Skip to Main Navigation
Skip to Page Content
Share This:
https://ntp.niehs.nih.gov/go/1613

TDMS Study 05169-01 Pathology Tables


                              INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)
                                                        C. I. DIRECT BLUE 15


NTP Experiment-Test: 05169-01                                                                                     Report: PEIRPT05
Study Type: CHRONIC                                                                                               Date: 09/18/94
Route: DOSED WATER                                                                                                Time: 03:28:37




       Facility:  Hazleton Laboratories America, Inc.

       Chemical CAS #:  2429-74-5

       Lock Date:  None

       Cage Range:  All

       Reasons For Removal:    All

       Removal Date Range:     All

       Treatment Groups:       Include All
































a  Number of animals examined microscopically at site and number of animals with lesion

                                                             Page   1

NTP Experiment-Test: 05169-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                        C. I. DIRECT BLUE 15                                   Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 03:28:37  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   CONTROL      0.063        0.125        0.25                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially in Study                          70           45           75           70                                     
  Scheduled Sacrifice                                 20           10           10           20                                     
  Early Deaths                                                                                                                      
    Dead                                               4            4           12           15                                     
    Moribund                                           6           18           31           31                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                40           13           22            4                                     
  Animals Examined Microscopically                    50           35           65           50                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large, Colon                             (50)         (35)         (65)         (50)                                   
      Polyp Adenomatous                                                          2 (3%)                                             
      Ascending Colon, Polyp Adenomatous                                         1 (2%)                                             
      Descending Colon, Polyp Adenomatous                                                     1 (2%)                                
   Intestine Small, Duodenum                          (50)         (35)         (64)         (50)                                   
      Adenocarcinoma, Cystic, Mucinous                                           1 (2%)                                             
   Intestine Small, Jejunum                           (50)         (35)         (64)         (50)                                   
      Adenocarcinoma                                                                          1 (2%)                                
      Adenocarcinoma, Cystic, Mucinous                                                        2 (4%)                                
   Liver                                              (50)         (35)         (65)         (50)                                   
      Hepatocellular Carcinoma                                                                1 (2%)                                
      Histiocytic Sarcoma                                                                     1 (2%)                                
      Neoplastic Nodule                                                          2 (3%)       4 (8%)                                
   Mesentery                                          (4)          (5)          (7)          (4)                                    
      Adenocarcinoma, Metastatic, Uterus               1 (25%)                                                                      
   Pancreas                                           (49)         (35)         (65)         (49)                                   
   Pharynx                                                         (4)          (21)         (12)                                   
      Palate, Squamous Cell Carcinoma                                            5 (24%)      3 (25%)                               
      Palate, Squamous Cell Papilloma                               2 (50%)     10 (48%)      7 (58%)                               
      Palate, Squamous Cell Papilloma, Multiple                                  1 (5%)                                             
   Salivary Glands                                    (50)         (35)         (65)         (50)                                   
      Sarcoma                                                                    1 (2%)                                             
   Stomach, Forestomach                               (50)         (35)         (65)         (50)                                   
   Stomach, Glandular                                 (50)         (35)         (65)         (50)                                   
   Tongue                                             (2)          (3)          (6)          (9)                                    
      Squamous Cell Carcinoma                                       1 (33%)      3 (50%)      3 (33%)                               
      Squamous Cell Papilloma                          2 (100%)     1 (33%)      1 (17%)      4 (44%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                             Page   2                                                               
NTP Experiment-Test: 05169-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                        C. I. DIRECT BLUE 15                                   Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 03:28:37  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   CONTROL      0.063        0.125        0.25                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (50)         (35)         (65)         (50)                                   
      Schwannoma Malignant                                                       1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Gland, Cortex                              (50)         (35)         (65)         (50)                                   
   Adrenal Gland, Medulla                             (50)         (35)         (65)         (50)                                   
      Pheochromocytoma Benign                          3 (6%)       2 (6%)       7 (11%)      1 (2%)                                
      Bilateral, Pheochromocytoma Benign               1 (2%)       2 (6%)                                                          
   Islets, Pancreatic                                 (50)         (35)         (65)         (50)                                   
      Carcinoma                                        1 (2%)                                                                       
   Pituitary Gland                                    (49)         (35)         (65)         (49)                                   
      Pars Distalis, Adenoma                          18 (37%)     10 (29%)     19 (29%)      6 (12%)                               
      Pars Distalis, Carcinoma                                                   1 (2%)                                             
