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https://ntp.niehs.nih.gov/go/2232

TDMS Study 05130-03 Pathology Tables



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


NTP Experiment-Test: 05130-03                                                                                     Report: PEIRPT03
Study Type: CHRONIC                                                                                               Date: 09/17/94
Route: DOSED FEED                                                                                                 Time: 01:29:33




       Facility:  Microbiological Associates

       Chemical CAS #:  10401-500

       Lock Date:  11/21/91

       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: 05130-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                       C. I. DIRECT BLUE 218                                   Date: 09/17/94  
Route: DOSED FEED                                                                                                 Time: 01:29:33  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   0 PPM        1000 PPM     3000 PPM     10000PPM                                  
                                                                                                                                    
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially In Study                          60           60           60           60                                     
  Scheduled Sacrifice                                  9            9           10           10                                     
  Early Deaths                                                                                                                      
    Moribund Sacrifice                                12           15           13           16                                     
    Natural Death                                      4            7            6            9                                     
  Survivors                                                                                                                         
    Moribund Sacrifice                                              1                                                               
    Terminal Sacrifice                                35           28           31           25                                     
  Animals Examined Microscopically                    50           50           50           50                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Small, Jejunum                           (48)         (45)         (49)         (47)                                   
      Mineralization, Focal                            1 (2%)                                                                       
   Liver                                              (50)         (50)         (50)         (50)                                   
      Angiectasis, Focal                               3 (6%)       1 (2%)                                                          
      Basophilic Focus                                38 (76%)     28 (56%)     41 (82%)     30 (60%)                               
      Clear Cell Focus                                11 (22%)      4 (8%)      16 (32%)     12 (24%)                               
      Congestion                                       2 (4%)       1 (2%)       3 (6%)                                             
      Cyst                                                                       1 (2%)                                             
      Degeneration, Cystic, Focal                      2 (4%)                                 1 (2%)                                
      Developmental Malformation                       1 (2%)       5 (10%)      1 (2%)                                             
      Eosinophilic Focus                               2 (4%)       2 (4%)       3 (6%)       3 (6%)                                
      Fatty Change, Diffuse                            4 (8%)       5 (10%)      2 (4%)       1 (2%)                                
      Fatty Change, Focal                             14 (28%)     11 (22%)      9 (18%)     18 (36%)                               
      Hematopoietic Cell Proliferation                 3 (6%)       1 (2%)                                                          
      Hemorrhage, Focal                                             1 (2%)                                                          
      Hepatodiaphragmatic Nodule                       4 (8%)       4 (8%)       2 (4%)       1 (2%)                                
      Hyperplasia, Focal                               4 (8%)       1 (2%)       1 (2%)                                             
      Inflammation, Chronic, Focal                    11 (22%)      9 (18%)      8 (16%)     10 (20%)                               
      Inflammation, Focal, Granulomatous               1 (2%)       2 (4%)       1 (2%)                                             
      Mixed Cell Focus                                 2 (4%)       2 (4%)                    4 (8%)                                
      Necrosis, Focal                                               2 (4%)       1 (2%)       3 (6%)                                
      Bile Duct, Dilatation, Focal                                               1 (2%)                                             
      Bile Duct, Hyperplasia, Focal                    3 (6%)       1 (2%)       2 (4%)       2 (4%)                                
      Centrilobular, Necrosis                                                                 2 (4%)                                
      Vein, Dilatation                                              1 (2%)       1 (2%)                                             
   Mesentery                                          (8)          (6)          (3)          (6)                                    
      Fat, Necrosis, Focal                             8 (100%)     3 (50%)      2 (67%)      5 (83%)                               
   Pancreas                                           (50)         (48)         (50)         (48)                                   
      Accessory Spleen                                                                        1 (2%)                                
      Acinus, Atrophy, Diffuse                         1 (2%)                                 1 (2%)                                
      Acinus, Atrophy, Focal                          15 (30%)      9 (19%)      9 (18%)     13 (27%)                               
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    2                                                              
NTP Experiment-Test: 05130-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                       C. I. DIRECT BLUE 218                                   Date: 09/17/94  
Route: DOSED FEED                                                                                                 Time: 01:29:33  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   0 PPM        1000 PPM     3000 PPM     10000PPM                                  
