 04                                                 PAGE   1
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/48 (4%)    0/32 (0%)    0/23 (0%)    3/48 (6%)  |  0/49 (0%)    1/15 (7%)    0/14 (0%)    1/48 (2%)  |
|ADJUSTED (b)           |   6.2%         0.0%         0.0%        10.0%      |   0.0%         0.0%         0.0%         2.7%      |
|TERMINAL (d)           |  1/29 (3%)    0/0          0/0          3/30 (10%) |  0/35 (0%)    0/0          0/0          0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   647          ---          ---          723 (T)   |   ---          613          ---          658       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.404      P=0.545N     P=0.500N     P=0.527    |  P=0.414      P=0.486        (e)        P=0.484    |
|INCIDENTAL TUMOR       |  P=0.415      P=0.343N     P=0.406N     P=0.581    |  P=0.416      P=0.331        (e)        P=0.419    |
|LOGISTIC REGRESSION    |  P=0.352      P=0.470N     P=0.537N     P=0.521    |  P=0.472      P=0.296        (e)        P=0.516    |
|COCHRAN-ARMITAGE       |  P=0.268                                           |  P=0.481                                           |
|FISHER EXACT           |               P=0.357N     P=0.454N     P=0.500    |               P=0.234        (e)        P=0.495    |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone Marrow                                                                                                                      |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/49 (2%)    0/31 (0%)    2/22 (9%)    0/48 (0%)  |  0/49 (0%)    0/49 (0%)    2/49 (4%)    2/49 (4%)  |
|ADJUSTED (b)           |   3.4%         0.0%         0.0%         0.0%      |   0.0%         0.0%         4.8%         5.7%      |
|TERMINAL (d)           |  1/29 (3%)    0/0          0/0          0/30 (0%)  |  0/35 (0%)    0/34 (0%)    1/35 (3%)    2/35 (6%)  |
|FIRST INCIDENCE (DAYS) |   723 (T)      ---          590          ---       |   ---          ---          472          723 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.418N       (e)        P=0.229      P=0.493N   |  P=0.082        (e)        P=0.238      P=0.238    |
|INCIDENTAL TUMOR       |  P=0.472N       (e)        P=0.231      P=0.493N   |  P=0.060        (e)        P=0.377      P=0.238    |
|LOGISTIC REGRESSION    |  P=0.446N       (e)        P=0.177      P=0.493N   |  P=0.077        (e)        P=0.305      P=0.238    |
|COCHRAN-ARMITAGE       |  P=0.470N                                          |  P=0.080                                           |
|FISHER EXACT           |               P=0.613N     P=0.225      P=0.505N   |                 (e)        P=0.247      P=0.247    |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05021 TEST: 04                                                 PAGE   2
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    1/50 (2%)    1/50 (2%)    1/50 (2%)  |  0/50 (0%)    2/50 (4%)    3/50 (6%)    0/49 (0%)  |
|ADJUSTED (b)           |   5.9%         5.9%         2.8%         3.3%      |   0.0%         5.9%         8.3%         0.0%      |
|TERMINAL (d)           |  1/29 (3%)    1/17 (6%)    0/27 (0%)    1/30 (3%)  |  0/35 (0%)    2/34 (6%)    3/36 (8%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   644          723 (T)      622          723 (T)   |   ---          723 (T)      723 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.360N     P=0.655N     P=0.530N     P=0.486N   |  P=0.507N     P=0.232      P=0.126        (e)      |
|INCIDENTAL TUMOR       |  P=0.382N     P=0.660N     P=0.508N     P=0.510N   |  P=0.507N     P=0.232      P=0.126        (e)      |
|LOGISTIC REGRESSION    |  P=0.381N     P=0.583N     P=0.505N     P=0.484N   |  P=0.507N     P=0.232      P=0.124        (e)      |
|COCHRAN-ARMITAGE       |  P=0.417N                                          |  P=0.519N                                          |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.500N   |               P=0.247      P=0.121        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    1/50 (2%)    1/50 (2%)    1/50 (2%)  |  0/50 (0%)    2/50 (4%)    4/50 (8%)    0/49 (0%)  |
|ADJUSTED (b)           |   5.9%         5.9%         2.8%         3.3%      |   0.0%         5.9%        10.2%         0.0%      |
|TERMINAL (d)           |  1/29 (3%)    1/17 (6%)    0/27 (0%)    1/30 (3%)  |  0/35 (0%)    2/34 (6%)    3/36 (8%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   644          723 (T)      622          723 (T)   |   ---          723 (T)      452          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.360N     P=0.655N     P=0.530N     P=0.486N   |  P=0.540N     P=0.232      P=0.067        (e)      |
|INCIDENTAL TUMOR       |  P=0.382N     P=0.660N     P=0.508N     P=0.510N   |  P=0.569N     P=0.232      P=0.106        (e)      |
|LOGISTIC REGRESSION    |  P=0.381N     P=0.583N     P=0.505N     P=0.484N   |  P=0.552N     P=0.232      P=0.070        (e)      |