   Thyroid Gland                                      (49)         (35)         (65)         (50)                                   
      Bilateral, Follicular Cell, Adenoma                           1 (3%)                                                          
      C-Cell, Adenoma                                 10 (20%)      3 (9%)       4 (6%)                                             
      C-Cell, Carcinoma                                3 (6%)                    3 (5%)                                             
      Follicular Cell, Carcinoma                                                              1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   Tissue NOS                                                      (1)          (1)                                                 
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (50)         (31)         (64)         (50)                                   
      Adenoma                                          5 (10%)      4 (13%)      9 (14%)      8 (16%)                               
      Carcinoma                                        1 (2%)       4 (13%)     10 (16%)      9 (18%)                               
      Bilateral, Adenoma                                            1 (3%)       3 (5%)       4 (8%)                                
      Bilateral, Carcinoma                             1 (2%)       2 (6%)       2 (3%)       6 (12%)                               
   Ovary                                              (50)         (35)         (64)         (50)                                   
      Adenoma                                                       1 (3%)                                                          
      Granulosa Cell Tumor Benign                      1 (2%)                                                                       
      Granulosa-Theca Tumor Benign                                               1 (2%)                                             
      Histiocytic Sarcoma                                                                     1 (2%)                                
   Uterus                                             (50)         (35)         (65)         (50)                                   
      Adenocarcinoma                                   1 (2%)                                 3 (6%)                                
      Adenoma                                                                    1 (2%)       1 (2%)                                
      Histiocytic Sarcoma                                                                     1 (2%)                                
      Leiomyosarcoma                                   1 (2%)                                                                       
      Polyp Stromal                                    4 (8%)       7 (20%)      9 (14%)      5 (10%)                               
      Polyp Stromal, Multiple                          1 (2%)       1 (3%)       3 (5%)                                             
                                                             Page   3                                                               
NTP Experiment-Test: 05169-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                        C. I. DIRECT BLUE 15                                   Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 03:28:37  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   CONTROL      0.063        0.125        0.25                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
GENITAL SYSTEM - cont                                                                                                               
      Sarcoma Stromal                                  1 (2%)                    1 (2%)       2 (4%)                                
      Cervix, Sarcoma Stromal, Metastatic, Uterus                                             1 (2%)                                
   Vagina                                             (2)          (1)          (1)          (1)                                    
      Sarcoma Stromal, Multiple, Metastatic, Uterus                                           1 (100%)                              
      Squamous Cell Carcinoma                          1 (50%)                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (35)         (64)         (49)                                   
   Lymph Node                                         (50)         (35)         (65)         (50)                                   
      Iliac, Carcinoma, Metastatic, Clitoral Gland                               1 (2%)                                             
      Iliac, Histiocytic Sarcoma                                                              1 (2%)                                
      Lumbar, Histiocytic Sarcoma                                                             1 (2%)                                
      Mediastinal, Histiocytic Sarcoma                                                        1 (2%)                                
      Pancreatic, Histiocytic Sarcoma                                                         1 (2%)                                
      Renal, Histiocytic Sarcoma                                                              1 (2%)                                
   Lymph Node, Mandibular                             (50)         (33)         (65)         (50)                                   
      Histiocytic Sarcoma                                                                     1 (2%)                                
      Squamous Cell Carcinoma, Metastatic,                                                                                          
          Uncertain Primary Site                                    1 (3%)                                                          
   Lymph Node, Mesenteric                             (50)         (34)         (65)         (50)                                   
      Histiocytic Sarcoma                                                                     1 (2%)                                
      Renal, Mediastinal, Pancreatic, Mandibular,                                                                                   
           Leukemia Mononuclear                                     1 (3%)                                                          
   Spleen                                             (50)         (35)         (65)         (50)                                   
      Histiocytic Sarcoma                                                                     1 (2%)                                
      Sarcoma                                                                    1 (2%)                                             
   Thymus                                             (47)         (31)         (63)         (45)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (49)         (34)         (63)         (44)                                   
      Adenocarcinoma                                   4 (8%)       3 (9%)       2 (3%)       2 (5%)                                
      Fibroadenoma                                    12 (24%)      2 (6%)      10 (16%)      2 (5%)                                
      Fibroadenoma, Multiple                           4 (8%)       2 (6%)       6 (10%)      2 (5%)                                
   Skin                                               (49)         (34)         (65)         (50)                                   
      Basal Cell Adenoma                               1 (2%)                                                                       
      Basal Cell Carcinoma                                                       1 (2%)                                             
