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TDMS Study 05169-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: HLA, VA                                              C. I. DIRECT BLUE 15                                 DATE: 09/18/94       
EXPERIMENT: 05169 TEST: 01                                                                                     TIME: 03:50:13       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1ES9565503          ROUTE: DOSED WATER                                                                 NTP C#: 61290        
PATHOLOGIST: B. ULLAND                       S. EUSTIS                                                         CAS: 2429-74-5       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: HLA, VA                                              C. I. DIRECT BLUE 15                                 DATE: 09/18/94      
EXPERIMENT: 05169 TEST: 01                                                                                     TIME: 03:50:13      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1ES9565503          ROUTE: DOSED WATER                                                                 NTP C#: 61290       
PATHOLOGIST: B. ULLAND                       S. EUSTIS                                                         CAS: 2429-74-5      
 
 
 
 
 
                                                    RATS(FISCHER344)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: HLA, VA                                              C. I. DIRECT BLUE 15                                 DATE: 09/18/94       
EXPERIMENT: 05169 TEST: 01                                                                                     TIME: 03:50:13       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1ES9565503          ROUTE: DOSED WATER                                                                 NTP C#: 61290        
PATHOLOGIST: B. ULLAND                       S. EUSTIS                                                         CAS: 2429-74-5       
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                      IN THE ANALYSIS OF THE STUDY OF C. I. DIRECT BLUE 15
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Benign
                                                           Pheochromocytoma Malignant
                                                           Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Brain                         Astrocytoma Malignant
                             Clitoral/Preputial Gland      Adenoma
                                                           Carcinoma
                                                           Carcinoma or Adenoma
                             Intestine Large               Carcinoma
                                                           Polyp Adenomatous
                             Intestine Small               Carcinoma
                                                           Carcinoma or Adenoma
                             Kidney: Renal Tubule          Adenoma
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)
                                                           Papilloma Squamous or Papilloma
                                                           Squamous Cell Carcinoma
                                                           Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
                             Pharynx                       Squamous Cell Carcinoma
                                                           Squamous Cell Papilloma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                                                           Carcinoma or Adenoma
                             Skin                          Basal Cell Adenoma
                                                           Basal Cell Carcinoma
                                                           Keratoacanthoma
                                                           Squamous Cell Carcinoma
                                                           Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
                                                           Squamous Cell Papilloma
                                                           Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma
                                                           Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,
                                                            Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma
                             Skin: Sebaceous Gland         Carcinoma, Basal Cell Carcinoma or Adenoma
                             Skin: Subcutaneous Tissue     Fibroma
                                                           Neurofibroma or Fibroma
                                                           Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
                                                            Neurofibroma, or Fibroma
                             Testes                        Adenoma
                             Thyroid Gland: C-Cell         Adenoma
                                                           Carcinoma or Adenoma
                             Thyroid Gland: Follicular Cell
                                                           Adenoma
                                                           Carcinoma
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: HLA, VA                                              C. I. DIRECT BLUE 15                                 DATE: 09/18/94       
EXPERIMENT: 05169 TEST: 01                                                                                     TIME: 03:50:13       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1ES9565503          ROUTE: DOSED WATER                                                                 NTP C#: 61290        
PATHOLOGIST: B. ULLAND                       S. EUSTIS                                                         CAS: 2429-74-5       
 
                                                           Carcinoma or Adenoma
                             Tongue                        Squamous Cell Carcinoma or Papilloma Squamous
                                                           Squamous Cell Papilloma
                             Zymbal's Gland                Adenoma
                                                           Carcinoma
                                                           Carcinoma or Adenoma
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Clitoral/Preputial Gland      Adenoma
                                                           Carcinoma
                                                           Carcinoma or Adenoma
                             Intestine Large               Polyp Adenomatous
                             Intestine Small               Carcinoma
                                                           Carcinoma or Adenoma
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Mammary Gland                 Fibroadenoma
                                                           Fibroma, Fibroadenoma, Carcinoma, or Adenoma
                             Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)
                                                           Papilloma Squamous or Papilloma
                                                           Squamous Cell Carcinoma
                                                           Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
                             Pharynx                       Squamous Cell Carcinoma
                                                           Squamous Cell Papilloma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                                                           Carcinoma or Adenoma
                             Skin                          Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
                                                           Squamous Cell Papilloma
                                                           Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,
                                                            Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma
                             Skin: Subcutaneous Tissue     Fibroma
                                                           Neurofibroma or Fibroma
                                                           Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
                                                            Neurofibroma, or Fibroma
                             Thyroid Gland: C-Cell         Adenoma
                                                           Carcinoma or Adenoma
                             Tongue                        Squamous Cell Carcinoma
                                                           Squamous Cell Carcinoma or Papilloma Squamous
                                                           Squamous Cell Papilloma
                             Uterus                        Carcinoma
                                                           Polyp Stromal
                                                           Sarcoma Stromal or Polyp Stromal
                             Zymbal's Gland                Adenoma
                                                           Carcinoma
                                                           Carcinoma or Adenoma
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: HLA, VA                                              C. I. DIRECT BLUE 15                                 DATE: 09/18/94       
EXPERIMENT: 05169 TEST: 01                                                                                     TIME: 03:50:13       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1ES9565503          ROUTE: DOSED WATER                                                                 NTP C#: 61290        
PATHOLOGIST: B. ULLAND                       S. EUSTIS                                                         CAS: 2429-74-5       
 
                                                            or Undifferentiated
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE   1
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 16/50 (32%)   5/35 (14%)  19/65 (29%)  17/50 (34%) |  4/50 (8%)    4/35 (11%)   7/65 (11%)   1/50 (2%)  |
|ADJUSTED (b)           |  39.9%        28.9%        72.7%        89.2%      |  10.0%        25.5%        21.2%         7.1%      |
|TERMINAL (d)           | 13/37 (35%)   0/8 (0%)     5/11 (45%)   1/2 (50%)  |  4/40 (10%)   3/13 (23%)   2/22 (9%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   637          566          460          460       |   682 (T)      506          368          620       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.489      P<0.001 **   P<0.001 ** |  P=0.223      P=0.121      P=0.090      P=0.555    |