|COCHRAN-ARMITAGE       |  P=0.417N                                          |  P=0.552N                                          |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.500N   |               P=0.247      P=0.059        (e)      |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05021 TEST: 04                                                 PAGE   3
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/49 (0%)    0/50 (0%)    4/50 (8%)    0/49 (0%)  |  0/49 (0%)    1/49 (2%)    0/50 (0%)    0/48 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%        11.2%         0.0%      |   0.0%         2.3%         0.0%         0.0%      |
|TERMINAL (d)           |  0/29 (0%)    0/17 (0%)    1/27 (4%)    0/30 (0%)  |  0/35 (0%)    0/34 (0%)    0/36 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          590          ---       |   ---          516          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.532        (e)        P=0.061        (e)      |  P=0.527N     P=0.479        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.519        (e)        P=0.075        (e)      |  P=0.603N     P=0.773        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.482        (e)        P=0.065        (e)      |  P=0.570N     P=0.622        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.472                                           |  P=0.529N                                          |
|FISHER EXACT           |                 (e)        P=0.061        (e)      |               P=0.500        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/49 (6%)    1/50 (2%)    4/50 (8%)    8/49 (16%) |  1/49 (2%)    5/49 (10%)   5/50 (10%)   1/48 (2%)  |
|ADJUSTED (b)           |  10.3%         2.6%        14.8%        23.9%      |   2.9%        13.9%        13.1%         2.9%      |
|TERMINAL (d)           |  3/29 (10%)   0/17 (0%)    4/27 (15%)   6/30 (20%) |  1/35 (3%)    4/34 (12%)   4/36 (11%)   1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |   723 (T)      422          723 (T)      638       |   723 (T)      613          631          723 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.037 *    P=0.477N     P=0.460      P=0.117    |  P=0.388N     P=0.097      P=0.111      P=0.762    |
|INCIDENTAL TUMOR       |  P=0.025 *    P=0.425N     P=0.460      P=0.126    |  P=0.370N     P=0.070      P=0.079      P=0.762    |
|LOGISTIC REGRESSION    |  P=0.027 *    P=0.337N     P=0.460      P=0.118    |  P=0.401N     P=0.093      P=0.108      P=0.762    |
|COCHRAN-ARMITAGE       |  P=0.014 *                                         |  P=0.400N                                          |
|FISHER EXACT           |               P=0.301N     P=0.511      P=0.100    |               P=0.102      P=0.107      P=0.747    |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05021 TEST: 04                                                 PAGE   4
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 12/49 (24%)   7/50 (14%)  10/50 (20%)  15/49 (31%) |  4/49 (8%)    4/49 (8%)    5/50 (10%)   3/48 (6%)  |
|ADJUSTED (b)           |  32.2%        29.4%        29.9%        36.5%      |  11.4%        11.8%        12.4%         8.6%      |
|TERMINAL (d)           |  6/29 (21%)   3/17 (18%)   6/27 (22%)   5/30 (17%) |  4/35 (11%)   4/34 (12%)   3/36 (8%)    3/35 (9%)  |
|FIRST INCIDENCE (DAYS) |   518          515          529          571       |   723 (T)      723 (T)      521          723 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.313      P=0.465N     P=0.470N     P=0.414    |  P=0.425N     P=0.629      P=0.512      P=0.500N   |
|INCIDENTAL TUMOR       |  P=0.235      P=0.232N     P=0.438N     P=0.538    |  P=0.447N     P=0.629      P=0.608      P=0.500N   |
|LOGISTIC REGRESSION    |  P=0.324      P=0.260N     P=0.401N     P=0.554    |  P=0.444N     P=0.629      P=0.514      P=0.500N   |
|COCHRAN-ARMITAGE       |  P=0.129                                           |  P=0.442N                                          |
|FISHER EXACT           |               P=0.142N     P=0.384N     P=0.326    |               P=0.643N     P=0.513      P=0.512N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 13/49 (27%)   8/50 (16%)  14/50 (28%)  21/49 (43%) |  5/49 (10%)   8/49 (16%)  10/50 (20%)   4/48 (8%)  |
|ADJUSTED (b)           |  35.1%        31.2%        43.3%        50.4%      |  14.3%        22.5%        24.7%        11.4%      |
|TERMINAL (d)           |  7/29 (24%)   3/17 (18%)  10/27 (37%)  10/30 (33%) |  5/35 (14%)   7/34 (21%)   7/36 (19%)   4/35 (11%) |
|FIRST INCIDENCE (DAYS) |   518          422          529          571       |   723 (T)      613          521          723 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.071      P=0.501N     P=0.428      P=0.135    |  P=0.359N     P=0.253      P=0.145      P=0.500N   |
|INCIDENTAL TUMOR       |  P=0.027 *    P=0.250N     P=0.450      P=0.152    |  P=0.361N     P=0.218      P=0.158      P=0.500N   |
