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TDMS Study 05057-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Mason                                                     HC YELLOW 4                                     DATE: 09/08/94       
EXPERIMENT: 05057 TEST: 01                                                                                     TIME: 04:40:13       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01ES9561901          ROUTE: DOSED FEED                                                                  NTP C#: 56019        
PATHOLOGIST: K. MURTHY                       S. EUSTIS                                                         CAS: 5982043-8       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Mason                                                     HC YELLOW 4                                     DATE: 09/08/94      
EXPERIMENT: 05057 TEST: 01                                                                                     TIME: 04:40:13      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01ES9561901          ROUTE: DOSED FEED                                                                  NTP C#: 56019       
PATHOLOGIST: K. MURTHY                       S. EUSTIS                                                         CAS: 5982043-8      
 
 
 
 
 
                                                    RATS(FISCHER344)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Mason                                                     HC YELLOW 4                                     DATE: 09/08/94       
EXPERIMENT: 05057 TEST: 01                                                                                     TIME: 04:40:13       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01ES9561901          ROUTE: DOSED FEED                                                                  NTP C#: 56019        
PATHOLOGIST: K. MURTHY                       S. EUSTIS                                                         CAS: 5982043-8       
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                          IN THE ANALYSIS OF THE STUDY OF HC YELLOW 4
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Mammary Gland                 Fibroadenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                                                           Carcinoma or Adenoma
                             Skin: Subcutaneous Tissue     Fibroma
                             Testes                        Adenoma
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Clitoral/Preputial Gland      Adenoma
                             Mammary Gland                 Fibroadenoma
                                                           Fibroma, Fibroadenoma or Adenoma
                                                           Fibroma, Fibroadenoma, Carcinoma, or Adenoma
                             Uterus                        Polyp Stromal
                                                           Sarcoma Stromal or Polyp Stromal
 
              ====================================================================================================
         DATE: 09/08/94                     EXPERIMENT: 05057 TEST: 01                                                 PAGE   1
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATE        0.25%           0.5%          |      UNTREATE        0.5%            1.0%          |
|                       |      D 61 UM         61LM            61HM          |      D 61UF          61LF            61HF          |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    19/50 (38%)     17/49 (35%)     16/48 (33%)     |     1/49 (2%)       3/46 (7%)       2/49 (4%)      |
|ADJUSTED (b)           |     58.9%           51.1%           45.6%          |      3.7%           10.0%            5.9%          |
|TERMINAL (d)           |     9/21 (43%)     13/29 (45%)     10/28 (36%)     |     1/27 (4%)       3/30 (10%)      2/34 (6%)      |
|FIRST INCIDENCE (DAYS) |      637             658             570           |      729 (T)         729 (T)         729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.108N        P=0.132N        P=0.143N       |     P=0.492         P=0.342         P=0.581        |
|INCIDENTAL TUMOR       |     P=0.251N        P=0.381N        P=0.323N       |     P=0.492         P=0.342         P=0.581        |
|LOGISTIC REGRESSION    |     P=0.253N        P=0.321N        P=0.317N       |     P=0.492         P=0.342         P=0.581        |
|COCHRAN-ARMITAGE       |     P=0.352N                                       |     P=0.400                                        |
|FISHER EXACT           |                     P=0.447N        P=0.393N       |                     P=0.285         P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/49 (2%)       0/48 (0%)      |     1/49 (2%)       0/46 (0%)       0/49 (0%)      |
|ADJUSTED (b)           |      7.1%            3.4%            0.0%          |      3.7%            0.0%            0.0%          |
|TERMINAL (d)           |     1/21 (5%)       1/29 (3%)       0/28 (0%)      |     1/27 (4%)       0/30 (0%)       0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      637             729 (T)         ---           |      729 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.111N        P=0.428N        P=0.208N       |     P=0.240N        P=0.479N        P=0.454N       |
|INCIDENTAL TUMOR       |     P=0.144N        P=0.492N        P=0.267N       |     P=0.240N        P=0.479N        P=0.454N       |
|LOGISTIC REGRESSION    |     P=0.143N        P=0.498N        P=0.246N       |     P=0.240N        P=0.479N        P=0.454N       |
|COCHRAN-ARMITAGE       |     P=0.149N                                       |     P=0.272N                                       |
|FISHER EXACT           |                     P=0.508N        P=0.258N       |                     P=0.516N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05057 TEST: 01                                                 PAGE   2
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATE        0.25%           0.5%          |      UNTREATE        0.5%            1.0%          |
|                       |      D 61 UM         61LM            61HM          |      D 61UF          61LF            61HF          |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    19/50 (38%)     18/49 (37%)     16/48 (33%)     |     2/49 (4%)       3/46 (7%)       2/49 (4%)      |
|ADJUSTED (b)           |     58.9%           54.1%           45.6%          |      7.4%           10.0%            5.9%          |