|INCIDENTAL TUMOR       |  P=0.012 *    P=0.058N     P=0.345      P=0.173    |  P=0.420N     P=0.198      P=0.352      P=0.644N   |
|LOGISTIC REGRESSION    |  P=0.002 **   P=0.210N     P=0.253      P=0.012 *  |  P=0.303N     P=0.298      P=0.385      P=0.718N   |
|COCHRAN-ARMITAGE       |  P=0.263                                           |  P=0.135N                                          |
|FISHER EXACT           |               P=0.052N     P=0.453N     P=0.500    |               P=0.432      P=0.433      P=0.181N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/35 (0%)    2/65 (3%)    1/50 (2%)  |  0/50 (0%)    0/35 (0%)    0/65 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%        11.7%         5.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/37 (0%)    0/8 (0%)     1/11 (9%)    0/2 (0%)   |  0/40 (0%)    0/13 (0%)    0/22 (0%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   ---          ---          628          565       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.035 *      (e)        P=0.105      P=0.343    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.148        (e)        P=0.226      P=0.731    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.153        (e)        P=0.208      P=0.527    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.273                                           |    (e)                                             |
|FISHER EXACT           |                 (e)        P=0.317      P=0.500    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE   2
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 16/50 (32%)   5/35 (14%)  21/65 (32%)  17/50 (34%) |  4/50 (8%)    4/35 (11%)   7/65 (11%)   1/50 (2%)  |
|ADJUSTED (b)           |  39.9%        28.9%        77.9%        89.2%      |  10.0%        25.5%        21.2%         7.1%      |
|TERMINAL (d)           | 13/37 (35%)   0/8 (0%)     6/11 (55%)   1/2 (50%)  |  4/40 (10%)   3/13 (23%)   2/22 (9%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   637          566          460          460       |   682 (T)      506          368          620       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.489      P<0.001 **   P<0.001 ** |  P=0.223      P=0.121      P=0.090      P=0.555    |
|INCIDENTAL TUMOR       |  P=0.008 **   P=0.058N     P=0.187      P=0.173    |  P=0.420N     P=0.198      P=0.352      P=0.644N   |
|LOGISTIC REGRESSION    |  P=0.001 **   P=0.210N     P=0.134      P=0.012 *  |  P=0.303N     P=0.298      P=0.385      P=0.718N   |
|COCHRAN-ARMITAGE       |  P=0.253                                           |  P=0.135N                                          |
|FISHER EXACT           |               P=0.052N     P=0.567      P=0.500    |               P=0.432      P=0.433      P=0.181N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Astrocytoma Malignant                                                                                                       |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    1/35 (3%)    1/65 (2%)    2/50 (4%)  |  1/50 (2%)    0/35 (0%)    2/65 (3%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         6.7%         2.0%        16.7%      |   2.0%         0.0%         7.2%         2.0%      |
|TERMINAL (d)           |  0/37 (0%)    0/8 (0%)     0/11 (0%)    0/2 (0%)   |  0/40 (0%)    0/13 (0%)    1/22 (5%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   ---          646          574          479       |   500          ---          638          316       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.029 *    P=0.305      P=0.530      P=0.066    |  P=0.290      P=0.585N     P=0.418      P=0.720    |
|INCIDENTAL TUMOR       |  P=0.328      P=0.669      P=0.852      P=0.532    |  P=0.496N     P=0.205N     P=0.717N     P=0.345N   |
|LOGISTIC REGRESSION    |  P=0.161      P=0.392      P=0.591      P=0.236    |  P=0.535N     P=0.535N     P=0.646      P=0.441N   |
|COCHRAN-ARMITAGE       |  P=0.176                                           |  P=0.542                                           |
|FISHER EXACT           |               P=0.412      P=0.565      P=0.247    |               P=0.588N     P=0.598      P=0.753N   |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE   3
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/49 (12%)   2/35 (6%)   12/64 (19%)   8/48 (17%) |  5/50 (10%)   5/31 (16%)  12/64 (19%)  12/50 (24%) |
|ADJUSTED (b)           |  15.5%        21.3%        51.2%        59.2%      |  12.1%        30.4%        36.5%        75.9%      |
|TERMINAL (d)           |  5/37 (14%)   1/8 (13%)    4/11 (36%)   0/2 (0%)   |  4/40 (10%)   3/13 (23%)   5/22 (23%)   2/4 (50%)  |
|FIRST INCIDENCE (DAYS) |   565          660          530          372       |   666          558          432          453       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.560      P=0.002 **   P<0.001 ** |  P<0.001 **   P=0.074      P=0.007 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.039 *    P=0.504N     P=0.119      P=0.432    |  P=0.008 **   P=0.225      P=0.140      P=0.039 *  |
|LOGISTIC REGRESSION    |  P=0.039 *    P=0.466N     P=0.143      P=0.228    |  P=0.003 **   P=0.197      P=0.077      P=0.006 ** |
|COCHRAN-ARMITAGE       |  P=0.190                                           |  P=0.043 *                                         |
|FISHER EXACT           |               P=0.270N     P=0.251      P=0.371    |               P=0.315      P=0.150      P=0.054    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/49 (4%)    3/35 (9%)   11/64 (17%)   1/48 (2%)  |  2/50 (4%)    6/31 (19%)  12/64 (19%)  15/50 (30%) |
|ADJUSTED (b)           |   5.4%        15.0%        27.0%         7.7%      |   5.0%        25.6%        30.1%        53.5%      |
|TERMINAL (d)           |  2/37 (5%)    0/8 (0%)     0/11 (0%)    0/2 (0%)   |  2/40 (5%)    1/13 (8%)    3/22 (14%)   0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   680 (T)      578          372          600       |   682 (T)      506          253          372       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.092      P=0.107      P=0.003 **   P=0.379    |  P<0.001 **   P=0.010 **   P=0.002 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.117N     P=0.510      P=0.260      P=0.756    |  P=0.033 *    P=0.099      P=0.033 *    P=0.091    |
|LOGISTIC REGRESSION    |  P=0.441N     P=0.300      P=0.056      P=0.687    |  P=0.025 *    P=0.057      P=0.063      P=0.005 ** |
|COCHRAN-ARMITAGE       |  P=0.445N                                          |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.343      P=0.027 *    P=0.508N   |               P=0.032 *    P=0.015 *    P<0.001 ** |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE   4
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  8/49 (16%)   5/35 (14%)  23/64 (36%)   9/48 (19%) |  7/50 (14%)  11/31 (35%)  24/64 (38%)  27/50 (54%) |
|ADJUSTED (b)           |  20.8%        33.1%        64.3%        62.4%      |  17.0%        49.7%        57.7%        89.3%      |
|TERMINAL (d)           |  7/37 (19%)   1/8 (13%)    4/11 (36%)   0/2 (0%)   |  6/40 (15%)   4/13 (31%)   8/22 (36%)   2/4 (50%)  |
|FIRST INCIDENCE (DAYS) |   565          578          372          372       |   666          506          253          372       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.141      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.001 **   P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.312      P=0.640N     P=0.046 *    P=0.394    |  P<0.001 **   P=0.035 *    P=0.008 **   P=0.002 ** |
|LOGISTIC REGRESSION    |  P=0.121      P=0.547      P=0.019 *    P=0.232    |  P<0.001 **   P=0.028 *    P=0.010 *    P<0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.301                                           |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.525N     P=0.017 *    P=0.481    |               P=0.025 *    P=0.004 **   P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Large: Colon                                                                                                           |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/35 (0%)    4/65 (6%)    3/50 (6%)  |  0/50 (0%)    0/35 (0%)    0/65 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%        14.4%        12.1%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/37 (0%)    0/8 (0%)     0/11 (0%)    0/2 (0%)   |  0/40 (0%)    0/13 (0%)    0/22 (0%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   ---          ---          628          505       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.002 **     (e)        P=0.025 *    P=0.044 *  |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.180        (e)        P=0.390      P=0.514    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.034 *      (e)        P=0.072      P=0.156    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.051                                           |    (e)                                             |
|FISHER EXACT           |                 (e)        P=0.098      P=0.121    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE   5
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Large: Colon                                                                                                           |
|     Polyp Adenomatous                                                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    1/35 (3%)    2/65 (3%)    5/50 (10%) |  0/50 (0%)    0/35 (0%)    3/65 (5%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         4.0%         6.3%        41.0%      |   0.0%         0.0%        11.7%        12.5%      |
|TERMINAL (d)           |  0/37 (0%)    0/8 (0%)     0/11 (0%)    0/2 (0%)   |  0/40 (0%)    0/13 (0%)    2/22 (9%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   ---          579          559          502       |   ---          ---          640          646       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.392      P=0.193      P<0.001 ** |  P=0.017 *      (e)        P=0.053      P=0.165    |
|INCIDENTAL TUMOR       |  P=0.025 *    P=0.690      P=0.608      P=0.202    |  P=0.123        (e)        P=0.113      P=0.500    |
|LOGISTIC REGRESSION    |  P=0.005 **   P=0.471      P=0.317      P=0.010 ** |  P=0.062        (e)        P=0.094      P=0.347    |
|COCHRAN-ARMITAGE       |  P=0.010 *                                         |  P=0.279                                           |
|FISHER EXACT           |               P=0.412      P=0.317      P=0.028 *  |                 (e)        P=0.177      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/35 (0%)    0/65 (0%)    2/50 (4%)  |  0/50 (0%)    0/35 (0%)    1/65 (2%)    3/50 (6%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         8.2%      |   0.0%         0.0%         1.8%        19.4%      |
