Skip to Main Navigation
Skip to Page Content

COVID-19 is an emerging, rapidly evolving situation.

Get the latest public health information from CDC and research information from NIH.

U.S. flag

An official website of the United States government

Dot gov

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Share This:
https://ntp.niehs.nih.gov/go/2220

TDMS Study 05130-02 Pathology Tables



                                     INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
                                                       C. I. DIRECT BLUE 218


NTP Experiment-Test: 05130-02                                                                                     Report: PEIRPT03
Study Type: CHRONIC                                                                                               Date: 09/16/94
Route: DOSED FEED                                                                                                 Time: 23:49:52




       Facility:  Microbiological Associates

       Chemical CAS #:  10401-500

       Lock Date:  10/29/91

       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: 05130-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                       C. I. DIRECT BLUE 218                                   Date: 09/16/94  
Route: DOSED FEED                                                                                                 Time: 23:49:52  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE FEMALE                        CONTROL      1000 PPM     3000 PPM     10000PPM                                  
                                                   FEMALE       LOW FEM      MID FEM      HIGH FEM                                  
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially In Study                          60           60           60           60                                     
  Scheduled Sacrifice                                 10           10           10           10                                     
  Early Deaths                                                                                                                      
    Moribund Sacrifice                                 5            8            1            3                                     
    Natural Death                                      4            2            2            5                                     
    Moribund                                           3                                      2                                     
    Accidently Killed                                                                         1                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                37           40           46           38                                     
  Missing                                              1                         1            1                                     
  Animals Examined Microscopically                    49           50           49           49                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Gallbladder                                        (47)         (45)         (46)         (42)                                   
      Dilatation                                                    1 (2%)       1 (2%)                                             
   Intestine Large, Cecum                             (47)         (50)         (48)         (45)                                   
      Hyperplasia, Lymphoid                                         1 (2%)                                                          
   Intestine Small, Duodenum                          (46)         (50)         (48)         (46)                                   
      Hyperplasia, Lymphoid                            1 (2%)       1 (2%)                                                          
      Intussusception                                               1 (2%)                                                          
   Liver                                              (49)         (50)         (49)         (49)                                   
      Angiectasis, Focal                               4 (8%)       3 (6%)                                                          
      Basophilic Focus                                 4 (8%)       2 (4%)       6 (12%)      7 (14%)                               
      Clear Cell Focus                                 2 (4%)       2 (4%)       1 (2%)      12 (24%)                               
      Cyst                                             1 (2%)                                                                       
      Eosinophilic Focus                              11 (22%)      7 (14%)     11 (22%)     21 (43%)                               
      Fatty Change, Focal                              1 (2%)       1 (2%)       1 (2%)       2 (4%)                                
      Infiltration Cellular, Focal, Lymphocyte                      2 (4%)       1 (2%)                                             
      Infiltration Cellular, Histiocyte                1 (2%)                                                                       
      Inflammation, Chronic, Focal                     1 (2%)                                                                       
      Mixed Cell Focus                                 1 (2%)       1 (2%)                                                          
      Necrosis, Focal                                  2 (4%)       1 (2%)                    2 (4%)                                
      Centrilobular, Cytomegaly                                     1 (2%)                                                          
   Mesentery                                          (6)          (5)          (3)          (5)                                    
      Fat, Necrosis, Focal                             6 (100%)     2 (40%)      3 (100%)     3 (60%)                               
   Pancreas                                           (49)         (50)         (48)         (49)                                   
      Accessory Spleen                                 1 (2%)       1 (2%)                                                          
      Fibrosis, Focal                                                                         1 (2%)                                
      Infiltration Cellular, Focal, Lymphocyte         1 (2%)                                                                       
      Inflammation, Chronic Active, Focal              2 (4%)       1 (2%)                                                          
      Acinar Cell, Atrophy                                                                    2 (4%)                                
