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TR 364 Mouse Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                   RHODAMINE 6G                                     DATE: 09/07/94       
EXPERIMENT: 05048 TEST: 02                                                                                     TIME: 01:46:59       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-28024          ROUTE: DOSED FEED                                                                  NTP C#: 56122        
PATHOLOGIST: R. THOMPSON                                                                                       CAS: 989-38-8        
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Southern Research Inst                                   RHODAMINE 6G                                     DATE: 09/07/94      
EXPERIMENT: 05048 TEST: 02                                                                                     TIME: 01:46:59      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-28024          ROUTE: DOSED FEED                                                                  NTP C#: 56122       
PATHOLOGIST: R. THOMPSON                                                                                       CAS: 989-38-8       
 
 
 
 
 
                                                    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                                   RHODAMINE 6G                                     DATE: 09/07/94       
EXPERIMENT: 05048 TEST: 02                                                                                     TIME: 01:46:59       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-28024          ROUTE: DOSED FEED                                                                  NTP C#: 56122        
PATHOLOGIST: R. THOMPSON                                                                                       CAS: 989-38-8        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                          IN THE ANALYSIS OF THE STUDY OF RHODAMINE 6G
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Harderian Gland               Adenoma
                             Thyroid Gland: Follicular Cell
                                                           Carcinoma or Adenoma
                             All Organs                    Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             All Organs                    Malignant Lymphoma And Histiocytic Sarcoma
                                                           Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
                                                            NOS, or Undifferentiated Cell Type
 
              ====================================================================================================
         DATE: 09/07/94                     EXPERIMENT: 05048 TEST: 02                                                 PAGE   1
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- RHODAMINE 6G
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.1%            0.2%          |      UNTREATD        0.05%           0.1%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     7/50 (14%)      2/50 (4%)       2/50 (4%)      |     0/50 (0%)       4/50 (8%)       0/50 (0%)      |
|ADJUSTED (b)           |     19.4%            6.3%            5.3%          |      0.0%           11.0%            0.0%          |
|TERMINAL (d)           |     7/36 (19%)      2/32 (6%)       2/38 (5%)      |     0/39 (0%)       3/35 (9%)       0/36 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         729 (T)       |      ---             709             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.037N*       P=0.108N        P=0.067N       |     P=0.595         P=0.052           (e)          |
|INCIDENTAL TUMOR       |     P=0.037N*       P=0.108N        P=0.067N       |     P=0.593         P=0.061           (e)          |
|LOGISTIC REGRESSION    |     P=0.037N*       P=0.108N        P=0.067N       |     P=0.606         P=0.054           (e)          |
|COCHRAN-ARMITAGE       |     P=0.042N*                                      |     P=0.622                                        |
|FISHER EXACT           |                     P=0.080N        P=0.080N       |                     P=0.059           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/48 (0%)       0/49 (0%)       0/48 (0%)      |     0/50 (0%)       1/48 (2%)       2/48 (4%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      0.0%            2.0%            5.3%          |
|TERMINAL (d)           |     0/36 (0%)       0/32 (0%)       0/38 (0%)      |     0/39 (0%)       0/35 (0%)       1/36 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      ---             546             725           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.140         P=0.496         P=0.228        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.150           (e)           P=0.200        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.146         P=0.775         P=0.224        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.136                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.490         P=0.237        |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05048 TEST: 02                                                 PAGE   2