|TERMINAL (d)           |     9/21 (43%)     14/29 (48%)     10/28 (36%)     |     2/27 (7%)       3/30 (10%)      2/34 (6%)      |
|FIRST INCIDENCE (DAYS) |      637             658             570           |      729 (T)         729 (T)         729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.105N        P=0.171N        P=0.143N       |     P=0.493N        P=0.549         P=0.610N       |
|INCIDENTAL TUMOR       |     P=0.245N        P=0.453N        P=0.323N       |     P=0.493N        P=0.549         P=0.610N       |
|LOGISTIC REGRESSION    |     P=0.251N        P=0.398N        P=0.317N       |     P=0.493N        P=0.549         P=0.610N       |
|COCHRAN-ARMITAGE       |     P=0.354N                                       |     P=0.593                                        |
|FISHER EXACT           |                     P=0.531N        P=0.393N       |                     P=0.470         P=0.691N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     9/48 (19%)     13/50 (26%)      8/49 (16%)     |     7/47 (15%)      5/47 (11%)      2/44 (5%)      |
|ADJUSTED (b)           |     37.9%           36.6%           23.9%          |     20.6%           15.2%            6.7%          |
|TERMINAL (d)           |     7/21 (33%)      8/29 (28%)      5/28 (18%)     |     3/25 (12%)      3/29 (10%)      2/30 (7%)      |
|FIRST INCIDENCE (DAYS) |      639             481             553           |      625             710             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.261N        P=0.485         P=0.310N       |     P=0.039N*       P=0.303N        P=0.059N       |
|INCIDENTAL TUMOR       |     P=0.365N        P=0.376         P=0.422N       |     P=0.087N        P=0.400N        P=0.106N       |
|LOGISTIC REGRESSION    |     P=0.410N        P=0.295         P=0.451N       |     P=0.063N        P=0.357N        P=0.091N       |
|COCHRAN-ARMITAGE       |     P=0.430N                                       |     P=0.073N                                       |
|FISHER EXACT           |                     P=0.269         P=0.481N       |                     P=0.379N        P=0.095N       |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05057 TEST: 01                                                 PAGE   3
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATE        0.25%           0.5%          |      UNTREATE        0.5%            1.0%          |
|                       |      D 61 UM         61LM            61HM          |      D 61UF          61LF            61HF          |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/48 (2%)       0/50 (0%)       0/49 (0%)      |     0/47 (0%)       0/47 (0%)       2/44 (5%)      |
|ADJUSTED (b)           |      2.1%            0.0%            0.0%          |      0.0%            0.0%            6.7%          |
|TERMINAL (d)           |     0/21 (0%)       0/29 (0%)       0/28 (0%)      |     0/25 (0%)       0/29 (0%)       2/30 (7%)      |
|FIRST INCIDENCE (DAYS) |      508             ---             ---           |      ---             ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.277N        P=0.508N        P=0.508N       |     P=0.112           (e)           P=0.279        |
|INCIDENTAL TUMOR       |     P=0.204N        P=0.362N        P=0.419N       |     P=0.112           (e)           P=0.279        |
|LOGISTIC REGRESSION    |     P=0.282N        P=0.511N        P=0.522N       |     P=0.112           (e)           P=0.279        |
|COCHRAN-ARMITAGE       |     P=0.266N                                       |     P=0.088                                        |
|FISHER EXACT           |                     P=0.490N        P=0.495N       |                       (e)           P=0.231        |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    10/48 (21%)     13/50 (26%)      8/49 (16%)     |     7/47 (15%)      5/47 (11%)      4/44 (9%)      |
|ADJUSTED (b)           |     39.2%           36.6%           23.9%          |     20.6%           15.2%           13.3%          |
|TERMINAL (d)           |     7/21 (33%)      8/29 (28%)      5/28 (18%)     |     3/25 (12%)      3/29 (10%)      4/30 (13%)     |
|FIRST INCIDENCE (DAYS) |      508             481             553           |      625             710             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.192N        P=0.576         P=0.232N       |     P=0.144N        P=0.303N        P=0.193N       |
|INCIDENTAL TUMOR       |     P=0.267N        P=0.505         P=0.306N       |     P=0.256N        P=0.400N        P=0.292N       |
|LOGISTIC REGRESSION    |     P=0.325N        P=0.373         P=0.367N       |     P=0.212N        P=0.357N        P=0.277N       |
|COCHRAN-ARMITAGE       |     P=0.335N                                       |     P=0.240N                                       |
|FISHER EXACT           |                     P=0.358         P=0.379N       |                     P=0.379N        P=0.301N       |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05057 TEST: 01                                                 PAGE   4
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATE        0.25%           0.5%          |      UNTREATE        0.5%            1.0%          |
|                       |      D 61 UM         61LM            61HM          |      D 61UF          61LF            61HF          |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/48 (2%)       4/47 (9%)       3/48 (6%)      |     1/50 (2%)       0/50 (0%)       1/48 (2%)      |
|ADJUSTED (b)           |      5.0%           13.4%            8.8%          |      3.7%            0.0%            2.5%          |
|TERMINAL (d)           |     1/20 (5%)       3/28 (11%)      1/28 (4%)      |     1/27 (4%)       0/31 (0%)       0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         723             570           |      729 (T)         ---             686           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.339         P=0.295         P=0.368        |     P=0.632N        P=0.472N        P=0.723N       |
|INCIDENTAL TUMOR       |     P=0.267         P=0.228         P=0.292        |     P=0.630         P=0.472N        P=0.722        |
|LOGISTIC REGRESSION    |     P=0.264         P=0.266         P=0.305        |     P=0.666N        P=0.472N        P=0.760N       |
|COCHRAN-ARMITAGE       |     P=0.253                                        |     P=0.661                                        |
|FISHER EXACT           |                     P=0.174         P=0.308        |                     P=0.500N        P=0.742        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       3/49 (6%)      |     2/50 (4%)       1/50 (2%)       2/50 (4%)      |