|LOGISTIC REGRESSION    |  P=0.023 *    P=0.260N     P=0.497      P=0.171    |  P=0.381N     P=0.253      P=0.139      P=0.500N   |
|COCHRAN-ARMITAGE       |  P=0.009 **                                        |  P=0.379N                                          |
|FISHER EXACT           |               P=0.150N     P=0.525      P=0.068    |               P=0.276      P=0.140      P=0.513N   |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05021 TEST: 04                                                 PAGE   5
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 13/49 (27%)   8/50 (16%)  14/50 (28%)  21/49 (43%) |  5/49 (10%)   8/49 (16%)  10/50 (20%)   4/48 (8%)  |
|ADJUSTED (b)           |  35.1%        31.2%        43.3%        50.4%      |  14.3%        22.5%        24.7%        11.4%      |
|TERMINAL (d)           |  7/29 (24%)   3/17 (18%)  10/27 (37%)  10/30 (33%) |  5/35 (14%)   7/34 (21%)   7/36 (19%)   4/35 (11%) |
|FIRST INCIDENCE (DAYS) |   518          422          529          571       |   723 (T)      613          521          723 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.071      P=0.501N     P=0.428      P=0.135    |  P=0.359N     P=0.253      P=0.145      P=0.500N   |
|INCIDENTAL TUMOR       |  P=0.027 *    P=0.250N     P=0.450      P=0.152    |  P=0.361N     P=0.218      P=0.158      P=0.500N   |
|LOGISTIC REGRESSION    |  P=0.023 *    P=0.260N     P=0.497      P=0.171    |  P=0.381N     P=0.253      P=0.139      P=0.500N   |
|COCHRAN-ARMITAGE       |  P=0.009 **                                        |  P=0.379N                                          |
|FISHER EXACT           |               P=0.150N     P=0.525      P=0.068    |               P=0.276      P=0.140      P=0.513N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/49 (8%)    6/49 (12%)   6/50 (12%)   3/50 (6%)  |  1/50 (2%)    1/50 (2%)    2/49 (4%)    4/49 (8%)  |
|ADJUSTED (b)           |  12.3%        25.5%        17.8%        10.0%      |   2.2%         2.9%         5.4%        10.6%      |
|TERMINAL (d)           |  3/29 (10%)   2/16 (13%)   2/27 (7%)    3/30 (10%) |  0/35 (0%)    1/34 (3%)    1/35 (3%)    3/35 (9%)  |
|FIRST INCIDENCE (DAYS) |   455          598          618          723 (T)   |   616          723 (T)      721          588       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.247N     P=0.144      P=0.338      P=0.481N   |  P=0.071      P=0.747      P=0.507      P=0.175    |
|INCIDENTAL TUMOR       |  P=0.254N     P=0.259      P=0.381      P=0.563N   |  P=0.084      P=0.667      P=0.406      P=0.196    |
|LOGISTIC REGRESSION    |  P=0.266N     P=0.256      P=0.372      P=0.470N   |  P=0.066      P=0.761N     P=0.496      P=0.184    |
|COCHRAN-ARMITAGE       |  P=0.330N                                          |  P=0.065                                           |
|FISHER EXACT           |               P=0.370      P=0.383      P=0.489N   |               P=0.753N     P=0.492      P=0.175    |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05021 TEST: 04                                                 PAGE   6
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/49 (4%)    1/49 (2%)    2/50 (4%)    4/50 (8%)  |  0/50 (0%)    1/50 (2%)    0/49 (0%)    1/49 (2%)  |
|ADJUSTED (b)           |   6.9%         4.3%         7.4%        12.4%      |   0.0%         2.4%         0.0%         2.9%      |
|TERMINAL (d)           |  2/29 (7%)    0/16 (0%)    2/27 (7%)    3/30 (10%) |  0/35 (0%)    0/34 (0%)    0/35 (0%)    1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |   723 (T)      721          723 (T)      672       |   ---          619          ---          723 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.230      P=0.665N     P=0.670      P=0.359    |  P=0.424      P=0.490        (e)        P=0.500    |
|INCIDENTAL TUMOR       |  P=0.253      P=0.550N     P=0.670      P=0.409    |  P=0.471      P=0.331        (e)        P=0.500    |
|LOGISTIC REGRESSION    |  P=0.202      P=0.609N     P=0.670      P=0.358    |  P=0.419      P=0.541        (e)        P=0.500    |
|COCHRAN-ARMITAGE       |  P=0.161                                           |  P=0.420                                           |
|FISHER EXACT           |               P=0.500N     P=0.684N     P=0.349    |               P=0.500        (e)        P=0.495    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/49 (10%)   7/49 (14%)   8/50 (16%)   7/50 (14%) |  1/50 (2%)    2/50 (4%)    2/49 (4%)    5/49 (10%) |
|ADJUSTED (b)           |  15.6%        28.8%        24.4%        22.2%      |   2.2%         5.3%         5.4%        13.4%      |
|TERMINAL (d)           |  4/29 (14%)   2/16 (13%)   4/27 (15%)   6/30 (20%) |  0/35 (0%)    1/34 (3%)    1/35 (3%)    4/35 (11%) |
|FIRST INCIDENCE (DAYS) |   455          598          618          672       |   616          619          721          588       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.517      P=0.135      P=0.244      P=0.408    |  P=0.053      P=0.480      P=0.507      P=0.102    |
