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TDMS Study 05163-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: HLA, VA                                               C. I. ACID RED 114                                  DATE: 09/17/94       
EXPERIMENT: 05163 TEST: 01                                                                                     TIME: 22:05:25       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1ES9565503          ROUTE: DOSED WATER                                                                 NTP C#: 61096        
PATHOLOGIST: G. PARKER                       S. EUSTIS                                                         CAS: 6459-94-5       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               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. ACID RED 114                                  DATE: 09/17/94      
EXPERIMENT: 05163 TEST: 01                                                                                     TIME: 22:05:25      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1ES9565503          ROUTE: DOSED WATER                                                                 NTP C#: 61096       
PATHOLOGIST: G. PARKER                       S. EUSTIS                                                         CAS: 6459-94-5      
 
 
 
 
 
                                                    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. ACID RED 114                                  DATE: 09/17/94       
EXPERIMENT: 05163 TEST: 01                                                                                     TIME: 22:05:25       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1ES9565503          ROUTE: DOSED WATER                                                                 NTP C#: 61096        
PATHOLOGIST: G. PARKER                       S. EUSTIS                                                         CAS: 6459-94-5       
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                       IN THE ANALYSIS OF THE STUDY OF C. I. ACID RED 114
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Benign
                                                           Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)
                                                           Papilloma Squamous or Papilloma
                                                           Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           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
                             Testes                        Adenoma
                             Thyroid Gland: Follicular Cell
                                                           Adenoma
                             Tongue                        Squamous Cell Carcinoma or Papilloma Squamous
                                                           Squamous Cell Papilloma
                             Zymbal's Gland                Carcinoma
                                                           Carcinoma or Adenoma
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: HLA, VA                                               C. I. ACID RED 114                                  DATE: 09/17/94       
EXPERIMENT: 05163 TEST: 01                                                                                     TIME: 22:05:25       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1ES9565503          ROUTE: DOSED WATER                                                                 NTP C#: 61096        
PATHOLOGIST: G. PARKER                       S. EUSTIS                                                         CAS: 6459-94-5       
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                       IN THE ANALYSIS OF THE STUDY OF C. I. ACID RED 114
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Benign
                                                           Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Clitoral/Preputial Gland      Adenoma
                                                           Carcinoma
                                                           Carcinoma or Adenoma
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             Mammary Gland                 Adenoma
                                                           Carcinoma
                                                           Carcinoma or Adenoma
                                                           Fibroadenoma
                                                           Fibroma, Fibroadenoma or Adenoma
                                                           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
                             Skin                          Basal Cell Adenoma
                                                           Basal Cell Carcinoma
                                                           Squamous Cell Carcinoma
                                                           Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
                                                           Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma
                                                           Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,
                                                            Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma
                             Skin: Subcutaneous Tissue     Fibroma
                                                           Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
                                                            Neurofibroma, or Fibroma
                             Thyroid Gland: C-Cell         Adenoma
                                                           Carcinoma
                                                           Carcinoma or Adenoma
                             Thyroid Gland: Follicular Cell
                                                           Adenoma
                                                           Carcinoma or Adenoma
                             Tongue                        Squamous Cell Carcinoma or Papilloma Squamous
                                                           Squamous Cell Papilloma
                             Tooth                         Odontoma
                             Uterus                        Polyp Stromal
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: HLA, VA                                               C. I. ACID RED 114                                  DATE: 09/17/94       
EXPERIMENT: 05163 TEST: 01                                                                                     TIME: 22:05:25       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1ES9565503          ROUTE: DOSED WATER                                                                 NTP C#: 61096        
PATHOLOGIST: G. PARKER                       S. EUSTIS                                                         CAS: 6459-94-5       
 
                                                           Sarcoma Stromal or Polyp Stromal
                             Zymbal's Gland                Adenoma
                                                           Carcinoma
                                                           Carcinoma or Adenoma
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Malignant Lymphoma And Histiocytic Sarcoma
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE   1
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 16/50 (32%)  11/35 (31%)  24/63 (38%)  20/49 (41%) |  1/50 (2%)    3/35 (9%)    4/64 (6%)    1/50 (2%)  |
|ADJUSTED (b)           |  50.8%        59.1%        60.5%       100.0%      |   2.4%        17.8%        31.1%         5.6%      |
|TERMINAL (d)           | 10/24 (42%)   8/15 (53%)  12/26 (46%)   1/1 (100%) |  0/36 (0%)    2/13 (15%)   1/6 (17%)    0/0        |
|FIRST INCIDENCE (DAYS) |   607          524          565          524       |   641          411          521          456       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.503      P=0.216      P<0.001 ** |  P=0.011 *    P=0.096      P=0.021 *    P=0.301    |
|INCIDENTAL TUMOR       |  P=0.007 **   P=0.496      P=0.338      P=0.025 *  |  P=0.566      P=0.199      P=0.400      P=0.517N   |
|LOGISTIC REGRESSION    |  P=0.003 **   P=0.573      P=0.312      P=0.007 ** |  P=0.460      P=0.259      P=0.156      P=0.871N   |
|COCHRAN-ARMITAGE       |  P=0.171                                           |  P=0.461N                                          |
|FISHER EXACT           |               P=0.574N     P=0.318      P=0.241    |               P=0.187      P=0.268      P=0.753N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    0/35 (0%)    3/63 (5%)    2/49 (4%)  |  0/50 (0%)    0/35 (0%)    1/64 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |   5.3%         0.0%        10.2%         6.0%      |   0.0%         0.0%        10.0%         0.0%      |
|TERMINAL (d)           |  0/24 (0%)    0/15 (0%)    2/26 (8%)    0/1 (0%)   |  0/36 (0%)    0/13 (0%)    0/6 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   607          ---          691          412       |   ---          ---          715          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.168      P=0.339N     P=0.568      P=0.511    |  P=0.277        (e)        P=0.236        (e)      |
|INCIDENTAL TUMOR       |  P=0.497      P=0.390N     P=0.638      P=0.481N   |  P=0.676        (e)        P=0.718        (e)      |
|LOGISTIC REGRESSION    |  P=0.478      P=0.319N     P=0.607      P=0.639N   |  P=0.363        (e)        P=0.318        (e)      |
|COCHRAN-ARMITAGE       |  P=0.459                                           |  P=0.713                                           |
|FISHER EXACT           |               P=0.343N     P=0.609      P=0.684    |                 (e)        P=0.561        (e)      |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE   2
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 17/50 (34%)  11/35 (31%)  27/63 (43%)  22/49 (45%) |  1/50 (2%)    3/35 (9%)    5/64 (8%)    1/50 (2%)  |
|ADJUSTED (b)           |  52.2%        59.1%        67.1%       100.0%      |   2.4%        17.8%        38.7%         5.6%      |
