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TDMS Study 05130-03 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Microbiological Assoc.                               C. I. DIRECT BLUE 218                                DATE: 09/17/94       
EXPERIMENT: 05130 TEST: 03                                                                                     TIME: 01:46:15       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-5096           ROUTE: DOSED FEED                                                                  NTP C#: 60877B       
PATHOLOGIST: L. BRENNECKE                    Hailey, Rick                                                      CAS: 10401-500       
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Microbiological Assoc.                               C. I. DIRECT BLUE 218                                DATE: 09/17/94      
EXPERIMENT: 05130 TEST: 03                                                                                     TIME: 01:46:15      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-5096           ROUTE: DOSED FEED                                                                  NTP C#: 60877B      
PATHOLOGIST: L. BRENNECKE                    Hailey, Rick                                                      CAS: 10401-500      
 
 
 
 
 
                                                    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 Cortex
                                                    Adrenal Medulla
                                                    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: Microbiological Assoc.                               C. I. DIRECT BLUE 218                                DATE: 09/17/94       
EXPERIMENT: 05130 TEST: 03                                                                                     TIME: 01:46:15       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-5096           ROUTE: DOSED FEED                                                                  NTP C#: 60877B       
PATHOLOGIST: L. BRENNECKE                    Hailey, Rick                                                      CAS: 10401-500       
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                     IN THE ANALYSIS OF THE STUDY OF C. I. DIRECT BLUE 218
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)
                                                           Papilloma Squamous or Papilloma
                                                           Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
                             Pharynx                       Squamous Cell Papilloma
                             Thyroid Gland: C-Cell         Adenoma
                                                           Carcinoma or Adenoma
                             All Organs                    Histiocytic Sarcoma
                                                           Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Malignant Lymphoma And Histiocytic Sarcoma
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Benign
                                                           Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Mammary Gland                 Fibroadenoma
                                                           Fibroma, Fibroadenoma, Carcinoma, or Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                             Thyroid Gland: C-Cell         Carcinoma
                             Uterus                        Polyp Stromal
                             All Organs                    Benign Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/17/94                     EXPERIMENT: 05130 TEST: 03                                                 PAGE   1
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        1000 PPM     3000 PPM     10000PPM  |   0 PPM        1000 PPM     3000 PPM     10000PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 15/49 (31%)   9/50 (18%)  12/50 (24%)  12/50 (24%) |  1/49 (2%)    0/50 (0%)    1/47 (2%)    3/49 (6%)  |
|ADJUSTED (b)           |  43.7%        27.4%        37.3%        40.6%      |   2.9%         0.0%         3.6%         9.9%      |
|TERMINAL (d)           | 11/30 (37%)   4/25 (16%)   9/29 (31%)   8/24 (33%) |  1/34 (3%)    0/29 (0%)    1/28 (4%)    1/25 (4%)  |
|FIRST INCIDENCE (DAYS) |   630          614          694          614       |   729 (T)      ---          729 (T)      649       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.445      P=0.207N     P=0.333N     P=0.522N   |  P=0.049 *    P=0.532N     P=0.718      P=0.212    |
|INCIDENTAL TUMOR       |  P=0.533      P=0.053N     P=0.189N     P=0.344N   |  P=0.065      P=0.532N     P=0.718      P=0.289    |
|LOGISTIC REGRESSION    |  P=0.526      P=0.088N     P=0.214N     P=0.363N   |  P=0.066      P=0.532N     P=0.718      P=0.276    |
|COCHRAN-ARMITAGE       |  P=0.494N                                          |  P=0.082                                           |
|FISHER EXACT           |               P=0.109N     P=0.304N     P=0.304N   |               P=0.495N     P=0.742      P=0.309    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/49 (4%)    0/50 (0%)    2/50 (4%)    1/50 (2%)  |  0/49 (0%)    0/50 (0%)    0/47 (0%)    0/49 (0%)  |
|ADJUSTED (b)           |   6.3%         0.0%         6.9%         2.7%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/30 (3%)    0/25 (0%)    2/29 (7%)    0/24 (0%)  |  0/34 (0%)    0/29 (0%)    0/28 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   682          ---          729 (T)      646       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.631N     P=0.263N     P=0.693N     P=0.526N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.593N     P=0.160N     P=0.627N     P=0.350N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.611N     P=0.226N     P=0.661N     P=0.500N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.588N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.242N     P=0.684N     P=0.492N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05130 TEST: 03                                                 PAGE   2
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        1000 PPM     3000 PPM     10000PPM  |   0 PPM        1000 PPM     3000 PPM     10000PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 17/49 (35%)   9/50 (18%)  13/50 (26%)  13/50 (26%) |  1/49 (2%)    0/50 (0%)    1/47 (2%)    3/49 (6%)  |
|ADJUSTED (b)           |  48.3%        27.4%        40.4%        42.3%      |   2.9%         0.0%         3.6%         9.9%      |
|TERMINAL (d)           | 12/30 (40%)   4/25 (16%)  10/29 (34%)   8/24 (33%) |  1/34 (3%)    0/29 (0%)    1/28 (4%)    1/25 (4%)  |
|FIRST INCIDENCE (DAYS) |   630          614          694          614       |   729 (T)      ---          729 (T)      649       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.454      P=0.115N     P=0.263N     P=0.447N   |  P=0.049 *    P=0.532N     P=0.718      P=0.212    |
|INCIDENTAL TUMOR       |  P=0.554      P=0.016N*    P=0.118N     P=0.221N   |  P=0.065      P=0.532N     P=0.718      P=0.289    |
|LOGISTIC REGRESSION    |  P=0.538      P=0.036N*    P=0.149N     P=0.213N   |  P=0.066      P=0.532N     P=0.718      P=0.276    |
|COCHRAN-ARMITAGE       |  P=0.477N                                          |  P=0.082                                           |
|FISHER EXACT           |               P=0.048N*    P=0.235N     P=0.235N   |               P=0.495N     P=0.742      P=0.309    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    3/50 (6%)    2/50 (4%)    2/49 (4%)  |  2/47 (4%)    0/48 (0%)    2/49 (4%)    2/47 (4%)  |