      Acinar Cell, Hypertrophy, Focal                  1 (2%)                                                                       
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    2                                                              
NTP Experiment-Test: 05130-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                       C. I. DIRECT BLUE 218                                   Date: 09/16/94  
Route: DOSED FEED                                                                                                 Time: 23:49:52  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE FEMALE                        CONTROL      1000 PPM     3000 PPM     10000PPM                                  
                                                   FEMALE       LOW FEM      MID FEM      HIGH FEM                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Duct, Dilatation                                              2 (4%)                    2 (4%)                                
   Salivary Glands                                    (49)         (50)         (49)         (48)                                   
      Arteriole, Inflammation, Chronic, Multifocal     1 (2%)                                                                       
   Stomach, Forestomach                               (49)         (50)         (48)         (49)                                   
      Hyperplasia, Focal                                                         1 (2%)       2 (4%)                                
      Ulcer, Focal                                                  2 (4%)       2 (4%)       1 (2%)                                
   Stomach, Glandular                                 (49)         (50)         (48)         (49)                                   
      Inflammation, Acute, Focal                                    1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (49)         (50)         (49)         (49)                                   
      Cardiomyopathy                                                1 (2%)                                                          
      Arteriole, Inflammation, Chronic, Focal          1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (49)         (49)         (48)         (48)                                   
      Cyst                                             1 (2%)                                 3 (6%)                                
      Cytoplasmic Alteration, Focal                                 1 (2%)       4 (8%)       1 (2%)                                
      Degeneration, Focal                                                        1 (2%)       1 (2%)                                
      Hemorrhage, Focal                                                          7 (15%)      1 (2%)                                
      Hyperplasia, Focal                               1 (2%)                                                                       
      Hypertrophy, Focal                                                         1 (2%)       1 (2%)                                
      Vacuolization Cytoplasmic, Focal                                                        1 (2%)                                
   Adrenal Medulla                                    (49)         (49)         (48)         (47)                                   
      Congestion                                       1 (2%)                                                                       
      Degeneration, Focal                                                                     1 (2%)                                
      Hyperplasia, Focal                                            1 (2%)       1 (2%)                                             
   Islets, Pancreatic                                 (49)         (50)         (48)         (49)                                   
      Hyperplasia, Focal                               1 (2%)                                 2 (4%)                                
   Parathyroid Gland                                  (33)         (34)         (40)         (40)                                   
      Infiltration Cellular, Focal, Lymphocyte                      1 (3%)                                                          
   Pituitary Gland                                    (48)         (50)         (49)         (45)                                   
      Pars Distalis, Angiectasis, Focal                2 (4%)                                                                       
      Pars Distalis, Cyst                              1 (2%)       1 (2%)                    1 (2%)                                
      Pars Distalis, Hyperplasia, Focal                6 (13%)     11 (22%)      7 (14%)      3 (7%)                                
   Thyroid Gland                                      (49)         (50)         (49)         (49)                                   
      Infiltration Cellular, Focal, Lymphocyte         2 (4%)                                                                       
      Inflammation, Chronic Active, Focal                                        1 (2%)                                             
      Arteriole, Inflammation, Chronic, Focal          1 (2%)                                                                       
      C-Cell, Hyperplasia, Focal                                    1 (2%)                    1 (2%)                                
      Follicle, Dilatation, Focal                      2 (4%)                    1 (2%)                                             
      Follicular Cell, Hyperplasia, Focal             11 (22%)      9 (18%)      7 (14%)      6 (12%)                               
      Follicular Cell, Hypertrophy, Focal              1 (2%)                                                                       
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    3                                                              
NTP Experiment-Test: 05130-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                       C. I. DIRECT BLUE 218                                   Date: 09/16/94  
Route: DOSED FEED                                                                                                 Time: 23:49:52  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE FEMALE                        CONTROL      1000 PPM     3000 PPM     10000PPM                                  
                                                   FEMALE       LOW FEM      MID FEM      HIGH FEM                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (1)                                    (1)                                    
      Inflammation, Chronic Active                     1 (100%)                               1 (100%)                              