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- RHODAMINE 6G
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.1%            0.2%          |      UNTREATD        0.05%           0.1%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/48 (0%)       0/49 (0%)       0/48 (0%)      |     0/50 (0%)       2/48 (4%)       2/48 (4%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      0.0%            4.8%            5.3%          |
|TERMINAL (d)           |     0/36 (0%)       0/32 (0%)       0/38 (0%)      |     0/39 (0%)       1/35 (3%)       1/36 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      ---             546             725           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.170         P=0.226         P=0.228        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.188         P=0.478         P=0.200        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.178         P=0.314         P=0.224        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.168                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.237         P=0.237        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/49 (10%)      7/49 (14%)      5/50 (10%)     |     5/50 (10%)      3/50 (6%)       1/49 (2%)      |
|ADJUSTED (b)           |     13.9%           20.8%           13.2%          |     12.8%            8.1%            2.8%          |
|TERMINAL (d)           |     5/36 (14%)      6/32 (19%)      5/38 (13%)     |     5/39 (13%)      2/35 (6%)       1/36 (3%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         663             729 (T)       |      729 (T)         693             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.525N        P=0.299         P=0.597N       |     P=0.087N        P=0.415N        P=0.121N       |
|INCIDENTAL TUMOR       |     P=0.537N        P=0.311         P=0.597N       |     P=0.087N        P=0.394N        P=0.121N       |
|LOGISTIC REGRESSION    |     P=0.538N        P=0.323         P=0.597N       |     P=0.080N        P=0.397N        P=0.121N       |
|COCHRAN-ARMITAGE       |     P=0.548N                                       |     P=0.073N                                       |
|FISHER EXACT           |                     P=0.380         P=0.617N       |                     P=0.357N        P=0.107N       |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05048 TEST: 02                                                 PAGE   3
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- RHODAMINE 6G
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.1%            0.2%          |      UNTREATD        0.05%           0.1%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    10/49 (20%)      6/49 (12%)      6/50 (12%)     |     3/50 (6%)       1/50 (2%)       4/49 (8%)      |
|ADJUSTED (b)           |     23.2%           16.7%           14.3%          |      7.4%            2.1%           11.1%          |
|TERMINAL (d)           |     5/36 (14%)      3/32 (9%)       3/38 (8%)      |     2/39 (5%)       0/35 (0%)       4/36 (11%)     |
|FIRST INCIDENCE (DAYS) |      546             666             522           |      695             581             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.162N        P=0.285N        P=0.207N       |     P=0.385         P=0.338N        P=0.461        |
|INCIDENTAL TUMOR       |     P=0.173N        P=0.154N        P=0.266N       |     P=0.409         P=0.307N        P=0.452        |
|LOGISTIC REGRESSION    |     P=0.361N        P=0.205N        P=0.613N       |     P=0.405         P=0.251N        P=0.474        |
|COCHRAN-ARMITAGE       |     P=0.151N                                       |     P=0.402                                        |
|FISHER EXACT           |                     P=0.207N        P=0.194N       |                     P=0.309N        P=0.489        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    13/49 (27%)     12/49 (24%)     11/50 (22%)     |     8/50 (16%)      4/50 (8%)       5/49 (10%)     |
|ADJUSTED (b)           |     30.7%           32.8%           26.5%          |     19.9%           10.0%           13.9%          |
|TERMINAL (d)           |     8/36 (22%)      8/32 (25%)      8/38 (21%)     |     7/39 (18%)      2/35 (6%)       5/36 (14%)     |
|FIRST INCIDENCE (DAYS) |      546             663             522           |      695             581             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.332N        P=0.559         P=0.379N       |     P=0.258N        P=0.233N        P=0.326N       |
|INCIDENTAL TUMOR       |     P=0.380N        P=0.474N        P=0.474N       |     P=0.244N        P=0.203N        P=0.332N       |