|ADJUSTED (b)           |   6.7%         6.7%         6.1%         6.2%      |   6.1%         0.0%         6.5%         6.0%      |
|TERMINAL (d)           |  2/30 (7%)    0/25 (0%)    1/29 (3%)    1/24 (4%)  |  2/33 (6%)    0/29 (0%)    2/31 (6%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      618          686          506       |   729 (T)      ---          729 (T)      572       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.586N     P=0.514      P=0.690N     P=0.631    |  P=0.352      P=0.267N     P=0.673      P=0.607    |
|INCIDENTAL TUMOR       |  P=0.561N     P=0.437      P=0.627N     P=0.697    |  P=0.468      P=0.267N     P=0.673      P=0.622N   |
|LOGISTIC REGRESSION    |  P=0.528N     P=0.485      P=0.663N     P=0.687    |  P=0.397      P=0.267N     P=0.673      P=0.683    |
|COCHRAN-ARMITAGE       |  P=0.545N                                          |  P=0.432                                           |
|FISHER EXACT           |               P=0.500      P=0.691N     P=0.684    |               P=0.242N     P=0.676N     P=0.692N   |
|=================================================================================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05130 TEST: 03                                                 PAGE   3
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        1000 PPM     3000 PPM     10000PPM  |   0 PPM        1000 PPM     3000 PPM     10000PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    3/50 (6%)    2/50 (4%)    2/49 (4%)  |  2/47 (4%)    1/48 (2%)    2/49 (4%)    2/47 (4%)  |
|ADJUSTED (b)           |   6.7%         6.7%         6.1%         6.2%      |   6.1%         2.2%         6.5%         6.0%      |
|TERMINAL (d)           |  2/30 (7%)    0/25 (0%)    1/29 (3%)    1/24 (4%)  |  2/33 (6%)    0/29 (0%)    2/31 (6%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      618          686          506       |   729 (T)      504          729 (T)      572       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.586N     P=0.514      P=0.690N     P=0.631    |  P=0.457      P=0.530N     P=0.673      P=0.607    |
|INCIDENTAL TUMOR       |  P=0.561N     P=0.437      P=0.627N     P=0.697    |  P=0.545      P=0.483N     P=0.673      P=0.622N   |
|LOGISTIC REGRESSION    |  P=0.528N     P=0.485      P=0.663N     P=0.687    |  P=0.544      P=0.490N     P=0.673      P=0.683    |
|COCHRAN-ARMITAGE       |  P=0.545N                                          |  P=0.534                                           |
|FISHER EXACT           |               P=0.500      P=0.691N     P=0.684    |               P=0.492N     P=0.676N     P=0.692N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    5/50 (10%)   3/50 (6%)    7/50 (14%) |  0/50 (0%)    1/48 (2%)    2/50 (4%)    0/48 (0%)  |
|ADJUSTED (b)           |  12.3%        16.4%        10.3%        25.3%      |   0.0%         3.4%         6.5%         0.0%      |
|TERMINAL (d)           |  3/30 (10%)   2/25 (8%)    3/29 (10%)   5/24 (21%) |  0/35 (0%)    1/29 (3%)    2/31 (6%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   618          637          729 (T)      531       |   ---          729 (T)      729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.125      P=0.452      P=0.503N     P=0.172    |  P=0.575N     P=0.462      P=0.212        (e)      |
|INCIDENTAL TUMOR       |  P=0.169      P=0.542      P=0.602N     P=0.215    |  P=0.575N     P=0.462      P=0.212        (e)      |
|LOGISTIC REGRESSION    |  P=0.159      P=0.526      P=0.453N     P=0.242    |  P=0.575N     P=0.462      P=0.212        (e)      |
|COCHRAN-ARMITAGE       |  P=0.194                                           |  P=0.507N                                          |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.262    |               P=0.490      P=0.247        (e)      |
|=================================================================================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05130 TEST: 03                                                 PAGE   4
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        1000 PPM     3000 PPM     10000PPM  |   0 PPM        1000 PPM     3000 PPM     10000PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    5/50 (10%)   4/50 (8%)    7/50 (14%) |  0/50 (0%)    1/48 (2%)    2/50 (4%)    0/48 (0%)  |
|ADJUSTED (b)           |  12.3%        16.4%        13.2%        25.3%      |   0.0%         3.4%         6.5%         0.0%      |
|TERMINAL (d)           |  3/30 (10%)   2/25 (8%)    3/29 (10%)   5/24 (21%) |  0/35 (0%)    1/29 (3%)    2/31 (6%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   618          637          714          531       |   ---          729 (T)      729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.135      P=0.452      P=0.640      P=0.172    |  P=0.575N     P=0.462      P=0.212        (e)      |
|INCIDENTAL TUMOR       |  P=0.189      P=0.542      P=0.617      P=0.215    |  P=0.575N     P=0.462      P=0.212        (e)      |
|LOGISTIC REGRESSION    |  P=0.170      P=0.526      P=0.596N     P=0.242    |  P=0.575N     P=0.462      P=0.212        (e)      |
|COCHRAN-ARMITAGE       |  P=0.208                                           |  P=0.507N                                          |
|FISHER EXACT           |               P=0.500      P=0.643N     P=0.262    |               P=0.490      P=0.247        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         6.9%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/30 (0%)    0/25 (0%)    2/29 (7%)    0/24 (0%)  |  0/35 (0%)    0/29 (0%)    0/31 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          729 (T)      ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.713N       (e)        P=0.230        (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.713N       (e)        P=0.230        (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.713N       (e)        P=0.230        (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.675N                                          |    (e)                                             |
|FISHER EXACT           |                 (e)        P=0.247        (e)      |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05130 TEST: 03                                                 PAGE   5
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        1000 PPM     3000 PPM     10000PPM  |   0 PPM        1000 PPM     3000 PPM     10000PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         6.9%         0.0%      |   0.0%         0.0%         0.0%         2.7%      |
|TERMINAL (d)           |  0/30 (0%)    0/25 (0%)    2/29 (7%)    0/24 (0%)  |  0/35 (0%)    0/29 (0%)    0/31 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          729 (T)      ---       |   ---          ---          ---          637       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.713N       (e)        P=0.230        (e)      |  P=0.200        (e)          (e)        P=0.465    |
|INCIDENTAL TUMOR       |  P=0.713N       (e)        P=0.230        (e)      |  P=0.412        (e)          (e)        P=0.892    |
|LOGISTIC REGRESSION    |  P=0.713N       (e)        P=0.230        (e)      |  P=0.236        (e)          (e)        P=0.515    |
|COCHRAN-ARMITAGE       |  P=0.675N                                          |  P=0.221                                           |