|INCIDENTAL TUMOR       |  P=0.518      P=0.283      P=0.275      P=0.382    |  P=0.070      P=0.303      P=0.406      P=0.114    |
|LOGISTIC REGRESSION    |  P=0.483      P=0.239      P=0.273      P=0.427    |  P=0.048 *    P=0.529      P=0.496      P=0.102    |
|COCHRAN-ARMITAGE       |  P=0.374                                           |  P=0.048 *                                         |
|FISHER EXACT           |               P=0.380      P=0.290      P=0.394    |               P=0.500      P=0.492      P=0.098    |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05021 TEST: 04                                                 PAGE   7
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Granulosa Cell Tumor, Benign, Malignant, NOS                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  2/47 (4%)    0/20 (0%)    0/28 (0%)    0/48 (0%)  |
|ADJUSTED (b)           |                                                    |   5.2%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |                                                    |  1/35 (3%)    0/5 (0%)     0/14 (0%)    0/34 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   655          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.136N     P=0.429N     P=0.336N     P=0.257N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.134N     P=0.388N     P=0.291N     P=0.268N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.129N     P=0.494N     P=0.358N     P=0.230N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.127N                                          |
|FISHER EXACT           |                                                    |               P=0.489N     P=0.390N     P=0.242N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/41 (0%)    0/29 (0%)    0/22 (0%)    2/48 (4%)  | 16/50 (32%)   7/23 (30%)   6/16 (38%)  11/47 (23%) |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         6.7%      |  41.6%        87.5%       100.0%        32.0%      |
|TERMINAL (d)           |  0/25 (0%)    0/0          0/0          2/30 (7%)  | 13/35 (37%)   7/8 (88%)    2/2 (100%)  10/33 (30%) |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          723 (T)   |   634          723 (T)      707          633       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.172        (e)          (e)        P=0.279    |  P=0.160N     P=0.197      P=0.232      P=0.239N   |
|INCIDENTAL TUMOR       |  P=0.172        (e)          (e)        P=0.279    |  P=0.180N     P=0.154      P=0.136      P=0.252N   |
|LOGISTIC REGRESSION    |  P=0.172        (e)          (e)        P=0.279    |  P=0.196N     P=0.257      P=0.061      P=0.278N   |
|COCHRAN-ARMITAGE       |  P=0.081                                           |  P=0.208N                                          |
|FISHER EXACT           |                 (e)          (e)        P=0.288    |               P=0.559N     P=0.453      P=0.237N   |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05021 TEST: 04                                                 PAGE   8
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/41 (0%)    0/29 (0%)    0/22 (0%)    0/48 (0%)  |  2/50 (4%)    0/23 (0%)    1/16 (6%)    2/47 (4%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   5.5%         0.0%         2.4%         6.1%      |
|TERMINAL (d)           |  0/25 (0%)    0/0          0/0          0/30 (0%)  |  1/35 (3%)    0/8 (0%)     0/2 (0%)     2/33 (6%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   694          ---          661          723 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.480      P=0.385N     P=0.712N     P=0.673    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.434      P=0.408N     P=0.733N     P=0.628    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.477      P=0.504N     P=0.577      P=0.656    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.475                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.466N     P=0.572      P=0.668    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/41 (0%)    0/29 (0%)    0/22 (0%)    2/48 (4%)  | 18/50 (36%)   7/23 (30%)   7/16 (44%)  13/47 (28%) |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         6.7%      |  45.8%        87.5%       100.0%        38.0%      |
|TERMINAL (d)           |  0/25 (0%)    0/0          0/0          2/30 (7%)  | 14/35 (40%)   7/8 (88%)    2/2 (100%)  12/33 (36%) |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          723 (T)   |   634          723 (T)      661          633       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.172        (e)          (e)        P=0.279    |  P=0.201N     P=0.348      P=0.271      P=0.256N   |
|INCIDENTAL TUMOR       |  P=0.172        (e)          (e)        P=0.279    |  P=0.235N     P=0.283      P=0.146      P=0.286N   |