|LOGISTIC REGRESSION    |     P=0.362N        P=0.509N        P=0.464        |     P=0.234N        P=0.181N        P=0.309N       |
|COCHRAN-ARMITAGE       |     P=0.342N                                       |     P=0.225N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.385N       |                     P=0.178N        P=0.290N       |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05048 TEST: 02                                                 PAGE   4
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- RHODAMINE 6G
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.1%            0.2%          |      UNTREATD        0.05%           0.1%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    13/49 (27%)     12/49 (24%)     11/50 (22%)     |     8/50 (16%)      4/50 (8%)       5/49 (10%)     |
|ADJUSTED (b)           |     30.7%           32.8%           26.5%          |     19.9%           10.0%           13.9%          |
|TERMINAL (d)           |     8/36 (22%)      8/32 (25%)      8/38 (21%)     |     7/39 (18%)      2/35 (6%)       5/36 (14%)     |
|FIRST INCIDENCE (DAYS) |      546             663             522           |      695             581             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.332N        P=0.559         P=0.379N       |     P=0.258N        P=0.233N        P=0.326N       |
|INCIDENTAL TUMOR       |     P=0.380N        P=0.474N        P=0.474N       |     P=0.244N        P=0.203N        P=0.332N       |
|LOGISTIC REGRESSION    |     P=0.362N        P=0.509N        P=0.464        |     P=0.234N        P=0.181N        P=0.309N       |
|COCHRAN-ARMITAGE       |     P=0.342N                                       |     P=0.225N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.385N       |                     P=0.178N        P=0.290N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/50 (12%)      5/50 (10%)      4/50 (8%)      |     3/50 (6%)       5/50 (10%)      3/49 (6%)      |
|ADJUSTED (b)           |     16.1%           15.6%           10.5%          |      7.7%           13.5%            8.3%          |
|TERMINAL (d)           |     5/36 (14%)      5/32 (16%)      4/38 (11%)     |     3/39 (8%)       4/35 (11%)      3/36 (8%)      |
|FIRST INCIDENCE (DAYS) |      705             729 (T)         729 (T)       |      729 (T)         667             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.280N        P=0.582N        P=0.338N       |     P=0.533         P=0.303         P=0.626        |
|INCIDENTAL TUMOR       |     P=0.291N        P=0.567N        P=0.360N       |     P=0.529         P=0.321         P=0.626        |
|LOGISTIC REGRESSION    |     P=0.277N        P=0.562N        P=0.339N       |     P=0.550         P=0.324         P=0.626        |
|COCHRAN-ARMITAGE       |     P=0.309N                                       |     P=0.565                                        |
|FISHER EXACT           |                     P=0.500N        P=0.370N       |                     P=0.357         P=0.651        |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05048 TEST: 02                                                 PAGE   5
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- RHODAMINE 6G
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.1%            0.2%          |      UNTREATD        0.05%           0.1%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       2/50 (4%)       1/50 (2%)      |     1/50 (2%)       1/50 (2%)       0/49 (0%)      |
|ADJUSTED (b)           |      8.3%            5.3%            2.6%          |      2.3%            2.9%            0.0%          |
|TERMINAL (d)           |     3/36 (8%)       1/32 (3%)       1/38 (3%)      |     0/39 (0%)       1/35 (3%)       0/36 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         621             729 (T)       |      693             729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.216N        P=0.545N        P=0.286N       |     P=0.345N        P=0.740         P=0.505N       |
|INCIDENTAL TUMOR       |     P=0.272N        P=0.523N        P=0.286N       |     P=0.351N        P=0.748N        P=0.527N       |
|LOGISTIC REGRESSION    |     P=0.228N        P=0.514N        P=0.286N       |     P=0.337N        P=0.761         P=0.490N       |
|COCHRAN-ARMITAGE       |     P=0.222N                                       |     P=0.335N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.309N       |                     P=0.753N        P=0.505N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     9/50 (18%)      7/50 (14%)      5/50 (10%)     |     4/50 (8%)       6/50 (12%)      3/49 (6%)      |
|ADJUSTED (b)           |     24.2%           20.6%           13.2%          |      9.8%           16.3%            8.3%          |
|TERMINAL (d)           |     8/36 (22%)      6/32 (19%)      5/38 (13%)     |     3/39 (8%)       5/35 (14%)      3/36 (8%)      |
|FIRST INCIDENCE (DAYS) |      705             621             729 (T)       |      693             667             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.136N        P=0.488N        P=0.164N       |     P=0.474N        P=0.312         P=0.539N       |