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Acinus, Ectopic Liver, Focal                                                            1 (2%)                                
      Artery, Inflammation, Focal                                                             1 (2%)                                
      Duct, Hyperplasia, Focal                                                                1 (2%)                                
   Salivary Glands                                    (50)         (50)         (50)         (50)                                   
      Inflammation, Chronic                                                                   1 (2%)                                
   Stomach, Forestomach                               (50)         (49)         (50)         (49)                                   
      Acanthosis, Focal                                2 (4%)       2 (4%)       3 (6%)       3 (6%)                                
      Hyperplasia, Basal Cell, Focal                   1 (2%)       1 (2%)       5 (10%)     11 (22%)                               
      Inflammation, Acute, Focal                       2 (4%)                                                                       
      Inflammation, Chronic, Focal                     1 (2%)       1 (2%)                    1 (2%)                                
      Mineralization, Focal                                                      1 (2%)                                             
      Ulcer                                            1 (2%)       1 (2%)                    1 (2%)                                
      Ulcer, Focal                                     2 (4%)       2 (4%)       2 (4%)       2 (4%)                                
   Stomach, Glandular                                 (50)         (48)         (50)         (48)                                   
      Erosion, Focal                                   1 (2%)                    1 (2%)                                             
      Inflammation, Chronic Active, Focal              1 (2%)                                                                       
      Ulcer, Focal                                                               1 (2%)                                             
   Tongue                                                                       (1)                                                 
      Acanthosis, Focal                                                          1 (100%)                                           
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (50)         (50)         (50)         (50)                                   
      Cardiomyopathy                                  22 (44%)     20 (40%)     21 (42%)     14 (28%)                               
      Atrium, Thrombosis                                            2 (4%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (50)         (50)         (50)         (49)                                   
      Angiectasis, Focal                               2 (4%)       5 (10%)     13 (26%)      7 (14%)                               
      Congestion                                                                              2 (4%)                                
      Cyst                                                          1 (2%)       1 (2%)                                             
      Degeneration, Cystic, Focal                                   2 (4%)       1 (2%)                                             
      Hematopoietic Cell Proliferation, Focal                                    1 (2%)                                             
      Hemorrhage                                                                 1 (2%)                                             
      Hyperplasia, Focal                               4 (8%)       3 (6%)       7 (14%)      6 (12%)                               
      Hypertrophy, Focal                               2 (4%)       3 (6%)       2 (4%)       4 (8%)                                
      Necrosis, Focal                                                                         2 (4%)                                
      Vacuolization Cytoplasmic, Diffuse                            2 (4%)                                                          
      Vacuolization Cytoplasmic, Focal                18 (36%)     21 (42%)     16 (32%)     18 (37%)                               
   Adrenal Medulla                                    (49)         (50)         (47)         (49)                                   
      Degeneration                                                  1 (2%)                                                          
      Hyperplasia                                      7 (14%)      5 (10%)      6 (13%)      3 (6%)                                
      Bilateral, Hyperplasia                                        2 (4%)       1 (2%)       1 (2%)                                
   Islets, Pancreatic                                 (50)         (48)         (50)         (48)                                   
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    3                                                              
NTP Experiment-Test: 05130-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                       C. I. DIRECT BLUE 218                                   Date: 09/17/94  
Route: DOSED FEED                                                                                                 Time: 01:29:33  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   0 PPM        1000 PPM     3000 PPM     10000PPM                                  
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
      Hyperplasia, Focal                               1 (2%)       1 (2%)       1 (2%)       1 (2%)                                
   Parathyroid Gland                                  (45)         (43)         (39)         (44)                                   
      Cyst                                                                                    1 (2%)                                
   Pituitary Gland                                    (50)         (47)         (49)         (47)                                   
      Hemorrhage, Focal                                                          1 (2%)                                             
      Pars Distalis, Angiectasis                                    2 (4%)                    1 (2%)                                
      Pars Distalis, Angiectasis, Focal                1 (2%)                                                                       
      Pars Distalis, Cyst                             10 (20%)     10 (21%)      7 (14%)     11 (23%)                               
      Pars Distalis, Hyperplasia, Focal               13 (26%)      9 (19%)      9 (18%)     14 (30%)                               
   Thyroid Gland                                      (50)         (50)         (49)         (49)                                   
      Inflammation                                     1 (2%)       1 (2%)                                                          