|TERMINAL (d)           | 10/24 (42%)   8/15 (53%)  14/26 (54%)   1/1 (100%) |  0/36 (0%)    2/13 (15%)   1/6 (17%)    0/0        |
|FIRST INCIDENCE (DAYS) |   607          524          565          412       |   641          411          521          456       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.572      P=0.142      P<0.001 ** |  P=0.003 **   P=0.096      P=0.004 **   P=0.301    |
|INCIDENTAL TUMOR       |  P=0.003 **   P=0.585      P=0.237      P=0.027 *  |  P=0.479      P=0.199      P=0.311      P=0.517N   |
|LOGISTIC REGRESSION    |  P=0.002 **   P=0.542N     P=0.212      P=0.009 ** |  P=0.306      P=0.259      P=0.060      P=0.871N   |
|COCHRAN-ARMITAGE       |  P=0.105                                           |  P=0.479N                                          |
|FISHER EXACT           |               P=0.496N     P=0.223      P=0.183    |               P=0.187      P=0.171      P=0.753N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/44 (5%)    1/34 (3%)    2/60 (3%)    1/48 (2%)  |  7/48 (15%)  10/32 (31%)  10/62 (16%)  10/50 (20%) |
|ADJUSTED (b)           |  11.1%         7.1%         4.6%         0.0%      |  18.9%        52.7%        62.7%        45.3%      |
|TERMINAL (d)           |  2/18 (11%)   1/14 (7%)    0/22 (0%)    0/0        |  5/34 (15%)   4/11 (36%)   3/6 (50%)    0/0        |
|FIRST INCIDENCE (DAYS) |   732 (T)      732 (T)      565          456       |   663          538          403          351       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.496      P=0.589N     P=0.620N     P=0.496    |  P<0.001 **   P=0.004 **   P=0.002 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.493N     P=0.589N     P=0.561N     P=0.805    |  P=0.211      P=0.072      P=0.197      P=0.322    |
|LOGISTIC REGRESSION    |  P=0.391N     P=0.589N     P=0.573N     P=0.516N   |  P=0.091      P=0.028 *    P=0.271      P=0.231    |
|COCHRAN-ARMITAGE       |  P=0.372N                                          |  P=0.480                                           |
|FISHER EXACT           |               P=0.597N     P=0.566N     P=0.467N   |               P=0.067      P=0.520      P=0.330    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE   3
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/44 (11%)   3/34 (9%)    3/60 (5%)    4/48 (8%)  |  4/48 (8%)    9/32 (28%)  19/62 (31%)  15/50 (30%) |
|ADJUSTED (b)           |  21.6%        13.1%         5.6%         0.0%      |  10.5%        47.6%        76.8%       100.0%      |
|TERMINAL (d)           |  3/18 (17%)   1/14 (7%)    0/22 (0%)    0/0        |  2/34 (6%)    4/11 (36%)   3/6 (50%)    0/0        |
|FIRST INCIDENCE (DAYS) |   680          530          530          530       |   641          411          400          339       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.318      P=0.545N     P=0.252N     P=0.093    |  P<0.001 **   P=0.003 **   P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.176N     P=0.392N     P=0.202N     P=0.606N   |  P=0.009 **   P=0.034 *    P=0.012 *    P=0.148    |
|LOGISTIC REGRESSION    |  P=0.323N     P=0.502N     P=0.199N     P=0.586N   |  P=0.003 **   P=0.030 *    P=0.001 **   P=0.022 *  |
|COCHRAN-ARMITAGE       |  P=0.363N                                          |  P=0.016 *                                         |
|FISHER EXACT           |               P=0.509N     P=0.202N     P=0.444N   |               P=0.021 *    P=0.003 **   P=0.006 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/44 (16%)   4/34 (12%)   5/60 (8%)    5/48 (10%) | 11/48 (23%)  17/32 (53%)  28/62 (45%)  23/50 (46%) |
|ADJUSTED (b)           |  32.0%        19.8%        10.0%         0.0%      |  28.2%        81.7%       100.0%       100.0%      |
|TERMINAL (d)           |  5/18 (28%)   2/14 (14%)   0/22 (0%)    0/0        |  7/34 (21%)   8/11 (73%)   6/6 (100%)   0/0        |
|FIRST INCIDENCE (DAYS) |   680          530          530          456       |   641          411          400          339       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.274      P=0.458N     P=0.252N     P=0.053    |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.158N     P=0.327N     P=0.181N     P=0.662N   |  P=0.003 **   P=0.006 **   P=0.003 **   P=0.067    |
|LOGISTIC REGRESSION    |  P=0.237N     P=0.423N     P=0.182N     P=0.449N   |  P<0.001 **   P=0.003 **   P=0.001 **   P=0.014 *  |
|COCHRAN-ARMITAGE       |  P=0.260N                                          |  P=0.041 *                                         |
|FISHER EXACT           |               P=0.428N     P=0.188N     P=0.318N   |               P=0.006 **   P=0.013 *    P=0.014 *  |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE   4
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Heart                                                                                                                            |
|     Schwannoma NOS                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/35 (0%)    2/65 (3%)    0/50 (0%)  |  0/50 (0%)    0/35 (0%)    0/64 (0%)    0/49 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         6.3%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/24 (0%)    0/15 (0%)    1/26 (4%)    0/1 (0%)   |  0/36 (0%)    0/13 (0%)    0/6 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          681          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.355        (e)        P=0.267        (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.515        (e)        P=0.307        (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.487        (e)        P=0.290        (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.619                                           |    (e)                                             |
|FISHER EXACT           |                 (e)        P=0.317        (e)      |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    1/35 (3%)    0/65 (0%)    0/50 (0%)  |  1/50 (2%)    0/35 (0%)    1/63 (2%)    0/49 (0%)  |
|ADJUSTED (b)           |   6.2%         4.3%         0.0%         0.0%      |   2.8%         0.0%         2.5%         0.0%      |
|TERMINAL (d)           |  1/24 (4%)    0/15 (0%)    0/26 (0%)    0/1 (0%)   |  1/36 (3%)    0/13 (0%)    0/6 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   454          658          ---          ---       |   733 (T)      ---          575          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.132N     P=0.643N     P=0.202N     P=0.478N   |  P=0.670      P=0.702N     P=0.577        (e)      |
|INCIDENTAL TUMOR       |  P=0.051N     P=0.527N     P=0.231N     P=0.195N   |  P=0.677N     P=0.702N     P=0.804        (e)      |
|LOGISTIC REGRESSION    |  P=0.070N     P=0.631N     P=0.205N     P=0.201N   |  P=0.632N     P=0.702N     P=0.778N       (e)      |
|COCHRAN-ARMITAGE       |  P=0.083N                                          |  P=0.381N                                          |
|FISHER EXACT           |               P=0.633N     P=0.187N     P=0.247N   |               P=0.588N     P=0.691N     P=0.505N   |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE   5
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    1/35 (3%)   10/65 (15%)  15/50 (30%) |  0/50 (0%)    0/35 (0%)   15/63 (24%)   6/50 (12%) |
|ADJUSTED (b)           |   6.5%         6.7%        31.9%       100.0%      |   0.0%         0.0%        64.0%       100.0%      |
|TERMINAL (d)           |  1/24 (4%)    1/15 (7%)    7/26 (27%)   1/1 (100%) |  0/36 (0%)    0/13 (0%)    1/6 (17%)    0/0        |
|FIRST INCIDENCE (DAYS) |   607          732 (T)      641          531       |   ---          ---          403          411       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.651N     P=0.030 *    P<0.001 ** |  P<0.001 **     (e)        P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.731      P=0.040 *    P=0.001 ** |  P=0.002 **     (e)        P=0.006 **   P=0.195    |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.631N     P=0.042 *    P<0.001 ** |  P<0.001 **     (e)        P<0.001 **   P=0.009 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.011 *                                         |
|FISHER EXACT           |               P=0.633N     P=0.043 *    P<0.001 ** |                 (e)        P<0.001 **   P=0.013 *  |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    1/35 (3%)    6/65 (9%)    7/50 (14%) |  0/50 (0%)    0/35 (0%)    6/63 (10%)   3/50 (6%)  |
|ADJUSTED (b)           |   0.0%         4.8%        21.4%        31.5%      |   0.0%         0.0%        31.2%       100.0%      |
|TERMINAL (d)           |  0/24 (0%)    0/15 (0%)    5/26 (19%)   0/1 (0%)   |  0/36 (0%)    0/13 (0%)    0/6 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   ---          694          687          530       |   ---          ---          400          501       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.422      P=0.023 *    P<0.001 ** |  P<0.001 **     (e)        P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.001 **   P=0.467      P=0.027 *    P=0.053    |  P=0.040 *      (e)        P=0.203      P=0.274    |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.423      P=0.023 *    P=0.008 ** |  P=0.003 **     (e)        P=0.026 *    P=0.009 ** |
|COCHRAN-ARMITAGE       |  P=0.003 **                                        |  P=0.063                                           |
|FISHER EXACT           |               P=0.412      P=0.029 *    P=0.006 ** |                 (e)        P=0.027 *    P=0.121    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE   6
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    2/35 (6%)   15/65 (23%)  20/50 (40%) |  0/50 (0%)    0/35 (0%)   19/63 (30%)   8/50 (16%) |
|ADJUSTED (b)           |   6.5%        11.1%        47.7%       100.0%      |   0.0%         0.0%        72.4%       100.0%      |
|TERMINAL (d)           |  1/24 (4%)    1/15 (7%)   11/26 (42%)   1/1 (100%) |  0/36 (0%)    0/13 (0%)    1/6 (17%)    0/0        |
|FIRST INCIDENCE (DAYS) |   607          694          641          530       |   ---          ---          400          411       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.532      P=0.002 **   P<0.001 ** |  P<0.001 **     (e)        P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.479      P=0.003 **   P<0.001 ** |  P<0.001 **     (e)        P=0.002 **   P=0.101    |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.553      P=0.003 **   P<0.001 ** |  P<0.001 **     (e)        P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.003 **                                        |