      Keratoacanthoma                                  2 (4%)       1 (3%)       3 (5%)                                             
      Squamous Cell Carcinoma                                                    1 (2%)                                             
      Squamous Cell Papilloma                                       2 (6%)       5 (8%)       5 (10%)                               
      Sebaceous Gland, Carcinoma                                    1 (3%)                                                          
      Subcutaneous Tissue, Fibroma                     3 (6%)                                                                       
      Subcutaneous Tissue, Neurofibroma                             1 (3%)                                                          
      Subcutaneous Tissue, Neurofibrosarcoma           1 (2%)                                                                       
                                                             Page   4                                                               
NTP Experiment-Test: 05169-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                        C. I. DIRECT BLUE 15                                   Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 03:28:37  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   CONTROL      0.063        0.125        0.25                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (13)         (4)          (12)         (7)                                    
      Cranium, Carcinoma, Metastatic, Zymbal's                                                                                      
          Gland                                                                  1 (8%)       1 (14%)                               
      Tibia, Osteosarcoma                                                        1 (8%)                                             
   Skeletal Muscle                                                              (2)          (1)                                    
      Back, Carcinoma, Metastatic, Clitoral Gland                                1 (50%)                                            
      Cervical, Carcinoma, Metastatic, Zymbal's                                                                                     
          Gland                                                                               1 (100%)                              
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (35)         (65)         (50)                                   
      Carcinoma, Metastatic, Zymbal's Gland                                                   1 (2%)                                
      Histiocytic Sarcoma                                                                     1 (2%)                                
      Cerebrum, Astrocytoma Malignant                  1 (2%)                    2 (3%)       1 (2%)                                
      Cranial Nerve, Carcinoma, Metastatic,                                                                                         
          Zymbal's Gland                                                                      1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (35)         (65)         (50)                                   
      Alveolar/Bronchiolar Adenoma                     1 (2%)       2 (6%)       1 (2%)                                             
      Carcinoma, Metastatic                                         1 (3%)                                                          
      Carcinoma, Metastatic, Clitoral Gland                         2 (6%)                                                          
      Histiocytic Sarcoma                                                                     1 (2%)                                
      Osteosarcoma, Multiple, Metastatic, Bone                                   1 (2%)                                             
      Squamous Cell Carcinoma, Metastatic                                                     1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Ear                                                (1)                                    (1)                                    
      Carcinoma, Metastatic, Zymbal's Gland                                                   1 (100%)                              
   Zymbal's Gland                                     (49)         (35)         (64)         (50)                                   
      Adenoma                                                       1 (3%)       5 (8%)       3 (6%)                                
      Carcinoma                                                     4 (11%)      7 (11%)     14 (28%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                             Page   5                                                               
NTP Experiment-Test: 05169-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                        C. I. DIRECT BLUE 15                                   Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 03:28:37  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   CONTROL      0.063        0.125        0.25                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (35)         (65)         (50)                                   
      Histiocytic Sarcoma                                                                     1 (2%)                                
   Ureter                                                                       (1)                                                 
      Transitional Epithelium, Papilloma                                         1 (100%)                                           
   Urinary Bladder                                    (50)         (35)         (65)         (50)                                   
      Histiocytic Sarcoma                                                                     1 (2%)                                
      Sarcoma Stromal, Metastatic, Uterus                                                     1 (2%)                                
      Transitional Epithelium, Papilloma                                         1 (2%)                                             
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SYSTEMIC LESIONS                                                                                                                   
   Multiple Organs                                   *(50)        *(35)        *(65)        *(50)                                   
      Histiocytic Sarcoma                                                                     1 (2%)                                
      Leukemia Mononuclear                             7 (14%)     13 (37%)     27 (42%)     15 (30%)                               
      Mesothelioma Malignant                                        1 (3%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
     *   Number of animals with any tissue examined microscopically                                                                 
                                                             Page   6                                                               
NTP Experiment-Test: 05169-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                        C. I. DIRECT BLUE 15                                   Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 03:28:37  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   CONTROL      0.063        0.125        0.25                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
TUMOR SUMMARY                                                                                                                       
                                                                                                                                    