|FISHER EXACT           |                 (e)        P=0.247        (e)      |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/50 (10%)   6/50 (12%)   2/50 (4%)    6/50 (12%) |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |  16.7%        19.2%         6.9%        21.3%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  5/30 (17%)   3/25 (12%)   2/29 (7%)    4/24 (17%) |  0/35 (0%)    0/29 (0%)    0/31 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      617          729 (T)      601       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.349      P=0.419      P=0.226N     P=0.372    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.333      P=0.448      P=0.226N     P=0.387    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.400      P=0.528      P=0.226N     P=0.462    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.451                                           |    (e)                                             |
|FISHER EXACT           |               P=0.500      P=0.218N     P=0.500    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05130 TEST: 03                                                 PAGE   6
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        1000 PPM     3000 PPM     10000PPM  |   0 PPM        1000 PPM     3000 PPM     10000PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    0/50 (0%)    1/50 (2%)    2/50 (4%)  |  0/50 (0%)    1/50 (2%)    0/50 (0%)    2/50 (4%)  |
|ADJUSTED (b)           |   5.5%         0.0%         3.4%         8.3%      |   0.0%         3.1%         0.0%         8.0%      |
|TERMINAL (d)           |  1/30 (3%)    0/25 (0%)    1/29 (3%)    2/24 (8%)  |  0/35 (0%)    0/29 (0%)    0/31 (0%)    2/25 (8%)  |
|FIRST INCIDENCE (DAYS) |   572          ---          729 (T)      729 (T)   |   ---          713          ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.355      P=0.247N     P=0.500N     P=0.629    |  P=0.100      P=0.477        (e)        P=0.167    |
|INCIDENTAL TUMOR       |  P=0.331      P=0.272N     P=0.637N     P=0.585    |  P=0.121      P=0.581        (e)        P=0.167    |
|LOGISTIC REGRESSION    |  P=0.392      P=0.254N     P=0.508N     P=0.688    |  P=0.102      P=0.491        (e)        P=0.167    |
|COCHRAN-ARMITAGE       |  P=0.408                                           |  P=0.149                                           |
|FISHER EXACT           |               P=0.247N     P=0.500N     P=0.691N   |               P=0.500        (e)        P=0.247    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)  |  3/50 (6%)    1/50 (2%)    2/50 (4%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         4.2%      |   7.9%         3.4%         5.2%         4.0%      |
|TERMINAL (d)           |  0/30 (0%)    0/25 (0%)    0/29 (0%)    1/24 (4%)  |  2/35 (6%)    1/29 (3%)    1/31 (3%)    1/25 (4%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          729 (T)   |   659          729 (T)      506          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.195        (e)          (e)        P=0.455    |  P=0.440N     P=0.367N     P=0.542N     P=0.431N   |
|INCIDENTAL TUMOR       |  P=0.195        (e)          (e)        P=0.455    |  P=0.448N     P=0.320N     P=0.545N     P=0.377N   |
|LOGISTIC REGRESSION    |  P=0.195        (e)          (e)        P=0.455    |  P=0.369N     P=0.320N     P=0.496N     P=0.370N   |
|COCHRAN-ARMITAGE       |  P=0.221                                           |  P=0.347N                                          |
|FISHER EXACT           |                 (e)          (e)        P=0.500    |               P=0.309N     P=0.500N     P=0.309N   |
|=================================================================================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05130 TEST: 03                                                 PAGE   7
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        1000 PPM     3000 PPM     10000PPM  |   0 PPM        1000 PPM     3000 PPM     10000PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)  |  3/50 (6%)    1/50 (2%)    2/50 (4%)    2/50 (4%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         4.2%      |   7.9%         3.4%         5.2%         6.5%      |
|TERMINAL (d)           |  0/30 (0%)    0/25 (0%)    0/29 (0%)    1/24 (4%)  |  2/35 (6%)    1/29 (3%)    1/31 (3%)    1/25 (4%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          729 (T)   |   659          729 (T)      506          618       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.195        (e)          (e)        P=0.455    |  P=0.567      P=0.367N     P=0.542N     P=0.632N   |
|INCIDENTAL TUMOR       |  P=0.195        (e)          (e)        P=0.455    |  P=0.617N     P=0.320N     P=0.545N     P=0.425N   |
|LOGISTIC REGRESSION    |  P=0.195        (e)          (e)        P=0.455    |  P=0.607N     P=0.320N     P=0.496N     P=0.545N   |
|COCHRAN-ARMITAGE       |  P=0.221                                           |  P=0.591N                                          |
|FISHER EXACT           |                 (e)          (e)        P=0.500    |               P=0.309N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    3/50 (6%)    1/50 (2%)    1/50 (2%)  | 19/50 (38%)  12/50 (24%)  19/50 (38%)  10/50 (20%) |
|ADJUSTED (b)           |   6.4%        12.0%         2.6%         3.4%      |  49.7%        35.4%        54.0%        34.3%      |
|TERMINAL (d)           |  1/30 (3%)    3/25 (12%)   0/29 (0%)    0/24 (0%)  | 16/35 (46%)   8/29 (28%)  15/31 (48%)   7/25 (28%) |
|FIRST INCIDENCE (DAYS) |   693          729 (T)      680          702       |   666          572          629          639       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.349N     P=0.431      P=0.481N     P=0.541N   |  P=0.283N     P=0.232N     P=0.402      P=0.233N   |
|INCIDENTAL TUMOR       |  P=0.300N     P=0.512      P=0.299N     P=0.350N   |  P=0.133N     P=0.112N     P=0.451      P=0.099N   |
|LOGISTIC REGRESSION    |  P=0.335N     P=0.497      P=0.482N     P=0.206N   |  P=0.181N     P=0.122N     P=0.462      P=0.116N   |
|COCHRAN-ARMITAGE       |  P=0.311N                                          |  P=0.069N                                          |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.500N   |               P=0.097N     P=0.582N     P=0.038N*  |
|=================================================================================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05130 TEST: 03                                                 PAGE   8
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        1000 PPM     3000 PPM     10000PPM  |   0 PPM        1000 PPM     3000 PPM     10000PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    3/50 (6%)    1/50 (2%)    1/50 (2%)  | 19/50 (38%)  12/50 (24%)  19/50 (38%)  11/50 (22%) |
|ADJUSTED (b)           |   6.4%        12.0%         2.6%         3.4%      |  49.7%        35.4%        54.0%        36.1%      |
|TERMINAL (d)           |  1/30 (3%)    3/25 (12%)   0/29 (0%)    0/24 (0%)  | 16/35 (46%)   8/29 (28%)  15/31 (48%)   7/25 (28%) |
|FIRST INCIDENCE (DAYS) |   693          729 (T)      680          702       |   666          572          629          618       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.349N     P=0.431      P=0.481N     P=0.541N   |  P=0.384N     P=0.232N     P=0.402      P=0.316N   |
|INCIDENTAL TUMOR       |  P=0.300N     P=0.512      P=0.299N     P=0.350N   |  P=0.179N     P=0.112N     P=0.451      P=0.110N   |
|LOGISTIC REGRESSION    |  P=0.335N     P=0.497      P=0.482N     P=0.206N   |  P=0.257N     P=0.122N     P=0.462      P=0.159N   |
|COCHRAN-ARMITAGE       |  P=0.311N                                          |  P=0.111N                                          |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.500N   |               P=0.097N     P=0.582N     P=0.063N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    3/50 (6%)    1/50 (2%)    2/50 (4%)  | 22/50 (44%)  13/50 (26%)  20/50 (40%)  12/50 (24%) |