|FISHER EXACT           |               P=0.547      P=0.003 **   P<0.001 ** |                 (e)        P<0.001 **   P=0.003 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    2/35 (6%)   15/65 (23%)  20/50 (40%) |  0/50 (0%)    0/35 (0%)   19/63 (30%)   8/50 (16%) |
|ADJUSTED (b)           |   6.5%        11.1%        47.7%       100.0%      |   0.0%         0.0%        72.4%       100.0%      |
|TERMINAL (d)           |  1/24 (4%)    1/15 (7%)   11/26 (42%)   1/1 (100%) |  0/36 (0%)    0/13 (0%)    1/6 (17%)    0/0        |
|FIRST INCIDENCE (DAYS) |   607          694          641          530       |   ---          ---          400          411       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.532      P=0.002 **   P<0.001 ** |  P<0.001 **     (e)        P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.479      P=0.003 **   P<0.001 ** |  P<0.001 **     (e)        P=0.002 **   P=0.101    |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.553      P=0.003 **   P<0.001 ** |  P<0.001 **     (e)        P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.003 **                                        |
|FISHER EXACT           |               P=0.547      P=0.003 **   P<0.001 ** |                 (e)        P<0.001 **   P=0.003 ** |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE   7
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    2/35 (6%)    1/65 (2%)    3/50 (6%)  |  1/50 (2%)    2/35 (6%)    8/65 (12%)   4/50 (8%)  |
|ADJUSTED (b)           |   0.0%        11.9%         2.1%       100.0%      |   2.8%         8.3%        46.0%        30.5%      |
|TERMINAL (d)           |  0/24 (0%)    1/15 (7%)    0/26 (0%)    1/1 (100%) |  1/36 (3%)    0/13 (0%)    1/6 (17%)    0/0        |
|FIRST INCIDENCE (DAYS) |   ---          701          654          694       |   733 (T)      411          582          454       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.003 **   P=0.140      P=0.563      P<0.001 ** |  P<0.001 **   P=0.263      P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.067      P=0.173      P=0.605      P=0.037 *  |  P=0.035 *    P=0.504      P=0.051      P=0.369    |
|LOGISTIC REGRESSION    |  P=0.022 *    P=0.148      P=0.550      P=0.002 ** |  P=0.013 *    P=0.508      P=0.003 **   P=0.120    |
|COCHRAN-ARMITAGE       |  P=0.131                                           |  P=0.151                                           |
|FISHER EXACT           |               P=0.167      P=0.565      P=0.121    |               P=0.367      P=0.040 *    P=0.181    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    0/35 (0%)    1/65 (2%)    0/50 (0%)  |  0/50 (0%)    0/35 (0%)    1/65 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |   8.3%         0.0%         3.8%         0.0%      |   0.0%         0.0%         7.1%         0.0%      |
|TERMINAL (d)           |  2/24 (8%)    0/15 (0%)    1/26 (4%)    0/1 (0%)   |  0/36 (0%)    0/13 (0%)    0/6 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   732 (T)      ---          732 (T)      ---       |   ---          ---          693          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.455N     P=0.346N     P=0.472N     P=0.939N   |  P=0.325        (e)        P=0.296        (e)      |
|INCIDENTAL TUMOR       |  P=0.455N     P=0.346N     P=0.472N     P=0.939N   |  P=0.676        (e)        P=0.718        (e)      |
|LOGISTIC REGRESSION    |  P=0.455N     P=0.346N     P=0.472N     P=0.939N   |  P=0.473        (e)        P=0.407        (e)      |
|COCHRAN-ARMITAGE       |  P=0.167N                                          |  P=0.714                                           |
|FISHER EXACT           |               P=0.343N     P=0.402N     P=0.247N   |                 (e)        P=0.565        (e)      |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE   8
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    2/35 (6%)    2/65 (3%)    3/50 (6%)  |  1/50 (2%)    2/35 (6%)    9/65 (14%)   4/50 (8%)  |
|ADJUSTED (b)           |   8.3%        11.9%         5.8%       100.0%      |   2.8%         8.3%        50.1%        30.5%      |
|TERMINAL (d)           |  2/24 (8%)    1/15 (7%)    1/26 (4%)    1/1 (100%) |  1/36 (3%)    0/13 (0%)    1/6 (17%)    0/0        |
|FIRST INCIDENCE (DAYS) |   732 (T)      701          654          694       |   733 (T)      411          582          454       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.020 *    P=0.512      P=0.644N     P<0.001 ** |  P<0.001 **   P=0.263      P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.157      P=0.547      P=0.625N     P=0.058    |  P=0.025 *    P=0.504      P=0.036 *    P=0.369    |
|LOGISTIC REGRESSION    |  P=0.102      P=0.521      P=0.618N     P=0.017 *  |  P=0.007 **   P=0.508      P=0.001 **   P=0.120    |
|COCHRAN-ARMITAGE       |  P=0.450                                           |  P=0.151                                           |
|FISHER EXACT           |               P=0.547      P=0.586N     P=0.500    |               P=0.367      P=0.024 *    P=0.181    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    1/35 (3%)    0/65 (0%)    0/50 (0%)  |  1/50 (2%)    1/35 (3%)    4/65 (6%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         6.7%         0.0%         0.0%      |   2.6%         5.3%        27.5%         0.0%      |
|TERMINAL (d)           |  0/24 (0%)    1/15 (7%)    0/26 (0%)    0/1 (0%)   |  0/36 (0%)    0/13 (0%)    1/6 (17%)    0/0        |
|FIRST INCIDENCE (DAYS) |   ---          732 (T)      ---          ---       |   711          663          538          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.822N     P=0.406        (e)          (e)      |  P=0.048 *    P=0.558      P=0.022 *      (e)      |
|INCIDENTAL TUMOR       |  P=0.822N     P=0.406        (e)          (e)      |  P=0.628N     P=0.629N     P=0.400        (e)      |
|LOGISTIC REGRESSION    |  P=0.822N     P=0.406        (e)          (e)      |  P=0.433      P=0.672      P=0.166      P=0.999N   |
|COCHRAN-ARMITAGE       |  P=0.533N                                          |  P=0.394N                                          |
|FISHER EXACT           |               P=0.412        (e)          (e)      |               P=0.657      P=0.274      P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE   9
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/35 (0%)    0/65 (0%)    0/50 (0%)  |  0/50 (0%)    3/35 (9%)    6/65 (9%)    3/50 (6%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%        12.6%        29.2%         7.7%      |
|TERMINAL (d)           |  0/24 (0%)    0/15 (0%)    0/26 (0%)    0/1 (0%)   |  0/36 (0%)    0/13 (0%)    1/6 (17%)    0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          582          285          351       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P<0.001 **   P=0.042 *    P=0.003 **   P=0.081    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.527      P=0.220      P=0.089      P=0.897    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.456      P=0.089      P=0.061      P=0.755    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.202                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.066      P=0.029 *    P=0.121    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    1/35 (3%)    0/65 (0%)    0/50 (0%)  |  1/50 (2%)    4/35 (11%)  10/65 (15%)   3/50 (6%)  |
|ADJUSTED (b)           |   0.0%         6.7%         0.0%         0.0%      |   2.6%        17.2%        50.7%         7.7%      |
|TERMINAL (d)           |  0/24 (0%)    1/15 (7%)    0/26 (0%)    0/1 (0%)   |  0/36 (0%)    0/13 (0%)    2/6 (33%)    0/0        |
|FIRST INCIDENCE (DAYS) |   ---          732 (T)      ---          ---       |   711          582          285          351       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.822N     P=0.406        (e)          (e)      |  P<0.001 **   P=0.040 *    P<0.001 **   P=0.081    |
|INCIDENTAL TUMOR       |  P=0.822N     P=0.406        (e)          (e)      |  P=0.548      P=0.362      P=0.058      P=0.897    |
|LOGISTIC REGRESSION    |  P=0.822N     P=0.406        (e)          (e)      |  P=0.388      P=0.107      P=0.018 *    P=0.803N   |
|COCHRAN-ARMITAGE       |  P=0.533N                                          |  P=0.358                                           |
|FISHER EXACT           |               P=0.412        (e)          (e)      |               P=0.090      P=0.014 *    P=0.309    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE  10
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    0/35 (0%)    3/65 (5%)    1/50 (2%)  | 19/50 (38%)  13/35 (37%)  12/65 (18%)   1/50 (2%)  |
|ADJUSTED (b)           |   8.3%         0.0%        11.5%        20.0%      |  47.5%        74.4%        78.3%        50.0%      |
|TERMINAL (d)           |  2/24 (8%)    0/15 (0%)    3/26 (12%)   0/1 (0%)   | 15/36 (42%)   9/13 (69%)   4/6 (67%)    0/0        |
|FIRST INCIDENCE (DAYS) |   732 (T)      ---          732 (T)      711       |   683          638          538          603       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.142      P=0.346N     P=0.537      P=0.275    |  P<0.001 **   P=0.038 *    P=0.004 **   P=0.015 *  |
|INCIDENTAL TUMOR       |  P=0.251      P=0.346N     P=0.537      P=0.622    |  P=0.551      P=0.283      P=0.609      P=0.567    |
|LOGISTIC REGRESSION    |  P=0.216      P=0.346N     P=0.537      P=0.495    |  P=0.394      P=0.194      P=0.466      P=0.641    |
|COCHRAN-ARMITAGE       |  P=0.513N                                          |  P<0.001N**                                        |
|FISHER EXACT           |               P=0.343N     P=0.623      P=0.500N   |               P=0.560N     P=0.017N*    P<0.001N** |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    1/35 (3%)    3/65 (5%)    1/50 (2%)  | 19/50 (38%)  13/35 (37%)  14/65 (22%)   1/50 (2%)  |
|ADJUSTED (b)           |   8.3%         6.7%        11.5%        20.0%      |  47.5%        74.4%        90.0%        50.0%      |