|INCIDENTAL TUMOR       |     P=0.168N        P=0.461N        P=0.177N       |     P=0.483N        P=0.344         P=0.548N       |
|LOGISTIC REGRESSION    |     P=0.148N        P=0.452N        P=0.161N       |     P=0.456N        P=0.338         P=0.526N       |
|COCHRAN-ARMITAGE       |     P=0.157N                                       |     P=0.442N                                       |
|FISHER EXACT           |                     P=0.393N        P=0.194N       |                     P=0.370         P=0.511N       |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05048 TEST: 02                                                 PAGE   6
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- RHODAMINE 6G
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.1%            0.2%          |      UNTREATD        0.05%           0.1%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     0/50 (0%)       2/50 (4%)       2/50 (4%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      0.0%            5.3%            5.6%          |
|TERMINAL (d)           |     0/36 (0%)       0/32 (0%)       0/38 (0%)      |     0/39 (0%)       1/35 (3%)       2/36 (6%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      ---             693             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.166         P=0.220         P=0.221        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.157         P=0.252         P=0.221        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.169         P=0.234         P=0.221        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.176                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.247         P=0.247        |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/41 (0%)       0/44 (0%)       0/45 (0%)      |     4/49 (8%)       4/44 (9%)       6/46 (13%)     |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |     10.5%           11.4%           17.1%          |
|TERMINAL (d)           |     0/30 (0%)       0/31 (0%)       0/37 (0%)      |     4/38 (11%)      3/33 (9%)       6/35 (17%)     |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      729 (T)         693             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.261         P=0.569         P=0.317        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.245         P=0.564         P=0.317        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.261         P=0.558         P=0.317        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.269                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.581         P=0.330        |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05048 TEST: 02                                                 PAGE   7
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- RHODAMINE 6G
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.1%            0.2%          |      UNTREATD        0.05%           0.1%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/41 (0%)       0/44 (0%)       0/45 (0%)      |     4/49 (8%)       5/44 (11%)      6/46 (13%)     |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |     10.5%           13.4%           17.1%          |
|TERMINAL (d)           |     0/30 (0%)       0/31 (0%)       0/37 (0%)      |     4/38 (11%)      3/33 (9%)       6/35 (17%)     |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      729 (T)         666             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.268         P=0.427         P=0.317        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.236         P=0.414         P=0.317        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.264         P=0.415         P=0.317        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.273                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.431         P=0.330        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       4/50 (8%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%           12.0%            5.3%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/36 (0%)       3/32 (9%)       2/38 (5%)      |     0/39 (0%)       0/35 (0%)       0/36 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             707             729 (T)       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.244         P=0.052         P=0.250        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.224         P=0.058         P=0.250        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.236         P=0.053         P=0.250        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.222                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.059         P=0.247        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05048 TEST: 02                                                 PAGE   8
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- RHODAMINE 6G