   Total Animals with Primary Neoplasms (b)            43          33          64          49                                       
     Total Primary Neoplasms                           91          75         175         117                                       
                                                                                                                                    
   Total Animals with Benign Neoplasms                 38          27          54          33                                       
     Total Benign Neoplasms                            68          46         105          53                                       
                                                                                                                                    
   Total Animals with Malignant Neoplasms              21          24          56          48                                       
     Total Malignant Neoplasms                         23          29          70          64                                       
                                                                                                                                    
   Total Animals with Metastatic Neoplasms              1           4           4           5                                       
     Total Metastatic Neoplasm                          1           4           4           9                                       
                                                                                                                                    
   Total Animals with Malignant Neoplasms                           1                                                               
   Uncertain Primary Site                                                                                                           
                                                                                                                                    
   Total Animals with Neoplasms Uncertain-                                                                                          
   Benign or Malignant                                                                                                              
     Total Uncertain Neoplasms                                                                                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Primary tumors: all tumors except metastatic tumors                                                                              
                                                             Page   7                                                               
NTP Experiment-Test: 05169-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                        C. I. DIRECT BLUE 15                                   Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 03:28:37  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     CONTROL      0.063        0.125        0.25                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially in Study                          70           45           75           70                                     
  Scheduled Sacrifice                                 20           10           10           20                                     
  Early Deaths                                                                                                                      
    Dead                                               5           12           24           12                                     
    Moribund                                           8           15           30           34                                     
    Accident                                                                                  2                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                37            8           11            2                                     
  Animals Examined Microscopically                    50           35           65           50                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large, Cecum                             (50)         (35)         (61)         (50)                                   
   Intestine Large, Colon                             (50)         (35)         (62)         (50)                                   
      Adenocarcinoma                                                             4 (6%)       3 (6%)                                
      Polyp Adenomatous                                                          1 (2%)       1 (2%)                                
      Ascending Colon, Polyp Adenomatous                            1 (3%)                                                          
      Descending Colon, Polyp Adenomatous                                        1 (2%)       4 (8%)                                
   Intestine Small, Duodenum                          (49)         (35)         (60)         (50)                                   
      Adenocarcinoma, Cystic, Mucinous                                                        1 (2%)                                
   Intestine Small, Ileum                             (49)         (35)         (60)         (50)                                   
   Intestine Small, Jejunum                           (49)         (35)         (60)         (50)                                   
      Adenocarcinoma                                                                          1 (2%)                                
      Adenocarcinoma, Cystic, Mucinous                                                        1 (2%)                                
      Carcinoma, Metastatic                                         1 (3%)                                                          
      Polyp Adenomatous                                             1 (3%)                                                          
   Liver                                              (50)         (35)         (65)         (50)                                   
      Carcinoma, Metastatic                                         1 (3%)                                                          
      Hepatocellular Carcinoma                                                   1 (2%)       4 (8%)                                
      Neoplastic Nodule                                             5 (14%)      7 (11%)      4 (8%)                                
      Neoplastic Nodule, Multiple                                   1 (3%)       1 (2%)       3 (6%)                                
   Mesentery                                          (8)          (6)          (11)         (6)                                    
      Carcinoma, Metastatic                                         1 (17%)                                                         
      Sarcoma                                                                    1 (9%)                                             
   Pancreas                                           (49)         (35)         (65)         (50)                                   
   Pharynx                                            (1)          (9)          (23)         (20)                                   
      Squamous Cell Carcinoma                                                    1 (4%)                                             
      Palate, Squamous Cell Carcinoma                  1 (100%)                  3 (13%)      2 (10%)                               
      Palate, Squamous Cell Papilloma                               9 (100%)    16 (70%)     15 (75%)                               
      Palate, Squamous Cell Papilloma, Multiple                                  1 (4%)                                             
   Salivary Glands                                    (50)         (35)         (65)         (50)                                   
      Schwannoma Malignant                                                       2 (3%)                                             
                                                             Page   8                                                               
NTP Experiment-Test: 05169-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                        C. I. DIRECT BLUE 15                                   Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 03:28:37  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     CONTROL      0.063        0.125        0.25                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - cont                                                                                                            
      Bilateral, Schwannoma Malignant                                            1 (2%)                                             
   Stomach, Forestomach                               (49)         (35)         (65)         (50)                                   
      Carcinoma, Metastatic                                         1 (3%)                                                          
      Squamous Cell Papilloma                                                    1 (2%)                                             
   Stomach, Glandular                                 (49)         (34)         (65)         (50)                                   