|TERMINAL (d)           |  2/24 (8%)    1/15 (7%)    3/26 (12%)   0/1 (0%)   | 15/36 (42%)   9/13 (69%)   5/6 (83%)    0/0        |
|FIRST INCIDENCE (DAYS) |   732 (T)      732 (T)      732 (T)      711       |   683          638          538          603       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.170      P=0.664N     P=0.537      P=0.275    |  P<0.001 **   P=0.038 *    P<0.001 **   P=0.015 *  |
|INCIDENTAL TUMOR       |  P=0.278      P=0.664N     P=0.537      P=0.622    |  P=0.355      P=0.283      P=0.352      P=0.567    |
|LOGISTIC REGRESSION    |  P=0.249      P=0.664N     P=0.537      P=0.495    |  P=0.202      P=0.194      P=0.214      P=0.641    |
|COCHRAN-ARMITAGE       |  P=0.421N                                          |  P<0.001N**                                        |
|FISHER EXACT           |               P=0.633N     P=0.623      P=0.500N   |               P=0.560N     P=0.042N*    P<0.001N** |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE  11
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    1/35 (3%)    3/65 (5%)    1/50 (2%)  | 19/50 (38%)  16/35 (46%)  18/65 (28%)   4/50 (8%)  |
|ADJUSTED (b)           |   8.3%         6.7%        11.5%        20.0%      |  47.5%        77.7%        91.0%        53.9%      |
|TERMINAL (d)           |  2/24 (8%)    1/15 (7%)    3/26 (12%)   0/1 (0%)   | 15/36 (42%)   9/13 (69%)   5/6 (83%)    0/0        |
|FIRST INCIDENCE (DAYS) |   732 (T)      732 (T)      732 (T)      711       |   683          582          285          351       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.170      P=0.664N     P=0.537      P=0.275    |  P<0.001 **   P=0.006 **   P<0.001 **   P=0.007 ** |
|INCIDENTAL TUMOR       |  P=0.278      P=0.664N     P=0.537      P=0.622    |  P=0.484      P=0.128      P=0.251      P=0.483    |
|LOGISTIC REGRESSION    |  P=0.249      P=0.664N     P=0.537      P=0.495    |  P=0.479      P=0.068      P=0.288      P=0.673N   |
|COCHRAN-ARMITAGE       |  P=0.421N                                          |  P<0.001N**                                        |
|FISHER EXACT           |               P=0.633N     P=0.623      P=0.500N   |               P=0.313      P=0.166N     P<0.001N** |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Papilloma Squamous or Papilloma                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/35 (0%)    1/65 (2%)    2/50 (4%)  |  0/50 (0%)    3/35 (9%)    6/65 (9%)    4/50 (8%)  |
|ADJUSTED (b)           |   0.0%         0.0%         3.8%       100.0%      |   0.0%        18.3%        15.7%        20.3%      |
|TERMINAL (d)           |  0/24 (0%)    0/15 (0%)    1/26 (4%)    1/1 (100%) |  0/36 (0%)    2/13 (15%)   0/6 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          732 (T)      663       |   ---          567          487          349       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.002 **     (e)        P=0.516      P=0.011 *  |  P<0.001 **   P=0.023 *    P=0.011 *    P=0.005 ** |
|INCIDENTAL TUMOR       |  P=0.007 **     (e)        P=0.516      P=0.051    |  P=0.410      P=0.040 *    P=0.254      P=0.632    |
|LOGISTIC REGRESSION    |  P=0.013 *      (e)        P=0.516      P=0.077    |  P=0.193      P=0.059      P=0.066      P=0.302    |
|COCHRAN-ARMITAGE       |  P=0.080                                           |  P=0.110                                           |
|FISHER EXACT           |                 (e)        P=0.565      P=0.247    |               P=0.066      P=0.029 *    P=0.059    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE  12
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/35 (0%)    0/65 (0%)    0/50 (0%)  |  0/50 (0%)    0/35 (0%)    3/65 (5%)    2/50 (4%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         6.2%         5.6%      |
|TERMINAL (d)           |  0/24 (0%)    0/15 (0%)    0/26 (0%)    0/1 (0%)   |  0/36 (0%)    0/13 (0%)    0/6 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          ---          454          372       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.016 *      (e)        P=0.129      P=0.167    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.539        (e)        P=0.476      P=0.744    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.408        (e)        P=0.295      P=0.795    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.115                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |                 (e)        P=0.177      P=0.247    |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/35 (0%)    1/65 (2%)    2/50 (4%)  |  0/50 (0%)    3/35 (9%)    9/65 (14%)   6/50 (12%) |
|ADJUSTED (b)           |   0.0%         0.0%         3.8%       100.0%      |   0.0%        18.3%        20.9%        24.8%      |
|TERMINAL (d)           |  0/24 (0%)    0/15 (0%)    1/26 (4%)    1/1 (100%) |  0/36 (0%)    2/13 (15%)   0/6 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          732 (T)      663       |   ---          567          454          349       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.002 **     (e)        P=0.516      P=0.011 *  |  P<0.001 **   P=0.023 *    P=0.002 **   P=0.001 ** |
|INCIDENTAL TUMOR       |  P=0.007 **     (e)        P=0.516      P=0.051    |  P=0.366      P=0.040 *    P=0.142      P=0.475    |
|LOGISTIC REGRESSION    |  P=0.013 *      (e)        P=0.516      P=0.077    |  P=0.156      P=0.059      P=0.025 *    P=0.225    |
|COCHRAN-ARMITAGE       |  P=0.080                                           |  P=0.030 *                                         |
|FISHER EXACT           |                 (e)        P=0.565      P=0.247    |               P=0.066      P=0.005 **   P=0.013 *  |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE  13
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pharynx                                                                                                                          |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/35 (0%)    0/65 (0%)    0/50 (0%)  |  0/50 (0%)    0/35 (0%)    1/65 (2%)    2/50 (4%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         2.5%         5.6%      |
|TERMINAL (d)           |  0/24 (0%)    0/15 (0%)    0/26 (0%)    0/1 (0%)   |  0/36 (0%)    0/13 (0%)    0/6 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          ---          575          372       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.020 *      (e)        P=0.481      P=0.167    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.263        (e)        P=0.783      P=0.744    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.256        (e)        P=0.634      P=0.795    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.081                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |                 (e)        P=0.565      P=0.247    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pharynx                                                                                                                          |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/35 (0%)    1/65 (2%)    0/50 (0%)  |  0/50 (0%)    1/35 (3%)    4/65 (6%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         3.8%         0.0%      |   0.0%         7.7%        10.5%         9.1%      |
|TERMINAL (d)           |  0/24 (0%)    0/15 (0%)    1/26 (4%)    0/1 (0%)   |  0/36 (0%)    1/13 (8%)    0/6 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          732 (T)      ---       |   ---          733 (T)      487          501       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.526        (e)        P=0.516        (e)      |  P=0.008 **   P=0.298      P=0.048 *    P=0.207    |
|INCIDENTAL TUMOR       |  P=0.526        (e)        P=0.516        (e)      |  P=0.612      P=0.298      P=0.379      P=0.897    |
|LOGISTIC REGRESSION    |  P=0.526        (e)        P=0.516        (e)      |  P=0.390      P=0.298      P=0.162      P=0.718    |
|COCHRAN-ARMITAGE       |  P=0.710                                           |  P=0.383                                           |
|FISHER EXACT           |                 (e)        P=0.565        (e)      |               P=0.412      P=0.098      P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE  14
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 12/50 (24%)   7/35 (20%)  14/65 (22%)   4/47 (9%)  | 25/50 (50%)  17/35 (49%)  17/64 (27%)   5/49 (10%) |
|ADJUSTED (b)           |  35.7%        32.4%        38.4%        10.3%      |  59.0%        74.5%        69.2%        56.7%      |
|TERMINAL (d)           |  4/24 (17%)   3/15 (20%)   7/26 (27%)   0/1 (0%)   | 19/36 (53%)   8/13 (62%)   2/6 (33%)    0/0        |
|FIRST INCIDENCE (DAYS) |   590          530          567          383       |   524          411          538          355       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.426      P=0.522N     P=0.561      P=0.569    |  P<0.001 **   P=0.046 *    P=0.008 **   P=0.016 *  |
|INCIDENTAL TUMOR       |  P=0.054N     P=0.371N     P=0.381N     P=0.019N*  |  P=0.092N     P=0.467      P=0.170N     P=0.090N   |
|LOGISTIC REGRESSION    |  P=0.073N     P=0.449N     P=0.463N     P=0.050N*  |  P=0.117N     P=0.505      P=0.290N     P=0.116N   |
|COCHRAN-ARMITAGE       |  P=0.036N*                                         |  P<0.001N**                                        |
|FISHER EXACT           |               P=0.436N     P=0.463N     P=0.036N*  |               P=0.536N     P=0.009N**   P<0.001N** |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Adenoma                                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    4/35 (11%)  26/65 (40%)  30/50 (60%) |  0/50 (0%)    3/35 (9%)    5/65 (8%)    3/50 (6%)  |
|ADJUSTED (b)           |   4.2%        23.2%        77.4%       100.0%      |   0.0%        19.8%        28.1%        20.5%      |
|TERMINAL (d)           |  1/24 (4%)    3/15 (20%)  19/26 (73%)   1/1 (100%) |  0/36 (0%)    2/13 (15%)   1/6 (17%)    0/0        |