|ADJUSTED (b)           |   6.4%        12.0%         2.6%         7.5%      |  56.0%        38.5%        55.0%        39.6%      |
|TERMINAL (d)           |  1/30 (3%)    3/25 (12%)   0/29 (0%)    1/24 (4%)  | 18/35 (51%)   9/29 (31%)  15/31 (48%)   8/25 (32%) |
|FIRST INCIDENCE (DAYS) |   693          729 (T)      680          702       |   659          572          506          618       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.606N     P=0.431      P=0.481N     P=0.640    |  P=0.316N     P=0.147N     P=0.548      P=0.228N   |
|INCIDENTAL TUMOR       |  P=0.559N     P=0.512      P=0.299N     P=0.601N   |  P=0.138N     P=0.054N     P=0.563N     P=0.059N   |
|LOGISTIC REGRESSION    |  P=0.593N     P=0.497      P=0.482N     P=0.677    |  P=0.178N     P=0.060N     P=0.508N     P=0.089N   |
|COCHRAN-ARMITAGE       |  P=0.555N                                          |  P=0.072N                                          |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.691N   |               P=0.046N*    P=0.420N     P=0.028N*  |
|=================================================================================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05130 TEST: 03                                                 PAGE   9
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        1000 PPM     3000 PPM     10000PPM  |   0 PPM        1000 PPM     3000 PPM     10000PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Papilloma Squamous or Papilloma                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    0/50 (0%)    5/50 (10%) |  1/50 (2%)    1/50 (2%)    0/50 (0%)    2/50 (4%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%        19.3%      |   2.9%         3.4%         0.0%         5.5%      |
|TERMINAL (d)           |  0/30 (0%)    0/25 (0%)    0/29 (0%)    4/24 (17%) |  1/35 (3%)    1/29 (3%)    0/31 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          684       |   729 (T)      729 (T)      ---          637       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **     (e)          (e)        P=0.020 *  |  P=0.261      P=0.720      P=0.524N     P=0.418    |
|INCIDENTAL TUMOR       |  P<0.001 **     (e)          (e)        P=0.029 *  |  P=0.393      P=0.720      P=0.524N     P=0.681    |
|LOGISTIC REGRESSION    |  P<0.001 **     (e)          (e)        P=0.026 *  |  P=0.305      P=0.720      P=0.524N     P=0.490    |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.325                                           |
|FISHER EXACT           |                 (e)          (e)        P=0.028 *  |               P=0.753N     P=0.500N     P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    0/50 (0%)    6/50 (12%) |  1/50 (2%)    1/50 (2%)    0/50 (0%)    2/50 (4%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%        23.3%      |   2.9%         3.4%         0.0%         5.5%      |
|TERMINAL (d)           |  0/30 (0%)    0/25 (0%)    0/29 (0%)    5/24 (21%) |  1/35 (3%)    1/29 (3%)    0/31 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          684       |   729 (T)      729 (T)      ---          637       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **     (e)          (e)        P=0.009 ** |  P=0.261      P=0.720      P=0.524N     P=0.418    |
|INCIDENTAL TUMOR       |  P<0.001 **     (e)          (e)        P=0.013 *  |  P=0.393      P=0.720      P=0.524N     P=0.681    |
|LOGISTIC REGRESSION    |  P<0.001 **     (e)          (e)        P=0.013 *  |  P=0.305      P=0.720      P=0.524N     P=0.490    |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.325                                           |
|FISHER EXACT           |                 (e)          (e)        P=0.013 *  |               P=0.753N     P=0.500N     P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05130 TEST: 03                                                 PAGE  10
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        1000 PPM     3000 PPM     10000PPM  |   0 PPM        1000 PPM     3000 PPM     10000PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pharynx                                                                                                                          |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    0/50 (0%)    5/50 (10%) |  1/50 (2%)    1/50 (2%)    0/50 (0%)    2/50 (4%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%        19.3%      |   2.9%         3.4%         0.0%         5.5%      |
|TERMINAL (d)           |  0/30 (0%)    0/25 (0%)    0/29 (0%)    4/24 (17%) |  1/35 (3%)    1/29 (3%)    0/31 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          684       |   729 (T)      729 (T)      ---          637       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **     (e)          (e)        P=0.020 *  |  P=0.261      P=0.720      P=0.524N     P=0.418    |
|INCIDENTAL TUMOR       |  P<0.001 **     (e)          (e)        P=0.029 *  |  P=0.393      P=0.720      P=0.524N     P=0.681    |
|LOGISTIC REGRESSION    |  P<0.001 **     (e)          (e)        P=0.026 *  |  P=0.305      P=0.720      P=0.524N     P=0.490    |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.325                                           |
|FISHER EXACT           |                 (e)          (e)        P=0.028 *  |               P=0.753N     P=0.500N     P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 15/50 (30%)  14/50 (28%)  16/48 (33%)  12/50 (24%) | 28/50 (56%)  31/47 (66%)  32/49 (65%)  21/47 (45%) |
|ADJUSTED (b)           |  42.1%        38.6%        45.6%        40.9%      |  66.3%        78.1%        79.6%        67.6%      |
|TERMINAL (d)           | 10/30 (33%)   5/25 (20%)  10/28 (36%)   8/24 (33%) | 21/35 (60%)  18/26 (69%)  22/30 (73%)  14/23 (61%) |
|FIRST INCIDENCE (DAYS) |   572          369          537          601       |   499          419          533          484       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.451N     P=0.562      P=0.487      P=0.516N   |  P=0.413N     P=0.075      P=0.108      P=0.449    |
|INCIDENTAL TUMOR       |  P=0.308N     P=0.343N     P=0.568N     P=0.422N   |  P=0.133N     P=0.213      P=0.228      P=0.394N   |
|LOGISTIC REGRESSION    |  P=0.334N     P=0.474N     P=0.533      P=0.363N   |  P=0.098N     P=0.193      P=0.163      P=0.318N   |
|COCHRAN-ARMITAGE       |  P=0.284N                                          |  P=0.046N*                                         |
|FISHER EXACT           |               P=0.500N     P=0.445      P=0.326N   |               P=0.213      P=0.229      P=0.181N   |
|=================================================================================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05130 TEST: 03                                                 PAGE  11
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        1000 PPM     3000 PPM     10000PPM  |   0 PPM        1000 PPM     3000 PPM     10000PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    0/50 (0%)    0/48 (0%)    0/50 (0%)  |  2/50 (4%)    0/47 (0%)    1/49 (2%)    2/47 (4%)  |
|ADJUSTED (b)           |   4.2%         0.0%         0.0%         0.0%      |   4.6%         0.0%         2.1%         6.5%      |
|TERMINAL (d)           |  0/30 (0%)    0/25 (0%)    0/28 (0%)    0/24 (0%)  |  0/35 (0%)    0/26 (0%)    0/30 (0%)    1/23 (4%)  |
|FIRST INCIDENCE (DAYS) |   506          ---          ---          ---       |   532          ---          532          502       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.273N     P=0.233N     P=0.237N     P=0.252N   |  P=0.355      P=0.256N     P=0.510N     P=0.614    |
|INCIDENTAL TUMOR       |  P=0.104N     P=0.500N     P=0.309N     P=0.091N   |  P=0.267      P=0.178N     P=0.516N     P=0.585    |