|TERMINAL (d)           |  0/37 (0%)    0/8 (0%)     0/11 (0%)    0/2 (0%)   |  0/40 (0%)    0/13 (0%)    0/22 (0%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          479       |   ---          ---          479          578       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.022 *      (e)          (e)        P=0.126    |  P=0.005 **     (e)        P=0.527      P=0.016 *  |
|INCIDENTAL TUMOR       |  P=0.132        (e)          (e)        P=0.604    |  P=0.087        (e)        P=0.860      P=0.384    |
|LOGISTIC REGRESSION    |  P=0.078        (e)          (e)        P=0.304    |  P=0.032 *      (e)        P=0.688      P=0.075    |
|COCHRAN-ARMITAGE       |  P=0.052                                           |  P=0.025 *                                         |
|FISHER EXACT           |                 (e)          (e)        P=0.247    |                 (e)        P=0.565      P=0.121    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE   6
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Jejunum                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/35 (0%)    0/65 (0%)    2/50 (4%)  |  0/50 (0%)    0/35 (0%)    0/65 (0%)    3/50 (6%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         8.2%      |   0.0%         0.0%         0.0%        19.4%      |
|TERMINAL (d)           |  0/37 (0%)    0/8 (0%)     0/11 (0%)    0/2 (0%)   |  0/40 (0%)    0/13 (0%)    0/22 (0%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          479       |   ---          ---          ---          578       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.022 *      (e)          (e)        P=0.126    |  P=0.002 **     (e)          (e)        P=0.016 *  |
|INCIDENTAL TUMOR       |  P=0.132        (e)          (e)        P=0.604    |  P=0.033 *      (e)          (e)        P=0.384    |
|LOGISTIC REGRESSION    |  P=0.078        (e)          (e)        P=0.304    |  P=0.008 **     (e)          (e)        P=0.075    |
|COCHRAN-ARMITAGE       |  P=0.052                                           |  P=0.014 *                                         |
|FISHER EXACT           |                 (e)          (e)        P=0.247    |                 (e)          (e)        P=0.121    |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/35 (0%)    0/65 (0%)    2/50 (4%)  |  0/50 (0%)    0/35 (0%)    0/65 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%        23.8%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/37 (0%)    0/8 (0%)     0/11 (0%)    0/2 (0%)   |  0/40 (0%)    0/13 (0%)    0/22 (0%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          624       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.003 **     (e)          (e)        P=0.012 *  |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.049 *      (e)          (e)        P=0.455    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.010 *      (e)          (e)        P=0.066    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.052                                           |    (e)                                             |
|FISHER EXACT           |                 (e)          (e)        P=0.247    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE   7
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    6/35 (17%)   8/65 (12%)   7/50 (14%) |  0/50 (0%)    0/35 (0%)    2/65 (3%)    4/50 (8%)  |
|ADJUSTED (b)           |   0.0%        45.9%        37.5%        44.2%      |   0.0%         0.0%         6.8%        37.0%      |
|TERMINAL (d)           |  0/37 (0%)    3/8 (38%)    2/11 (18%)   0/2 (0%)   |  0/40 (0%)    0/13 (0%)    1/22 (5%)    1/4 (25%)  |
|FIRST INCIDENCE (DAYS) |   ---          544          579          463       |   ---          ---          625          585       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P<0.001 **     (e)        P=0.171      P=0.001 ** |
|INCIDENTAL TUMOR       |  P=0.015 *    P=0.002 **   P=0.023 *    P=0.120    |  P=0.009 **     (e)        P=0.332      P=0.108    |
|LOGISTIC REGRESSION    |  P=0.003 **   P=0.002 **   P=0.003 **   P=0.003 ** |  P=0.002 **     (e)        P=0.246      P=0.016 *  |
|COCHRAN-ARMITAGE       |  P=0.046 *                                         |  P=0.011 *                                         |
|FISHER EXACT           |               P=0.004 **   P=0.009 **   P=0.006 ** |                 (e)        P=0.317      P=0.059    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/35 (0%)    1/65 (2%)    4/50 (8%)  |  0/50 (0%)    0/35 (0%)    0/65 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         3.1%        44.6%      |   0.0%         0.0%         0.0%         3.7%      |
|TERMINAL (d)           |  0/37 (0%)    0/8 (0%)     0/11 (0%)    0/2 (0%)   |  0/40 (0%)    0/13 (0%)    0/22 (0%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   ---          ---          632          547       |   ---          ---          ---          564       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **     (e)        P=0.446      P<0.001 ** |  P=0.155        (e)          (e)        P=0.394    |
|INCIDENTAL TUMOR       |  P=0.007 **     (e)        P=0.852      P=0.226    |  P=0.364        (e)          (e)        P=0.916    |
|LOGISTIC REGRESSION    |  P<0.001 **     (e)        P=0.540      P=0.009 ** |  P=0.242        (e)          (e)        P=0.587    |
|COCHRAN-ARMITAGE       |  P=0.007 **                                        |  P=0.211                                           |
|FISHER EXACT           |                 (e)        P=0.565      P=0.059    |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE   8
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    6/35 (17%)   9/65 (14%)  11/50 (22%) |  0/50 (0%)    0/35 (0%)    2/65 (3%)    5/50 (10%) |
|ADJUSTED (b)           |   0.0%        45.9%        39.4%        69.9%      |   0.0%         0.0%         6.8%        39.3%      |
|TERMINAL (d)           |  0/37 (0%)    3/8 (38%)    2/11 (18%)   0/2 (0%)   |  0/40 (0%)    0/13 (0%)    1/22 (5%)    1/4 (25%)  |
|FIRST INCIDENCE (DAYS) |   ---          544          579          463       |   ---          ---          625          564       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P<0.001 **     (e)        P=0.171      P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.002 **   P=0.021 *    P=0.025 *  |  P=0.004 **     (e)        P=0.332      P=0.099    |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.002 **   P=0.002 **   P<0.001 ** |  P<0.001 **     (e)        P=0.246      P=0.010 ** |
|COCHRAN-ARMITAGE       |  P=0.002 **                                        |  P=0.004 **                                        |
|FISHER EXACT           |               P=0.004 **   P=0.005 **   P<0.001 ** |                 (e)        P=0.317      P=0.028 *  |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    6/35 (17%)   9/65 (14%)  11/50 (22%) |  0/50 (0%)    0/35 (0%)    2/65 (3%)    5/50 (10%) |
|ADJUSTED (b)           |   0.0%        45.9%        39.4%        69.9%      |   0.0%         0.0%         6.8%        39.3%      |
|TERMINAL (d)           |  0/37 (0%)    3/8 (38%)    2/11 (18%)   0/2 (0%)   |  0/40 (0%)    0/13 (0%)    1/22 (5%)    1/4 (25%)  |
|FIRST INCIDENCE (DAYS) |   ---          544          579          463       |   ---          ---          625          564       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P<0.001 **     (e)        P=0.171      P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.002 **   P=0.021 *    P=0.025 *  |  P=0.004 **     (e)        P=0.332      P=0.099    |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.002 **   P=0.002 **   P<0.001 ** |  P<0.001 **     (e)        P=0.246      P=0.010 ** |
|COCHRAN-ARMITAGE       |  P=0.002 **                                        |  P=0.004 **                                        |
|FISHER EXACT           |               P=0.004 **   P=0.005 **   P<0.001 ** |                 (e)        P=0.317      P=0.028 *  |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE   9
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    1/35 (3%)    4/65 (6%)    1/50 (2%)  |  1/50 (2%)    2/35 (6%)    1/65 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |   5.0%        12.5%        15.4%         6.7%      |   2.5%        10.9%         4.5%         0.0%      |
|TERMINAL (d)           |  1/37 (3%)    1/8 (13%)    1/11 (9%)    0/2 (0%)   |  1/40 (3%)    1/13 (8%)    1/22 (5%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   589          680 (T)      579          583       |   682 (T)      529          682 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.153      P=0.612      P=0.187      P=0.534    |  P=0.609N     P=0.209      P=0.623      P=0.923N   |
|INCIDENTAL TUMOR       |  P=0.583      P=0.728N     P=0.675      P=0.452N   |  P=0.447N     P=0.395      P=0.623      P=0.923N   |
|LOGISTIC REGRESSION    |  P=0.563      P=0.698N     P=0.448      P=0.658N   |  P=0.324N     P=0.399      P=0.623      P=0.923N   |
|COCHRAN-ARMITAGE       |  P=0.441N                                          |  P=0.215N                                          |
|FISHER EXACT           |               P=0.633N     P=0.471      P=0.500N   |               P=0.367      P=0.683N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/35 (0%)    0/65 (0%)    0/50 (0%)  |  4/50 (8%)    3/35 (9%)    2/65 (3%)    2/50 (4%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   9.6%        15.0%         6.8%        27.7%      |
|TERMINAL (d)           |  0/37 (0%)    0/8 (0%)     0/11 (0%)    0/2 (0%)   |  3/40 (8%)    1/13 (8%)    1/22 (5%)    1/4 (25%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   664          506          625          547       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.312      P=0.308      P=0.575N     P=0.194    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.345N     P=0.640N     P=0.320N     P=0.631    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.400N     P=0.592      P=0.387N     P=0.641    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.194N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.612      P=0.225N     P=0.339N   |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE  10
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/35 (0%)    1/65 (2%)    0/50 (0%)  | 16/50 (32%)   4/35 (11%)  16/65 (25%)   4/50 (8%)  |
|ADJUSTED (b)           |   0.0%         0.0%         2.3%         0.0%      |  40.0%        20.9%        44.9%        28.1%      |
|TERMINAL (d)           |  0/37 (0%)    0/8 (0%)     0/11 (0%)    0/2 (0%)   | 16/40 (40%)   1/13 (8%)    6/22 (27%)   0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   ---          ---          605          ---       |   682 (T)      579          555          502       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.600        (e)        P=0.505        (e)      |  P=0.120      P=0.363N     P=0.094      P=0.214    |