|ADJUSTED (b)           |      7.6%            3.4%           10.7%          |      5.3%            2.1%            5.6%          |
|TERMINAL (d)           |     1/21 (5%)       1/29 (3%)       3/28 (11%)     |     0/27 (0%)       0/31 (0%)       1/34 (3%)      |
|FIRST INCIDENCE (DAYS) |      666             729 (T)         729 (T)       |      658             545             715           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.501         P=0.412N        P=0.619        |     P=0.562N        P=0.477N        P=0.637N       |
|INCIDENTAL TUMOR       |     P=0.469         P=0.475N        P=0.580        |     P=0.495         P=0.585N        P=0.577        |
|LOGISTIC REGRESSION    |     P=0.429         P=0.481N        P=0.535        |     P=0.571         P=0.579N        P=0.686N       |
|COCHRAN-ARMITAGE       |     P=0.391                                        |     P=0.610                                        |
|FISHER EXACT           |                     P=0.500N        P=0.490        |                     P=0.500N        P=0.691N       |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05057 TEST: 01                                                 PAGE   5
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATE        0.25%           0.5%          |      UNTREATE        0.5%            1.0%          |
|                       |      D 61 UM         61LM            61HM          |      D 61UF          61LF            61HF          |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       4/49 (8%)      |     2/50 (4%)       1/50 (2%)       2/50 (4%)      |
|ADJUSTED (b)           |      7.6%            3.4%           12.9%          |      5.3%            2.1%            5.6%          |
|TERMINAL (d)           |     1/21 (5%)       1/29 (3%)       3/28 (11%)     |     0/27 (0%)       0/31 (0%)       1/34 (3%)      |
|FIRST INCIDENCE (DAYS) |      666             729 (T)         654           |      658             545             715           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.321         P=0.412N        P=0.451        |     P=0.562N        P=0.477N        P=0.637N       |
|INCIDENTAL TUMOR       |     P=0.275         P=0.475N        P=0.384        |     P=0.495         P=0.585N        P=0.577        |
|LOGISTIC REGRESSION    |     P=0.246         P=0.481N        P=0.347        |     P=0.571         P=0.579N        P=0.686N       |
|COCHRAN-ARMITAGE       |     P=0.231                                        |     P=0.610                                        |
|FISHER EXACT           |                     P=0.500N        P=0.329        |                     P=0.500N        P=0.691N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       0/50 (0%)       1/49 (2%)      |     3/50 (6%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      3.6%            0.0%            3.6%          |     10.1%            0.0%            5.9%          |
|TERMINAL (d)           |     0/21 (0%)       0/29 (0%)       1/28 (4%)      |     2/27 (7%)       0/31 (0%)       2/34 (6%)      |
|FIRST INCIDENCE (DAYS) |      710             ---             729 (T)       |      700             ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.636N        P=0.461N        P=0.721N       |     P=0.319N        P=0.102N        P=0.407N       |
|INCIDENTAL TUMOR       |     P=0.665         P=0.587N        P=0.760N       |     P=0.360N        P=0.119N        P=0.462N       |
|LOGISTIC REGRESSION    |     P=0.653N        P=0.487N        P=0.742N       |     P=0.345N        P=0.107N        P=0.442N       |
|COCHRAN-ARMITAGE       |     P=0.665                                        |     P=0.390N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.747        |                     P=0.121N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05057 TEST: 01                                                 PAGE   6
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATE        0.25%           0.5%          |      UNTREATE        0.5%            1.0%          |
|                       |      D 61 UM         61LM            61HM          |      D 61UF          61LF            61HF          |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       0/50 (0%)       1/49 (2%)      |     4/50 (8%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      3.6%            0.0%            3.6%          |     11.9%            0.0%            5.9%          |
|TERMINAL (d)           |     0/21 (0%)       0/29 (0%)       1/28 (4%)      |     2/27 (7%)       0/31 (0%)       2/34 (6%)      |
|FIRST INCIDENCE (DAYS) |      710             ---             729 (T)       |      409             ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.636N        P=0.461N        P=0.721N       |     P=0.175N        P=0.055N        P=0.264N       |
|INCIDENTAL TUMOR       |     P=0.665         P=0.587N        P=0.760N       |     P=0.217N        P=0.073N        P=0.327N       |
|LOGISTIC REGRESSION    |     P=0.653N        P=0.487N        P=0.742N       |     P=0.252N        P=0.081N        P=0.371N       |
|COCHRAN-ARMITAGE       |     P=0.665                                        |     P=0.222N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.747        |                     P=0.059N        P=0.339N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       1/50 (2%)       0/49 (0%)      |    28/50 (56%)     19/50 (38%)     18/50 (36%)     |
|ADJUSTED (b)           |     13.6%            3.4%            0.0%          |     74.5%           47.7%           49.6%          |
|TERMINAL (d)           |     2/21 (10%)      1/29 (3%)       0/28 (0%)      |    18/27 (67%)     11/31 (35%)     16/34 (47%)     |
|FIRST INCIDENCE (DAYS) |      725             729 (T)         ---           |      582             612             650           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.034N*       P=0.198N        P=0.079N       |     P=0.005N**      P=0.030N*       P=0.005N**     |
|INCIDENTAL TUMOR       |     P=0.047N*       P=0.257N        P=0.103N       |     P=0.015N*       P=0.040N*       P=0.013N*      |
|LOGISTIC REGRESSION    |     P=0.039N*       P=0.207N        P=0.090N       |     P=0.013N*       P=0.034N*       P=0.015N*      |
|COCHRAN-ARMITAGE       |     P=0.062N                                       |     P=0.028N*                                      |
|FISHER EXACT           |                     P=0.309N        P=0.125N       |                     P=0.054N        P=0.035N*      |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05057 TEST: 01                                                 PAGE   7