|LOGISTIC REGRESSION    |  P=0.229N     P=0.340N     P=0.333N     P=0.221N   |  P=0.503      P=0.254N     P=0.505N     P=0.664N   |
|COCHRAN-ARMITAGE       |  P=0.262N                                          |  P=0.394                                           |
|FISHER EXACT           |               P=0.247N     P=0.258N     P=0.247N   |               P=0.263N     P=0.508N     P=0.668    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 17/50 (34%)  14/50 (28%)  16/48 (33%)  12/50 (24%) | 30/50 (60%)  31/47 (66%)  33/49 (67%)  23/47 (49%) |
|ADJUSTED (b)           |  44.5%        38.6%        45.6%        40.9%      |  67.9%        78.1%        80.0%        71.8%      |
|TERMINAL (d)           | 10/30 (33%)   5/25 (20%)  10/28 (36%)   8/24 (33%) | 21/35 (60%)  18/26 (69%)  22/30 (73%)  15/23 (65%) |
|FIRST INCIDENCE (DAYS) |   506          369          537          601       |   499          419          532          484       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.354N     P=0.438N     P=0.512N     P=0.357N   |  P=0.502N     P=0.141      P=0.153      P=0.421    |
|INCIDENTAL TUMOR       |  P=0.174N     P=0.264N     P=0.427N     P=0.216N   |  P=0.215N     P=0.374      P=0.296      P=0.445N   |
|LOGISTIC REGRESSION    |  P=0.226N     P=0.340N     P=0.515N     P=0.205N   |  P=0.127N     P=0.330      P=0.243      P=0.295N   |
|COCHRAN-ARMITAGE       |  P=0.200N                                          |  P=0.069N                                          |
|FISHER EXACT           |               P=0.333N     P=0.557N     P=0.189N   |               P=0.346      P=0.291      P=0.187N   |
|=================================================================================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05130 TEST: 03                                                 PAGE  12
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        1000 PPM     3000 PPM     10000PPM  |   0 PPM        1000 PPM     3000 PPM     10000PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Adenoma                                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    2/50 (4%)    0/50 (0%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   6.7%         6.5%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  2/30 (7%)    1/25 (4%)    0/29 (0%)    0/24 (0%)  |  0/35 (0%)    0/29 (0%)    0/31 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      651          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.153N     P=0.652      P=0.245N     P=0.288N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.139N     P=0.670N     P=0.245N     P=0.288N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.142N     P=0.681N     P=0.245N     P=0.288N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.136N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.691N     P=0.247N     P=0.247N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    3/50 (6%)    2/50 (4%)    3/50 (6%)  |  0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   3.3%        11.0%         5.6%         9.3%      |   0.0%         3.4%         0.0%         0.0%      |
|TERMINAL (d)           |  1/30 (3%)    2/25 (8%)    1/29 (3%)    1/24 (4%)  |  0/35 (0%)    1/29 (3%)    0/31 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      713          632          601       |   ---          729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.306      P=0.259      P=0.518      P=0.269    |  P=0.647N     P=0.462        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.300      P=0.330      P=0.363      P=0.284    |  P=0.647N     P=0.462        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.343      P=0.290      P=0.514      P=0.299    |  P=0.647N     P=0.462        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.363                                           |  P=0.601N                                          |
|FISHER EXACT           |               P=0.309      P=0.500      P=0.309    |               P=0.500        (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05130 TEST: 03                                                 PAGE  13
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        1000 PPM     3000 PPM     10000PPM  |   0 PPM        1000 PPM     3000 PPM     10000PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    3/50 (6%)    0/50 (0%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   6.7%         8.5%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  2/30 (7%)    1/25 (4%)    0/29 (0%)    0/24 (0%)  |  0/35 (0%)    0/29 (0%)    0/31 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      621          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.116N     P=0.473      P=0.245N     P=0.288N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.120N     P=0.519      P=0.245N     P=0.288N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.103N     P=0.511      P=0.245N     P=0.288N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.101N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.500      P=0.247N     P=0.247N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    6/50 (12%)   2/50 (4%)    4/50 (8%)  |  0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |  13.3%        18.9%         5.6%        12.3%      |   0.0%         3.4%         0.0%         0.0%      |
|TERMINAL (d)           |  4/30 (13%)   3/25 (12%)   1/29 (3%)    1/24 (4%)  |  0/35 (0%)    1/29 (3%)    0/31 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      621          632          601       |   ---          729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.567N     P=0.309      P=0.333N     P=0.562    |  P=0.647N     P=0.462        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.562N     P=0.389      P=0.435N     P=0.636    |  P=0.647N     P=0.462        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.514N     P=0.395      P=0.297N     P=0.624    |  P=0.647N     P=0.462        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.487N                                          |  P=0.601N                                          |
|FISHER EXACT           |               P=0.370      P=0.339N     P=0.643N   |               P=0.500        (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05130 TEST: 03                                                 PAGE  14
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        1000 PPM     3000 PPM     10000PPM  |   0 PPM        1000 PPM     3000 PPM     10000PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    4/50 (8%)    5/50 (10%)   2/50 (4%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |  12.3%        15.3%        15.2%         7.3%      |   0.0%         0.0%         0.0%         2.6%      |
|TERMINAL (d)           |  3/30 (10%)   3/25 (12%)   3/29 (10%)   1/24 (4%)  |  0/35 (0%)    0/29 (0%)    0/31 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   618          721          686          692       |   ---          ---          ---          595       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.309N     P=0.571      P=0.515      P=0.415N   |  P=0.204        (e)          (e)        P=0.476    |
|INCIDENTAL TUMOR       |  P=0.277N     P=0.621      P=0.531      P=0.387N   |  P=0.412        (e)          (e)        P=0.892    |
|LOGISTIC REGRESSION    |  P=0.278N     P=0.627N     P=0.547      P=0.354N   |  P=0.262        (e)          (e)        P=0.540    |
|COCHRAN-ARMITAGE       |  P=0.246N                                          |  P=0.221                                           |