|FIRST INCIDENCE (DAYS) |   732 (T)      651          641          473       |   ---          663          521          454       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.071      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.016 *    P=0.005 **   P=0.006 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.078      P<0.001 **   P<0.001 ** |  P=0.085      P=0.045 *    P=0.089      P=0.632    |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.073      P<0.001 **   P<0.001 ** |  P=0.040 *    P=0.036 *    P=0.049 *    P=0.211    |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.203                                           |
|FISHER EXACT           |               P=0.090      P<0.001 **   P<0.001 ** |               P=0.066      P=0.054      P=0.121    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE  15
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Carcinoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    1/35 (3%)    5/65 (8%)    6/50 (12%) |  0/50 (0%)    1/35 (3%)    2/65 (3%)    2/50 (4%)  |
|ADJUSTED (b)           |   0.0%         6.3%        17.4%        30.6%      |   0.0%         3.8%        11.5%        26.7%      |
|TERMINAL (d)           |  0/24 (0%)    0/15 (0%)    4/26 (15%)   0/1 (0%)   |  0/36 (0%)    0/13 (0%)    0/6 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   ---          724          673          473       |   ---          614          581          344       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.411      P=0.043 *    P=0.002 ** |  P=0.002 **   P=0.404      P=0.104      P=0.049 *  |
|INCIDENTAL TUMOR       |  P=0.004 **   P=0.467      P=0.049 *    P=0.088    |  P=0.264      P=0.567      P=0.539      P=0.567    |
|LOGISTIC REGRESSION    |  P=0.003 **   P=0.408      P=0.046 *    P=0.020 *  |  P=0.170      P=0.494      P=0.241      P=0.496    |
|COCHRAN-ARMITAGE       |  P=0.007 **                                        |  P=0.187                                           |
|FISHER EXACT           |               P=0.412      P=0.054      P=0.013 *  |               P=0.412      P=0.317      P=0.247    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    1/35 (3%)    4/65 (6%)    7/50 (14%) |  0/50 (0%)    0/35 (0%)    0/65 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   4.2%         6.7%        15.4%       100.0%      |   0.0%         0.0%         0.0%         6.3%      |
|TERMINAL (d)           |  1/24 (4%)    1/15 (7%)    4/26 (15%)   1/1 (100%) |  0/36 (0%)    0/13 (0%)    0/6 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   732 (T)      732 (T)      732 (T)      582       |   ---          ---          ---          473       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.654      P=0.200      P<0.001 ** |  P=0.090        (e)          (e)        P=0.278    |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.654      P=0.200      P=0.007 ** |  P=0.452        (e)          (e)        P=0.897    |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.654      P=0.200      P=0.005 ** |  P=0.327        (e)          (e)        P=0.795    |
|COCHRAN-ARMITAGE       |  P=0.008 **                                        |  P=0.211                                           |
|FISHER EXACT           |               P=0.657      P=0.274      P=0.030 *  |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE  16
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    2/35 (6%)    8/65 (12%)   7/50 (14%) |  0/50 (0%)    0/35 (0%)    3/65 (5%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%        13.3%        25.1%        26.3%      |   0.0%         0.0%        33.3%         0.0%      |
|TERMINAL (d)           |  0/24 (0%)    2/15 (13%)   5/26 (19%)   0/1 (0%)   |  0/36 (0%)    0/13 (0%)    1/6 (17%)    0/0        |
|FIRST INCIDENCE (DAYS) |   ---          732 (T)      565          512       |   ---          ---          715          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.141      P=0.009 **   P=0.002 ** |  P=0.003 **     (e)        P=0.002 **     (e)      |
|INCIDENTAL TUMOR       |  P=0.005 **   P=0.141      P=0.013 *    P=0.126    |  P=0.069        (e)        P=0.107        (e)      |
|LOGISTIC REGRESSION    |  P=0.006 **   P=0.141      P=0.013 *    P=0.017 *  |  P=0.009 **     (e)        P=0.007 **     (e)      |
|COCHRAN-ARMITAGE       |  P=0.008 **                                        |  P=0.575                                           |
|FISHER EXACT           |               P=0.167      P=0.009 **   P=0.006 ** |                 (e)        P=0.177        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    2/35 (6%)   11/65 (17%)   9/50 (18%) |  0/50 (0%)    0/35 (0%)    4/65 (6%)    1/50 (2%)  |
|ADJUSTED (b)           |   4.2%        13.3%        31.8%        59.0%      |   0.0%         0.0%        35.7%         3.0%      |
|TERMINAL (d)           |  1/24 (4%)    2/15 (13%)   6/26 (23%)   0/1 (0%)   |  0/36 (0%)    0/13 (0%)    1/6 (17%)    0/0        |
|FIRST INCIDENCE (DAYS) |   732 (T)      732 (T)      565          512       |   ---          ---          614          403       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.336      P=0.007 **   P<0.001 ** |  P<0.001 **     (e)        P=0.001 **   P=0.417    |
|INCIDENTAL TUMOR       |  P=0.002 **   P=0.336      P=0.011 *    P=0.057    |  P=0.077        (e)        P=0.094      P=0.897    |
|LOGISTIC REGRESSION    |  P=0.001 **   P=0.336      P=0.010 *    P=0.011 *  |  P=0.034 *      (e)        P=0.011 *    P=0.931    |
|COCHRAN-ARMITAGE       |  P=0.005 **                                        |  P=0.281                                           |
|FISHER EXACT           |               P=0.367      P=0.008 **   P=0.008 ** |                 (e)        P=0.098      P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE  17
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/35 (0%)    3/65 (5%)    2/50 (4%)  |  0/50 (0%)    0/35 (0%)    1/65 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |   4.2%         0.0%         8.1%        44.4%      |   0.0%         0.0%         3.6%         3.0%      |
|TERMINAL (d)           |  1/24 (4%)    0/15 (0%)    1/26 (4%)    0/1 (0%)   |  0/36 (0%)    0/13 (0%)    0/6 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   732 (T)      ---          654          704       |   ---          ---          614          403       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.020 *    P=0.594N     P=0.368      P=0.012 *  |  P=0.064        (e)        P=0.419      P=0.417    |
|INCIDENTAL TUMOR       |  P=0.183      P=0.594N     P=0.417      P=0.351    |  P=0.447        (e)        P=0.783      P=0.897    |
|LOGISTIC REGRESSION    |  P=0.093      P=0.594N     P=0.401      P=0.078    |  P=0.396        (e)        P=0.582      P=0.931    |
|COCHRAN-ARMITAGE       |  P=0.275                                           |  P=0.256                                           |
|FISHER EXACT           |               P=0.588N     P=0.414      P=0.500    |                 (e)        P=0.565      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    5/35 (14%)  28/65 (43%)  32/50 (64%) |  0/50 (0%)    4/35 (11%)   7/65 (11%)   5/50 (10%) |
|ADJUSTED (b)           |   4.2%        28.0%        81.1%       100.0%      |   0.0%        22.9%        36.4%        41.7%      |
|TERMINAL (d)           |  1/24 (4%)    3/15 (20%)  20/26 (77%)   1/1 (100%) |  0/36 (0%)    2/13 (15%)   1/6 (17%)    0/0        |
|FIRST INCIDENCE (DAYS) |   732 (T)      651          641          473       |   ---          614          521          344       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.032 *    P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.006 **   P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.039 *    P<0.001 **   P<0.001 ** |  P=0.039 *    P=0.030 *    P=0.058      P=0.369    |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.030 *    P<0.001 **   P<0.001 ** |  P=0.012 *    P=0.020 *    P=0.013 *    P=0.071    |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.083                                           |
|FISHER EXACT           |               P=0.041 *    P<0.001 **   P<0.001 ** |               P=0.026 *    P=0.016 *    P=0.028 *  |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE  18
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    6/35 (17%)  33/65 (51%)  39/50 (78%) |  0/50 (0%)    4/35 (11%)  11/65 (17%)   7/50 (14%) |
|ADJUSTED (b)           |  12.5%        34.0%        85.7%       100.0%      |   0.0%        22.9%        60.7%        47.0%      |
|TERMINAL (d)           |  3/24 (13%)   4/15 (27%)  21/26 (81%)   1/1 (100%) |  0/36 (0%)    2/13 (15%)   2/6 (33%)    0/0        |
|FIRST INCIDENCE (DAYS) |   732 (T)      651          565          473       |   ---          614          521          344       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.071      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.006 **   P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.083      P<0.001 **   P<0.001 ** |  P=0.004 **   P=0.030 *    P=0.006 **   P=0.288    |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.069      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.020 *    P<0.001 **   P=0.035 *  |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.024 *                                         |
|FISHER EXACT           |               P=0.100      P<0.001 **   P<0.001 ** |               P=0.026 *    P=0.001 **   P=0.006 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Sebaceous Gland                                                                                                            |
|     Carcinoma, Basal Cell Carcinoma or Adenoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    1/35 (3%)    5/65 (8%)    6/50 (12%) |  0/50 (0%)    0/35 (0%)    0/65 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   3.4%         6.7%        16.8%        54.8%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/24 (0%)    1/15 (7%)    4/26 (15%)   0/1 (0%)   |  0/36 (0%)    0/13 (0%)    0/6 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   706          732 (T)      593          512       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.638      P=0.132      P=0.001 ** |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.009 **   P=0.689      P=0.164      P=0.226    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.007 **   P=0.663      P=0.166      P=0.036 *  |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.022 *                                         |    (e)                                             |