      C-Cell, Hyperplasia, Diffuse                     1 (2%)                                                                       
      C-Cell, Hyperplasia, Focal                      10 (20%)      4 (8%)       6 (12%)     11 (22%)                               
      Follicle, Dilatation, Focal                                   1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (47)         (48)         (49)         (47)                                   
      Hyperplasia                                                                3 (6%)       3 (6%)                                
      Inflammation, Chronic                            2 (4%)                                 1 (2%)                                
      Inflammation, Suppurative                        3 (6%)                    1 (2%)       2 (4%)                                
      Bilateral, Duct, Dilatation                                                1 (2%)                                             
      Duct, Dilatation                                 8 (17%)     12 (25%)     15 (31%)      9 (19%)                               
   Ovary                                              (50)         (50)         (50)         (50)                                   
      Congestion                                                                 1 (2%)                                             
      Cyst                                             3 (6%)       9 (18%)      5 (10%)      4 (8%)                                
      Bilateral, Cyst                                                                         1 (2%)                                
   Uterus                                             (50)         (50)         (50)         (50)                                   
      Cyst                                             5 (10%)      7 (14%)      8 (16%)      6 (12%)                               
      Cyst, Multiple                                   2 (4%)       3 (6%)                    2 (4%)                                
      Dilatation                                       3 (6%)       5 (10%)      6 (12%)                                            
      Hypoplasia                                       1 (2%)                                                                       
      Inflammation, Acute                                                        1 (2%)                                             
   Vagina                                             (1)          (1)          (2)          (3)                                    
      Cyst                                                                       2 (100%)                                           
      Hyperplasia, Focal, Squamous                                               1 (50%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    4                                                              
NTP Experiment-Test: 05130-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                       C. I. DIRECT BLUE 218                                   Date: 09/17/94  
Route: DOSED FEED                                                                                                 Time: 01:29:33  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   0 PPM        1000 PPM     3000 PPM     10000PPM                                  
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (49)         (49)         (50)         (49)                                   
      Atrophy                                          7 (14%)      4 (8%)      10 (20%)      8 (16%)                               
      Hyperplasia                                                   1 (2%)                                                          
   Lymph Node                                         (7)          (12)         (6)          (14)                                   
      Axillary, Hyperplasia, Lymphoid                                                         1 (7%)                                
      Axillary, Hyperplasia, Plasma Cell                                         1 (17%)                                            
      Iliac, Hyperplasia, Plasma Cell                               1 (8%)                                                          
      Mediastinal, Hemorrhage                          1 (14%)      2 (17%)      3 (50%)      4 (29%)                               
      Mediastinal, Infiltration Cellular,                                                                                           
          Histiocyte                                                1 (8%)                                                          
      Pancreatic, Infiltration Cellular, Histiocyte                                           1 (7%)                                
      Renal, Hemorrhage                                2 (29%)      1 (8%)       1 (17%)      2 (14%)                               
   Lymph Node, Mandibular                             (49)         (50)         (50)         (50)                                   
      Cyst                                                          3 (6%)                                                          
      Hemorrhage                                       3 (6%)       1 (2%)       3 (6%)       2 (4%)                                
      Hyperplasia, Lymphoid                            1 (2%)                                 1 (2%)                                
      Hyperplasia, Plasma Cell                         3 (6%)       1 (2%)                    3 (6%)                                
   Lymph Node, Mesenteric                             (50)         (50)         (50)         (50)                                   
      Hemorrhage                                       6 (12%)      4 (8%)       3 (6%)       1 (2%)                                
      Hyperplasia, Lymphoid                                                      1 (2%)                                             
      Hyperplasia, Plasma Cell                                      1 (2%)                                                          
   Spleen                                             (50)         (49)         (50)         (48)                                   
      Hematopoietic Cell Proliferation                 1 (2%)                    2 (4%)       1 (2%)                                
      Inflammation, Chronic, Focal                                  1 (2%)                                                          
   Thymus                                             (48)         (49)         (42)         (45)                                   
      Congestion                                                                 1 (2%)                                             
      Cyst, Multiple                                                1 (2%)                                                          
      Hemorrhage                                       1 (2%)                                 2 (4%)                                