      Duct, Dilatation                                                                        1 (100%)                              
   Ovary                                              (47)         (50)         (48)         (49)                                   
      Abscess                                          2 (4%)                                                                       
      Angiectasis                                                                1 (2%)       3 (6%)                                
      Cyst                                            12 (26%)     17 (34%)     15 (31%)     28 (57%)                               
      Ectopic Tissue                                                                          1 (2%)                                
      Hematocyst                                                    1 (2%)       3 (6%)       2 (4%)                                
      Hemorrhage, Focal                                1 (2%)                                                                       
      Hyperplasia, Tubular                                                                    1 (2%)                                
      Infiltration Cellular, Focal, Lymphocyte                      1 (2%)                    1 (2%)                                
      Inflammation, Chronic, Focal                     2 (4%)                                                                       
      Mineralization, Focal                                         1 (2%)       1 (2%)                                             
      Pigmentation, Focal                                           1 (2%)                                                          
      Bilateral, Abscess                               1 (2%)                                                                       
      Follicle, Hyperplasia, Cystic, Focal                          1 (2%)                                                          
   Uterus                                             (49)         (50)         (49)         (49)                                   
      Dilatation                                      13 (27%)     12 (24%)     15 (31%)      9 (18%)                               
      Ectopic Tissue, Focal                                                      1 (2%)                                             
      Inflammation, Acute                              1 (2%)                                                                       
      Inflammation, Chronic Active                     2 (4%)                                                                       
      Thrombosis, Focal                                             1 (2%)                                                          
      Endometrium, Hyperplasia, Cystic                31 (63%)     42 (84%)     38 (78%)     31 (63%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (49)         (50)         (49)         (49)                                   
      Angiectasis, Focal                                                                      1 (2%)                                
      Congestion                                       1 (2%)                                                                       
      Hyperplasia                                      5 (10%)                                2 (4%)                                
      Hyperplasia, Lymphoid                            1 (2%)                                                                       
   Lymph Node                                         (9)          (10)         (8)          (7)                                    
      Iliac, Hyperplasia, Lymphoid                     1 (11%)                                                                      
      Iliac, Hyperplasia, Plasma Cell                  1 (11%)                                1 (14%)                               
      Lumbar, Hyperplasia, Lymphoid                    3 (33%)      1 (10%)      1 (13%)                                            
      Lumbar, Hyperplasia, Plasma Cell                 1 (11%)                                                                      
      Mediastinal, Hyperplasia, Lymphoid               1 (11%)                                1 (14%)                               
      Mediastinal, Hyperplasia, Plasma Cell            1 (11%)                                                                      
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    4                                                              
NTP Experiment-Test: 05130-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                       C. I. DIRECT BLUE 218                                   Date: 09/16/94  
Route: DOSED FEED                                                                                                 Time: 23:49:52  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE FEMALE                        CONTROL      1000 PPM     3000 PPM     10000PPM                                  
                                                   FEMALE       LOW FEM      MID FEM      HIGH FEM                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Renal, Hyperplasia, Lymphoid                     2 (22%)                                                                      
      Renal, Hyperplasia, Plasma Cell                  2 (22%)                                1 (14%)                               
   Lymph Node, Mandibular                             (49)         (48)         (48)         (47)                                   
      Congestion                                                    1 (2%)                                                          
      Cyst                                             2 (4%)       3 (6%)       2 (4%)       3 (6%)                                
      Edema                                                         1 (2%)                                                          
      Hemorrhage                                       1 (2%)                    1 (2%)                                             
      Hyperplasia, Lymphoid                            3 (6%)       7 (15%)      4 (8%)       2 (4%)                                
      Hyperplasia, Plasma Cell                         1 (2%)       2 (4%)       2 (4%)       1 (2%)                                
      Infiltration Cellular, Mast Cell                              1 (2%)                                                          
      Inflammation, Acute                              1 (2%)                                                                       
   Lymph Node, Mesenteric                             (46)         (48)         (47)         (46)                                   