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.1%            0.2%          |      UNTREATD        0.05%           0.1%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    10/50 (20%)     12/50 (24%)      6/50 (12%)     |     0/50 (0%)       1/50 (2%)       1/50 (2%)      |
|ADJUSTED (b)           |     23.9%           32.3%           14.7%          |      0.0%            2.2%            2.8%          |
|TERMINAL (d)           |     5/36 (14%)      8/32 (25%)      4/38 (11%)     |     0/39 (0%)       0/35 (0%)       1/36 (3%)      |
|FIRST INCIDENCE (DAYS) |      639             573             433           |      ---             640             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.182N        P=0.310         P=0.200N       |     P=0.318         P=0.496         P=0.484        |
|INCIDENTAL TUMOR       |     P=0.283N        P=0.400         P=0.284N       |     P=0.406         P=0.500         P=0.484        |
|LOGISTIC REGRESSION    |     P=0.190N        P=0.388         P=0.209N       |     P=0.346         P=0.592         P=0.484        |
|COCHRAN-ARMITAGE       |     P=0.185N                                       |     P=0.331                                        |
|FISHER EXACT           |                     P=0.405         P=0.207N       |                     P=0.500         P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    14/50 (28%)     17/50 (34%)      9/50 (18%)     |     0/50 (0%)       1/50 (2%)       1/50 (2%)      |
|ADJUSTED (b)           |     31.6%           42.7%           21.6%          |      0.0%            2.2%            2.8%          |
|TERMINAL (d)           |     6/36 (17%)     10/32 (31%)      6/38 (16%)     |     0/39 (0%)       0/35 (0%)       1/36 (3%)      |
|FIRST INCIDENCE (DAYS) |      579             573             433           |      ---             640             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.161N        P=0.244         P=0.172N       |     P=0.318         P=0.496         P=0.484        |
|INCIDENTAL TUMOR       |     P=0.324N        P=0.344         P=0.338N       |     P=0.406         P=0.500         P=0.484        |
|LOGISTIC REGRESSION    |     P=0.367N        P=0.316         P=0.425N       |     P=0.346         P=0.592         P=0.484        |
|COCHRAN-ARMITAGE       |     P=0.154N                                       |     P=0.331                                        |
|FISHER EXACT           |                     P=0.333         P=0.171N       |                     P=0.500         P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05048 TEST: 02                                                 PAGE   9
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- RHODAMINE 6G
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.1%            0.2%          |      UNTREATD        0.05%           0.1%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    14/50 (28%)     14/50 (28%)      7/50 (14%)     |     0/50 (0%)       1/50 (2%)       1/50 (2%)      |
|ADJUSTED (b)           |     31.6%           35.6%           16.7%          |      0.0%            2.2%            2.8%          |
|TERMINAL (d)           |     6/36 (17%)      8/32 (25%)      4/38 (11%)     |     0/39 (0%)       0/35 (0%)       1/36 (3%)      |
|FIRST INCIDENCE (DAYS) |      579             573             433           |      ---             640             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.073N        P=0.463         P=0.078N       |     P=0.318         P=0.496         P=0.484        |
|INCIDENTAL TUMOR       |     P=0.156N        P=0.563N        P=0.159N       |     P=0.406         P=0.500         P=0.484        |
|LOGISTIC REGRESSION    |     P=0.194N        P=0.591N        P=0.240N       |     P=0.346         P=0.592         P=0.484        |
|COCHRAN-ARMITAGE       |     P=0.062N                                       |     P=0.331                                        |
|FISHER EXACT           |                     P=0.588N        P=0.070N       |                     P=0.500         P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Sarcoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       2/50 (4%)       1/50 (2%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      9.4%            4.8%            2.4%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/36 (3%)       0/32 (0%)       0/38 (0%)      |     0/39 (0%)       0/35 (0%)       0/36 (0%)      |
|FIRST INCIDENCE (DAYS) |      579             635             699           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.126N        P=0.382N        P=0.182N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.243N        P=0.277N        P=0.387N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.352N        P=0.339N        P=0.176N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.118N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.339N        P=0.181N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05048 TEST: 02                                                 PAGE  10