|LOGISTIC REGRESSION    |  P=0.172        (e)          (e)        P=0.279    |  P=0.243N     P=0.370      P=0.041 *    P=0.302N   |
|COCHRAN-ARMITAGE       |  P=0.081                                           |  P=0.256N                                          |
|FISHER EXACT           |                 (e)          (e)        P=0.288    |               P=0.425N     P=0.393      P=0.254N   |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05021 TEST: 04                                                 PAGE   9
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    1/50 (2%)    2/50 (4%)    2/50 (4%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/49 (0%)  |
|ADJUSTED (b)           |  13.8%         5.9%         6.2%         6.7%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  4/29 (14%)   1/17 (6%)    1/27 (4%)    2/30 (7%)  |  0/35 (0%)    0/34 (0%)    0/36 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   723 (T)      723 (T)      603          723 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.289N     P=0.368N     P=0.370N     P=0.319N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.296N     P=0.368N     P=0.365N     P=0.319N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.314N     P=0.368N     P=0.354N     P=0.319N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.367N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.181N     P=0.339N     P=0.339N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/50 (10%)   5/50 (10%)   5/50 (10%)   5/50 (10%) |  1/50 (2%)    0/50 (0%)    0/50 (0%)    1/49 (2%)  |
|ADJUSTED (b)           |  15.9%        21.7%        14.7%        13.7%      |   2.3%         0.0%         0.0%         2.4%      |
|TERMINAL (d)           |  3/29 (10%)   2/17 (12%)   1/27 (4%)    2/30 (7%)  |  0/35 (0%)    0/34 (0%)    0/36 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   687          515          603          542       |   618          ---          ---          627       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.442N     P=0.370      P=0.595      P=0.604N   |  P=0.571      P=0.514N     P=0.500N     P=0.750    |
|INCIDENTAL TUMOR       |  P=0.456N     P=0.635N     P=0.560N     P=0.533N   |  P=0.637      P=0.669N     P=0.669N     P=0.738N   |
|LOGISTIC REGRESSION    |  P=0.488N     P=0.482      P=0.612      P=0.606N   |  P=0.560      P=0.459N     P=0.449N     P=0.721N   |
|COCHRAN-ARMITAGE       |  P=0.562                                           |  P=0.571                                           |
|FISHER EXACT           |               P=0.630N     P=0.630N     P=0.630N   |               P=0.500N     P=0.500N     P=0.747    |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05021 TEST: 04                                                 PAGE  10
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Sarcoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/50 (10%)   7/50 (14%)   5/50 (10%)   6/50 (12%) |  0/50 (0%)    2/50 (4%)    0/50 (0%)    1/49 (2%)  |
|ADJUSTED (b)           |  12.5%        22.7%        16.0%        18.6%      |   0.0%         4.5%         0.0%         2.5%      |
|TERMINAL (d)           |  0/29 (0%)    0/17 (0%)    2/27 (7%)    5/30 (17%) |  0/35 (0%)    0/34 (0%)    0/36 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   463          472          647          603       |   ---          420          ---          633       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.459N     P=0.213      P=0.595      P=0.530    |  P=0.564      P=0.230        (e)        P=0.486    |
|INCIDENTAL TUMOR       |  P=0.514N     P=0.489      P=0.577N     P=0.493    |  P=0.537      P=0.371        (e)        P=0.527    |
|LOGISTIC REGRESSION    |  P=0.539N     P=0.243      P=0.625      P=0.497    |  P=0.538      P=0.336        (e)        P=0.539    |
|COCHRAN-ARMITAGE       |  P=0.529                                           |  P=0.572                                           |
|FISHER EXACT           |               P=0.380      P=0.630N     P=0.500    |               P=0.247        (e)        P=0.495    |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/49 (2%)    1/31 (3%)    1/26 (4%)    0/47 (0%)  |  0/50 (0%)    0/21 (0%)    2/25 (8%)    0/48 (0%)  |
|ADJUSTED (b)           |   3.4%         0.0%         2.5%         0.0%      |   0.0%         0.0%        11.0%         0.0%      |
|TERMINAL (d)           |  1/29 (3%)    0/0          0/3 (0%)     0/30 (0%)  |  0/35 (0%)    0/6 (0%)     1/11 (9%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   723 (T)      598          590          ---       |   ---          ---          516          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.270N     P=0.446      P=0.556      P=0.493N   |  P=0.603        (e)        P=0.122        (e)      |
|INCIDENTAL TUMOR       |  P=0.309N     P=0.433      P=0.564      P=0.493N   |  P=0.582        (e)        P=0.215        (e)      |
|LOGISTIC REGRESSION    |  P=0.296N     P=0.573      P=0.579      P=0.493N   |  P=0.587        (e)        P=0.173        (e)      |