      Angiectasis, Focal                                            1 (2%)                                                          
      Hemorrhage                                       1 (2%)       1 (2%)                    1 (2%)                                
      Hyperplasia, Lymphoid                            5 (11%)      2 (4%)       1 (2%)       1 (2%)                                
      Hyperplasia, Plasma Cell                                                                1 (2%)                                
      Necrosis                                         1 (2%)                                 1 (2%)                                
   Spleen                                             (48)         (50)         (49)         (49)                                   
      Amyloid Deposition, Focal                                                  1 (2%)                                             
      Depletion Lymphoid                               1 (2%)                                 1 (2%)                                
      Hematopoietic Cell Proliferation                10 (21%)      9 (18%)      3 (6%)       6 (12%)                               
      Hyperplasia, Lymphoid                            6 (13%)      5 (10%)     10 (20%)      5 (10%)                               
   Thymus                                             (46)         (48)         (48)         (46)                                   
      Atrophy                                                                                 1 (2%)                                
      Cyst                                             1 (2%)       2 (4%)                    1 (2%)                                
      Depletion Lymphoid                               1 (2%)                                 1 (2%)                                
      Hemorrhage, Focal                                             1 (2%)                                                          
      Hyperplasia, Lymphoid                            1 (2%)       3 (6%)       2 (4%)                                             
      Necrosis                                         1 (2%)       1 (2%)                    2 (4%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (49)         (50)         (49)         (49)                                   
      Acanthosis, Focal                                             1 (2%)                                                          
      Inflammation, Acute, Focal                       1 (2%)                    1 (2%)                                             
      Inflammation, Chronic Active, Focal              1 (2%)       4 (8%)       1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (49)         (50)         (49)         (49)                                   
      Fibrous Osteodystrophy                                        1 (2%)                                                          
      Intervertebral Disc, Dysplasia, Focal                         1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    5                                                              
NTP Experiment-Test: 05130-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                       C. I. DIRECT BLUE 218                                   Date: 09/16/94  
Route: DOSED FEED                                                                                                 Time: 23:49:52  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE FEMALE                        CONTROL      1000 PPM     3000 PPM     10000PPM                                  
                                                   FEMALE       LOW FEM      MID FEM      HIGH FEM                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (49)         (50)         (49)         (49)                                   
      Hemorrhage, Focal                                             1 (2%)                                                          
      Hydrocephalus                                                 1 (2%)                                                          
      Mineralization, Focal                           29 (59%)     45 (90%)     34 (69%)     38 (78%)                               
      Necrosis, Focal                                  1 (2%)                                                                       
      Artery, Inflammation, Chronic, Focal             1 (2%)                                                                       
   Spinal Cord                                                     (1)                                                              
      Infiltration Cellular, Focal, Histiocyte                      1 (100%)                                                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (49)         (50)         (49)         (49)                                   
      Congestion                                       1 (2%)                    1 (2%)       1 (2%)                                
      Hemorrhage, Focal                                1 (2%)       1 (2%)       1 (2%)                                             
      Hemorrhage, Multifocal                                                                  1 (2%)                                
      Infiltration Cellular, Focal, Lymphocyte         1 (2%)                                                                       
      Infiltration Cellular, Focal, Histiocyte                      2 (4%)                                                          
      Alveolar Epithelium, Hyperplasia, Focal                                                 2 (4%)                                
      Arteriole, Hypertrophy, Focal                                              1 (2%)                                             
      Interstitium, Inflammation, Focal                             1 (2%)       3 (6%)                                             
   Nose                                               (49)         (50)         (49)         (49)                                   
      Congestion                                                                 1 (2%)                                             
      Inflammation, Acute, Focal                                    2 (4%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Ear                                                (2)          (1)                                                              
      Arteriole, Inflammation, Chronic, Focal          1 (50%)                                                                      
      Pinna, Inflammation, Chronic Active, Focal                    1 (100%)                                                        