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- RHODAMINE 6G
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.1%            0.2%          |      UNTREATD        0.05%           0.1%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       1/50 (2%)      |     1/50 (2%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |      5.6%            3.1%            2.6%          |      2.6%            2.9%            0.0%          |
|TERMINAL (d)           |     2/36 (6%)       1/32 (3%)       1/38 (3%)      |     1/39 (3%)       1/35 (3%)       0/36 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         729 (T)         729 (T)       |      729 (T)         729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.363N        P=0.541N        P=0.481N       |     P=0.351N        P=0.738         P=0.516N       |
|INCIDENTAL TUMOR       |     P=0.363N        P=0.541N        P=0.481N       |     P=0.351N        P=0.738         P=0.516N       |
|LOGISTIC REGRESSION    |     P=0.363N        P=0.541N        P=0.481N       |     P=0.351N        P=0.738         P=0.516N       |
|COCHRAN-ARMITAGE       |     P=0.378N                                       |     P=0.331N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.500N       |                     P=0.753N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       3/49 (6%)       3/50 (6%)      |     1/50 (2%)       2/50 (4%)       1/48 (2%)      |
|ADJUSTED (b)           |      0.0%            9.4%            7.9%          |      2.6%            5.7%            2.8%          |
|TERMINAL (d)           |     0/36 (0%)       3/32 (9%)       3/38 (8%)      |     1/39 (3%)       2/35 (6%)       1/36 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             729 (T)         729 (T)       |      729 (T)         729 (T)         729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.116         P=0.101         P=0.131        |     P=0.595         P=0.462         P=0.744        |
|INCIDENTAL TUMOR       |     P=0.116         P=0.101         P=0.131        |     P=0.595         P=0.462         P=0.744        |
|LOGISTIC REGRESSION    |     P=0.116         P=0.101         P=0.131        |     P=0.595         P=0.462         P=0.744        |
|COCHRAN-ARMITAGE       |     P=0.102                                        |     P=0.609                                        |
|FISHER EXACT           |                     P=0.117         P=0.121        |                     P=0.500         P=0.742        |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05048 TEST: 02                                                 PAGE  11
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- RHODAMINE 6G
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.1%            0.2%          |      UNTREATD        0.05%           0.1%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       4/49 (8%)       3/50 (6%)      |     1/50 (2%)       2/50 (4%)       1/48 (2%)      |
|ADJUSTED (b)           |      0.0%           12.5%            7.9%          |      2.6%            5.7%            2.8%          |
|TERMINAL (d)           |     0/36 (0%)       4/32 (13%)      3/38 (8%)      |     1/39 (3%)       2/35 (6%)       1/36 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             729 (T)         729 (T)       |      729 (T)         729 (T)         729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.135         P=0.049 *       P=0.131        |     P=0.595         P=0.462         P=0.744        |
|INCIDENTAL TUMOR       |     P=0.135         P=0.049 *       P=0.131        |     P=0.595         P=0.462         P=0.744        |
|LOGISTIC REGRESSION    |     P=0.135         P=0.049 *       P=0.131        |     P=0.595         P=0.462         P=0.744        |
|COCHRAN-ARMITAGE       |     P=0.119                                        |     P=0.609                                        |
|FISHER EXACT           |                     P=0.056         P=0.121        |                     P=0.500         P=0.742        |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Leiomyoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     0/50 (0%)       2/50 (4%)       0/50 (0%)      |
|ADJUSTED (b)           |                                                    |      0.0%            5.4%            0.0%          |
|TERMINAL (d)           |                                                    |     0/39 (0%)       1/35 (3%)       0/36 (0%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      ---             706             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.650         P=0.220           (e)          |
|INCIDENTAL TUMOR       |                                                    |     P=0.649         P=0.252           (e)          |
|LOGISTIC REGRESSION    |                                                    |     P=0.662         P=0.228           (e)          |
|COCHRAN-ARMITAGE       |                                                    |     P=0.669                                        |