|COCHRAN-ARMITAGE       |  P=0.312N                                          |  P=0.598                                           |
|FISHER EXACT           |               P=0.628      P=0.576      P=0.510N   |                 (e)        P=0.108        (e)      |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05021 TEST: 04                                                 PAGE  11
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/49 (4%)    2/30 (7%)    0/23 (0%)    2/50 (4%)  |  2/50 (4%)    1/15 (7%)    1/14 (7%)    3/49 (6%)  |
|ADJUSTED (b)           |   6.7%         0.0%         0.0%         5.4%      |   5.7%       100.0%         0.0%         7.9%      |
|TERMINAL (d)           |  1/29 (3%)    0/0          0/0          0/30 (0%)  |  2/35 (6%)    1/1 (100%)   0/0          2/35 (6%)  |
|FIRST INCIDENCE (DAYS) |   722          721          ---          672       |   723 (T)      723 (T)      707          588       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.463N     P=0.377      P=0.521N     P=0.669N   |  P=0.458      P=0.066      P=0.521      P=0.494    |
|INCIDENTAL TUMOR       |  P=0.368N     P=0.721N     P=0.406N     P=0.469N   |  P=0.458      P=0.066      P=0.500      P=0.512    |
|LOGISTIC REGRESSION    |  P=0.423N     P=0.131      P=0.841N     P=0.671N   |  P=0.437      P=0.066      P=0.335      P=0.484    |
|COCHRAN-ARMITAGE       |  P=0.494N                                          |  P=0.423                                           |
|FISHER EXACT           |               P=0.491      P=0.460N     P=0.684N   |               P=0.551      P=0.530      P=0.490    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/49 (6%)    2/30 (7%)    1/23 (4%)    3/50 (6%)  |  2/50 (4%)    1/15 (7%)    1/14 (7%)    3/49 (6%)  |
|ADJUSTED (b)           |  10.0%         0.0%         0.0%         7.8%      |   5.7%       100.0%         0.0%         7.9%      |
|TERMINAL (d)           |  2/29 (7%)    0/0          0/0          0/30 (0%)  |  2/35 (6%)    1/1 (100%)   0/0          2/35 (6%)  |
|FIRST INCIDENCE (DAYS) |   722          721          452          648       |   723 (T)      723 (T)      707          588       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.496N     P=0.377      P=0.746      P=0.622N   |  P=0.458      P=0.066      P=0.521      P=0.494    |
|INCIDENTAL TUMOR       |  P=0.467N     P=0.721N     P=0.759N     P=0.403N   |  P=0.458      P=0.066      P=0.500      P=0.512    |
|LOGISTIC REGRESSION    |  P=0.482N     P=0.207      P=0.687N     P=0.633N   |  P=0.437      P=0.066      P=0.335      P=0.484    |
|COCHRAN-ARMITAGE       |  P=0.550N                                          |  P=0.423                                           |
|FISHER EXACT           |               P=0.633      P=0.618N     P=0.651N   |               P=0.551      P=0.530      P=0.490    |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05021 TEST: 04                                                 PAGE  12
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  1/50 (2%)    4/50 (8%)    0/50 (0%)    4/49 (8%)  |
|ADJUSTED (b)           |                                                    |   2.9%        11.8%         0.0%        11.4%      |
|TERMINAL (d)           |                                                    |  1/35 (3%)    4/34 (12%)   0/36 (0%)    4/35 (11%) |
|FIRST INCIDENCE (DAYS) |                                                    |   723 (T)      723 (T)      ---          723 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.260      P=0.170      P=0.494N     P=0.178    |
|INCIDENTAL TUMOR       |                                                    |  P=0.260      P=0.170      P=0.494N     P=0.178    |
|LOGISTIC REGRESSION    |                                                    |  P=0.260      P=0.170      P=0.494N     P=0.178    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.247                                           |
|FISHER EXACT           |                                                    |               P=0.181      P=0.500N     P=0.175    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    1/50 (2%)    4/50 (8%)    0/50 (0%)  |  0/50 (0%)    2/50 (4%)    4/50 (8%)    2/49 (4%)  |
|ADJUSTED (b)           |   5.9%         3.1%        11.2%         0.0%      |   0.0%         4.5%         9.4%         5.7%      |
|TERMINAL (d)           |  1/29 (3%)    0/17 (0%)    1/27 (4%)    0/30 (0%)  |  0/35 (0%)    0/34 (0%)    2/36 (6%)    2/35 (6%)  |
|FIRST INCIDENCE (DAYS) |   618          598          590          ---       |   ---          516          472          723 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.246N     P=0.628N     P=0.317      P=0.231N   |  P=0.242      P=0.216      P=0.067      P=0.238    |
|INCIDENTAL TUMOR       |  P=0.263N     P=0.641N     P=0.346      P=0.253N   |  P=0.181      P=0.267      P=0.150      P=0.238    |