   Eye                                                (2)          (1)          (1)                                                 
      Cornea, Inflammation, Chronic                    2 (100%)                                                                     
      Lens, Cataract                                                1 (100%)     1 (100%)                                           
   Zymbal's Gland                                     (38)         (38)         (37)         (32)                                   
      Inflammation, Acute, Focal                       1 (3%)                    1 (3%)                                             
      Inflammation, Chronic Active                                               1 (3%)                                             
      Duct, Dilatation                                 1 (3%)       1 (3%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (49)         (50)         (49)         (49)                                   
      Infarct, Chronic, Focal                                                    1 (2%)       1 (2%)                                
      Infiltration Cellular, Focal, Lymphocyte         1 (2%)       2 (4%)       2 (4%)       1 (2%)                                
      Metaplasia, Focal, Osseous                       2 (4%)       1 (2%)                    2 (4%)                                
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    6                                                              
NTP Experiment-Test: 05130-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                       C. I. DIRECT BLUE 218                                   Date: 09/16/94  
Route: DOSED FEED                                                                                                 Time: 23:49:52  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE FEMALE                        CONTROL      1000 PPM     3000 PPM     10000PPM                                  
                                                   FEMALE       LOW FEM      MID FEM      HIGH FEM                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
URINARY SYSTEM - CONT                                                                                                               
      Nephropathy                                      4 (8%)       3 (6%)       5 (10%)      3 (6%)                                
      Artery, Inflammation, Chronic, Focal             1 (2%)                                                                       
      Glomerulus, Inflammation, Chronic                1 (2%)       1 (2%)                                                          
      Renal Tubule, Dilatation, Focal                                            2 (4%)                                             
   Urinary Bladder                                    (48)         (50)         (48)         (49)                                   
      Dilatation                                                    1 (2%)       1 (2%)                                             
      Inflammation, Acute                              1 (2%)                                                                       
      Inflammation, Chronic Active, Focal                                                     2 (4%)                                
      Arteriole, Inflammation, Chronic, Focal          1 (2%)                                                                       
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    7                                                              
NTP Experiment-Test: 05130-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                       C. I. DIRECT BLUE 218                                   Date: 09/16/94  
Route: DOSED FEED                                                                                                 Time: 23:49:52  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE MALE                          CONTROL      1000 PPM     3000 PPM     10000PPM                                  
                                                   MALE         LOW MALE     MID MALE     HIGHMALE                                  
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially In Study                          60           60           60           60                                     
  Scheduled Sacrifice                                  9           10           10           10                                     
  Early Deaths                                                                                                                      
    Accidently Killed                                  1                                                                            
    Natural Death                                      3            2            5            4                                     
    Moribund Sacrifice                                 2            2            3            1                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                44           46           42           45                                     
  Missing                                              1                                                                            
  Animals Examined Microscopically                    50           50           50           50                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Gallbladder                                        (45)         (47)         (46)         (47)                                   
      Hyperplasia                                                                             1 (2%)                                
      Inflammation, Acute                                                                     2 (4%)                                
   Intestine Large, Colon                             (48)         (50)         (50)         (49)                                   
      Diverticulum                                                  1 (2%)                                                          
   Intestine Large, Cecum                             (48)         (49)         (48)         (48)                                   
      Hyperplasia, Lymphoid                                         1 (2%)                                                          
   Intestine Small, Duodenum                          (48)         (48)         (47)         (49)                                   
      Hyperplasia, Lymphoid                                         1 (2%)                                                          
      Inflammation, Acute, Focal                                                              1 (2%)                                