      Necrosis                                                                                1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (50)         (50)         (50)         (50)                                   
      Degeneration, Focal                              1 (2%)                                                                       
      Galactocele                                     13 (26%)     14 (28%)     10 (20%)     17 (34%)                               
      Hyperplasia, Focal                               1 (2%)       1 (2%)                    4 (8%)                                
      Inflammation, Acute, Focal                       1 (2%)       1 (2%)                    1 (2%)                                
      Inflammation, Chronic, Focal                     1 (2%)       2 (4%)                    1 (2%)                                
      Duct, Dilatation                                 2 (4%)                    1 (2%)                                             
   Skin                                               (50)         (50)         (50)         (50)                                   
      Cyst Epithelial Inclusion                        1 (2%)                                 1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    5                                                              
NTP Experiment-Test: 05130-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                       C. I. DIRECT BLUE 218                                   Date: 09/17/94  
Route: DOSED FEED                                                                                                 Time: 01:29:33  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   0 PPM        1000 PPM     3000 PPM     10000PPM                                  
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (50)         (50)         (50)         (50)                                   
      Hyperostosis                                     5 (10%)      2 (4%)       5 (10%)      1 (2%)                                
      Inflammation, Acute                              1 (2%)                                                                       
      Femur, Osteoporosis                              1 (2%)                                                                       
   Skeletal Muscle                                    (1)                                    (1)                                    
      Diaphragm, Ectopic Tissue                        1 (100%)                                                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (50)         (50)         (50)                                   
      Hemorrhage, Focal                                             1 (2%)       2 (4%)                                             
      Hydrocephalus                                    1 (2%)       6 (12%)      3 (6%)       5 (10%)                               
      Infiltration Cellular, Focal, Lymphocyte                                                1 (2%)                                
      Inflammation, Focal                                           1 (2%)                                                          
      Meninges, Angiectasis, Focal                                  1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (50)         (50)         (50)                                   
      Congestion                                       1 (2%)                    2 (4%)       5 (10%)                               
      Hemorrhage, Focal                                1 (2%)       3 (6%)       2 (4%)                                             
      Infiltration Cellular, Focal, Lymphocyte                      1 (2%)       2 (4%)                                             
      Infiltration Cellular, Focal, Histiocyte        10 (20%)      7 (14%)      7 (14%)     11 (22%)                               
      Inflammation, Focal                              9 (18%)      6 (12%)     11 (22%)      8 (16%)                               
      Alveolar Epithelium, Hyperplasia, Focal          1 (2%)       1 (2%)       1 (2%)       1 (2%)                                
      Arteriole, Mineralization, Focal                                                        1 (2%)                                
   Nose                                               (50)         (50)         (50)         (50)                                   
      Foreign Body                                                  1 (2%)                    1 (2%)                                
      Fungus                                           1 (2%)       1 (2%)       6 (12%)      8 (16%)                               
      Hemorrhage                                       1 (2%)                    2 (4%)                                             
      Inflammation, Acute                              2 (4%)       3 (6%)       2 (4%)       3 (6%)                                
      Inflammation, Chronic Active                     6 (12%)      6 (12%)      9 (18%)      9 (18%)                               
      Inflammation, Subacute                           2 (4%)       5 (10%)      3 (6%)       4 (8%)                                
      Goblet Cell, Hyperplasia                                                   1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (2)          (4)          (6)                                                 
      Hemorrhage                                                    1 (25%)                                                         
      Inflammation, Acute                                                        1 (17%)                                            
      Phthisis Bulbi                                   1 (50%)                                                                      
      Bilateral, Lens, Cataract                                     2 (50%)      3 (50%)                                            
      Bilateral, Retina, Atrophy                                    2 (50%)      3 (50%)                                            
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    6                                                              
NTP Experiment-Test: 05130-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                       C. I. DIRECT BLUE 218                                   Date: 09/17/94  
Route: DOSED FEED                                                                                                 Time: 01:29:33  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   0 PPM        1000 PPM     3000 PPM     10000PPM                                  
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
SPECIAL SENSES SYSTEM - CONT                                                                                                        
      Lens, Cataract                                                1 (25%)      1 (17%)                                            
      Retina, Atrophy                                  1 (50%)      1 (25%)      1 (17%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (50)         (50)         (50)                                   