|FISHER EXACT           |                                                    |                     P=0.247           (e)          |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05048 TEST: 02                                                 PAGE  12
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- RHODAMINE 6G
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.1%            0.2%          |      UNTREATD        0.05%           0.1%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       0/50 (0%)       0/50 (0%)      |     2/50 (4%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      2.8%            0.0%            0.0%          |      5.1%            0.0%            2.6%          |
|TERMINAL (d)           |     1/36 (3%)       0/32 (0%)       0/38 (0%)      |     2/39 (5%)       0/35 (0%)       0/36 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         ---             ---           |      729 (T)         ---             725           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.267N        P=0.523N        P=0.489N       |     P=0.380N        P=0.262N        P=0.522N       |
|INCIDENTAL TUMOR       |     P=0.267N        P=0.523N        P=0.489N       |     P=0.386N        P=0.262N        P=0.534N       |
|LOGISTIC REGRESSION    |     P=0.267N        P=0.523N        P=0.489N       |     P=0.377N        P=0.262N        P=0.520N       |
|COCHRAN-ARMITAGE       |     P=0.269N                                       |     P=0.360N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.500N       |                     P=0.247N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       0/50 (0%)       0/50 (0%)      |     2/50 (4%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      5.6%            0.0%            0.0%          |      5.1%            0.0%            2.6%          |
|TERMINAL (d)           |     2/36 (6%)       0/32 (0%)       0/38 (0%)      |     2/39 (5%)       0/35 (0%)       0/36 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         ---             ---           |      729 (T)         ---             725           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.095N        P=0.264N        P=0.226N       |     P=0.380N        P=0.262N        P=0.522N       |
|INCIDENTAL TUMOR       |     P=0.095N        P=0.264N        P=0.226N       |     P=0.386N        P=0.262N        P=0.534N       |
|LOGISTIC REGRESSION    |     P=0.095N        P=0.264N        P=0.226N       |     P=0.377N        P=0.262N        P=0.520N       |
|COCHRAN-ARMITAGE       |     P=0.095N                                       |     P=0.360N                                       |
|FISHER EXACT           |                     P=0.247N        P=0.247N       |                     P=0.247N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05048 TEST: 02                                                 PAGE  13
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- RHODAMINE 6G
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.1%            0.2%          |      UNTREATD        0.05%           0.1%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      4/50 (8%)       3/50 (6%)      |    16/50 (32%)      8/50 (16%)      7/50 (14%)     |
|ADJUSTED (b)           |     12.9%            9.1%            7.6%          |     34.5%           20.5%           16.7%          |
|TERMINAL (d)           |     4/36 (11%)      0/32 (0%)       2/38 (5%)      |     9/39 (23%)      5/35 (14%)      3/36 (8%)      |
|FIRST INCIDENCE (DAYS) |      474             479             705           |      630             440             459           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.293N        P=0.545N        P=0.342N       |     P=0.037N*       P=0.100N        P=0.056N       |
|INCIDENTAL TUMOR       |     P=0.271N        P=0.380N        P=0.282N       |     P=0.012N*       P=0.025N*       P=0.015N*      |
|LOGISTIC REGRESSION    |     P=0.280N        P=0.508N        P=0.359N       |     P=0.012N*       P=0.038N*       P=0.018N*      |
|COCHRAN-ARMITAGE       |     P=0.290N                                       |     P=0.018N*                                      |
|FISHER EXACT           |                     P=0.500N        P=0.357N       |                     P=0.050N        P=0.028N*      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      4/50 (8%)       3/50 (6%)      |    16/50 (32%)      8/50 (16%)      7/50 (14%)     |
|ADJUSTED (b)           |     12.9%            9.1%            7.6%          |     34.5%           20.5%           16.7%          |
|TERMINAL (d)           |     4/36 (11%)      0/32 (0%)       2/38 (5%)      |     9/39 (23%)      5/35 (14%)      3/36 (8%)      |
|FIRST INCIDENCE (DAYS) |      474             479             705           |      630             440             459           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.293N        P=0.545N        P=0.342N       |     P=0.037N*       P=0.100N        P=0.056N       |
