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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                                                              
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                             ----------              END OF REPORT             ----------                                           
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