      Congestion                                                                 1 (2%)                                             
      Cyst                                                          1 (2%)       1 (2%)                                             
      Cyst, Multiple                                                             1 (2%)                                             
      Hemorrhage, Focal                                1 (2%)                                                                       
      Infiltration Cellular, Focal, Lymphocyte         1 (2%)                                                                       
      Mineralization, Focal                           32 (64%)     25 (50%)     28 (56%)     34 (68%)                               
      Nephropathy                                     39 (78%)     38 (76%)     41 (82%)     40 (80%)                               
      Pigmentation, Focal                             34 (68%)     24 (48%)     28 (56%)     42 (84%)                               
      Bilateral, Hydronephrosis                                     1 (2%)                                                          
   Urethra                                                                                   (1)                                    
      Cyst                                                                                    1 (100%)                              
   Urinary Bladder                                    (48)         (48)         (50)         (49)                                   
      Hemorrhage                                                                              1 (2%)                                
      Mucosa, Hyperplasia                                           1 (2%)                                                          
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    7                                                              
NTP Experiment-Test: 05130-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                       C. I. DIRECT BLUE 218                                   Date: 09/17/94  
Route: DOSED FEED                                                                                                 Time: 01:29:33  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     0 PPM        1000 PPM     3000 PPM     10000PPM                                  
                                                                                                                                    
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially In Study                          60           60           60           60                                     
  Scheduled Sacrifice                                 10           10           10            9                                     
  Early Deaths                                                                                                                      
    Natural Death                                      7            3            5            9                                     
    Moribund Sacrifice                                13           22           16           18                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                30           25           29           24                                     
  Animals Examined Microscopically                    50           50           50           50                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large, Cecum                             (46)         (49)         (49)         (49)                                   
      Hyperplasia, Focal, Lymphoid                                               1 (2%)                                             
   Liver                                              (50)         (50)         (50)         (50)                                   
      Angiectasis, Focal                                            2 (4%)       7 (14%)      2 (4%)                                
      Basophilic Focus                                30 (60%)     26 (52%)     34 (68%)     18 (36%)                               
      Clear Cell Focus                                13 (26%)     13 (26%)     19 (38%)     17 (34%)                               
      Congestion                                       3 (6%)       4 (8%)       4 (8%)       1 (2%)                                
      Degeneration, Cystic, Focal                     15 (30%)     13 (26%)     18 (36%)     25 (50%)                               
      Developmental Malformation                       2 (4%)       1 (2%)                                                          
      Eosinophilic Focus                               9 (18%)     11 (22%)     15 (30%)     20 (40%)                               
      Fatty Change, Diffuse                            1 (2%)       5 (10%)      1 (2%)                                             
      Fatty Change, Focal                             11 (22%)     11 (22%)     12 (24%)     16 (32%)                               
      Hematopoietic Cell Proliferation                 1 (2%)                                                                       
      Hepatodiaphragmatic Nodule                                                              1 (2%)                                
      Hyperplasia, Focal                                                         1 (2%)                                             
      Infiltration Cellular, Focal, Lymphocyte         1 (2%)                                                                       
      Inflammation, Chronic, Focal                     6 (12%)      2 (4%)       5 (10%)      2 (4%)                                
      Mixed Cell Focus                                 4 (8%)       1 (2%)                    7 (14%)                               
      Necrosis, Focal                                  2 (4%)       3 (6%)       1 (2%)       3 (6%)                                
      Pigmentation, Focal                              1 (2%)                                 1 (2%)                                
      Bile Duct, Cyst                                  1 (2%)                    2 (4%)       1 (2%)                                
      Bile Duct, Fibrosis                                                                     1 (2%)                                
      Bile Duct, Hyperplasia, Focal                    6 (12%)      3 (6%)       9 (18%)      2 (4%)                                
      Centrilobular, Atrophy, Focal                                                           1 (2%)                                
      Centrilobular, Necrosis                          1 (2%)                                                                       
      Vein, Dilatation                                                                        1 (2%)                                
   Mesentery                                          (5)          (5)          (7)          (4)                                    
      Fat, Necrosis, Focal                             4 (80%)      5 (100%)     5 (71%)      3 (75%)                               