|INCIDENTAL TUMOR       |  P=0.761N       (e)        P=0.852        (e)      |  P=0.164N     P=0.141N     P=0.586      P=0.578N   |
|LOGISTIC REGRESSION    |  P=0.714        (e)        P=0.571        (e)      |  P=0.245N     P=0.162N     P=0.559      P=0.317N   |
|COCHRAN-ARMITAGE       |  P=0.714                                           |  P=0.008N**                                        |
|FISHER EXACT           |                 (e)        P=0.565        (e)      |               P=0.024N*    P=0.252N     P=0.003N** |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/35 (0%)    1/65 (2%)    0/50 (0%)  | 18/50 (36%)   7/35 (20%)  17/65 (26%)   6/50 (12%) |
|ADJUSTED (b)           |   0.0%         0.0%         2.3%         0.0%      |  43.8%        33.5%        46.2%        48.0%      |
|TERMINAL (d)           |  0/37 (0%)    0/8 (0%)     0/11 (0%)    0/2 (0%)   | 17/40 (43%)   2/13 (15%)   6/22 (27%)   1/4 (25%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          605          ---       |   664          506          555          502       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.600        (e)        P=0.505        (e)      |  P=0.059      P=0.504      P=0.121      P=0.045 *  |
|INCIDENTAL TUMOR       |  P=0.761N       (e)        P=0.852        (e)      |  P=0.123N     P=0.223N     P=0.426N     P=0.604    |
|LOGISTIC REGRESSION    |  P=0.714        (e)        P=0.571        (e)      |  P=0.228N     P=0.284N     P=0.519N     P=0.439N   |
|COCHRAN-ARMITAGE       |  P=0.714                                           |  P=0.007N**                                        |
|FISHER EXACT           |                 (e)        P=0.565        (e)      |               P=0.087N     P=0.175N     P=0.005N** |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE  11
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Papilloma Squamous or Papilloma                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    9/35 (26%)  18/65 (28%)  15/50 (30%) |  2/50 (4%)    3/35 (9%)   12/65 (18%)   9/50 (18%) |
|ADJUSTED (b)           |   0.0%        55.8%        55.9%        53.8%      |   5.0%         9.5%        32.7%        48.0%      |
|TERMINAL (d)           |  0/37 (0%)    3/8 (38%)    1/11 (9%)    0/2 (0%)   |  2/40 (5%)    0/13 (0%)    3/22 (14%)   1/4 (25%)  |
|FIRST INCIDENCE (DAYS) |   ---          316          460          372       |   682 (T)      463          583          372       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.213      P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.012 *    P<0.001 **   P=0.005 **   P=0.028 *  |  P=0.119      P=0.684      P=0.068      P=0.134    |
|LOGISTIC REGRESSION    |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P=0.015 *    P=0.491      P=0.008 **   P=0.035 *  |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.018 *                                         |
|FISHER EXACT           |               P<0.001 **   P<0.001 **   P<0.001 ** |               P=0.334      P=0.016 *    P=0.026 *  |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    1/35 (3%)    6/65 (9%)    2/50 (4%)  |  0/50 (0%)    1/35 (3%)    8/65 (12%)   6/50 (12%) |
|ADJUSTED (b)           |   2.7%         2.9%        13.4%        11.6%      |   0.0%         7.7%        18.0%        40.3%      |
|TERMINAL (d)           |  1/37 (3%)    0/8 (0%)     0/11 (0%)    0/2 (0%)   |  0/40 (0%)    1/13 (8%)    0/22 (0%)    1/4 (25%)  |
|FIRST INCIDENCE (DAYS) |   680 (T)      293          502          479       |   ---          682 (T)      432          359       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.055      P=0.557      P=0.040 *    P=0.117    |  P<0.001 **   P=0.277      P=0.005 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.568N     P=0.611      P=0.424      P=0.631    |  P=0.132      P=0.277      P=0.257      P=0.088    |
|LOGISTIC REGRESSION    |  P=0.503      P=0.739N     P=0.141      P=0.461    |  P=0.015 *    P=0.277      P=0.023 *    P=0.023 *  |
|COCHRAN-ARMITAGE       |  P=0.350                                           |  P=0.010 *                                         |
|FISHER EXACT           |               P=0.657      P=0.110      P=0.500    |               P=0.412      P=0.009 **   P=0.013 *  |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE  12
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)   10/35 (29%)  24/65 (37%)  17/50 (34%) |  2/50 (4%)    4/35 (11%)  19/65 (29%)  15/50 (30%) |
|ADJUSTED (b)           |   2.7%        57.0%        61.9%        59.2%      |   5.0%        16.5%        43.2%        72.7%      |
|TERMINAL (d)           |  1/37 (3%)    3/8 (38%)    1/11 (9%)    0/2 (0%)   |  2/40 (5%)    1/13 (8%)    3/22 (14%)   2/4 (50%)  |
|FIRST INCIDENCE (DAYS) |   680 (T)      293          460          372       |   682 (T)      463          432          359       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.079      P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.020 *    P<0.001 **   P=0.004 **   P=0.020 *  |  P=0.022 *    P=0.369      P=0.023 *    P=0.011 *  |
|LOGISTIC REGRESSION    |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.294      P=0.005 **   P=0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P<0.001 **   P<0.001 **   P<0.001 ** |               P=0.187      P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Pharynx                                                                                                                          |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/35 (0%)    4/65 (6%)    2/50 (4%)  |  0/50 (0%)    0/35 (0%)    5/65 (8%)    3/50 (6%)  |
|ADJUSTED (b)           |   2.7%         0.0%         8.8%        11.6%      |   0.0%         0.0%        12.1%         9.4%      |
|TERMINAL (d)           |  1/37 (3%)    0/8 (0%)     0/11 (0%)    0/2 (0%)   |  0/40 (0%)    0/13 (0%)    0/22 (0%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   680 (T)      ---          572          479       |   ---          ---          524          359       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.033 *    P=0.800N     P=0.128      P=0.117    |  P=0.006 **     (e)        P=0.029 *    P=0.065    |
|INCIDENTAL TUMOR       |  P=0.395      P=0.800N     P=0.588      P=0.631    |  P=0.406        (e)        P=0.373      P=0.576    |
|LOGISTIC REGRESSION    |  P=0.264      P=0.800N     P=0.292      P=0.461    |  P=0.112        (e)        P=0.074      P=0.289    |
|COCHRAN-ARMITAGE       |  P=0.280                                           |  P=0.058                                           |
|FISHER EXACT           |               P=0.588N     P=0.274      P=0.500    |                 (e)        P=0.054      P=0.121    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE  13
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pharynx                                                                                                                          |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    9/35 (26%)  17/65 (26%)  15/50 (30%) |  0/50 (0%)    2/35 (6%)   11/65 (17%)   7/50 (14%) |
|ADJUSTED (b)           |   0.0%        55.8%        51.9%        53.8%      |   0.0%         5.9%        29.2%        28.8%      |
|TERMINAL (d)           |  0/37 (0%)    3/8 (38%)    1/11 (9%)    0/2 (0%)   |  0/40 (0%)    0/13 (0%)    2/22 (9%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   ---          316          460          372       |   ---          463          583          372       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.165      P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.012 *    P<0.001 **   P=0.009 **   P=0.028 *  |  P=0.185      P=0.604      P=0.031 *    P=0.403    |
|LOGISTIC REGRESSION    |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P=0.012 *    P=0.187      P=0.002 **   P=0.022 *  |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.010 **                                        |
|FISHER EXACT           |               P<0.001 **   P<0.001 **   P<0.001 ** |               P=0.167      P=0.001 **   P=0.006 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/49 (10%)   1/34 (3%)    3/63 (5%)    3/50 (6%)  | 18/49 (37%)  10/35 (29%)  19/65 (29%)   6/49 (12%) |
|ADJUSTED (b)           |  13.3%         7.1%        15.2%        63.8%      |  42.4%        53.2%        52.0%        50.2%      |
|TERMINAL (d)           |  4/36 (11%)   0/8 (0%)     1/11 (9%)    1/2 (50%)  | 15/39 (38%)   5/13 (38%)   8/22 (36%)   1/4 (25%)  |
|FIRST INCIDENCE (DAYS) |   659          646          605          521       |   550          495          524          402       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.026 *    P=0.629N     P=0.441      P=0.015 *  |  P=0.049 *    P=0.146      P=0.084      P=0.086    |
|INCIDENTAL TUMOR       |  P=0.393      P=0.282N     P=0.477N     P=0.489    |  P=0.128N     P=0.560N     P=0.413N     P=0.233N   |
|LOGISTIC REGRESSION    |  P=0.289      P=0.434N     P=0.512N     P=0.343    |  P=0.149N     P=0.588      P=0.488N     P=0.197N   |
|COCHRAN-ARMITAGE       |  P=0.339N                                          |  P=0.005N**                                        |
|FISHER EXACT           |               P=0.209N     P=0.229N     P=0.346N   |               P=0.293N     P=0.259N     P=0.004N** |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE  14
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/49 (10%)   1/34 (3%)    3/63 (5%)    3/50 (6%)  | 18/49 (37%)  10/35 (29%)  20/65 (31%)   6/49 (12%) |
|ADJUSTED (b)           |  13.3%         7.1%        15.2%        63.8%      |  42.4%        53.2%        53.3%        50.2%      |
|TERMINAL (d)           |  4/36 (11%)   0/8 (0%)     1/11 (9%)    1/2 (50%)  | 15/39 (38%)   5/13 (38%)   8/22 (36%)   1/4 (25%)  |
|FIRST INCIDENCE (DAYS) |   659          646          605          521       |   550          495          524          402       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.026 *    P=0.629N     P=0.441      P=0.015 *  |  P=0.041 *    P=0.146      P=0.059      P=0.086    |
|INCIDENTAL TUMOR       |  P=0.393      P=0.282N     P=0.477N     P=0.489    |  P=0.116N     P=0.560N     P=0.431N     P=0.233N   |
|LOGISTIC REGRESSION    |  P=0.289      P=0.434N     P=0.512N     P=0.343    |  P=0.161N     P=0.588      P=0.560N     P=0.197N   |
|COCHRAN-ARMITAGE       |  P=0.339N                                          |  P=0.005N**                                        |
|FISHER EXACT           |               P=0.209N     P=0.229N     P=0.346N   |               P=0.293N     P=0.319N     P=0.004N** |
|=================================================================================================================================|