|FISHER EXACT           |               P=0.643N     P=0.500      P=0.339N   |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/50 (10%)   4/50 (8%)    5/50 (10%)   3/50 (6%)  |  0/50 (0%)    2/50 (4%)    1/50 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |  14.3%        15.3%        15.2%        10.0%      |   0.0%         5.4%         3.2%         2.6%      |
|TERMINAL (d)           |  3/30 (10%)   3/25 (12%)   3/29 (10%)   1/24 (4%)  |  0/35 (0%)    1/29 (3%)    1/31 (3%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   572          721          686          680       |   ---          452          729 (T)      595       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.397N     P=0.563N     P=0.609N     P=0.428N   |  P=0.576      P=0.221      P=0.476      P=0.476    |
|INCIDENTAL TUMOR       |  P=0.368N     P=0.531N     P=0.593      P=0.383N   |  P=0.657      P=0.238      P=0.476      P=0.892    |
|LOGISTIC REGRESSION    |  P=0.356N     P=0.478N     P=0.611N     P=0.364N   |  P=0.667N     P=0.218      P=0.476      P=0.540    |
|COCHRAN-ARMITAGE       |  P=0.325N                                          |  P=0.627                                           |
|FISHER EXACT           |               P=0.500N     P=0.630N     P=0.357N   |               P=0.247      P=0.500      P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05130 TEST: 03                                                 PAGE  15
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        1000 PPM     3000 PPM     10000PPM  |   0 PPM        1000 PPM     3000 PPM     10000PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/50 (0%)    0/50 (0%)    1/50 (2%)  |  0/50 (0%)    2/50 (4%)    1/50 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |   2.3%         0.0%         0.0%         2.9%      |   0.0%         5.4%         3.2%         0.0%      |
|TERMINAL (d)           |  0/30 (0%)    0/25 (0%)    0/29 (0%)    0/24 (0%)  |  0/35 (0%)    1/29 (3%)    1/31 (3%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   572          ---          ---          680       |   ---          452          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.529      P=0.479N     P=0.487N     P=0.758    |  P=0.432N     P=0.221      P=0.476        (e)      |
|INCIDENTAL TUMOR       |  P=0.512      P=0.521N     P=0.739N     P=0.744N   |  P=0.475N     P=0.238      P=0.476        (e)      |
|LOGISTIC REGRESSION    |  P=0.561      P=0.572N     P=0.566N     P=0.757N   |  P=0.344N     P=0.218      P=0.476        (e)      |
|COCHRAN-ARMITAGE       |  P=0.536                                           |  P=0.383N                                          |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.753N   |               P=0.247      P=0.500        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    3/50 (6%)    1/50 (2%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%        10.3%         4.2%      |   0.0%         0.0%         0.0%         2.9%      |
|TERMINAL (d)           |  0/30 (0%)    0/25 (0%)    3/29 (10%)   1/24 (4%)  |  0/35 (0%)    0/29 (0%)    0/31 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          729 (T)      729 (T)   |   ---          ---          ---          658       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.370        (e)        P=0.114      P=0.455    |  P=0.192        (e)          (e)        P=0.453    |
|INCIDENTAL TUMOR       |  P=0.370        (e)        P=0.114      P=0.455    |  P=0.235        (e)          (e)        P=0.545    |
|LOGISTIC REGRESSION    |  P=0.370        (e)        P=0.114      P=0.455    |  P=0.224        (e)          (e)        P=0.503    |
|COCHRAN-ARMITAGE       |  P=0.423                                           |  P=0.221                                           |
|FISHER EXACT           |                 (e)        P=0.121      P=0.500    |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05130 TEST: 03                                                 PAGE  16
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        1000 PPM     3000 PPM     10000PPM  |   0 PPM        1000 PPM     3000 PPM     10000PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    2/50 (4%)    1/50 (2%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         6.9%         4.2%      |   0.0%         0.0%         0.0%         2.9%      |
|TERMINAL (d)           |  0/30 (0%)    0/25 (0%)    2/29 (7%)    1/24 (4%)  |  0/35 (0%)    0/29 (0%)    0/31 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          729 (T)      729 (T)   |   ---          ---          ---          658       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.337        (e)        P=0.230      P=0.455    |  P=0.192        (e)          (e)        P=0.453    |
|INCIDENTAL TUMOR       |  P=0.337        (e)        P=0.230      P=0.455    |  P=0.235        (e)          (e)        P=0.545    |
|LOGISTIC REGRESSION    |  P=0.337        (e)        P=0.230      P=0.455    |  P=0.224        (e)          (e)        P=0.503    |
|COCHRAN-ARMITAGE       |  P=0.383                                           |  P=0.221                                           |
|FISHER EXACT           |                 (e)        P=0.247      P=0.500    |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 45/50 (90%)  46/50 (92%)  48/50 (96%)  44/50 (88%) |                                                    |
|ADJUSTED (b)           | 100.0%        97.8%        98.0%       100.0%      |                                                    |
|TERMINAL (d)           | 30/30 (100%) 24/25 (96%)  28/29 (97%)  24/24 (100%)|                                                    |
|FIRST INCIDENCE (DAYS) |   539          601          533          460       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.271      P=0.267      P=0.426      P=0.209    |                                                    |
|INCIDENTAL TUMOR       |  P=0.547      P=0.528N     P=0.230      P=0.620    |                                                    |
|LOGISTIC REGRESSION    |  P=0.538      P=0.450N     P=0.451      P=0.641    |                                                    |
|COCHRAN-ARMITAGE       |  P=0.325N                                          |                                                    |
|FISHER EXACT           |               P=0.500      P=0.218      P=0.500N   |                                                    |
|=================================================================================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05130 TEST: 03                                                 PAGE  17
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        1000 PPM     3000 PPM     10000PPM  |   0 PPM        1000 PPM     3000 PPM     10000PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/50 (14%)   1/50 (2%)    4/50 (8%)    4/50 (8%)  |  3/50 (6%)    4/50 (8%)    2/49 (4%)    3/49 (6%)  |
|ADJUSTED (b)           |  19.1%         4.0%        11.6%        15.4%      |   8.6%        13.8%         5.8%        12.0%      |
|TERMINAL (d)           |  3/30 (10%)   1/25 (4%)    2/29 (7%)    3/24 (13%) |  3/35 (9%)    4/29 (14%)   1/30 (3%)    3/25 (12%) |
|FIRST INCIDENCE (DAYS) |   548          729 (T)      581          699       |   729 (T)      729 (T)      639          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.593      P=0.047N*    P=0.256N     P=0.360N   |  P=0.527      P=0.397      P=0.567N     P=0.500    |
|INCIDENTAL TUMOR       |  P=0.589N     P=0.022N*    P=0.295N     P=0.264N   |  P=0.602      P=0.397      P=0.422N     P=0.500    |
|LOGISTIC REGRESSION    |  P=0.530N     P=0.033N*    P=0.273N     P=0.273N   |  P=0.546      P=0.397      P=0.534N     P=0.500    |
|COCHRAN-ARMITAGE       |  P=0.513N                                          |  P=0.557N                                          |