   Intestine Small, Jejunum                           (49)         (49)         (49)         (49)                                   
      Hyperplasia, Lymphoid                                                                   1 (2%)                                
   Liver                                              (50)         (50)         (50)         (50)                                   
      Angiectasis, Focal                                            1 (2%)       1 (2%)                                             
      Basophilic Focus                                 7 (14%)      5 (10%)      4 (8%)       9 (18%)                               
      Clear Cell Focus                                 8 (16%)      5 (10%)      5 (10%)      4 (8%)                                
      Cytomegaly, Focal                                             1 (2%)                                                          
      Developmental Malformation                       1 (2%)                                                                       
      Eosinophilic Focus                              13 (26%)     12 (24%)     10 (20%)     28 (56%)                               
      Fatty Change, Focal                                           1 (2%)       3 (6%)       4 (8%)                                
      Hematopoietic Cell Proliferation                              1 (2%)                                                          
      Infarct, Chronic                                 1 (2%)                                                                       
      Inflammation, Chronic, Focal                     1 (2%)                    1 (2%)                                             
      Leukocytosis                                     1 (2%)                    1 (2%)                                             
      Mixed Cell Focus                                 3 (6%)       5 (10%)      2 (4%)       1 (2%)                                
      Necrosis, Focal                                                            4 (8%)       3 (6%)                                
   Mesentery                                          (3)          (1)                                                              
      Fat, Necrosis, Focal                             3 (100%)                                                                     
   Pancreas                                           (49)         (50)         (50)         (50)                                   
      Cyst                                                                       1 (2%)                                             
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    8                                                              
NTP Experiment-Test: 05130-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                       C. I. DIRECT BLUE 218                                   Date: 09/16/94  
Route: DOSED FEED                                                                                                 Time: 23:49:52  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE MALE                          CONTROL      1000 PPM     3000 PPM     10000PPM                                  
                                                   MALE         LOW MALE     MID MALE     HIGHMALE                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Acinar Cell, Atrophy                                          1 (2%)                    1 (2%)                                
   Stomach, Forestomach                               (50)         (50)         (50)         (50)                                   
      Hyperplasia, Focal                               1 (2%)       3 (6%)       1 (2%)                                             
      Inflammation, Chronic Active, Focal              1 (2%)                                                                       
      Ulcer, Focal                                     1 (2%)       1 (2%)       1 (2%)                                             
   Stomach, Glandular                                 (50)         (50)         (50)         (50)                                   
      Hyperplasia, Focal                                                                      1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (50)         (50)         (50)         (50)                                   
      Cardiomyopathy                                   1 (2%)                                                                       
      Inflammation, Acute, Focal                                                 1 (2%)                                             
      Inflammation, Chronic Active, Focal                                        1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (50)         (50)         (50)         (50)                                   
      Accessory Adrenal Cortical Nodule                             1 (2%)                                                          
      Atrophy                                                                                 1 (2%)                                
      Hemorrhage, Focal                                                                       1 (2%)                                
      Hyperplasia, Focal                               1 (2%)       2 (4%)       2 (4%)       3 (6%)                                
      Hypertrophy, Focal                               1 (2%)       1 (2%)       3 (6%)       4 (8%)                                
   Adrenal Medulla                                    (50)         (50)         (50)         (50)                                   
      Hyperplasia, Focal                                                         1 (2%)       1 (2%)                                
   Islets, Pancreatic                                 (49)         (50)         (50)         (50)                                   
      Hyperplasia, Focal                               1 (2%)                    1 (2%)                                             
   Parathyroid Gland                                  (41)         (43)         (42)         (43)                                   
      Cyst                                                                       1 (2%)                                             
      Inflammation, Chronic, Focal                     1 (2%)                                                                       
   Pituitary Gland                                    (49)         (48)         (48)         (48)                                   
      Pars Distalis, Cyst                              1 (2%)       2 (4%)                                                          
      Pars Distalis, Hyperplasia, Focal                                          2 (4%)                                             