|LOGISTIC REGRESSION    |  P=0.199N     P=0.540N     P=0.334      P=0.234N   |  P=0.206      P=0.327      P=0.086      P=0.238    |
|COCHRAN-ARMITAGE       |  P=0.296N                                          |  P=0.229                                           |
|FISHER EXACT           |               P=0.500N     P=0.339      P=0.247N   |               P=0.247      P=0.059      P=0.242    |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05021 TEST: 04                                                 PAGE  13
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    1/50 (2%)    4/50 (8%)    0/50 (0%)  |  0/50 (0%)    2/50 (4%)    4/50 (8%)    2/49 (4%)  |
|ADJUSTED (b)           |   5.9%         3.1%        11.2%         0.0%      |   0.0%         4.5%         9.4%         5.7%      |
|TERMINAL (d)           |  1/29 (3%)    0/17 (0%)    1/27 (4%)    0/30 (0%)  |  0/35 (0%)    0/34 (0%)    2/36 (6%)    2/35 (6%)  |
|FIRST INCIDENCE (DAYS) |   618          598          590          ---       |   ---          516          472          723 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.246N     P=0.628N     P=0.317      P=0.231N   |  P=0.242      P=0.216      P=0.067      P=0.238    |
|INCIDENTAL TUMOR       |  P=0.263N     P=0.641N     P=0.346      P=0.253N   |  P=0.181      P=0.267      P=0.150      P=0.238    |
|LOGISTIC REGRESSION    |  P=0.199N     P=0.540N     P=0.334      P=0.234N   |  P=0.206      P=0.327      P=0.086      P=0.238    |
|COCHRAN-ARMITAGE       |  P=0.296N                                          |  P=0.229                                           |
|FISHER EXACT           |               P=0.500N     P=0.339      P=0.247N   |               P=0.247      P=0.059      P=0.242    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Histiocytic Sarcoma                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    3/50 (6%)    2/50 (4%)    0/50 (0%)  |  2/50 (4%)    1/50 (2%)    1/50 (2%)    1/49 (2%)  |
|ADJUSTED (b)           |   0.0%        11.1%         5.3%         0.0%      |   4.8%         2.9%         2.2%         2.1%      |
|TERMINAL (d)           |  0/29 (0%)    1/17 (6%)    0/27 (0%)    0/30 (0%)  |  0/35 (0%)    1/34 (3%)    0/36 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          436          452          ---       |   634          723 (T)      585          515       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.332N     P=0.071      P=0.231        (e)      |  P=0.427N     P=0.515N     P=0.502N     P=0.526N   |
|INCIDENTAL TUMOR       |  P=0.542N     P=0.116      P=0.224        (e)      |  P=0.421N     P=0.615N     P=0.694N     P=0.548N   |
|LOGISTIC REGRESSION    |  P=0.411N     P=0.130      P=0.247        (e)      |  P=0.439N     P=0.499N     P=0.436N     P=0.394N   |
|COCHRAN-ARMITAGE       |  P=0.370N                                          |  P=0.423N                                          |
|FISHER EXACT           |               P=0.121      P=0.247        (e)      |               P=0.500N     P=0.500N     P=0.508N   |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05021 TEST: 04                                                 PAGE  14
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    3/50 (6%)    3/50 (6%)    6/50 (12%) |  8/50 (16%)  10/50 (20%)  10/50 (20%)  10/49 (20%) |
|ADJUSTED (b)           |   5.9%        11.1%         8.0%        16.1%      |  20.0%        26.9%        25.0%        24.6%      |
|TERMINAL (d)           |  1/29 (3%)    1/17 (6%)    0/27 (0%)    2/30 (7%)  |  4/35 (11%)   7/34 (21%)   7/36 (19%)   6/35 (17%) |
|FIRST INCIDENCE (DAYS) |   644          436          452          606       |   634          683          585          515       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.140      P=0.339      P=0.469      P=0.158    |  P=0.388      P=0.383      P=0.426      P=0.376    |
|INCIDENTAL TUMOR       |  P=0.058      P=0.426      P=0.483      P=0.165    |  P=0.345      P=0.293      P=0.295      P=0.312    |
|LOGISTIC REGRESSION    |  P=0.081      P=0.491      P=0.505      P=0.140    |  P=0.367      P=0.254      P=0.396      P=0.400    |
|COCHRAN-ARMITAGE       |  P=0.081                                           |  P=0.367                                           |
|FISHER EXACT           |               P=0.500      P=0.500      P=0.134    |               P=0.398      P=0.398      P=0.379    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    0/50 (0%)    1/50 (2%)    6/50 (12%) |  6/50 (12%)   9/50 (18%)   9/50 (18%)   9/49 (18%) |
|ADJUSTED (b)           |   5.9%         0.0%         2.8%        16.1%      |  16.0%        24.2%        23.3%        23.0%      |
|TERMINAL (d)           |  1/29 (3%)    0/17 (0%)    0/27 (0%)    2/30 (7%)  |  4/35 (11%)   6/34 (18%)   7/36 (19%)   6/35 (17%) |
|FIRST INCIDENCE (DAYS) |   644          ---          622          606       |   661          683          606          583       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.030 *    P=0.334N     P=0.530N     P=0.158    |  P=0.307      P=0.281      P=0.316      P=0.278    |