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATE        0.25%           0.5%          |      UNTREATE        0.5%            1.0%          |
|                       |      D 61 UM         61LM            61HM          |      D 61UF          61LF            61HF          |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       1/50 (2%)       1/49 (2%)      |    29/50 (58%)     19/50 (38%)     20/50 (40%)     |
|ADJUSTED (b)           |     16.7%            3.4%            3.6%          |     75.3%           47.7%           55.2%          |
|TERMINAL (d)           |     2/21 (10%)      1/29 (3%)       1/28 (4%)      |    18/27 (67%)     11/31 (35%)     18/34 (53%)     |
|FIRST INCIDENCE (DAYS) |      710             729 (T)         729 (T)       |      582             612             650           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.060N        P=0.104N        P=0.119N       |     P=0.009N**      P=0.021N*       P=0.008N**     |
|INCIDENTAL TUMOR       |     P=0.086N        P=0.170N        P=0.160N       |     P=0.025N*       P=0.026N*       P=0.022N*      |
|LOGISTIC REGRESSION    |     P=0.073N        P=0.124N        P=0.137N       |     P=0.022N*       P=0.021N*       P=0.023N*      |
|COCHRAN-ARMITAGE       |     P=0.104N                                       |     P=0.044N*                                      |
|FISHER EXACT           |                     P=0.181N        P=0.187N       |                     P=0.036N*       P=0.055N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       1/50 (2%)       1/49 (2%)      |    30/50 (60%)     19/50 (38%)     20/50 (40%)     |
|ADJUSTED (b)           |     16.7%            3.4%            3.6%          |     75.8%           47.7%           55.2%          |
|TERMINAL (d)           |     2/21 (10%)      1/29 (3%)       1/28 (4%)      |    18/27 (67%)     11/31 (35%)     18/34 (53%)     |
|FIRST INCIDENCE (DAYS) |      710             729 (T)         729 (T)       |      409             612             650           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.060N        P=0.104N        P=0.119N       |     P=0.006N**      P=0.015N*       P=0.005N**     |
|INCIDENTAL TUMOR       |     P=0.086N        P=0.170N        P=0.160N       |     P=0.018N*       P=0.019N*       P=0.015N*      |
|LOGISTIC REGRESSION    |     P=0.073N        P=0.124N        P=0.137N       |     P=0.016N*       P=0.016N*       P=0.019N*      |
|COCHRAN-ARMITAGE       |     P=0.104N                                       |     P=0.028N*                                      |
|FISHER EXACT           |                     P=0.181N        P=0.187N       |                     P=0.022N*       P=0.036N*      |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05057 TEST: 01                                                 PAGE   8
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATE        0.25%           0.5%          |      UNTREATE        0.5%            1.0%          |
|                       |      D 61 UM         61LM            61HM          |      D 61UF          61LF            61HF          |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Papilloma Squamous or Papilloma                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       0/50 (0%)       2/49 (4%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      2.4%            0.0%            6.9%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/21 (0%)       0/29 (0%)       1/28 (4%)      |     0/27 (0%)       0/31 (0%)       0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      625             ---             715           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.393         P=0.500N        P=0.547        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.308         P=0.581N        P=0.435        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.357         P=0.503N        P=0.496        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.355                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.500N        P=0.492        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       0/50 (0%)       2/49 (4%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      2.4%            0.0%            6.9%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/21 (0%)       0/29 (0%)       1/28 (4%)      |     0/27 (0%)       0/31 (0%)       0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      625             ---             715           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.393         P=0.500N        P=0.547        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.308         P=0.581N        P=0.435        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.357         P=0.503N        P=0.496        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.355                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.500N        P=0.492        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05057 TEST: 01                                                 PAGE   9
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATE        0.25%           0.5%          |      UNTREATE        0.5%            1.0%          |
|                       |      D 61 UM         61LM            61HM          |      D 61UF          61LF            61HF          |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       4/48 (8%)       2/48 (4%)      |     2/49 (4%)       2/50 (4%)       0/49 (0%)      |
|ADJUSTED (b)           |      8.7%           13.8%            6.0%          |      7.1%            6.5%            0.0%          |
|TERMINAL (d)           |     1/21 (5%)       4/29 (14%)      1/28 (4%)      |     1/27 (4%)       2/31 (6%)       0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      722             729 (T)         658           |      728             729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.478N        P=0.493         P=0.616N       |     P=0.133N        P=0.647N        P=0.194N       |
|INCIDENTAL TUMOR       |     P=0.539N        P=0.422         P=0.686        |     P=0.169N        P=0.677N        P=0.278N       |
|LOGISTIC REGRESSION    |     P=0.556N        P=0.464         P=0.689N       |     P=0.134N        P=0.661N        P=0.195N       |
|COCHRAN-ARMITAGE       |     P=0.569                                        |     P=0.175N                                       |
|FISHER EXACT           |                     P=0.319         P=0.676        |                     P=0.684N        P=0.247N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Parathyroid Gland                                                                                                                |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/47 (0%)       0/44 (0%)       2/37 (5%)      |     1/46 (2%)       1/39 (3%)       0/45 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%           10.0%          |      3.6%            2.6%            0.0%          |