   Pancreas                                           (50)         (50)         (50)         (50)                                   
      Accessory Spleen                                              1 (2%)                                                          
      Inflammation, Acute, Focal                                                 1 (2%)                                             
      Acinus, Atrophy, Diffuse                         1 (2%)       1 (2%)       1 (2%)       1 (2%)                                
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    8                                                              
NTP Experiment-Test: 05130-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                       C. I. DIRECT BLUE 218                                   Date: 09/17/94  
Route: DOSED FEED                                                                                                 Time: 01:29:33  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     0 PPM        1000 PPM     3000 PPM     10000PPM                                  
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Acinus, Atrophy, Focal                          28 (56%)     26 (52%)     29 (58%)     26 (52%)                               
      Acinus, Cytoplasmic Alteration, Focal                                                   1 (2%)                                
      Acinus, Hyperplasia, Focal                                                 1 (2%)                                             
      Acinus, Vacuolization Cytoplasmic, Focal         1 (2%)                                                                       
      Artery, Inflammation, Focal                      1 (2%)                    1 (2%)                                             
   Pharynx                                                         (1)                       (9)                                    
      Palate, Hyperplasia, Focal, Squamous                                                    2 (22%)                               
      Palate, Inflammation, Chronic Active                          1 (100%)                                                        
   Salivary Glands                                    (50)         (50)         (50)         (50)                                   
      Atrophy, Focal                                   1 (2%)                                                                       
      Hyperplasia, Focal                                                                      1 (2%)                                
   Stomach, Forestomach                               (50)         (50)         (50)         (50)                                   
      Acanthosis, Focal                                             1 (2%)                    1 (2%)                                
      Hyperplasia, Basal Cell, Focal                                2 (4%)      10 (20%)     19 (38%)                               
      Hyperplasia, Focal, Plasma Cell                                                         1 (2%)                                
      Hyperplasia, Focal, Squamous                     1 (2%)       1 (2%)       6 (12%)      4 (8%)                                
      Inflammation, Chronic, Focal                     1 (2%)       1 (2%)                                                          
      Inflammation, Chronic Active, Focal                           2 (4%)       2 (4%)                                             
      Ulcer, Focal                                     4 (8%)       3 (6%)       3 (6%)                                             
   Stomach, Glandular                                 (50)         (50)         (50)         (50)                                   
      Cyst                                                                       1 (2%)                                             
      Erosion, Focal                                                2 (4%)                    1 (2%)                                
      Hyperplasia, Basal Cell, Focal                                             1 (2%)                                             
      Inflammation, Acute, Focal                                    1 (2%)                                                          
      Ulcer, Focal                                                  3 (6%)                                                          
   Tooth                                                           (1)          (1)                                                 
      Gingiva, Inflammation, Chronic Active                         1 (100%)                                                        
      Peridontal Tissue, Inflammation, Focal                                     1 (100%)                                           
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (50)         (50)         (50)         (50)                                   
      Cardiomyopathy                                  37 (74%)     31 (62%)     38 (76%)     32 (64%)                               
      Mineralization, Focal                            1 (2%)                    1 (2%)       1 (2%)                                
      Atrium, Dilatation                               2 (4%)       3 (6%)       3 (6%)                                             
      Atrium, Thrombosis                               6 (12%)      2 (4%)       1 (2%)       1 (2%)                                
      Valve, Degeneration                              1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (49)         (50)         (50)         (50)                                   
      Angiectasis, Focal                                            1 (2%)                                                          
      Congestion                                                    1 (2%)                    1 (2%)                                
      Cyst                                                          1 (2%)                                                          
      Cyst, Multiple                                                                          1 (2%)                                
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    9                                                              
NTP Experiment-Test: 05130-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                       C. I. DIRECT BLUE 218                                   Date: 09/17/94  
Route: DOSED FEED                                                                                                 Time: 01:29:33  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     0 PPM        1000 PPM     3000 PPM     10000PPM                                  
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
      Degeneration, Cystic, Focal                                   2 (4%)                                                          
      Hemorrhage                                       1 (2%)                                 1 (2%)                                