|FISHER EXACT           |               P=0.030N*    P=0.262N     P=0.262N   |               P=0.500      P=0.510N     P=0.651    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/50 (0%)    1/50 (2%)    1/50 (2%)  |  1/50 (2%)    0/50 (0%)    0/49 (0%)    3/49 (6%)  |
|ADJUSTED (b)           |   3.3%         0.0%         3.0%         4.2%      |   2.9%         0.0%         0.0%        12.0%      |
|TERMINAL (d)           |  1/30 (3%)    0/25 (0%)    0/29 (0%)    1/24 (4%)  |  1/35 (3%)    0/29 (0%)    0/30 (0%)    3/25 (12%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          700          729 (T)   |   729 (T)      ---          ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.525      P=0.536N     P=0.757N     P=0.712    |  P=0.028 *    P=0.538N     P=0.531N     P=0.193    |
|INCIDENTAL TUMOR       |  P=0.554      P=0.536N     P=0.669N     P=0.712    |  P=0.028 *    P=0.538N     P=0.531N     P=0.193    |
|LOGISTIC REGRESSION    |  P=0.537      P=0.536N     P=0.743N     P=0.712    |  P=0.028 *    P=0.538N     P=0.531N     P=0.193    |
|COCHRAN-ARMITAGE       |  P=0.559                                           |  P=0.051                                           |
|FISHER EXACT           |               P=0.500N     P=0.753N     P=0.753N   |               P=0.500N     P=0.505N     P=0.301    |
|=================================================================================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05130 TEST: 03                                                 PAGE  18
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        1000 PPM     3000 PPM     10000PPM  |   0 PPM        1000 PPM     3000 PPM     10000PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  8/50 (16%)   1/50 (2%)    5/50 (10%)   5/50 (10%) |  4/50 (8%)    4/50 (8%)    2/49 (4%)    6/49 (12%) |
|ADJUSTED (b)           |  22.1%         4.0%        14.2%        19.4%      |  11.4%        13.8%         5.8%        24.0%      |
|TERMINAL (d)           |  4/30 (13%)   1/25 (4%)    2/29 (7%)    4/24 (17%) |  4/35 (11%)   4/29 (14%)   1/30 (3%)    6/25 (24%) |
|FIRST INCIDENCE (DAYS) |   548          729 (T)      581          699       |   729 (T)      729 (T)      639          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.510      P=0.029N*    P=0.271N     P=0.393N   |  P=0.117      P=0.538      P=0.408N     P=0.176    |
|INCIDENTAL TUMOR       |  P=0.528      P=0.013N*    P=0.264N     P=0.302N   |  P=0.155      P=0.538      P=0.279N     P=0.176    |
|LOGISTIC REGRESSION    |  P=0.573      P=0.017N*    P=0.278N     P=0.293N   |  P=0.125      P=0.538      P=0.375N     P=0.176    |
|COCHRAN-ARMITAGE       |  P=0.573N                                          |  P=0.231                                           |
|FISHER EXACT           |               P=0.015N*    P=0.277N     P=0.277N   |               P=0.643N     P=0.349N     P=0.357    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    2/49 (4%)    0/49 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         6.7%         0.0%      |
|TERMINAL (d)           |  0/30 (0%)    0/25 (0%)    0/29 (0%)    0/24 (0%)  |  0/35 (0%)    0/29 (0%)    2/30 (7%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          ---          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.735N       (e)        P=0.205        (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.735N       (e)        P=0.205        (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.735N       (e)        P=0.205        (e)      |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.680N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |                 (e)        P=0.242        (e)      |
|=================================================================================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05130 TEST: 03                                                 PAGE  19
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        1000 PPM     3000 PPM     10000PPM  |   0 PPM        1000 PPM     3000 PPM     10000PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    1/50 (2%)    1/50 (2%)  |  0/50 (0%)    0/50 (0%)    2/49 (4%)    0/49 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         3.4%         3.3%      |   0.0%         0.0%         6.7%         0.0%      |
|TERMINAL (d)           |  0/30 (0%)    0/25 (0%)    1/29 (3%)    0/24 (0%)  |  0/35 (0%)    0/29 (0%)    2/30 (7%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          729 (T)      699       |   ---          ---          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.302        (e)        P=0.493      P=0.493    |  P=0.735N       (e)        P=0.205        (e)      |
|INCIDENTAL TUMOR       |  P=0.330        (e)        P=0.493      P=0.654    |  P=0.735N       (e)        P=0.205        (e)      |
|LOGISTIC REGRESSION    |  P=0.304        (e)        P=0.493      P=0.494    |  P=0.735N       (e)        P=0.205        (e)      |
|COCHRAN-ARMITAGE       |  P=0.325                                           |  P=0.680N                                          |
|FISHER EXACT           |                 (e)        P=0.500      P=0.500    |                 (e)        P=0.242        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  1/50 (2%)   12/50 (24%)  10/50 (20%)  10/50 (20%) |
|ADJUSTED (b)           |                                                    |   2.9%        36.6%        28.4%        36.6%      |
|TERMINAL (d)           |                                                    |  1/35 (3%)    9/29 (31%)   7/31 (23%)   8/25 (32%) |
|FIRST INCIDENCE (DAYS) |                                                    |   729 (T)      670          583          660       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.034 *    P<0.001 **   P=0.004 **   P<0.001 ** |
|INCIDENTAL TUMOR       |                                                    |  P=0.076      P<0.001 **   P=0.009 **   P=0.001 ** |
|LOGISTIC REGRESSION    |                                                    |  P=0.053      P<0.001 **   P=0.004 **   P=0.001 ** |
|COCHRAN-ARMITAGE       |                                                    |  P=0.131                                           |
|FISHER EXACT           |                                                    |               P<0.001 **   P=0.004 **   P=0.004 ** |
|=================================================================================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05130 TEST: 03                                                 PAGE  20
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        1000 PPM     3000 PPM     10000PPM  |   0 PPM        1000 PPM     3000 PPM     10000PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Histiocytic Sarcoma                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         7.3%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/30 (0%)    0/25 (0%)    0/29 (0%)    1/24 (4%)  |  0/35 (0%)    0/29 (0%)    0/31 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          692       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.034 *      (e)          (e)        P=0.212    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.041 *      (e)          (e)        P=0.293    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.035 *      (e)          (e)        P=0.226    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.042 *                                         |    (e)                                             |
|FISHER EXACT           |                 (e)          (e)        P=0.247    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 18/50 (36%)  25/50 (50%)  23/50 (46%)  26/50 (52%) | 11/50 (22%)  16/50 (32%)   9/50 (18%)  16/50 (32%) |