|TERMINAL (d)           |     0/20 (0%)       0/27 (0%)       2/20 (10%)     |     0/24 (0%)       0/24 (0%)       0/32 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             729 (T)       |      728             685             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.083           (e)           P=0.237        |     P=0.301N        P=0.740N        P=0.461N       |
|INCIDENTAL TUMOR       |     P=0.083           (e)           P=0.237        |     P=0.424N        P=0.730         P=0.588N       |
|LOGISTIC REGRESSION    |     P=0.083           (e)           P=0.237        |     P=0.324N        P=0.745         P=0.451N       |
|COCHRAN-ARMITAGE       |     P=0.072                                        |     P=0.340N                                       |
|FISHER EXACT           |                       (e)           P=0.191        |                     P=0.710         P=0.505N       |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05057 TEST: 01                                                 PAGE  10
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATE        0.25%           0.5%          |      UNTREATE        0.5%            1.0%          |
|                       |      D 61 UM         61LM            61HM          |      D 61UF          61LF            61HF          |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    17/45 (38%)     20/49 (41%)     28/49 (57%)     |    33/49 (67%)     35/48 (73%)     30/49 (61%)     |
|ADJUSTED (b)           |     59.1%           53.0%           67.4%          |     77.8%           89.2%           69.2%          |
|TERMINAL (d)           |    10/20 (50%)     12/29 (41%)     15/28 (54%)     |    18/27 (67%)     25/29 (86%)     20/33 (61%)     |
|FIRST INCIDENCE (DAYS) |      598             626             367           |      447             478             557           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.140         P=0.434N        P=0.176        |     P=0.091N        P=0.526N        P=0.131N       |
|INCIDENTAL TUMOR       |     P=0.031 *       P=0.455         P=0.048 *      |     P=0.259N        P=0.383         P=0.355N       |
|LOGISTIC REGRESSION    |     P=0.034 *       P=0.489         P=0.047 *      |     P=0.248N        P=0.390         P=0.295N       |
|COCHRAN-ARMITAGE       |     P=0.036 *                                      |     P=0.295N                                       |
|FISHER EXACT           |                     P=0.464         P=0.047 *      |                     P=0.353         P=0.337N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    17/45 (38%)     20/49 (41%)     28/49 (57%)     |    34/49 (69%)     35/48 (73%)     30/49 (61%)     |
|ADJUSTED (b)           |     59.1%           53.0%           67.4%          |     78.5%           89.2%           69.2%          |
|TERMINAL (d)           |    10/20 (50%)     12/29 (41%)     15/28 (54%)     |    18/27 (67%)     25/29 (86%)     20/33 (61%)     |
|FIRST INCIDENCE (DAYS) |      598             626             367           |      447             478             557           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.140         P=0.434N        P=0.176        |     P=0.067N        P=0.453N        P=0.100N       |
|INCIDENTAL TUMOR       |     P=0.031 *       P=0.455         P=0.048 *      |     P=0.203N        P=0.459         P=0.295N       |
|LOGISTIC REGRESSION    |     P=0.034 *       P=0.489         P=0.047 *      |     P=0.182N        P=0.479         P=0.222N       |
|COCHRAN-ARMITAGE       |     P=0.036 *                                      |     P=0.225N                                       |
|FISHER EXACT           |                     P=0.464         P=0.047 *      |                     P=0.437         P=0.262N       |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05057 TEST: 01                                                 PAGE  11
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATE        0.25%           0.5%          |      UNTREATE        0.5%            1.0%          |
|                       |      D 61 UM         61LM            61HM          |      D 61UF          61LF            61HF          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       2/49 (4%)      |     1/50 (2%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |      4.3%            6.6%            5.6%          |      3.7%            3.2%            0.0%          |
|TERMINAL (d)           |     0/21 (0%)       1/29 (3%)       1/28 (4%)      |     1/27 (4%)       1/31 (3%)       0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      724             728             436           |      729 (T)         729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.458         P=0.615         P=0.551        |     P=0.284N        P=0.731N        P=0.454N       |
|INCIDENTAL TUMOR       |     P=0.410         P=0.436         P=0.549        |     P=0.284N        P=0.731N        P=0.454N       |
|LOGISTIC REGRESSION    |     P=0.381         P=0.430         P=0.486        |     P=0.284N        P=0.731N        P=0.454N       |
|COCHRAN-ARMITAGE       |     P=0.383                                        |     P=0.331N                                       |
|FISHER EXACT           |                     P=0.500         P=0.492        |                     P=0.753N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       5/50 (10%)      0/49 (0%)      |     1/50 (2%)       3/50 (6%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%           15.6%            0.0%          |      3.2%            6.9%            2.2%          |
|TERMINAL (d)           |     0/21 (0%)       3/29 (10%)      0/28 (0%)      |     0/27 (0%)       0/31 (0%)       0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             672             ---           |      710             544             632           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.520N        P=0.067           (e)          |     P=0.568N        P=0.349         P=0.727N       |
|INCIDENTAL TUMOR       |     P=0.594N        P=0.033 *         (e)          |     P=0.478         P=0.222         P=0.705        |
|LOGISTIC REGRESSION    |     P=0.585N        P=0.041 *         (e)          |     P=0.533         P=0.250         P=0.749        |
|COCHRAN-ARMITAGE       |     P=0.603                                        |     P=0.610                                        |