   Tongue                                                          (2)          (4)          (2)                                    
      Squamous Cell Carcinoma                                       1 (50%)      2 (50%)                                            
      Squamous Cell Papilloma                                                    1 (25%)      2 (100%)                              
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (50)         (35)         (65)         (50)                                   
      Carcinoma, Metastatic, Zymbal's Gland                                                   1 (2%)                                
      Schwannoma Malignant                                                                    1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Gland, Cortex                              (50)         (35)         (65)         (50)                                   
   Adrenal Gland, Medulla                             (50)         (35)         (65)         (50)                                   
      Pheochromocytoma Malignant                                                 2 (3%)       1 (2%)                                
      Pheochromocytoma Complex                                                                1 (2%)                                
      Pheochromocytoma Benign                         12 (24%)      3 (9%)      10 (15%)     14 (28%)                               
      Bilateral, Pheochromocytoma Benign               4 (8%)       2 (6%)       9 (14%)      3 (6%)                                
   Islets, Pancreatic                                 (50)         (35)         (65)         (50)                                   
      Adenoma                                          1 (2%)                    1 (2%)                                             
   Pituitary Gland                                    (49)         (34)         (63)         (50)                                   
      Pars Distalis, Adenoma                           5 (10%)      1 (3%)       3 (5%)       3 (6%)                                
   Thyroid Gland                                      (50)         (35)         (65)         (50)                                   
      Bilateral, C-Cell, Adenoma                                                 1 (2%)                                             
      Bilateral, C-Cell, Carcinoma                     1 (2%)                    1 (2%)                                             
      C-Cell, Adenoma                                  5 (10%)      8 (23%)      6 (9%)       4 (8%)                                
      C-Cell, Carcinoma                                2 (4%)       1 (3%)       1 (2%)       1 (2%)                                
      Follicular Cell, Adenoma                                      4 (11%)      1 (2%)                                             
      Follicular Cell, Carcinoma                                                 3 (5%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   Tissue NOS                                                      (1)                                                              
      Carcinoma                                                     1 (100%)                                                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                             Page   9                                                               
NTP Experiment-Test: 05169-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                        C. I. DIRECT BLUE 15                                   Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 03:28:37  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     CONTROL      0.063        0.125        0.25                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (50)         (35)         (64)         (50)                                   
      Carcinoma, Multiple, Metastatic                               1 (3%)                                                          
   Preputial Gland                                    (49)         (35)         (64)         (48)                                   
      Adenoma                                          5 (10%)      1 (3%)      10 (16%)      8 (17%)                               
      Carcinoma                                        2 (4%)       2 (6%)      10 (16%)      1 (2%)                                
      Bilateral, Adenoma                               1 (2%)       1 (3%)       2 (3%)                                             
      Bilateral, Carcinoma                                          1 (3%)       1 (2%)                                             
   Prostate                                           (50)         (35)         (64)         (49)                                   
      Adenoma                                                                    1 (2%)                                             
      Schwannoma Malignant                                                       1 (2%)                                             
   Seminal Vesicle                                    (47)         (32)         (57)         (42)                                   
      Carcinoma, Metastatic                                         1 (3%)                                                          
      Schwannoma Malignant, Metastatic, Prostate                                 1 (2%)                                             
   Testes                                             (50)         (35)         (65)         (50)                                   
      Carcinoma, Metastatic                                         1 (3%)                                                          
      Bilateral, Interstitial Cell, Adenoma           43 (86%)     29 (83%)     52 (80%)     33 (66%)                               
      Interstitial Cell, Adenoma                       5 (10%)      3 (9%)       9 (14%)     10 (20%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (49)         (35)         (63)         (50)                                   
   Lymph Node                                         (50)         (35)         (64)         (50)                                   
      Axillary, Carcinoma, Metastatic                                                         1 (2%)                                
      Axillary, Squamous Cell Carcinoma,                                                                                            
          Metastatic, Skin                                                                    1 (2%)                                
      Mediastinal, Squamous Cell Carcinoma,                                                                                         
          Metastatic                                                                          1 (2%)                                
   Lymph Node, Mandibular                             (50)         (35)         (62)         (50)                                   
      Squamous Cell Carcinoma, Metastatic, Tongue                                1 (2%)                                             
      Mediastinal, Carcinoma, Multiple, Metastatic,                                                                                 
           Zymbal's Gland                                                                     1 (2%)                                
   Lymph Node, Mesenteric                             (50)         (35)         (64)         (50)                                   
      Carcinoma, Metastatic                                         1 (3%)                                                          
   Spleen                                             (50)         (35)         (64)         (50)                                   
      Carcinoma, Metastatic                                         1 (3%)                                                          
   Thymus                                             (43)         (34)         (51)         (43)                                   
      Carcinoma, Metastatic, Zymbal's Gland                                                   1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (48)         (34)         (59)         (42)                                   
      Fibroadenoma                                                               1 (2%)                                             
   Skin                                               (50)         (35)         (65)         (50)                                   
      Basal Cell Adenoma                               2 (4%)       5 (14%)     15 (23%)      9 (18%)                               
                                                             Page  10                                                               
NTP Experiment-Test: 05169-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                        C. I. DIRECT BLUE 15                                   Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 03:28:37  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     CONTROL      0.063        0.125        0.25                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
INTEGUMENTARY SYSTEM - cont                                                                                                         