|INCIDENTAL TUMOR       |     P=0.271N        P=0.380N        P=0.282N       |     P=0.012N*       P=0.025N*       P=0.015N*      |
|LOGISTIC REGRESSION    |     P=0.280N        P=0.508N        P=0.359N       |     P=0.012N*       P=0.038N*       P=0.018N*      |
|COCHRAN-ARMITAGE       |     P=0.290N                                       |     P=0.018N*                                      |
|FISHER EXACT           |                     P=0.500N        P=0.357N       |                     P=0.050N        P=0.028N*      |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05048 TEST: 02                                                 PAGE  14
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- RHODAMINE 6G
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.1%            0.2%          |      UNTREATD        0.05%           0.1%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    18/50 (36%)     17/50 (34%)     15/50 (30%)     |    13/50 (26%)     20/50 (40%)     11/50 (22%)     |
|ADJUSTED (b)           |     48.6%           49.7%           39.5%          |     33.3%           49.5%           29.7%          |
|TERMINAL (d)           |    17/36 (47%)     15/32 (47%)     15/38 (39%)     |    13/39 (33%)     15/35 (43%)     10/36 (28%)     |
|FIRST INCIDENCE (DAYS) |      705             663             729 (T)       |      729 (T)         546             725           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.226N        P=0.499         P=0.257N       |     P=0.467N        P=0.053         P=0.494N       |
|INCIDENTAL TUMOR       |     P=0.245N        P=0.529         P=0.270N       |     P=0.447N        P=0.092         P=0.499N       |
|LOGISTIC REGRESSION    |     P=0.223N        P=0.547         P=0.250N       |     P=0.420N        P=0.071         P=0.475N       |
|COCHRAN-ARMITAGE       |     P=0.298N                                       |     P=0.371N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.335N       |                     P=0.101         P=0.408N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    30/50 (60%)     25/50 (50%)     16/50 (32%)     |    21/50 (42%)     17/50 (34%)     18/50 (36%)     |
|ADJUSTED (b)           |     62.4%           55.1%           36.3%          |     44.5%           38.4%           41.6%          |
|TERMINAL (d)           |    18/36 (50%)     12/32 (38%)     10/38 (26%)     |    13/39 (33%)      9/35 (26%)     11/36 (31%)     |
|FIRST INCIDENCE (DAYS) |      474             479             433           |      630             440             459           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.011N*       P=0.420N        P=0.011N*      |     P=0.406N        P=0.402N        P=0.447N       |
|INCIDENTAL TUMOR       |     P=0.009N**      P=0.119N        P=0.007N**     |     P=0.269N        P=0.193N        P=0.337N       |
|LOGISTIC REGRESSION    |     P=0.034N*       P=0.145N        P=0.036N*      |     P=0.261N        P=0.193N        P=0.315N       |
|COCHRAN-ARMITAGE       |     P=0.003N**                                     |     P=0.303N                                       |
|FISHER EXACT           |                     P=0.211N        P=0.004N**     |                     P=0.268N        P=0.341N       |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05048 TEST: 02                                                 PAGE  15
                                STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- RHODAMINE 6G
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.1%            0.2%          |      UNTREATD        0.05%           0.1%          |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    39/50 (78%)     33/50 (66%)     29/50 (58%)     |    29/50 (58%)     33/50 (66%)     25/50 (50%)     |
|ADJUSTED (b)           |     81.2%           73.1%           65.9%          |     61.6%           71.4%           57.9%          |
|TERMINAL (d)           |    27/36 (75%)     20/32 (63%)     23/38 (61%)     |    21/39 (54%)     22/35 (63%)     18/36 (50%)     |
|FIRST INCIDENCE (DAYS) |      474             479             433           |      630             440             459           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.040N*       P=0.417N        P=0.040N*      |     P=0.400N        P=0.170         P=0.422N       |
|INCIDENTAL TUMOR       |     P=0.052N        P=0.106N        P=0.038N*      |     P=0.246N        P=0.349         P=0.315N       |
|LOGISTIC REGRESSION    |     P=0.114N        P=0.118N        P=0.122N       |     P=0.229N        P=0.307         P=0.287N       |
|COCHRAN-ARMITAGE       |     P=0.021N*                                      |     P=0.239N                                       |
|FISHER EXACT           |                     P=0.133N        P=0.026N*      |                     P=0.268         P=0.274N       |
|=================================================================================================================================|
 
 (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).

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