|                                                                                                                                 |
|Salivary Glands                                                                                                                  |
|     Schwannoma Malignant                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/35 (0%)    3/65 (5%)    0/50 (0%)  |  0/50 (0%)    0/35 (0%)    0/65 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         5.8%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/37 (0%)    0/8 (0%)     0/11 (0%)    0/2 (0%)   |  0/40 (0%)    0/13 (0%)    0/22 (0%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   ---          ---          534          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.392        (e)        P=0.152        (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.484N       (e)        P=0.505        (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.654        (e)        P=0.214        (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.576                                           |    (e)                                             |
|FISHER EXACT           |                 (e)        P=0.177        (e)      |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE  15
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Adenoma                                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    8/35 (23%)  23/65 (35%)  26/50 (52%) |  1/50 (2%)    0/35 (0%)    0/65 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   5.1%        53.6%        85.0%       100.0%      |   2.3%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/37 (3%)    2/8 (25%)    8/11 (73%)   2/2 (100%) |  0/40 (0%)    0/13 (0%)    0/22 (0%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   659          632          460          408       |   664          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P=0.525N     P=0.742N     P=0.605N     P=0.934N   |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.030 *    P<0.001 **   P<0.001 ** |  P=0.267N     P=0.500N     P=0.343N     P=0.500N   |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.011 *    P<0.001 **   P<0.001 ** |  P=0.396N     P=0.640N     P=0.507N     P=0.760N   |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.286N                                          |
|FISHER EXACT           |               P=0.010 *    P<0.001 **   P<0.001 ** |               P=0.588N     P=0.435N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Carcinoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    2/35 (6%)    4/65 (6%)   10/50 (20%) |  0/50 (0%)    0/35 (0%)    1/65 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%        13.3%        16.0%       100.0%      |   0.0%         0.0%         4.5%         0.0%      |
|TERMINAL (d)           |  0/37 (0%)    0/8 (0%)     0/11 (0%)    2/2 (100%) |  0/40 (0%)    0/13 (0%)    1/22 (5%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   ---          646          637          551       |   ---          ---          682 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.063      P=0.018 *    P<0.001 ** |  P=0.473        (e)        P=0.381        (e)      |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.435      P=0.390      P=0.001 ** |  P=0.473        (e)        P=0.381        (e)      |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.122      P=0.065      P<0.001 ** |  P=0.473        (e)        P=0.381        (e)      |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.714                                           |
|FISHER EXACT           |               P=0.167      P=0.098      P<0.001 ** |                 (e)        P=0.565        (e)      |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE  16
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    1/35 (3%)    7/65 (11%)   2/50 (4%)  |  2/50 (4%)    1/35 (3%)    3/65 (5%)    0/50 (0%)  |
|ADJUSTED (b)           |   5.4%         5.9%        30.2%        25.0%      |   4.7%         4.8%         8.6%         0.0%      |
|TERMINAL (d)           |  2/37 (5%)    0/8 (0%)     1/11 (9%)    0/2 (0%)   |  1/40 (3%)    0/13 (0%)    0/22 (0%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   680 (T)      626          575          645       |   664          622          616          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.004 **   P=0.581      P=0.006 **   P=0.036 *  |  P=0.590      P=0.647      P=0.346      P=0.793N   |
|INCIDENTAL TUMOR       |  P=0.336      P=0.728N     P=0.220      P=0.463    |  P=0.083N     P=0.477N     P=0.487N     P=0.437N   |
|LOGISTIC REGRESSION    |  P=0.071      P=0.740      P=0.065      P=0.159    |  P=0.379N     P=0.694N     P=0.535      P=0.610N   |
|COCHRAN-ARMITAGE       |  P=0.493                                           |  P=0.202N                                          |
|FISHER EXACT           |               P=0.633N     P=0.162      P=0.691N   |               P=0.633N     P=0.623      P=0.247N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    1/35 (3%)    7/65 (11%)  13/50 (26%) |  0/50 (0%)    0/35 (0%)    1/65 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         4.3%        31.6%        77.5%      |   0.0%         0.0%         3.8%         0.0%      |
|TERMINAL (d)           |  0/37 (0%)    0/8 (0%)     2/11 (18%)   1/2 (50%)  |  0/40 (0%)    0/13 (0%)    0/22 (0%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   ---          591          460          539       |   ---          ---          666          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.380      P<0.001 **   P<0.001 ** |  P=0.479        (e)        P=0.400        (e)      |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.690      P=0.031 *    P=0.004 ** |  P=0.733        (e)        P=0.657        (e)      |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.461      P=0.018 *    P<0.001 ** |  P=0.595        (e)        P=0.487        (e)      |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.714                                           |
|FISHER EXACT           |               P=0.412      P=0.016 *    P<0.001 ** |                 (e)        P=0.565        (e)      |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE  17
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    4/35 (11%)  11/65 (17%)  19/50 (38%) |  0/50 (0%)    2/35 (6%)    6/65 (9%)    5/50 (10%) |
|ADJUSTED (b)           |   5.4%        23.6%        47.2%        87.1%      |   0.0%        11.0%        24.5%        38.9%      |
|TERMINAL (d)           |  2/37 (5%)    1/8 (13%)    3/11 (27%)   1/2 (50%)  |  0/40 (0%)    1/13 (8%)    4/22 (18%)   0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   680 (T)      578          460          460       |   ---          535          666          607       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.034 *    P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.087      P=0.002 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.206      P=0.023 *    P<0.001 ** |  P=0.005 **   P=0.225      P=0.008 **   P=0.170    |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.146      P=0.011 *    P<0.001 ** |  P=0.001 **   P=0.199      P=0.004 **   P=0.003 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.035 *                                         |
|FISHER EXACT           |               P=0.187      P=0.027 *    P<0.001 ** |               P=0.167      P=0.029 *    P=0.028 *  |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    3/35 (9%)    5/65 (8%)    8/50 (16%) |  0/50 (0%)    2/35 (6%)    5/65 (8%)    5/50 (10%) |
|ADJUSTED (b)           |   5.4%        20.2%        28.9%        72.3%      |   0.0%        11.0%        21.5%        38.9%      |
|TERMINAL (d)           |  2/37 (5%)    1/8 (13%)    2/11 (18%)   1/2 (50%)  |  0/40 (0%)    1/13 (8%)    4/22 (18%)   0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   680 (T)      578          617          460       |   ---          535          673          607       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.087      P=0.018 *    P<0.001 ** |  P<0.001 **   P=0.087      P=0.005 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.002 **   P=0.279      P=0.148      P=0.042 *  |  P=0.005 **   P=0.225      P=0.011 *    P=0.170    |
|LOGISTIC REGRESSION    |  P=0.001 **   P=0.258      P=0.107      P=0.005 ** |  P=0.001 **   P=0.199      P=0.007 **   P=0.003 ** |
|COCHRAN-ARMITAGE       |  P=0.030 *                                         |  P=0.032 *                                         |
|FISHER EXACT           |               P=0.334      P=0.341      P=0.046 *  |               P=0.167      P=0.054      P=0.028 *  |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE  18
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    9/35 (26%)  27/65 (42%)  28/50 (56%) |  1/50 (2%)    0/35 (0%)    1/65 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |   5.1%        57.8%        87.5%       100.0%      |   2.3%         0.0%         4.5%         0.0%      |
|TERMINAL (d)           |  1/37 (3%)    2/8 (25%)    8/11 (73%)   2/2 (100%) |  0/40 (0%)    0/13 (0%)    1/22 (5%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   659          632          460          408       |   664          ---          682 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P=0.708      P=0.742N     P=0.630      P=0.934N   |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.013 *    P<0.001 **   P<0.001 ** |  P=0.562N     P=0.500N     P=0.754N     P=0.500N   |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.004 **   P<0.001 **   P<0.001 ** |  P=0.664N     P=0.640N     P=0.728      P=0.760N   |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.376N                                          |
|FISHER EXACT           |               P=0.005 **   P<0.001 **   P<0.001 ** |               P=0.588N     P=0.683N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/50 (12%)  14/35 (40%)  34/65 (52%)  32/50 (64%) |  2/50 (4%)    3/35 (9%)   10/65 (15%)   5/50 (10%) |
|ADJUSTED (b)           |  15.7%        71.1%        90.6%       100.0%      |   4.7%        15.2%        34.8%        38.9%      |
|TERMINAL (d)           |  5/37 (14%)   3/8 (38%)    8/11 (73%)   2/2 (100%) |  1/40 (3%)    1/13 (8%)    5/22 (23%)   0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   659          578          460          408       |   664          535          616          607       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.135      P=0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.009 **   P<0.001 **   P<0.001 ** |  P=0.094      P=0.545      P=0.026 *    P=0.419    |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.011 *    P<0.001 **   P<0.001 ** |  P=0.010 **   P=0.347      P=0.007 **   P=0.729    |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.188                                           |