|INCIDENTAL TUMOR       |  P=0.022 *    P=0.339N     P=0.508N     P=0.165    |  P=0.263      P=0.233      P=0.265      P=0.226    |
|LOGISTIC REGRESSION    |  P=0.019 *    P=0.283N     P=0.505N     P=0.140    |  P=0.280      P=0.248      P=0.291      P=0.263    |
|COCHRAN-ARMITAGE       |  P=0.014 *                                         |  P=0.285                                           |
|FISHER EXACT           |               P=0.247N     P=0.500N     P=0.134    |               P=0.288      P=0.288      P=0.274    |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05021 TEST: 04                                                 PAGE  15
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 17/50 (34%)  13/50 (26%)  12/50 (24%)  20/50 (40%) | 19/50 (38%)  19/50 (38%)  17/50 (34%)  18/49 (37%) |
|ADJUSTED (b)           |  50.6%        48.0%        36.0%        58.0%      |  48.1%        52.5%        40.2%        47.0%      |
|TERMINAL (d)           | 13/29 (45%)   4/17 (24%)   7/27 (26%)  16/30 (53%) | 15/35 (43%)  17/34 (50%)  11/36 (31%)  15/35 (43%) |
|FIRST INCIDENCE (DAYS) |   455          422          603          638       |   616          613          585          588       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.456      P=0.383      P=0.260N     P=0.406    |  P=0.421N     P=0.530      P=0.382N     P=0.524N   |
|INCIDENTAL TUMOR       |  P=0.431      P=0.435N     P=0.207N     P=0.440    |  P=0.423N     P=0.424      P=0.520N     P=0.546N   |
|LOGISTIC REGRESSION    |  P=0.371      P=0.530N     P=0.213N     P=0.411    |  P=0.472N     P=0.488      P=0.415N     P=0.584N   |
|COCHRAN-ARMITAGE       |  P=0.208                                           |  P=0.459N                                          |
|FISHER EXACT           |               P=0.257N     P=0.189N     P=0.339    |               P=0.582N     P=0.418N     P=0.531N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 27/50 (54%)  22/50 (44%)  28/50 (56%)  31/50 (62%) | 14/50 (28%)  20/50 (40%)  21/50 (42%)  18/49 (37%) |
|ADJUSTED (b)           |  62.4%        64.3%        65.0%        67.1%      |  33.6%        45.2%        44.6%        41.1%      |
|TERMINAL (d)           | 13/29 (45%)   6/17 (35%)  12/27 (44%)  15/30 (50%) |  8/35 (23%)  10/34 (29%)  11/36 (31%)  10/35 (29%) |
|FIRST INCIDENCE (DAYS) |   463          436          452          542       |   618          420          452          515       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.459      P=0.312      P=0.405      P=0.418    |  P=0.329      P=0.151      P=0.152      P=0.253    |
|INCIDENTAL TUMOR       |  P=0.243      P=0.329N     P=0.515      P=0.451    |  P=0.225      P=0.068      P=0.139      P=0.183    |
|LOGISTIC REGRESSION    |  P=0.403      P=0.549      P=0.512      P=0.517    |  P=0.315      P=0.135      P=0.103      P=0.261    |
|COCHRAN-ARMITAGE       |  P=0.110                                           |  P=0.287                                           |
|FISHER EXACT           |               P=0.212N     P=0.500      P=0.272    |               P=0.146      P=0.104      P=0.238    |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05021 TEST: 04                                                 PAGE  16
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23
 
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     1.0%         2.5%         5.0%      |   UNTREATD     1.0%         2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 35/50 (70%)  27/50 (54%)  33/50 (66%)  41/50 (82%) | 27/50 (54%)  31/50 (62%)  31/50 (62%)  32/49 (65%) |
|ADJUSTED (b)           |  79.3%        74.2%        76.7%        89.0%      |  61.1%        70.3%        62.0%        72.4%      |
|TERMINAL (d)           | 20/29 (69%)   8/17 (47%)  17/27 (63%)  25/30 (83%) | 18/35 (51%)  21/34 (62%)  17/36 (47%)  23/35 (66%) |
|FIRST INCIDENCE (DAYS) |   455          422          452          542       |   616          420          452          515       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.373      P=0.324      P=0.558      P=0.316    |  P=0.265      P=0.253      P=0.363      P=0.216    |
|INCIDENTAL TUMOR       |  P=0.110      P=0.202N     P=0.449N     P=0.241    |  P=0.143      P=0.122      P=0.296      P=0.129    |
|LOGISTIC REGRESSION    |  P=0.156      P=0.448N     P=0.455N     P=0.185    |  P=0.181      P=0.179      P=0.273      P=0.155    |
|COCHRAN-ARMITAGE       |  P=0.025 *                                         |  P=0.179                                           |
|FISHER EXACT           |               P=0.074N     P=0.415N     P=0.121    |               P=0.272      P=0.272      P=0.173    |
|=================================================================================================================================|
 
 (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).