      Pars Nervosa, Cyst                                            1 (2%)                                                          
   Thyroid Gland                                      (50)         (50)         (50)         (50)                                   
      Follicle, Dilatation, Focal                                                1 (2%)       1 (2%)                                
      Follicular Cell, Hyperplasia, Focal              3 (6%)       1 (2%)                    5 (10%)                               
      Follicular Cell, Hypertrophy, Focal                                        1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    9                                                              
NTP Experiment-Test: 05130-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                       C. I. DIRECT BLUE 218                                   Date: 09/16/94  
Route: DOSED FEED                                                                                                 Time: 23:49:52  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE MALE                          CONTROL      1000 PPM     3000 PPM     10000PPM                                  
                                                   MALE         LOW MALE     MID MALE     HIGHMALE                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (50)         (50)         (50)         (50)                                   
      Granuloma Sperm                                  2 (4%)       2 (4%)                                                          
      Inflammation, Chronic, Focal                     1 (2%)       2 (4%)                                                          
   Preputial Gland                                    (29)         (23)         (23)         (21)                                   
      Inflammation, Chronic Active                     2 (7%)                    2 (9%)       1 (5%)                                
      Duct, Dilatation                                27 (93%)     23 (100%)    22 (96%)     21 (100%)                              
   Prostate                                           (50)         (49)         (50)         (50)                                   
      Dilatation                                                    1 (2%)                                                          
      Hyperplasia, Focal                               2 (4%)       4 (8%)       6 (12%)      2 (4%)                                
   Seminal Vesicle                                    (50)         (50)         (50)         (50)                                   
      Dilatation                                       2 (4%)       1 (2%)       1 (2%)                                             
      Inflammation, Acute                              1 (2%)                                                                       
   Testes                                             (50)         (50)         (50)         (50)                                   
      Angiectasis, Focal                                                         1 (2%)                                             
      Atrophy                                                       1 (2%)                                                          
      Atrophy, Focal                                                1 (2%)                                                          
      Degeneration, Focal                              1 (2%)                    1 (2%)                                             
      Seminiferous Tubule, Degeneration, Focal         1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (50)         (50)         (50)                                   
      Angiectasis, Focal                                            1 (2%)                    1 (2%)                                
      Hyperplasia                                      1 (2%)       1 (2%)                                                          
   Lymph Node                                         (4)          (1)          (2)          (3)                                    
      Hyperplasia, Lymphoid                                                      1 (50%)                                            
      Bronchial, Hyperplasia, Lymphoid                 1 (25%)                                                                      
      Mediastinal, Congestion                                                                 1 (33%)                               
      Renal, Hyperplasia, Lymphoid                     1 (25%)                                                                      
   Lymph Node, Mandibular                             (46)         (49)         (49)         (48)                                   
      Cyst                                                                       1 (2%)       1 (2%)                                
      Hemorrhage                                                    1 (2%)                                                          
      Hyperplasia, Lymphoid                            4 (9%)       4 (8%)       4 (8%)       1 (2%)                                
      Hyperplasia, Plasma Cell                                      1 (2%)       1 (2%)                                             
      Infiltration Cellular, Histiocyte                                                       1 (2%)                                
   Lymph Node, Mesenteric                             (48)         (49)         (50)         (50)                                   
      Hemorrhage                                       3 (6%)       3 (6%)       2 (4%)                                             
      Hyperplasia, Lymphoid                            2 (4%)       4 (8%)                    1 (2%)                                
      Hyperplasia, Plasma Cell                         1 (2%)                                                                       
      Necrosis                                         1 (2%)                                                                       
   Spleen                                             (49)         (50)         (50)         (50)                                   
      Developmental Malformation                                    1 (2%)                                                          
      Hematopoietic Cell Proliferation                 3 (6%)       3 (6%)       3 (6%)       4 (8%)                                
      Hyperplasia, Lymphoid                            2 (4%)       4 (8%)       2 (4%)                                             
      Lymphocyte, Necrosis, Focal                      1 (2%)                                                                       