|FISHER EXACT           |               P=0.003 **   P<0.001 **   P<0.001 ** |               P=0.334      P=0.043 *    P=0.218    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE  19
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Sebaceous Gland                                                                                                            |
|     Carcinoma, Basal Cell Carcinoma or Adenoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    1/35 (3%)    7/65 (11%)   3/50 (6%)  |  0/50 (0%)    1/35 (3%)    0/65 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%        12.5%        33.2%        44.4%      |   0.0%         4.5%         0.0%         0.0%      |
|TERMINAL (d)           |  0/37 (0%)    1/8 (13%)    0/11 (0%)    0/2 (0%)   |  0/40 (0%)    0/13 (0%)    0/22 (0%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   ---          680 (T)      633          561       |   ---          579          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.200      P<0.001 **   P=0.001 ** |  P=0.628N     P=0.353        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.082      P=0.200      P=0.173      P=0.296    |  P=0.335N     P=0.773        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.002 **   P=0.200      P=0.004 **   P=0.026 *  |  P=0.509N     P=0.485        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.105                                           |  P=0.549N                                          |
|FISHER EXACT           |               P=0.412      P=0.016 *    P=0.121    |               P=0.412        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    2/35 (6%)    5/65 (8%)    3/50 (6%)  |  3/50 (6%)    0/35 (0%)    0/65 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   5.4%        25.0%        22.7%        14.5%      |   6.8%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  2/37 (5%)    2/8 (25%)    1/11 (9%)    0/2 (0%)   |  1/40 (3%)    0/13 (0%)    0/22 (0%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   680 (T)      680 (T)      623          317       |   292          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.003 **   P=0.143      P=0.033 *    P=0.054    |  P=0.105N     P=0.305N     P=0.175N     P=0.390N   |
|INCIDENTAL TUMOR       |  P=0.113      P=0.143      P=0.330      P=0.400    |  P=0.019N*    P=0.355N     P=0.105N     P=0.102N   |
|LOGISTIC REGRESSION    |  P=0.208      P=0.143      P=0.152      P=0.550    |  P=0.011N*    P=0.111N     P=0.027N*    P=0.028N*  |
|COCHRAN-ARMITAGE       |  P=0.412                                           |  P=0.038N*                                         |
|FISHER EXACT           |               P=0.547      P=0.341      P=0.500    |               P=0.198N     P=0.079N     P=0.121N   |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE  20
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibroma or Fibroma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    2/35 (6%)    5/65 (8%)    3/50 (6%)  |  3/50 (6%)    1/35 (3%)    0/65 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   5.4%        25.0%        22.7%        14.5%      |   6.8%         5.6%         0.0%         0.0%      |
|TERMINAL (d)           |  2/37 (5%)    2/8 (25%)    1/11 (9%)    0/2 (0%)   |  1/40 (3%)    0/13 (0%)    0/22 (0%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   680 (T)      680 (T)      623          317       |   292          646          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.003 **   P=0.143      P=0.033 *    P=0.054    |  P=0.128N     P=0.637N     P=0.175N     P=0.390N   |
|INCIDENTAL TUMOR       |  P=0.113      P=0.143      P=0.330      P=0.400    |  P=0.017N*    P=0.626N     P=0.105N     P=0.102N   |
|LOGISTIC REGRESSION    |  P=0.208      P=0.143      P=0.152      P=0.550    |  P=0.013N*    P=0.306N     P=0.027N*    P=0.028N*  |
|COCHRAN-ARMITAGE       |  P=0.412                                           |  P=0.034N*                                         |
|FISHER EXACT           |               P=0.547      P=0.341      P=0.500    |               P=0.453N     P=0.079N     P=0.121N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    3/35 (9%)    6/65 (9%)    4/50 (8%)  |  4/50 (8%)    1/35 (3%)    0/65 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   5.4%        28.4%        26.3%        26.7%      |   9.2%         5.6%         0.0%         0.0%      |
|TERMINAL (d)           |  2/37 (5%)    2/8 (25%)    1/11 (9%)    0/2 (0%)   |  2/40 (5%)    0/13 (0%)    0/22 (0%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   680 (T)      592          623          317       |   292          646          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.050 *    P=0.014 *    P=0.008 ** |  P=0.084N     P=0.528N     P=0.118N     P=0.350N   |
|INCIDENTAL TUMOR       |  P=0.099      P=0.108      P=0.270      P=0.283    |  P=0.011N*    P=0.504N     P=0.072N     P=0.097N   |
|LOGISTIC REGRESSION    |  P=0.110      P=0.177      P=0.090      P=0.306    |  P=0.006N**   P=0.196N     P=0.013N*    P=0.019N*  |
|COCHRAN-ARMITAGE       |  P=0.315                                           |  P=0.014N*                                         |
|FISHER EXACT           |               P=0.334      P=0.238      P=0.339    |               P=0.310N     P=0.033N*    P=0.059N   |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE  21
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 48/50 (96%)  32/35 (91%)  61/65 (94%)  43/50 (86%) |                                                    |
|ADJUSTED (b)           | 100.0%       100.0%        98.4%       100.0%      |                                                    |
|TERMINAL (d)           | 37/37 (100%)  8/8 (100%)  10/11 (91%)   2/2 (100%) |                                                    |
|FIRST INCIDENCE (DAYS) |   445          421          372          317       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |                                                    |
|INCIDENTAL TUMOR       |  P=0.422N     P=0.602N     P=0.158N     P=0.565N   |                                                    |
|LOGISTIC REGRESSION    |  P=0.352      P=0.797N     P=0.616N     P=0.595    |                                                    |
|COCHRAN-ARMITAGE       |  P=0.059N                                          |                                                    |
|FISHER EXACT           |               P=0.334N     P=0.471N     P=0.080N   |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/50 (10%)   8/35 (23%)   7/65 (11%)   4/50 (8%)  | 10/49 (20%)   3/35 (9%)    4/65 (6%)    0/50 (0%)  |
|ADJUSTED (b)           |  12.7%        48.2%        24.5%        47.9%      |  24.1%        18.6%        14.7%         0.0%      |
|TERMINAL (d)           |  4/37 (11%)   2/8 (25%)    1/11 (9%)    0/2 (0%)   |  8/39 (21%)   1/13 (8%)    1/22 (5%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   445          578          460          505       |   659          647          659          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.026 *    P=0.002 **   P=0.100      P=0.032 *  |  P=0.178N     P=0.565N     P=0.348N     P=0.313N   |
|INCIDENTAL TUMOR       |  P=0.311N     P=0.140      P=0.610      P=0.674N   |  P=0.012N*    P=0.302N     P=0.087N     P=0.108N   |
|LOGISTIC REGRESSION    |  P=0.493N     P=0.061      P=0.598      P=0.567    |  P=0.031N*    P=0.375N     P=0.150N     P=0.165N   |
|COCHRAN-ARMITAGE       |  P=0.239N                                          |  P<0.001N**                                        |
|FISHER EXACT           |               P=0.095      P=0.573      P=0.500N   |               P=0.119N     P=0.023N*    P<0.001N** |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE  22
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    1/35 (3%)    2/65 (3%)    1/50 (2%)  |  3/49 (6%)    0/35 (0%)    3/65 (5%)    0/50 (0%)  |
|ADJUSTED (b)           |   8.1%         5.6%        12.7%        11.1%      |   7.4%         0.0%        13.6%         0.0%      |
|TERMINAL (d)           |  3/37 (8%)    0/8 (0%)     1/11 (9%)    0/2 (0%)   |  2/39 (5%)    0/13 (0%)    3/22 (14%)   0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   680 (T)      624          640          624       |   669          ---          682 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.258      P=0.663      P=0.414      P=0.375    |  P=0.593      P=0.375N     P=0.389      P=0.677N   |
|INCIDENTAL TUMOR       |  P=0.632N     P=0.622N     P=0.623      P=0.769    |  P=0.573N     P=0.262N     P=0.497      P=0.386N   |
|LOGISTIC REGRESSION    |  P=0.566      P=0.627N     P=0.642      P=0.673    |  P=0.645N     P=0.322N     P=0.463      P=0.559N   |
|COCHRAN-ARMITAGE       |  P=0.233N                                          |  P=0.127N                                          |
|FISHER EXACT           |               P=0.453N     P=0.377N     P=0.309N   |               P=0.193N     P=0.519N     P=0.117N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  8/50 (16%)   9/35 (26%)   9/65 (14%)   5/50 (10%) | 11/49 (22%)   3/35 (9%)    7/65 (11%)   0/50 (0%)  |
|ADJUSTED (b)           |  20.6%        51.1%        34.7%        53.7%      |  26.6%        18.6%        26.9%         0.0%      |
|TERMINAL (d)           |  7/37 (19%)   2/8 (25%)    2/11 (18%)   0/2 (0%)   |  9/39 (23%)   1/13 (8%)    4/22 (18%)   0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   445          578          460          505       |   659          647          659          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.014 *    P=0.004 **   P=0.065      P=0.012 *  |  P=0.352N     P=0.498N     P=0.525      P=0.282N   |
|INCIDENTAL TUMOR       |  P=0.325N     P=0.206      P=0.539      P=0.667    |  P=0.054N     P=0.251N     P=0.363N     P=0.097N   |
|LOGISTIC REGRESSION    |  P=0.478N     P=0.115      P=0.541N     P=0.562    |  P=0.116N     P=0.313N     P=0.449N     P=0.148N   |
|COCHRAN-ARMITAGE       |  P=0.127N                                          |  P<0.001N**                                        |
|FISHER EXACT           |               P=0.204      P=0.474N     P=0.277N   |               P=0.080N     P=0.076N     P<0.001N** |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE  23
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    4/35 (11%)   1/65 (2%)    0/50 (0%)  |  0/49 (0%)    1/35 (3%)    0/65 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%        32.4%         4.5%         0.0%      |   0.0%         3.1%         0.0%         0.0%      |