|FISHER EXACT           |                     P=0.028 *         (e)          |                     P=0.309         P=0.753N       |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05057 TEST: 01                                                 PAGE  12
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATE        0.25%           0.5%          |      UNTREATE        0.5%            1.0%          |
|                       |      D 61 UM         61LM            61HM          |      D 61UF          61LF            61HF          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       0/50 (0%)       1/49 (2%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      7.0%            0.0%            2.6%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/21 (5%)       0/29 (0%)       0/28 (0%)      |     0/27 (0%)       0/31 (0%)       0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      619             ---             676           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.322N        P=0.200N        P=0.449N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.418N        P=0.245N        P=0.565N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.367N        P=0.238N        P=0.508N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.366N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.247N        P=0.508N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       5/50 (10%)      1/49 (2%)      |     1/50 (2%)       3/50 (6%)       1/50 (2%)      |
|ADJUSTED (b)           |      7.0%           15.6%            2.6%          |      3.2%            6.9%            2.2%          |
|TERMINAL (d)           |     1/21 (5%)       3/29 (10%)      0/28 (0%)      |     0/27 (0%)       0/31 (0%)       0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      619             672             676           |      710             544             632           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.318N        P=0.336         P=0.449N       |     P=0.568N        P=0.349         P=0.727N       |
|INCIDENTAL TUMOR       |     P=0.436N        P=0.217         P=0.565N       |     P=0.478         P=0.222         P=0.705        |
|LOGISTIC REGRESSION    |     P=0.408N        P=0.232         P=0.508N       |     P=0.533         P=0.250         P=0.749        |
|COCHRAN-ARMITAGE       |     P=0.421N                                       |     P=0.610                                        |
|FISHER EXACT           |                     P=0.218         P=0.508N       |                     P=0.309         P=0.753N       |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05057 TEST: 01                                                 PAGE  13
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATE        0.25%           0.5%          |      UNTREATE        0.5%            1.0%          |
|                       |      D 61 UM         61LM            61HM          |      D 61UF          61LF            61HF          |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    47/50 (94%)     43/50 (86%)     41/49 (84%)     |                                                    |
|ADJUSTED (b)           |    100.0%          100.0%           97.5%          |                                                    |
|TERMINAL (d)           |    21/21 (100%)    29/29 (100%)    27/28 (96%)     |                                                    |
|FIRST INCIDENCE (DAYS) |      508             467             436           |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.011N*       P=0.018N*       P=0.018N*      |                                                    |
|INCIDENTAL TUMOR       |     P=0.016N*       P=0.063N        P=0.026N*      |                                                    |
|LOGISTIC REGRESSION    |     P=0.056N        P=0.140N        P=0.075N       |                                                    |
|COCHRAN-ARMITAGE       |     P=0.077N                                       |                                                    |
|FISHER EXACT           |                     P=0.159N        P=0.094N       |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     7/49 (14%)      5/49 (10%)      6/48 (13%)     |     9/50 (18%)      7/50 (14%)      8/50 (16%)     |
|ADJUSTED (b)           |     30.3%           14.7%           21.4%          |     27.0%           18.5%           20.5%          |
|TERMINAL (d)           |     6/21 (29%)      3/29 (10%)      6/28 (21%)     |     5/27 (19%)      4/31 (13%)      5/34 (15%)     |
|FIRST INCIDENCE (DAYS) |      637             588             729 (T)       |      645             611             531           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.272N        P=0.220N        P=0.294N       |     P=0.317N        P=0.310N        P=0.356N       |
|INCIDENTAL TUMOR       |     P=0.332N        P=0.280N        P=0.326N       |     P=0.450N        P=0.374N        P=0.553N       |
|LOGISTIC REGRESSION    |     P=0.407N        P=0.344N        P=0.410N       |     P=0.454N        P=0.390N        P=0.485N       |
|COCHRAN-ARMITAGE       |     P=0.454N                                       |     P=0.446N                                       |
|FISHER EXACT           |                     P=0.380N        P=0.516N       |                     P=0.393N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05057 TEST: 01                                                 PAGE  14
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATE        0.25%           0.5%          |      UNTREATE        0.5%            1.0%          |
|                       |      D 61 UM         61LM            61HM          |      D 61UF          61LF            61HF          |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     7/49 (14%)      5/49 (10%)      6/48 (13%)     |    10/50 (20%)      7/50 (14%)      8/50 (16%)     |
|ADJUSTED (b)           |     30.3%           14.7%           21.4%          |     28.6%           18.5%           20.5%          |
|TERMINAL (d)           |     6/21 (29%)      3/29 (10%)      6/28 (21%)     |     5/27 (19%)      4/31 (13%)      5/34 (15%)     |
|FIRST INCIDENCE (DAYS) |      637             588             729 (T)       |      600             611             531           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.272N        P=0.220N        P=0.294N       |     P=0.234N        P=0.230N        P=0.271N       |
|INCIDENTAL TUMOR       |     P=0.332N        P=0.280N        P=0.326N       |     P=0.347N        P=0.277N        P=0.448N       |
|LOGISTIC REGRESSION    |     P=0.407N        P=0.344N        P=0.410N       |     P=0.363N        P=0.308N        P=0.399N       |