      Hyperplasia, Focal                               6 (12%)      6 (12%)      6 (12%)      2 (4%)                                
      Vacuolization Cytoplasmic, Focal                 8 (16%)     12 (24%)      3 (6%)      12 (24%)                               
   Adrenal Medulla                                    (49)         (50)         (50)         (50)                                   
      Cyst                                                                       1 (2%)                                             
      Hyperplasia                                     16 (33%)     12 (24%)     14 (28%)      8 (16%)                               
      Infiltration Cellular, Focal, Lymphocyte         1 (2%)                                                                       
      Bilateral, Hyperplasia                           4 (8%)       3 (6%)       3 (6%)       1 (2%)                                
   Islets, Pancreatic                                 (50)         (50)         (50)         (50)                                   
      Hyperplasia, Focal                               5 (10%)      4 (8%)       7 (14%)     10 (20%)                               
   Parathyroid Gland                                  (43)         (47)         (46)         (45)                                   
      Hyperplasia                                      1 (2%)                    2 (4%)                                             
      Bilateral, Hyperplasia                           1 (2%)                                 2 (4%)                                
   Pituitary Gland                                    (50)         (50)         (48)         (50)                                   
      Angiectasis, Focal                               1 (2%)       1 (2%)                                                          
      Pigmentation, Focal                                           1 (2%)                                                          
      Pars Distalis, Cyst                              3 (6%)       2 (4%)       3 (6%)                                             
      Pars Distalis, Hyperplasia, Focal               12 (24%)     16 (32%)     11 (23%)     18 (36%)                               
      Pars Distalis, Hypertrophy, Focal                1 (2%)                                                                       
      Pars Nervosa, Hyperplasia, Focal                                                        1 (2%)                                
   Thyroid Gland                                      (50)         (50)         (50)         (50)                                   
      C-Cell, Hyperplasia, Focal                       7 (14%)      6 (12%)     10 (20%)      4 (8%)                                
      Follicle, Dilatation, Focal                                                             4 (8%)                                
      Follicular Cell, Hyperplasia, Focal                                        1 (2%)       1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (50)         (50)         (50)         (50)                                   
      Degeneration, Focal                             31 (62%)     38 (76%)     37 (74%)     33 (66%)                               
   Preputial Gland                                    (50)         (50)         (50)         (49)                                   
      Hyperplasia                                      3 (6%)       1 (2%)       2 (4%)       1 (2%)                                
      Inflammation, Chronic                                                                   1 (2%)                                
      Inflammation, Suppurative                        5 (10%)      3 (6%)       2 (4%)       1 (2%)                                
      Duct, Dilatation                                10 (20%)     17 (34%)      9 (18%)     11 (22%)                               
   Prostate                                           (50)         (50)         (50)         (49)                                   
      Abscess                                                       1 (2%)                    2 (4%)                                
      Atrophy                                         10 (20%)      7 (14%)     11 (22%)     13 (27%)                               
      Degeneration, Focal                              1 (2%)       1 (2%)                                                          
      Hyperplasia, Focal                               3 (6%)                    3 (6%)                                             
      Inflammation, Chronic, Focal                     1 (2%)       1 (2%)       2 (4%)       4 (8%)                                
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   10                                                              
NTP Experiment-Test: 05130-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                       C. I. DIRECT BLUE 218                                   Date: 09/17/94  
Route: DOSED FEED                                                                                                 Time: 01:29:33  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     0 PPM        1000 PPM     3000 PPM     10000PPM                                  
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
GENITAL SYSTEM - CONT                                                                                                               
      Inflammation, Focal, Granulomatous                                         3 (6%)       2 (4%)                                
      Inflammation, Focal, Suppurative                 3 (6%)       2 (4%)       4 (8%)       4 (8%)                                
      Inflammation, Suppurative                        3 (6%)                                                                       
      Vacuolization Cytoplasmic, Focal                 1 (2%)                                                                       
   Seminal Vesicle                                    (50)         (50)         (50)         (49)                                   
      Abscess                                                                                 1 (2%)                                
      Dilatation                                                                 1 (2%)                                             
      Hyperplasia, Focal                                            1 (2%)                                                          
      Inflammation, Chronic, Focal                                                            1 (2%)                                
   Testes                                             (50)         (50)         (50)         (50)                                   
      Atrophy                                          4 (8%)       3 (6%)       4 (8%)       9 (18%)                               
      Cyst                                                                       2 (4%)                                             
      Cyst, Multiple                                   1 (2%)                                                                       