|TERMINAL (d)           |  0/37 (0%)    2/8 (25%)    0/11 (0%)    0/2 (0%)   |  0/39 (0%)    0/13 (0%)    0/22 (0%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   ---          583          646          ---       |   ---          506          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.481      P=0.002 **   P=0.381        (e)      |  P=0.607N     P=0.423        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.418N     P=0.018 *    P=0.757        (e)      |  P=0.344N     P=0.795        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.494N     P=0.015 *    P=0.512        (e)      |  P=0.416N     P=0.472        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.258N                                          |  P=0.547N                                          |
|FISHER EXACT           |               P=0.026 *    P=0.565        (e)      |               P=0.417        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/35 (0%)    3/65 (5%)    0/50 (0%)  |  0/49 (0%)    0/35 (0%)    0/65 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%        19.5%         0.0%      |   0.0%         0.0%         0.0%        12.5%      |
|TERMINAL (d)           |  0/37 (0%)    0/8 (0%)     2/11 (18%)   0/2 (0%)   |  0/39 (0%)    0/13 (0%)    0/22 (0%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   ---          ---          460          ---       |   ---          ---          ---          646       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.168        (e)        P=0.027 *      (e)      |  P=0.057        (e)          (e)        P=0.165    |
|INCIDENTAL TUMOR       |  P=0.328        (e)        P=0.040 *      (e)      |  P=0.180        (e)          (e)        P=0.500    |
|LOGISTIC REGRESSION    |  P=0.531        (e)        P=0.182        (e)      |  P=0.121        (e)          (e)        P=0.350    |
|COCHRAN-ARMITAGE       |  P=0.576                                           |  P=0.212                                           |
|FISHER EXACT           |                 (e)        P=0.177        (e)      |                 (e)          (e)        P=0.505    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE  24
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    4/35 (11%)   4/65 (6%)    0/50 (0%)  |  0/49 (0%)    1/35 (3%)    0/65 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%        32.4%        23.2%         0.0%      |   0.0%         3.1%         0.0%        12.5%      |
|TERMINAL (d)           |  0/37 (0%)    2/8 (25%)    2/11 (18%)   0/2 (0%)   |  0/39 (0%)    0/13 (0%)    0/22 (0%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   ---          583          460          ---       |   ---          506          ---          646       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.172      P=0.002 **   P=0.010 **     (e)      |  P=0.245      P=0.423        (e)        P=0.165    |
|INCIDENTAL TUMOR       |  P=0.580      P=0.018 *    P=0.038 *      (e)      |  P=0.574      P=0.795        (e)        P=0.500    |
|LOGISTIC REGRESSION    |  P=0.571N     P=0.015 *    P=0.100        (e)      |  P=0.497      P=0.472        (e)        P=0.350    |
|COCHRAN-ARMITAGE       |  P=0.349N                                          |  P=0.435                                           |
|FISHER EXACT           |               P=0.026 *    P=0.098        (e)      |               P=0.417        (e)        P=0.505    |
|=================================================================================================================================|
|                                                                                                                                 |
|Tongue                                                                                                                           |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    1/35 (3%)    2/65 (3%)    0/50 (0%)  |  0/50 (0%)    1/35 (3%)    3/65 (5%)    3/50 (6%)  |
|ADJUSTED (b)           |   0.0%         2.9%         5.1%         0.0%      |   0.0%         7.7%         6.7%        34.1%      |
|TERMINAL (d)           |  0/37 (0%)    0/8 (0%)     0/11 (0%)    0/2 (0%)   |  0/40 (0%)    1/13 (8%)    0/22 (0%)    1/4 (25%)  |
|FIRST INCIDENCE (DAYS) |   ---          293          502          ---       |   ---          682 (T)      432          585       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.597      P=0.429      P=0.226        (e)      |  P=0.003 **   P=0.277      P=0.118      P=0.003 ** |
|INCIDENTAL TUMOR       |  P=0.321N     P=0.500      P=0.608        (e)      |  P=0.147      P=0.277      P=0.622      P=0.114    |
|LOGISTIC REGRESSION    |  P=0.334N     P=0.500      P=0.344        (e)      |  P=0.057      P=0.277      P=0.236      P=0.031 *  |
|COCHRAN-ARMITAGE       |  P=0.583N                                          |  P=0.085                                           |
|FISHER EXACT           |               P=0.412      P=0.317        (e)      |               P=0.412      P=0.177      P=0.121    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE  25
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Tongue                                                                                                                           |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    1/35 (3%)    3/65 (5%)    2/50 (4%)  |  2/50 (4%)    2/35 (6%)    4/65 (6%)    7/50 (14%) |
|ADJUSTED (b)           |   0.0%         2.9%        13.0%         8.9%      |   5.0%        11.2%        10.9%        60.0%      |
|TERMINAL (d)           |  0/37 (0%)    0/8 (0%)     0/11 (0%)    0/2 (0%)   |  2/40 (5%)    1/13 (8%)    1/22 (5%)    2/4 (50%)  |
|FIRST INCIDENCE (DAYS) |   ---          293          502          551       |   682 (T)      558          432          372       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.035 *    P=0.429      P=0.059      P=0.104    |  P<0.001 **   P=0.322      P=0.209      P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.428      P=0.500      P=0.460      P=0.516    |  P=0.032 *    P=0.517      P=0.594      P=0.027 *  |
|LOGISTIC REGRESSION    |  P=0.326      P=0.500      P=0.185      P=0.248    |  P=0.033 *    P=0.520      P=0.483      P=0.054    |
|COCHRAN-ARMITAGE       |  P=0.194                                           |  P=0.039 *                                         |
|FISHER EXACT           |               P=0.412      P=0.177      P=0.247    |               P=0.547      P=0.471      P=0.080    |
|=================================================================================================================================|
|                                                                                                                                 |
|Tongue                                                                                                                           |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/35 (0%)    1/65 (2%)    2/50 (4%)  |  2/50 (4%)    1/35 (3%)    1/65 (2%)    4/50 (8%)  |
|ADJUSTED (b)           |   0.0%         0.0%         8.3%         8.9%      |   5.0%         3.8%         4.5%        31.6%      |
|TERMINAL (d)           |  0/37 (0%)    0/8 (0%)     0/11 (0%)    0/2 (0%)   |  2/40 (5%)    0/13 (0%)    1/22 (5%)    1/4 (25%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          679          551       |   682 (T)      558          682 (T)      372       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.006 **     (e)        P=0.277      P=0.104    |  P=0.015 *    P=0.676      P=0.703N     P=0.022 *  |
|INCIDENTAL TUMOR       |  P=0.097        (e)        P=0.757      P=0.516    |  P=0.114      P=0.614N     P=0.703N     P=0.228    |
|LOGISTIC REGRESSION    |  P=0.054        (e)        P=0.303      P=0.248    |  P=0.231      P=0.631N     P=0.703N     P=0.426    |
|COCHRAN-ARMITAGE       |  P=0.081                                           |  P=0.201                                           |
|FISHER EXACT           |                 (e)        P=0.565      P=0.247    |               P=0.633N     P=0.402N     P=0.339    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE  26
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  1/50 (2%)    0/35 (0%)    0/65 (0%)    3/50 (6%)  |
|ADJUSTED (b)           |                                                    |   2.5%         0.0%         0.0%        19.1%      |
|TERMINAL (d)           |                                                    |  1/40 (3%)    0/13 (0%)    0/22 (0%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |                                                    |   682 (T)      ---          ---          607       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.008 **   P=0.723N     P=0.619N     P=0.018 *  |
|INCIDENTAL TUMOR       |                                                    |  P=0.162      P=0.723N     P=0.619N     P=0.707    |
|LOGISTIC REGRESSION    |                                                    |  P=0.042 *    P=0.723N     P=0.619N     P=0.132    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.101                                           |
|FISHER EXACT           |                                                    |               P=0.588N     P=0.435N     P=0.309    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  5/50 (10%)   8/35 (23%)  12/65 (18%)   5/50 (10%) |
|ADJUSTED (b)           |                                                    |  12.5%        41.5%        39.4%        32.4%      |
|TERMINAL (d)           |                                                    |  5/40 (13%)   4/13 (31%)   7/22 (32%)   1/4 (25%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   682 (T)      540          432          453       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.007 **   P=0.005 **   P=0.005 **   P=0.034 *  |
|INCIDENTAL TUMOR       |                                                    |  P=0.316      P=0.068      P=0.038 *    P=0.340    |
|LOGISTIC REGRESSION    |                                                    |  P=0.514      P=0.056      P=0.078      P=0.630N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.408N                                          |
|FISHER EXACT           |                                                    |               P=0.095      P=0.158      P=0.630N   |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE  27
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  1/50 (2%)    0/35 (0%)    1/65 (2%)    2/50 (4%)  |
|ADJUSTED (b)           |                                                    |   2.1%         0.0%         4.5%         6.9%      |
|TERMINAL (d)           |                                                    |  0/40 (0%)    0/13 (0%)    1/22 (5%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |                                                    |   502          ---          682 (T)      408       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.117      P=0.581N     P=0.711      P=0.361    |
|INCIDENTAL TUMOR       |                                                    |  P=0.434      P=0.205N     P=0.682N     P=0.343N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.434      P=0.533N     P=0.658N     P=0.712N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.279                                           |