|FISHER EXACT           |               P=0.657      P=0.176      P=0.056    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE  19
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    3/35 (9%)    5/65 (8%)    1/50 (2%)  |  3/50 (6%)    0/35 (0%)    3/65 (5%)    1/50 (2%)  |
|ADJUSTED (b)           |  14.8%        11.2%        15.3%         6.3%      |   8.3%         0.0%        13.3%        50.0%      |
|TERMINAL (d)           |  3/24 (13%)   0/15 (0%)    2/26 (8%)    0/1 (0%)   |  3/36 (8%)    0/13 (0%)    0/6 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   641          631          641          663       |   733 (T)      ---          567          603       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.583N     P=0.593      P=0.580      P=0.647    |  P=0.026 *    P=0.346N     P=0.168      P=0.015 *  |
|INCIDENTAL TUMOR       |  P=0.188N     P=0.423      P=0.605N     P=0.602N   |  P=0.415      P=0.346N     P=0.626      P=0.567    |
|LOGISTIC REGRESSION    |  P=0.239N     P=0.616      P=0.629N     P=0.449N   |  P=0.317      P=0.346N     P=0.540      P=0.381    |
|COCHRAN-ARMITAGE       |  P=0.130N                                          |  P=0.320N                                          |
|FISHER EXACT           |               P=0.612      P=0.608N     P=0.181N   |               P=0.198N     P=0.529N     P=0.309N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/50 (10%)   3/35 (9%)    5/65 (8%)    1/50 (2%)  |  4/50 (8%)    0/35 (0%)    3/65 (5%)    2/50 (4%)  |
|ADJUSTED (b)           |  17.6%        11.2%        15.3%         6.3%      |  10.2%         0.0%        13.3%        52.8%      |
|TERMINAL (d)           |  3/24 (13%)   0/15 (0%)    2/26 (8%)    0/1 (0%)   |  3/36 (8%)    0/13 (0%)    0/6 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   641          631          641          663       |   431          ---          567          456       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.469N     P=0.594N     P=0.553N     P=0.705    |  P=0.029 *    P=0.219N     P=0.351      P=0.095    |
|INCIDENTAL TUMOR       |  P=0.102N     P=0.576      P=0.434N     P=0.331N   |  P=0.608N     P=0.158N     P=0.452N     P=0.580N   |
|LOGISTIC REGRESSION    |  P=0.156N     P=0.569N     P=0.473N     P=0.328N   |  P=0.621      P=0.089N     P=0.429N     P=0.736N   |
|COCHRAN-ARMITAGE       |  P=0.076N                                          |  P=0.370N                                          |
|FISHER EXACT           |               P=0.568N     P=0.455N     P=0.102N   |               P=0.114N     P=0.356N     P=0.339N   |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE  20
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 44/50 (88%)  35/35 (100%) 59/64 (92%)  43/50 (86%) |                                                    |
|ADJUSTED (b)           |  97.7%       100.0%        98.3%       100.0%      |                                                    |
|TERMINAL (d)           | 23/24 (96%)  15/15 (100%) 25/26 (96%)   1/1 (100%) |                                                    |
|FIRST INCIDENCE (DAYS) |   454          352          499          456       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.129      P=0.201      P<0.001 ** |                                                    |
|INCIDENTAL TUMOR       |  P=0.540N     P=0.036 *    P=0.493      P=0.407    |                                                    |
|LOGISTIC REGRESSION    |  P=0.489      P=0.045 *    P=0.468      P=0.288    |                                                    |
|COCHRAN-ARMITAGE       |  P=0.232N                                          |                                                    |
|FISHER EXACT           |               P=0.036 *    P=0.331      P=0.500N   |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/50 (10%)   2/35 (6%)    6/65 (9%)    3/49 (6%)  |  6/50 (12%)   2/35 (6%)    2/64 (3%)    3/50 (6%)  |
|ADJUSTED (b)           |  15.8%        13.3%        18.0%        20.5%      |  16.1%        15.4%        21.3%        40.9%      |
|TERMINAL (d)           |  2/24 (8%)    2/15 (13%)   3/26 (12%)   0/1 (0%)   |  5/36 (14%)   2/13 (15%)   1/6 (17%)    0/0        |
|FIRST INCIDENCE (DAYS) |   636          732 (T)      530          638       |   711          733 (T)      658          411       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.163      P=0.436N     P=0.594      P=0.283    |  P=0.002 **   P=0.621N     P=0.447      P=0.003 ** |
|INCIDENTAL TUMOR       |  P=0.552N     P=0.443N     P=0.564N     P=0.473N   |  P=0.156      P=0.500N     P=0.557N     P=0.420    |
|LOGISTIC REGRESSION    |  P=0.553      P=0.398N     P=0.568N     P=0.651N   |  P=0.230      P=0.556N     P=0.606N     P=0.327    |
|COCHRAN-ARMITAGE       |  P=0.363N                                          |  P=0.178N                                          |
|FISHER EXACT           |               P=0.388N     P=0.567N     P=0.369N   |               P=0.280N     P=0.071N     P=0.243N   |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE  21
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    1/35 (3%)    0/65 (0%)    1/49 (2%)  |  6/50 (12%)   0/35 (0%)    2/64 (3%)    0/50 (0%)  |
|ADJUSTED (b)           |   4.0%         4.5%         0.0%         6.3%      |  15.2%         0.0%        19.6%         0.0%      |
|TERMINAL (d)           |  0/24 (0%)    0/15 (0%)    0/26 (0%)    0/1 (0%)   |  4/36 (11%)   0/13 (0%)    1/6 (17%)    0/0        |
|FIRST INCIDENCE (DAYS) |   729          666          ---          663       |   589          ---          614          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.495      P=0.648      P=0.492N     P=0.384    |  P=0.510N     P=0.117N     P=0.642      P=0.961N   |
|INCIDENTAL TUMOR       |  P=0.502N     P=0.727      P=0.395N     P=0.689N   |  P=0.108N     P=0.055N     P=0.260N     P=0.158N   |
|LOGISTIC REGRESSION    |  P=0.657      P=0.674      P=0.486N     P=0.606    |  P=0.107N     P=0.051N     P=0.234N     P=0.297N   |
|COCHRAN-ARMITAGE       |  P=0.583N                                          |  P=0.009N**                                        |
|FISHER EXACT           |               P=0.657      P=0.435N     P=0.747    |               P=0.036N*    P=0.071N     P=0.013N*  |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/50 (12%)   3/35 (9%)    6/65 (9%)    4/49 (8%)  | 12/50 (24%)   2/35 (6%)    4/64 (6%)    3/50 (6%)  |
|ADJUSTED (b)           |  19.2%        17.3%        18.0%        25.8%      |  30.3%        15.4%        39.3%        40.9%      |
|TERMINAL (d)           |  2/24 (8%)    2/15 (13%)   3/26 (12%)   0/1 (0%)   |  9/36 (25%)   2/13 (15%)   2/6 (33%)    0/0        |
|FIRST INCIDENCE (DAYS) |   636          666          530          638       |   589          733 (T)      614          411       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.135      P=0.510N     P=0.524N     P=0.147    |  P=0.020 *    P=0.175N     P=0.439      P=0.006 ** |
|INCIDENTAL TUMOR       |  P=0.475N     P=0.473N     P=0.409N     P=0.428N   |  P=0.602      P=0.074N     P=0.229N     P=0.485N   |
|LOGISTIC REGRESSION    |  P=0.544      P=0.463N     P=0.428N     P=0.568    |  P=0.537N     P=0.064N     P=0.204N     P=0.725    |
|COCHRAN-ARMITAGE       |  P=0.344N                                          |  P=0.008N**                                        |
|FISHER EXACT           |               P=0.449N     P=0.427N     P=0.383N   |               P=0.023N*    P=0.007N**   P=0.011N*  |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE  22
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/35 (0%)    1/65 (2%)    2/49 (4%)  |  0/50 (0%)    1/35 (3%)    3/64 (5%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         3.8%       100.0%      |   0.0%         7.7%        23.1%         0.0%      |
|TERMINAL (d)           |  0/24 (0%)    0/15 (0%)    1/26 (4%)    1/1 (100%) |  0/36 (0%)    1/13 (8%)    1/6 (17%)    0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          732 (T)      524       |   ---          733 (T)      515          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.004 **     (e)        P=0.516      P=0.033 *  |  P=0.028 *    P=0.298      P=0.022 *      (e)      |
|INCIDENTAL TUMOR       |  P=0.022 *      (e)        P=0.516      P=0.069    |  P=0.308      P=0.298      P=0.123        (e)      |
|LOGISTIC REGRESSION    |  P=0.055        (e)        P=0.516      P=0.218    |  P=0.246      P=0.298      P=0.124        (e)      |
|COCHRAN-ARMITAGE       |  P=0.077                                           |  P=0.596N                                          |
|FISHER EXACT           |                 (e)        P=0.565      P=0.242    |               P=0.412      P=0.173        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    2/35 (6%)    2/65 (3%)    0/49 (0%)  |  0/50 (0%)    2/35 (6%)    0/64 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   7.7%        10.4%         3.4%         0.0%      |   0.0%        15.4%         0.0%         3.2%      |
|TERMINAL (d)           |  1/24 (4%)    1/15 (7%)    0/26 (0%)    0/1 (0%)   |  0/36 (0%)    2/13 (15%)   0/6 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   715          651          565          ---       |   ---          733 (T)      ---          411       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.345N     P=0.521      P=0.625N     P=0.842N   |  P=0.067      P=0.058        (e)        P=0.405    |
|INCIDENTAL TUMOR       |  P=0.141N     P=0.576      P=0.537N     P=0.410N   |  P=0.223      P=0.058        (e)        P=0.897    |
|LOGISTIC REGRESSION    |  P=0.144N     P=0.542      P=0.605N     P=0.632N   |  P=0.391      P=0.058        (e)        P=0.919    |
|COCHRAN-ARMITAGE       |  P=0.132N                                          |  P=0.574                                           |
|FISHER EXACT           |               P=0.547      P=0.586N     P=0.253N   |               P=0.167        (e)        P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE  23
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    2/35 (6%)    3/65 (5%)    2/49 (4%)  |  0/50 (0%)    3/35 (9%)    3/64 (5%)    1/50 (2%)  |
|ADJUSTED (b)           |   7.7%        10.4%         7.1%       100.0%      |   0.0%        23.1%        23.1%         3.2%      |