      Basal Cell Adenoma, Multiple                                  3 (9%)       8 (12%)     17 (34%)                               
      Basal Cell Carcinoma                                          2 (6%)       3 (5%)      10 (20%)                               
      Basal Cell Carcinoma, Multiple                                             1 (2%)                                             
      Carcinoma                                                                  1 (2%)                                             
      Keratoacanthoma                                  2 (4%)       1 (3%)       7 (11%)      2 (4%)                                
      Squamous Cell Carcinoma                                       1 (3%)       7 (11%)      7 (14%)                               
      Squamous Cell Carcinoma, Multiple                                                       6 (12%)                               
      Squamous Cell Papilloma                          2 (4%)       3 (9%)       3 (5%)       7 (14%)                               
      Squamous Cell Papilloma, Multiple                                          2 (3%)       1 (2%)                                
      Sebaceous Gland, Adenoma                                      1 (3%)       6 (9%)       3 (6%)                                
      Sebaceous Gland, Adenoma, Multiple                                         1 (2%)                                             
      Subcutaneous Tissue, Carcinoma, Metastatic,                                                                                   
           Zymbal's Gland                                                                     1 (2%)                                
      Subcutaneous Tissue, Fibroma                     2 (4%)       2 (6%)       5 (8%)       3 (6%)                                
      Subcutaneous Tissue, Fibrous Histiocytoma                                  1 (2%)                                             
      Subcutaneous Tissue, Neurofibrosarcoma                                     1 (2%)                                             
      Subcutaneous Tissue, Sarcoma                                  1 (3%)                    1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (1)          (1)          (1)                                                 
      Cranium, Carcinoma, Metastatic, Zymbal's                                                                                      
          Gland                                                                  1 (100%)                                           
      Vertebra, Osteoma                                             1 (100%)                                                        
   Skeletal Muscle                                                                           (1)                                    
      Back, Schwannoma Malignant, Metastatic,                                                                                       
          Spinal Cord                                                                         1 (100%)                              
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (35)         (65)         (50)                                   
      Cerebrum, Astrocytoma Malignant                               1 (3%)       1 (2%)       1 (2%)                                
      Medulla, Astrocytoma Malignant                                                          1 (2%)                                
   Spinal Cord                                                                               (1)                                    
      Nerve, Schwannoma Malignant                                                             1 (100%)                              
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (35)         (65)         (50)                                   
      Alveolar/Bronchiolar Adenoma                     1 (2%)       1 (3%)       4 (6%)       1 (2%)                                
      Alveolar/Bronchiolar Adenoma, Multiple           1 (2%)                                                                       
      Carcinoma, Multiple, Metastatic, Zymbal's                                                                                     
          Gland                                                     1 (3%)       1 (2%)       1 (2%)                                
      Carcinoma, Metastatic                                         1 (3%)                                                          
                                                             Page  11                                                               
NTP Experiment-Test: 05169-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                        C. I. DIRECT BLUE 15                                   Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 03:28:37  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     CONTROL      0.063        0.125        0.25                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
RESPIRATORY SYSTEM - cont                                                                                                           
      Carcinoma, Metastatic, Thyroid Gland                          1 (3%)                                                          
      Carcinoma, Metastatic, Zymbal's Gland                                      1 (2%)                                             
      Neoplasm NOS, Metastatic, Uncertain Primary                                                                                   
          Site                                                                   1 (2%)                                             
      Neurofibrosarcoma, Multiple, Metastatic, Skin                              1 (2%)                                             
      Squamous Cell Carcinoma, Multiple,                                                                                            
          Metastatic, Skin                                                       1 (2%)       2 (4%)                                
      Squamous Cell Carcinoma, Metastatic                                                     1 (2%)                                
      Squamous Cell Carcinoma, Metastatic, Skin                                               1 (2%)                                
   Nose                                               (50)         (35)         (65)         (49)                                   
      Squamous Cell Carcinoma                                       1 (3%)       1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Zymbal's Gland                                     (50)         (35)         (64)         (50)                                   
      Adenoma                                                       2 (6%)       2 (3%)       4 (8%)                                
      Carcinoma                                        1 (2%)       3 (9%)       8 (13%)     17 (34%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (35)         (65)         (50)                                   
      Carcinoma, Metastatic                                         1 (3%)                                                          
      Renal Tubule, Adenoma                                                                   2 (4%)                                
   Urinary Bladder                                    (50)         (35)         (65)         (50)                                   
      Carcinoma, Metastatic                                         1 (3%)                                                          
      Schwannoma Malignant, Metastatic, Prostate                                 1 (2%)                                             
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SYSTEMIC LESIONS                                                                                                                   
   Multiple Organs                                   *(50)        *(35)        *(65)        *(50)                                   
      Leukemia Mononuclear                            17 (34%)     19 (54%)     28 (43%)     20 (40%)                               
      Mesothelioma Malignant                           1 (2%)       3 (9%)       2 (3%)       2 (4%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
     *   Number of animals with any tissue examined microscopically                                                                 
                                                             Page  12                                                               
NTP Experiment-Test: 05169-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                        C. I. DIRECT BLUE 15                                   Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 03:28:37  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     CONTROL      0.063        0.125        0.25                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
TUMOR SUMMARY                                                                                                                       
                                                                                                                                    