|FISHER EXACT           |                                                    |               P=0.588N     P=0.683N     P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  6/50 (12%)   8/35 (23%)  13/65 (20%)   7/50 (14%) |
|ADJUSTED (b)           |                                                    |  14.3%        41.5%        43.5%        37.1%      |
|TERMINAL (d)           |                                                    |  5/40 (13%)   4/13 (31%)   8/22 (36%)   1/4 (25%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   502          540          432          408       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.002 **   P=0.014 *    P=0.006 **   P=0.021 *  |
|INCIDENTAL TUMOR       |                                                    |  P=0.250      P=0.190      P=0.057      P=0.642    |
|LOGISTIC REGRESSION    |                                                    |  P=0.453      P=0.148      P=0.115      P=0.542N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.549N                                          |
|FISHER EXACT           |                                                    |               P=0.151      P=0.187      P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE  28
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    2/35 (6%)    2/65 (3%)    4/50 (8%)  |  0/50 (0%)    1/35 (3%)    5/65 (8%)    3/50 (6%)  |
|ADJUSTED (b)           |   0.0%        21.3%         5.0%        22.2%      |   0.0%         3.0%        15.4%        13.1%      |
|TERMINAL (d)           |  0/37 (0%)    1/8 (13%)    0/11 (0%)    0/2 (0%)   |  0/40 (0%)    0/13 (0%)    1/22 (5%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   ---          660          577          551       |   ---          495          432          547       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.023 *    P=0.228      P=0.004 ** |  P=0.006 **   P=0.421      P=0.016 *    P=0.031 *  |
|INCIDENTAL TUMOR       |  P=0.045 *    P=0.149      P=0.678      P=0.282    |  P=0.284      P=0.795      P=0.136      P=0.672    |
|LOGISTIC REGRESSION    |  P=0.024 *    P=0.054      P=0.316      P=0.041 *  |  P=0.118      P=0.462      P=0.067      P=0.122    |
|COCHRAN-ARMITAGE       |  P=0.057                                           |  P=0.097                                           |
|FISHER EXACT           |               P=0.167      P=0.317      P=0.059    |               P=0.412      P=0.054      P=0.121    |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    3/35 (9%)    8/65 (12%)  17/50 (34%) |  0/50 (0%)    4/35 (11%)   7/65 (11%)  14/50 (28%) |
|ADJUSTED (b)           |   2.2%        13.3%        22.5%        46.3%      |   0.0%        14.5%        17.0%        60.2%      |
|TERMINAL (d)           |  0/37 (0%)    0/8 (0%)     0/11 (0%)    0/2 (0%)   |  0/40 (0%)    0/13 (0%)    1/22 (5%)    1/4 (25%)  |
|FIRST INCIDENCE (DAYS) |   501          583          323          372       |   ---          465          432          296       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.128      P=0.014 *    P<0.001 ** |  P<0.001 **   P=0.017 *    P=0.007 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.016 *    P=0.631      P=0.262      P=0.172    |  P=0.006 **   P=0.247      P=0.140      P=0.013 *  |
|LOGISTIC REGRESSION    |  P=0.006 **   P=0.247      P=0.083      P=0.088    |  P=0.007 **   P=0.056      P=0.037 *    P=0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.187      P=0.040 *    P<0.001 ** |               P=0.026 *    P=0.016 *    P<0.001 ** |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE  29
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    5/35 (14%)  10/65 (15%)  20/50 (40%) |  0/50 (0%)    4/35 (11%)  11/65 (17%)  17/50 (34%) |
|ADJUSTED (b)           |   2.2%        31.7%        26.4%        54.0%      |   0.0%        14.5%        28.8%        65.4%      |
|TERMINAL (d)           |  0/37 (0%)    1/8 (13%)    0/11 (0%)    0/2 (0%)   |  0/40 (0%)    0/13 (0%)    2/22 (9%)    1/4 (25%)  |
|FIRST INCIDENCE (DAYS) |   501          583          323          372       |   ---          465          432          296       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.007 **   P=0.005 **   P<0.001 ** |  P<0.001 **   P=0.017 *    P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.004 **   P=0.216      P=0.206      P=0.077    |  P=0.001 **   P=0.247      P=0.026 *    P=0.009 ** |
|LOGISTIC REGRESSION    |  P=0.002 **   P=0.045 *    P=0.037 *    P=0.040 *  |  P<0.001 **   P=0.056      P=0.004 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.041 *    P=0.014 *    P<0.001 ** |               P=0.026 *    P=0.001 **   P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 17/50 (34%)  19/35 (54%)  28/65 (43%)  20/50 (40%) |  7/50 (14%)  13/35 (37%)  27/65 (42%)  15/50 (30%) |
|ADJUSTED (b)           |  39.1%        84.3%        91.6%       100.0%      |  16.3%        51.0%        67.2%        83.6%      |
|TERMINAL (d)           | 11/37 (30%)   5/8 (63%)    9/11 (82%)   2/2 (100%) |  5/40 (13%)   3/13 (23%)  11/22 (50%)   2/4 (50%)  |
|FIRST INCIDENCE (DAYS) |   445          544          472          452       |   624          463          449          453       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.067      P=0.187      P=0.140      P=0.372    |  P=0.115      P=0.137      P=0.003 **   P=0.076    |
|LOGISTIC REGRESSION    |  P=0.004 **   P=0.018 *    P=0.053      P=0.012 *  |  P=0.066      P=0.025 *    P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.471                                           |  P=0.089                                           |
|FISHER EXACT           |               P=0.051      P=0.213      P=0.339    |               P=0.014 *    P=0.001 **   P=0.045 *  |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE  30
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma Benign, Malignant, NOS                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    3/35 (9%)    2/65 (3%)    2/50 (4%)  |  0/50 (0%)    1/35 (3%)    0/65 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   2.7%        19.3%         6.1%         7.5%      |   0.0%         5.9%         0.0%         0.0%      |
|TERMINAL (d)           |  1/37 (3%)    1/8 (13%)    0/11 (0%)    0/2 (0%)   |  0/40 (0%)    0/13 (0%)    0/22 (0%)    0/4 (0%)   |
|FIRST INCIDENCE (DAYS) |   680 (T)      513          451          463       |   ---          647          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.148      P=0.053      P=0.333      P=0.167    |  P=0.815      P=0.306        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.506N     P=0.174      P=0.663      P=0.631    |  P=0.561N     P=0.500        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.575N     P=0.193      P=0.640      P=0.534    |  P=0.655N     P=0.410        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.558                                           |  P=0.549N                                          |
|FISHER EXACT           |               P=0.187      P=0.598      P=0.500    |               P=0.412        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 48/50 (96%)  33/35 (94%)  62/65 (95%)  46/50 (92%) | 38/50 (76%)  27/35 (77%)  54/65 (83%)  33/50 (66%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  79.1%        89.3%       100.0%       100.0%      |
|TERMINAL (d)           | 37/37 (100%)  8/8 (100%)  11/11 (100%)  2/2 (100%) | 30/40 (75%)  10/13 (77%)  22/22 (100%)  4/4 (100%) |
|FIRST INCIDENCE (DAYS) |   445          316          372          317       |   292          463          368          372       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.304      P=0.705      P=0.551N     P=0.692    |  P=0.334      P=0.485      P=0.050      P=0.459    |
|LOGISTIC REGRESSION    |  P=0.093      P=0.623      P=0.760N     P=0.249    |  P=0.158      P=0.471      P=0.019 *    P=0.259    |
|COCHRAN-ARMITAGE       |  P=0.268N                                          |  P=0.144N                                          |
|FISHER EXACT           |               P=0.547N     P=0.623N     P=0.339N   |               P=0.558      P=0.240      P=0.189N   |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE  31
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.063        0.125        0.25      |   CONTROL      0.063        0.125        0.25      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 23/50 (46%)  27/35 (77%)  54/65 (83%)  45/50 (90%) | 21/50 (42%)  25/35 (71%)  56/65 (86%)  48/50 (96%) |
|ADJUSTED (b)           |  51.9%        89.3%        95.9%       100.0%      |  45.3%        74.2%        91.4%       100.0%      |
|TERMINAL (d)           | 16/37 (43%)   5/8 (63%)    9/11 (82%)   2/2 (100%) | 15/40 (38%)   5/13 (38%)  17/22 (77%)   4/4 (100%) |
|FIRST INCIDENCE (DAYS) |   445          293          323          243       |   500          463          253          296       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.063      P=0.003 **   P=0.002 ** |  P<0.001 **   P=0.349      P<0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.003 **   P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.076      P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.004 **   P<0.001 **   P<0.001 ** |               P=0.007 **   P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 48/50 (96%)  34/35 (97%)  65/65 (100%) 48/50 (96%) | 43/50 (86%)  33/35 (94%)  64/65 (98%)  49/50 (98%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  86.0%        94.3%       100.0%       100.0%      |
|TERMINAL (d)           | 37/37 (100%)  8/8 (100%)  11/11 (100%)  2/2 (100%) | 33/40 (83%)  11/13 (85%)  22/22 (100%)  4/4 (100%) |
|FIRST INCIDENCE (DAYS) |   445          293          323          243       |   292          463          253          296       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.286      P=0.434      P=0.362      P=0.390    |  P=0.098      P=0.597      P=0.069      P=0.531    |
|LOGISTIC REGRESSION    |  P=0.018 *    P=0.334      P=0.138      P=0.022 *  |  P=0.010 *    P=0.597      P=0.014 *    P=0.071    |
|COCHRAN-ARMITAGE       |  P=0.607                                           |  P=0.009 **                                        |
|FISHER EXACT           |               P=0.633      P=0.187      P=0.691N   |               P=0.196      P=0.012 *    P=0.030 *  |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05169 TEST: 01                                                 PAGE  32
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15
 
                                                 TERMINAL SACRIFICE AT 98 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).

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