|COCHRAN-ARMITAGE       |     P=0.454N                                       |     P=0.344N                                       |
|FISHER EXACT           |                     P=0.380N        P=0.516N       |                     P=0.298N        P=0.398N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Tongue                                                                                                                           |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       2/49 (4%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            6.9%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/21 (0%)       0/29 (0%)       1/28 (4%)      |     0/27 (0%)       0/31 (0%)       0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             715           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.109           (e)           P=0.289        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.097           (e)           P=0.240        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.101           (e)           P=0.262        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.093                                        |       (e)                                          |
|FISHER EXACT           |                       (e)           P=0.242        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05057 TEST: 01                                                 PAGE  15
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATE        0.25%           0.5%          |      UNTREATE        0.5%            1.0%          |
|                       |      D 61 UM         61LM            61HM          |      D 61UF          61LF            61HF          |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     4/50 (8%)       8/50 (16%)     12/50 (24%)     |
|ADJUSTED (b)           |                                                    |     11.4%           23.6%           31.3%          |
|TERMINAL (d)           |                                                    |     0/27 (0%)       6/31 (19%)      9/34 (26%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      625             686             632           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.056         P=0.246         P=0.071        |
|INCIDENTAL TUMOR       |                                                    |     P=0.024 *       P=0.168         P=0.029 *      |
|LOGISTIC REGRESSION    |                                                    |     P=0.025 *       P=0.201         P=0.031 *      |
|COCHRAN-ARMITAGE       |                                                    |     P=0.020 *                                      |
|FISHER EXACT           |                                                    |                     P=0.178         P=0.027 *      |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     4/50 (8%)       9/50 (18%)     12/50 (24%)     |
|ADJUSTED (b)           |                                                    |     11.4%           26.7%           31.3%          |
|TERMINAL (d)           |                                                    |     0/27 (0%)       7/31 (23%)      9/34 (26%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      625             686             632           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.061         P=0.176         P=0.071        |
|INCIDENTAL TUMOR       |                                                    |     P=0.027 *       P=0.114         P=0.029 *      |
|LOGISTIC REGRESSION    |                                                    |     P=0.028 *       P=0.137         P=0.031 *      |
|COCHRAN-ARMITAGE       |                                                    |     P=0.022 *                                      |
|FISHER EXACT           |                                                    |                     P=0.117         P=0.027 *      |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05057 TEST: 01                                                 PAGE  16
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATE        0.25%           0.5%          |      UNTREATE        0.5%            1.0%          |
|                       |      D 61 UM         61LM            61HM          |      D 61UF          61LF            61HF          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    19/50 (38%)     21/50 (42%)     16/49 (33%)     |    14/50 (28%)     15/50 (30%)     10/50 (20%)     |
|ADJUSTED (b)           |     46.1%           51.1%           40.5%          |     37.1%           34.6%           23.2%          |
|TERMINAL (d)           |     2/21 (10%)     10/29 (34%)      6/28 (21%)     |     6/27 (22%)      5/31 (16%)      4/34 (12%)     |
|FIRST INCIDENCE (DAYS) |      485             467             570           |      447             544             497           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.192N        P=0.466N        P=0.238N       |     P=0.135N        P=0.534N        P=0.159N       |
|INCIDENTAL TUMOR       |     P=0.536N        P=0.199         P=0.561        |     P=0.343N        P=0.411         P=0.361N       |
|LOGISTIC REGRESSION    |     P=0.515N        P=0.251         P=0.575        |     P=0.257N        P=0.443         P=0.321N       |
|COCHRAN-ARMITAGE       |     P=0.330N                                       |     P=0.212N                                       |
|FISHER EXACT           |                     P=0.419         P=0.365N       |                     P=0.500         P=0.241N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/50 (4%)       1/49 (2%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            4.1%            2.3%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/21 (0%)       0/29 (0%)       0/28 (0%)      |     0/27 (0%)       0/31 (0%)       0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             367             588           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.349         P=0.242         P=0.487        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.278         P=0.262         P=0.383        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.329         P=0.207         P=0.488        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.355                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.247         P=0.495        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05057 TEST: 01                                                 PAGE  17
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATE        0.25%           0.5%          |      UNTREATE        0.5%            1.0%          |