|TERMINAL (d)           |  1/24 (4%)    1/15 (7%)    1/26 (4%)    1/1 (100%) |  0/36 (0%)    3/13 (23%)   1/6 (17%)    0/0        |
|FIRST INCIDENCE (DAYS) |   715          651          565          524       |   ---          733 (T)      515          411       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.195      P=0.521      P=0.573      P=0.093    |  P=0.002 **   P=0.011 *    P=0.022 *    P=0.405    |
|INCIDENTAL TUMOR       |  P=0.530      P=0.576      P=0.656      P=0.492    |  P=0.095      P=0.011 *    P=0.123      P=0.897    |
|LOGISTIC REGRESSION    |  P=0.572      P=0.542      P=0.618      P=0.536    |  P=0.135      P=0.011 *    P=0.124      P=0.919    |
|COCHRAN-ARMITAGE       |  P=0.560N                                          |  P=0.580                                           |
|FISHER EXACT           |               P=0.547      P=0.623      P=0.684    |               P=0.066      P=0.173      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Tongue                                                                                                                           |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/35 (0%)    0/65 (0%)    0/50 (0%)  |  0/50 (0%)    0/35 (0%)    2/65 (3%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         3.8%         0.0%      |
|TERMINAL (d)           |  0/24 (0%)    0/15 (0%)    0/26 (0%)    0/1 (0%)   |  0/36 (0%)    0/13 (0%)    0/6 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          ---          454          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.406        (e)        P=0.261        (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.359N       (e)        P=0.614        (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.565N       (e)        P=0.478        (e)      |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.624                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |                 (e)        P=0.317        (e)      |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE  24
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Tongue                                                                                                                           |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/35 (0%)    0/65 (0%)    2/50 (4%)  |  0/50 (0%)    2/35 (6%)    4/65 (6%)    3/50 (6%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%       100.0%      |   0.0%        10.9%         9.3%        12.4%      |
|TERMINAL (d)           |  0/24 (0%)    0/15 (0%)    0/26 (0%)    1/1 (100%) |  0/36 (0%)    1/13 (8%)    0/6 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          663       |   ---          567          454          349       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.003 **     (e)          (e)        P=0.011 *  |  P=0.001 **   P=0.102      P=0.058      P=0.034 *  |
|INCIDENTAL TUMOR       |  P=0.012 *      (e)          (e)        P=0.051    |  P=0.604      P=0.163      P=0.386      P=0.744    |
|LOGISTIC REGRESSION    |  P=0.015 *      (e)          (e)        P=0.077    |  P=0.386      P=0.184      P=0.187      P=0.546    |
|COCHRAN-ARMITAGE       |  P=0.052                                           |  P=0.143                                           |
|FISHER EXACT           |                 (e)          (e)        P=0.247    |               P=0.167      P=0.098      P=0.121    |
|=================================================================================================================================|
|                                                                                                                                 |
|Tongue                                                                                                                           |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/35 (0%)    0/65 (0%)    2/50 (4%)  |  0/50 (0%)    2/35 (6%)    2/65 (3%)    3/50 (6%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%       100.0%      |   0.0%        10.9%         5.8%        12.4%      |
|TERMINAL (d)           |  0/24 (0%)    0/15 (0%)    0/26 (0%)    1/1 (100%) |  0/36 (0%)    1/13 (8%)    0/6 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          663       |   ---          567          531          349       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.003 **     (e)          (e)        P=0.011 *  |  P=0.001 **   P=0.102      P=0.192      P=0.034 *  |
|INCIDENTAL TUMOR       |  P=0.012 *      (e)          (e)        P=0.051    |  P=0.402      P=0.163      P=0.597      P=0.744    |
|LOGISTIC REGRESSION    |  P=0.015 *      (e)          (e)        P=0.077    |  P=0.280      P=0.184      P=0.365      P=0.546    |
|COCHRAN-ARMITAGE       |  P=0.052                                           |  P=0.133                                           |
|FISHER EXACT           |                 (e)          (e)        P=0.247    |               P=0.167      P=0.317      P=0.121    |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE  25
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Tooth                                                                                                                            |
|     Odontoma                                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/35 (0%)    0/65 (0%)    0/50 (0%)  |  0/50 (0%)    0/35 (0%)    0/65 (0%)    2/50 (4%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%        10.7%      |
|TERMINAL (d)           |  0/24 (0%)    0/15 (0%)    0/26 (0%)    0/1 (0%)   |  0/36 (0%)    0/13 (0%)    0/6 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          ---          ---          413       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.010 *      (e)          (e)        P=0.069    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.240        (e)          (e)        P=0.744    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.143        (e)          (e)        P=0.579    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.052                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |                 (e)          (e)        P=0.247    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  4/50 (8%)    8/35 (23%)   8/65 (12%)   2/50 (4%)  |
|ADJUSTED (b)           |                                                    |  10.4%        38.9%        37.2%        19.0%      |
|TERMINAL (d)           |                                                    |  3/36 (8%)    2/13 (15%)   0/6 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |                                                    |   562          567          400          456       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P<0.001 **   P=0.008 **   P=0.007 **   P=0.058    |
|INCIDENTAL TUMOR       |                                                    |  P=0.358N     P=0.098      P=0.507      P=0.726N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.490      P=0.041 *    P=0.276      P=0.761    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.135N                                          |
|FISHER EXACT           |                                                    |               P=0.054      P=0.334      P=0.339N   |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE  26
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  1/50 (2%)    2/35 (6%)    2/65 (3%)    0/50 (0%)  |
|ADJUSTED (b)           |                                                    |   2.8%        12.8%        19.0%         0.0%      |
|TERMINAL (d)           |                                                    |  1/36 (3%)    1/13 (8%)    1/6 (17%)    0/0        |
|FIRST INCIDENCE (DAYS) |                                                    |   733 (T)      665          588          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.131      P=0.197      P=0.136        (e)      |
|INCIDENTAL TUMOR       |                                                    |  P=0.420      P=0.338      P=0.259        (e)      |
|LOGISTIC REGRESSION    |                                                    |  P=0.465      P=0.293      P=0.386        (e)      |
|COCHRAN-ARMITAGE       |                                                    |  P=0.256N                                          |
|FISHER EXACT           |                                                    |               P=0.367      P=0.598      P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  5/50 (10%)   9/35 (26%)  10/65 (15%)   2/50 (4%)  |
|ADJUSTED (b)           |                                                    |  13.1%        42.3%        49.2%        19.0%      |
|TERMINAL (d)           |                                                    |  4/36 (11%)   2/13 (15%)   1/6 (17%)    0/0        |
|FIRST INCIDENCE (DAYS) |                                                    |   562          567          400          456       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P<0.001 **   P=0.006 **   P=0.001 **   P=0.058    |
|INCIDENTAL TUMOR       |                                                    |  P=0.434N     P=0.101      P=0.266      P=0.726N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.429      P=0.038 *    P=0.173      P=0.761    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.087N                                          |
|FISHER EXACT           |                                                    |               P=0.053      P=0.287      P=0.218N   |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE  27
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/35 (0%)    1/65 (2%)    1/50 (2%)  |  0/50 (0%)    0/35 (0%)    2/65 (3%)    6/50 (12%) |
|ADJUSTED (b)           |   0.0%         0.0%         1.9%         4.2%      |   0.0%         0.0%        19.4%       100.0%      |
|TERMINAL (d)           |  0/24 (0%)    0/15 (0%)    0/26 (0%)    0/1 (0%)   |  0/36 (0%)    0/13 (0%)    1/6 (17%)    0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          641          625       |   ---          ---          599          412       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.156        (e)        P=0.566      P=0.403    |  P<0.001 **     (e)        P=0.060      P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.360        (e)        P=0.607      P=0.571    |  P=0.002 **     (e)        P=0.149      P=0.195    |