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   10                                                              
NTP Experiment-Test: 05130-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                       C. I. DIRECT BLUE 218                                   Date: 09/16/94  
Route: DOSED FEED                                                                                                 Time: 23:49:52  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE MALE                          CONTROL      1000 PPM     3000 PPM     10000PPM                                  
                                                   MALE         LOW MALE     MID MALE     HIGHMALE                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
   Thymus                                             (49)         (45)         (46)         (42)                                   
      Cyst                                             2 (4%)       2 (4%)       3 (7%)       2 (5%)                                
      Necrosis                                         1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (50)         (50)         (50)         (50)                                   
      Inflammation, Chronic Active, Focal              1 (2%)       3 (6%)                                                          
      Subcutaneous Tissue, Abscess                                               1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (50)         (50)         (50)                                   
      Hemorrhage, Focal                                1 (2%)                    1 (2%)                                             
      Mineralization, Focal                           36 (72%)     42 (84%)     43 (86%)     43 (86%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (50)         (50)         (50)                                   
      Hemorrhage, Focal                                                                       1 (2%)                                
      Infiltration Cellular, Focal, Histiocyte                      2 (4%)       1 (2%)                                             
      Leukocytosis                                     1 (2%)                    1 (2%)                                             
      Alveolar Epithelium, Hyperplasia, Focal          5 (10%)      2 (4%)       3 (6%)       2 (4%)                                
      Interstitium, Inflammation, Focal                4 (8%)       1 (2%)       3 (6%)       2 (4%)                                
   Nose                                               (50)         (50)         (50)         (50)                                   
      Congestion                                       1 (2%)                                 1 (2%)                                
      Inflammation, Acute, Focal                                                 3 (6%)       1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Ear                                                (2)                                                                           
      Middle Ear, Inflammation, Chronic Active,                                                                                     
           Focal                                       1 (50%)                                                                      
   Eye                                                (1)          (2)          (2)                                                 
      Cornea, Inflammation, Chronic                                 1 (50%)      1 (50%)                                            
      Lens, Cataract                                                1 (50%)                                                         
   Zymbal's Gland                                     (39)         (34)         (42)         (37)                                   
      Inflammation, Chronic Active                                               1 (2%)                                             
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   11                                                              
NTP Experiment-Test: 05130-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                       C. I. DIRECT BLUE 218                                   Date: 09/16/94  
Route: DOSED FEED                                                                                                 Time: 23:49:52  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE MALE                          CONTROL      1000 PPM     3000 PPM     10000PPM                                  
                                                   MALE         LOW MALE     MID MALE     HIGHMALE                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
SPECIAL SENSES SYSTEM - CONT                                                                                                        
      Duct, Dilatation                                                           1 (2%)       1 (3%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (50)         (50)         (50)                                   
      Infarct, Chronic, Focal                                                    2 (4%)                                             
      Metaplasia, Focal, Osseous                                                              1 (2%)                                
      Mineralization, Focal                                                      1 (2%)                                             
      Nephropathy                                     25 (50%)     20 (40%)     30 (60%)     19 (38%)                               
      Renal Tubule, Dilatation, Focal                  1 (2%)       1 (2%)       3 (6%)       2 (4%)                                
   Urinary Bladder                                    (50)         (50)         (50)         (50)                                   
      Dilatation                                       1 (2%)                    1 (2%)                                             
      Metaplasia, Focal, Osseous                                                              1 (2%)                                
      Transitional Epithelium, Hyperplasia, Focal      1 (2%)                                                                       
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   12                                                              
                             ------------------------------------------------------------                                           
                             ----------              END OF REPORT             ----------                                           
                             ------------------------------------------------------------