|                       |      D 61 UM         61LM            61HM          |      D 61UF          61LF            61HF          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/50 (4%)       1/49 (2%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            4.1%            2.3%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/21 (0%)       0/29 (0%)       0/28 (0%)      |     0/27 (0%)       0/31 (0%)       0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             367             588           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.349         P=0.242         P=0.487        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.278         P=0.262         P=0.383        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.329         P=0.207         P=0.488        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.355                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.247         P=0.495        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma Benign, Malignant, NOS                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       0/49 (0%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      7.6%            2.4%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/21 (5%)       0/29 (0%)       0/28 (0%)      |     0/27 (0%)       0/31 (0%)       0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      666             626             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.119N        P=0.447N        P=0.191N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.181N        P=0.559N        P=0.236N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.146N        P=0.501N        P=0.237N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.145N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.500N        P=0.253N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05057 TEST: 01                                                 PAGE  18
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATE        0.25%           0.5%          |      UNTREATE        0.5%            1.0%          |
|                       |      D 61 UM         61LM            61HM          |      D 61UF          61LF            61HF          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    49/50 (98%)     49/50 (98%)     48/49 (98%)     |    43/50 (86%)     48/50 (96%)     43/50 (86%)     |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%          |     95.4%           96.0%           91.4%          |
|TERMINAL (d)           |    21/21 (100%)    29/29 (100%)    28/28 (100%)    |    25/27 (93%)     29/31 (94%)     30/34 (88%)     |
|FIRST INCIDENCE (DAYS) |      485             367             367           |      447             478             531           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.085N        P=0.084N        P=0.104N       |     P=0.106N        P=0.540N        P=0.131N       |
|INCIDENTAL TUMOR       |     P=0.388N        P=0.638N        P=0.581N       |     P=0.527N        P=0.096         P=0.544N       |
|LOGISTIC REGRESSION    |     P=0.694N        P=0.962         P=0.887N       |     P=0.441N        P=0.122         P=0.470N       |
|COCHRAN-ARMITAGE       |     P=0.634N                                       |     P=0.564N                                       |
|FISHER EXACT           |                     P=0.753N        P=0.747N       |                     P=0.080         P=0.613N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    27/50 (54%)     27/50 (54%)     19/49 (39%)     |    19/50 (38%)     18/50 (36%)     13/50 (26%)     |
|ADJUSTED (b)           |     59.9%           59.8%           44.7%          |     44.6%           39.9%           30.2%          |
|TERMINAL (d)           |     4/21 (19%)     12/29 (41%)      6/28 (21%)     |     6/27 (22%)      6/31 (19%)      6/34 (18%)     |
|FIRST INCIDENCE (DAYS) |      485             367             436           |      409             544             497           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.054N        P=0.307N        P=0.070N       |     P=0.078N        P=0.373N        P=0.093N       |
|INCIDENTAL TUMOR       |     P=0.177N        P=0.352         P=0.230N       |     P=0.244N        P=0.527         P=0.263N       |
|LOGISTIC REGRESSION    |     P=0.131N        P=0.443         P=0.226N       |     P=0.205N        P=0.533         P=0.233N       |
|COCHRAN-ARMITAGE       |     P=0.079N                                       |     P=0.122N                                       |
|FISHER EXACT           |                     P=0.579N        P=0.094N       |                     P=0.500N        P=0.142N       |
|=================================================================================================================================|
 
         DATE: 09/08/94                     EXPERIMENT: 05057 TEST: 01                                                 PAGE  19
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATE        0.25%           0.5%          |      UNTREATE        0.5%            1.0%          |
|                       |      D 61 UM         61LM            61HM          |      D 61UF          61LF            61HF          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    49/50 (98%)     50/50 (100%)    48/49 (98%)     |    49/50 (98%)     49/50 (98%)     48/50 (96%)     |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%          |     98.0%           98.0%           96.0%          |
|TERMINAL (d)           |    21/21 (100%)    29/29 (100%)    28/28 (100%)    |    26/27 (96%)     30/31 (97%)     32/34 (94%)     |
|FIRST INCIDENCE (DAYS) |      485             367             367           |      409             478             497           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.087N        P=0.111N        P=0.104N       |     P=0.074N        P=0.238N        P=0.095N       |
|INCIDENTAL TUMOR       |     P=0.299N          (e)           P=0.581N       |     P=0.451N        P=0.731         P=0.581N       |
|LOGISTIC REGRESSION    |     P=0.608N          (e)           P=0.887N       |     P=0.451N        P=0.731         P=0.581N       |
|COCHRAN-ARMITAGE       |     P=0.665N                                       |     P=0.378N                                       |
|FISHER EXACT           |                     P=0.500         P=0.747N       |                     P=0.753N        P=0.500N       |
|=================================================================================================================================|
 
 (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).