|ADJUSTED (b)           |  47.3%        59.3%        57.2%        64.7%      |  25.6%        39.2%        24.1%        45.3%      |
|TERMINAL (d)           | 11/30 (37%)   9/25 (36%)  13/29 (45%)  11/24 (46%) |  5/35 (14%)   5/29 (17%)   4/31 (13%)   7/25 (28%) |
|FIRST INCIDENCE (DAYS) |   548          614          537          450       |   428          621          617          554       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.086      P=0.113      P=0.266      P=0.048 *  |  P=0.080      P=0.135      P=0.503N     P=0.058    |
|INCIDENTAL TUMOR       |  P=0.119      P=0.278      P=0.121      P=0.093    |  P=0.314      P=0.386      P=0.355N     P=0.227    |
|LOGISTIC REGRESSION    |  P=0.116      P=0.124      P=0.235      P=0.074    |  P=0.321      P=0.262      P=0.393N     P=0.164    |
|COCHRAN-ARMITAGE       |  P=0.150                                           |  P=0.235                                           |
|FISHER EXACT           |               P=0.113      P=0.208      P=0.079    |               P=0.184      P=0.402N     P=0.184    |
|=================================================================================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05130 TEST: 03                                                 PAGE  21
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        1000 PPM     3000 PPM     10000PPM  |   0 PPM        1000 PPM     3000 PPM     10000PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)  |  0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         7.3%      |   0.0%         2.1%         0.0%         0.0%      |
|TERMINAL (d)           |  0/30 (0%)    0/25 (0%)    0/29 (0%)    1/24 (4%)  |  0/35 (0%)    0/29 (0%)    0/31 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          692       |   ---          494          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.034 *      (e)          (e)        P=0.212    |  P=0.609N     P=0.500        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.041 *      (e)          (e)        P=0.293    |  P=0.706N     P=0.536        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.035 *      (e)          (e)        P=0.226    |  P=0.455N     P=0.427        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.042 *                                         |  P=0.601N                                          |
|FISHER EXACT           |                 (e)          (e)        P=0.247    |               P=0.500        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 47/50 (94%)  50/50 (100%) 49/50 (98%)  46/50 (92%) | 37/50 (74%)  39/50 (78%)  39/50 (78%)  38/50 (76%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  85.9%        86.5%        92.8%        92.4%      |
|TERMINAL (d)           | 30/30 (100%) 25/25 (100%) 29/29 (100%) 24/24 (100%)| 29/35 (83%)  23/29 (79%)  28/31 (90%)  22/25 (88%) |
|FIRST INCIDENCE (DAYS) |   539          369          533          460       |   499          419          533          484       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.308      P=0.182      P=0.498      P=0.217    |  P=0.043 *    P=0.126      P=0.156      P=0.024 *  |
|INCIDENTAL TUMOR       |  P=0.436N     P=0.500      P=0.309      P=0.697    |  P=0.268      P=0.392      P=0.402      P=0.335    |
|LOGISTIC REGRESSION    |  P=0.328N     P=0.160      P=0.309      P=0.723    |  P=0.218      P=0.378      P=0.284      P=0.187    |
|COCHRAN-ARMITAGE       |  P=0.144N                                          |  P=0.551                                           |
|FISHER EXACT           |               P=0.121      P=0.309      P=0.500N   |               P=0.408      P=0.408      P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05130 TEST: 03                                                 PAGE  22
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        1000 PPM     3000 PPM     10000PPM  |   0 PPM        1000 PPM     3000 PPM     10000PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 27/50 (54%)  27/50 (54%)  28/50 (56%)  31/50 (62%) | 17/50 (34%)  22/50 (44%)  17/50 (34%)  22/50 (44%) |
|ADJUSTED (b)           |  60.2%        61.0%        63.8%        72.6%      |  37.6%        47.8%        38.8%        58.2%      |
|TERMINAL (d)           | 13/30 (43%)   9/25 (36%)  14/29 (48%)  13/24 (54%) |  8/35 (23%)   6/29 (21%)   6/31 (19%)  10/25 (40%) |
|FIRST INCIDENCE (DAYS) |   438          601          533          450       |   428          452          428          502       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.127      P=0.499      P=0.555      P=0.169    |  P=0.092      P=0.157      P=0.473      P=0.054    |
|INCIDENTAL TUMOR       |  P=0.207      P=0.439N     P=0.311      P=0.307    |  P=0.229      P=0.445      P=0.529N     P=0.195    |
|LOGISTIC REGRESSION    |  P=0.229      P=0.553N     P=0.414      P=0.302    |  P=0.374      P=0.375      P=0.399N     P=0.186    |
|COCHRAN-ARMITAGE       |  P=0.211                                           |  P=0.270                                           |
|FISHER EXACT           |               P=0.579N     P=0.500      P=0.272    |               P=0.206      P=0.583N     P=0.206    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 49/50 (98%)  50/50 (100%) 49/50 (98%)  49/50 (98%) | 45/50 (90%)  46/50 (92%)  46/50 (92%)  45/50 (90%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  91.8%        92.0%        95.8%        97.8%      |
|TERMINAL (d)           | 30/30 (100%) 25/25 (100%) 29/29 (100%) 24/24 (100%)| 31/35 (89%)  25/29 (86%)  29/31 (94%)  24/25 (96%) |
|FIRST INCIDENCE (DAYS) |   438          369          533          450       |   428          419          428          484       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.200      P=0.280      P=0.501N     P=0.187    |  P=0.050 *    P=0.166      P=0.224      P=0.031 *  |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.184      P=0.538N     P=0.567      P=0.292    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.197      P=0.498      P=0.486      P=0.279    |
|COCHRAN-ARMITAGE       |  P=0.559N                                          |  P=0.513N                                          |
|FISHER EXACT           |               P=0.500      P=0.753N     P=0.753N   |               P=0.500      P=0.500      P=0.630N   |
|=================================================================================================================================|
 
         DATE: 09/17/94                     EXPERIMENT: 05130 TEST: 03                                                 PAGE  23
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 218
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (d)  Observed incidence at terminal kill.
 (f)  Beneath the control incidence are the P-values associated with the trend 
      test.  Beneath the dosed group incidence are the P-values corresponding to 
      pairwise comparisons between the controls and that dosed group.  The life
      table analysis regards tumors in animals dying  prior to terminal kill as
      being (directly or indirectly) the cause of death.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's exact tests compare directly the overall incidence rates.  
      For all tests, a negative trend is indicated by "N".
 (e)  Value of Statistic cannot be computed. 
 (I)  Interim sacrifice
 (T)  Terminal sacrifice
  #   Tumor rates based on number of animals necropsied.
 
  *   To the right of any statistical result, indicates significance at (P<=0.05).
  **  To the right of any statistical result, indicates significance at (P<=0.01).