|LOGISTIC REGRESSION    |  P=0.266        (e)        P=0.545      P=0.502    |  P<0.001 **     (e)        P=0.191      P=0.007 ** |
|COCHRAN-ARMITAGE       |  P=0.254                                           |  P=0.001 **                                        |
|FISHER EXACT           |                 (e)        P=0.565      P=0.500    |                 (e)        P=0.317      P=0.013 *  |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/35 (0%)    7/65 (11%)   6/50 (12%) |  0/50 (0%)    3/35 (9%)   17/65 (26%)  13/50 (26%) |
|ADJUSTED (b)           |   0.0%         0.0%        16.6%        30.1%      |   0.0%        13.0%        53.5%        70.0%      |
|TERMINAL (d)           |  0/24 (0%)    0/15 (0%)    2/26 (8%)    0/1 (0%)   |  0/36 (0%)    1/13 (8%)    1/6 (17%)    0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          325          524       |   ---          411          403          355       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **     (e)        P=0.022 *    P=0.002 ** |  P<0.001 **   P=0.042 *    P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.014 *      (e)        P=0.016 *    P=0.088    |  P=0.095      P=0.095      P=0.008 **   P=0.135    |
|LOGISTIC REGRESSION    |  P=0.011 *      (e)        P=0.013 *    P=0.018 *  |  P=0.073      P=0.163      P<0.001 **   P=0.021 *  |
|COCHRAN-ARMITAGE       |  P=0.004 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |                 (e)        P=0.016 *    P=0.013 *  |               P=0.066      P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE  28
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/35 (0%)    8/65 (12%)   7/50 (14%) |  0/50 (0%)    3/35 (9%)   18/65 (28%)  19/50 (38%) |
|ADJUSTED (b)           |   0.0%         0.0%        18.2%        33.0%      |   0.0%        13.0%        55.0%       100.0%      |
|TERMINAL (d)           |  0/24 (0%)    0/15 (0%)    2/26 (8%)    0/1 (0%)   |  0/36 (0%)    1/13 (8%)    1/6 (17%)    0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          325          524       |   ---          411          403          355       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **     (e)        P=0.014 *    P<0.001 ** |  P<0.001 **   P=0.042 *    P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.009 **     (e)        P=0.011 *    P=0.055    |  P=0.004 **   P=0.095      P=0.006 **   P=0.026 *  |
|LOGISTIC REGRESSION    |  P=0.005 **     (e)        P=0.008 **   P=0.009 ** |  P=0.002 **   P=0.163      P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.002 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |                 (e)        P=0.009 **   P=0.006 ** |               P=0.066      P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 20/50 (40%)  20/35 (57%)  37/65 (57%)  12/50 (24%) | 12/50 (24%)  13/35 (37%)  18/65 (28%)   5/50 (10%) |
|ADJUSTED (b)           |  54.8%        73.4%        69.0%       100.0%      |  28.4%        58.4%        79.6%        57.7%      |
|TERMINAL (d)           |  9/24 (38%)   8/15 (53%)  11/26 (42%)   1/1 (100%) |  7/36 (19%)   4/13 (31%)   3/6 (50%)    0/0        |
|FIRST INCIDENCE (DAYS) |   564          352          455          456       |   533          607          344          229       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.021 *    P=0.081      P=0.053      P=0.027 *  |  P<0.001 **   P=0.012 *    P<0.001 **   P=0.007 ** |
|INCIDENTAL TUMOR       |  P=0.049N*    P=0.059      P=0.114      P=0.229N   |  P=0.573      P=0.328      P=0.425      P=0.160N   |
|LOGISTIC REGRESSION    |  P=0.112N     P=0.084      P=0.118      P=0.261N   |  P=0.371      P=0.319      P=0.107      P=0.093N   |
|COCHRAN-ARMITAGE       |  P=0.028N*                                         |  P=0.023N*                                         |
|FISHER EXACT           |               P=0.090      P=0.053      P=0.066N   |               P=0.143      P=0.410      P=0.054N   |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE  29
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/35 (0%)    0/65 (0%)    1/50 (2%)  |  0/50 (0%)    0/35 (0%)    2/65 (3%)    1/50 (2%)  |
|ADJUSTED (b)           |   2.6%         0.0%         0.0%        20.0%      |   0.0%         0.0%         9.0%         3.7%      |
|TERMINAL (d)           |  0/24 (0%)    0/15 (0%)    0/26 (0%)    0/1 (0%)   |  0/36 (0%)    0/13 (0%)    0/6 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   641          ---          ---          711       |   ---          ---          599          412       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.436      P=0.568N     P=0.434N     P=0.498    |  P=0.020 *      (e)        P=0.122      P=0.377    |
|INCIDENTAL TUMOR       |  P=0.661N     P=0.748N     P=0.393N     P=0.676N   |  P=0.322        (e)        P=0.539      P=0.897    |
|LOGISTIC REGRESSION    |  P=0.578      P=0.572N     P=0.455N     P=0.689    |  P=0.279        (e)        P=0.257      P=0.917    |
|COCHRAN-ARMITAGE       |  P=0.619                                           |  P=0.272                                           |
|FISHER EXACT           |               P=0.588N     P=0.435N     P=0.753N   |                 (e)        P=0.317      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma Benign, Malignant, NOS                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    6/35 (17%)   4/65 (6%)    3/50 (6%)  |  0/50 (0%)    0/35 (0%)    0/65 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |  11.3%        25.7%        13.0%         7.9%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/24 (4%)    2/15 (13%)   2/26 (8%)    0/1 (0%)   |  0/36 (0%)    0/13 (0%)    0/6 (0%)     0/0        |
|FIRST INCIDENCE (DAYS) |   458          447          693          501       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.476      P=0.161      P=0.571N     P=0.510    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.074N     P=0.343      P=0.516N     P=0.087N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.169N     P=0.165      P=0.499N     P=0.382N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.233N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.172      P=0.488N     P=0.500N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE  30
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 48/50 (96%)  35/35 (100%) 61/65 (94%)  45/50 (90%) | 41/50 (82%)  31/35 (89%)  50/65 (77%)  32/50 (64%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  89.1%        96.8%       100.0%       100.0%      |
|TERMINAL (d)           | 24/24 (100%) 15/15 (100%) 26/26 (100%)  1/1 (100%) | 31/36 (86%)  12/13 (92%)   6/6 (100%)   0/0        |
|FIRST INCIDENCE (DAYS) |   454          352          499          383       |   524          411          400          349       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.265      P=0.309      P<0.001 ** |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.222N     P=0.362      P=0.142N     P=0.391N   |  P=0.081      P=0.196      P=0.137      P=0.240    |
|LOGISTIC REGRESSION    |  P=0.211N     P=0.477      P=0.165N     P=0.421N   |  P=0.009 **   P=0.108      P=0.047 *    P=0.044 *  |
|COCHRAN-ARMITAGE       |  P=0.069N                                          |  P=0.008N**                                        |
|FISHER EXACT           |               P=0.343      P=0.471N     P=0.218N   |               P=0.305      P=0.335N     P=0.035N*  |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 33/50 (66%)  27/35 (77%)  54/65 (83%)  43/50 (86%) | 22/50 (44%)  25/35 (71%)  53/65 (82%)  42/50 (84%) |
|ADJUSTED (b)           |  75.7%        83.9%        88.0%       100.0%      |  49.4%        85.4%        97.8%       100.0%      |
|TERMINAL (d)           | 14/24 (58%)  10/15 (67%)  19/26 (73%)   1/1 (100%) | 14/36 (39%)   9/13 (69%)   5/6 (83%)    0/0        |
|FIRST INCIDENCE (DAYS) |   131          352          325          377       |   431          411          285          229       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.185      P=0.055      P<0.001 ** |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.120      P=0.284      P=0.045 *    P=0.202    |  P=0.003 **   P=0.041 *    P=0.004 **   P=0.105    |
|LOGISTIC REGRESSION    |  P=0.022 *    P=0.199      P=0.027 *    P=0.019 *  |  P=0.002 **   P=0.019 *    P<0.001 **   P=0.130    |
|COCHRAN-ARMITAGE       |  P=0.011 *                                         |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.193      P=0.029 *    P=0.017 *  |               P=0.011 *    P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05163 TEST: 01                                                 PAGE  31
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. ACID RED 114
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.007        0.015        0.03      |   CONTROL      0.015        0.03         0.06      |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 49/50 (98%)  35/35 (100%) 64/65 (98%)  49/50 (98%) | 47/50 (94%)  35/35 (100%) 61/65 (94%)  47/50 (94%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  95.9%       100.0%       100.0%       100.0%      |
|TERMINAL (d)           | 24/24 (100%) 15/15 (100%) 26/26 (100%)  1/1 (100%) | 34/36 (94%)  13/13 (100%)  6/6 (100%)   0/0        |
|FIRST INCIDENCE (DAYS) |   131          352          325          377       |   431          411          285          229       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.311      P=0.253      P<0.001 ** |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.462N     P=0.638      P=0.753N     P=0.638N   |  P=0.149      P=0.212      P=0.370      P=0.580    |
|LOGISTIC REGRESSION    |  P=0.605N     P=0.724      P=0.765N     P=0.776N   |  P=0.066      P=0.157      P=0.142      P=0.431    |
|COCHRAN-ARMITAGE       |  P=0.569N                                          |  P=0.434N                                          |
|FISHER EXACT           |               P=0.588      P=0.683      P=0.753N   |               P=0.198      P=0.644N     P=0.661N   |
|=================================================================================================================================|
 
 (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).