   Total Animals with Primary Neoplasms (b)            48          34          65          48                                       
     Total Primary Neoplasms                          116         125         276         236                                       
                                                                                                                                    
   Total Animals with Benign Neoplasms                 48          33          62          46                                       
     Total Benign Neoplasms                            91          88         188         153                                       
                                                                                                                                    
   Total Animals with Malignant Neoplasms              23          27          54          45                                       
     Total Malignant Neoplasms                         25          37          88          83                                       
                                                                                                                                    
   Total Animals with Metastatic Neoplasms              1           5           8           9                                       
     Total Metastatic Neoplasm                          2          26          12          15                                       
                                                                                                                                    
   Total Animals with Malignant Neoplasms                                       1                                                   
   Uncertain Primary Site                                                                                                           
                                                                                                                                    
   Total Animals with Neoplasms Uncertain-                                                                                          
   Benign or Malignant                                                                                                              
     Total Uncertain Neoplasms                                                                                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Primary tumors: all tumors except metastatic tumors                                                                              
                                                             Page  13                                                               
                             ------------------------------------------------------------                                           
                             ----------              END OF REPORT             ----------                                           
                             ------------------------------------------------------------                                           

--multipart-boundary
Content-type: text/plain
Range: bytes 80832-80832/80832


--multipart-boundary--