      Mineralization, Focal                                         1 (2%)                                                          
      Artery, Inflammation, Focal                                                1 (2%)                                             
      Bilateral, Atrophy                                            2 (4%)                                                          
      Interstitial Cell, Hyperplasia, Focal            4 (8%)       2 (4%)       1 (2%)       5 (10%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (50)         (50)         (50)                                   
      Atrophy                                                                    1 (2%)                                             
      Hyperplasia                                      1 (2%)                    3 (6%)       4 (8%)                                
   Lymph Node                                         (15)         (16)         (23)         (18)                                   
      Axillary, Hyperplasia, Plasma Cell                                                      1 (6%)                                
      Bronchial, Hemorrhage                            1 (7%)                                                                       
      Bronchial, Infiltration Cellular, Histiocyte                  1 (6%)                                                          
      Iliac, Cyst                                                                             1 (6%)                                
      Iliac, Infiltration Cellular, Histiocyte                                                1 (6%)                                
      Inguinal, Cyst                                                                          1 (6%)                                
      Lumbar, Hemorrhage                                                         1 (4%)       2 (11%)                               
      Lumbar, Hyperplasia, Plasma Cell                                                        1 (6%)                                
      Lumbar, Infiltration Cellular, Histiocyte                                  2 (9%)                                             
      Mediastinal, Cyst                                                          1 (4%)                                             
      Mediastinal, Hemorrhage                          5 (33%)      2 (13%)      5 (22%)      2 (11%)                               
      Mediastinal, Hyperplasia, Plasma Cell            2 (13%)                   1 (4%)                                             
      Mediastinal, Infiltration Cellular,                                                                                           
          Histiocyte                                                             1 (4%)       1 (6%)                                
      Pancreatic, Hemorrhage                                                     1 (4%)       2 (11%)                               
      Pancreatic, Infiltration Cellular, Histiocyte                              1 (4%)                                             
      Renal, Hemorrhage                                1 (7%)       1 (6%)       1 (4%)       1 (6%)                                
      Renal, Infiltration Cellular, Histiocyte                                                1 (6%)                                
   Lymph Node, Mandibular                             (48)         (50)         (49)         (50)                                   
      Cyst                                             3 (6%)       2 (4%)       6 (12%)      3 (6%)                                
      Hemorrhage                                       3 (6%)       2 (4%)       3 (6%)       2 (4%)                                
      Hyperplasia, Plasma Cell                         9 (19%)     10 (20%)      4 (8%)       3 (6%)                                
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   11                                                              
NTP Experiment-Test: 05130-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                       C. I. DIRECT BLUE 218                                   Date: 09/17/94  
Route: DOSED FEED                                                                                                 Time: 01:29:33  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     0 PPM        1000 PPM     3000 PPM     10000PPM                                  
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
   Lymph Node, Mesenteric                             (49)         (50)         (50)         (50)                                   
      Cyst                                                          1 (2%)                                                          
      Edema                                                                      1 (2%)                                             
      Hemorrhage                                       2 (4%)       2 (4%)       1 (2%)       3 (6%)                                
      Hyperplasia, Lymphoid                            1 (2%)                                                                       
      Infiltration Cellular, Histiocyte                1 (2%)                                                                       
   Spleen                                             (50)         (50)         (50)         (49)                                   
      Congestion                                       1 (2%)                    1 (2%)                                             
      Depletion Cellular                                            1 (2%)                                                          
      Fibrosis, Focal                                  2 (4%)       1 (2%)       4 (8%)       4 (8%)                                
      Hematopoietic Cell Proliferation                 2 (4%)       1 (2%)                    2 (4%)                                
      Pigmentation, Hemosiderin                        1 (2%)                                                                       
      Capsule, Cyst                                                                           1 (2%)                                
   Thymus                                             (48)         (40)         (49)         (48)                                   
      Congestion                                                                              1 (2%)                                
      Hemorrhage                                       1 (2%)       1 (3%)                    1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (48)         (49)         (50)         (46)                                   
      Galactocele                                      6 (13%)      7 (14%)      1 (2%)       1 (2%)                                
      Hyperplasia, Focal                               1 (2%)       2 (4%)       3 (6%)       2 (4%)                                
      Inflammation, Acute, Focal                                    1 (2%)                                                          
      Inflammation, Chronic, Focal                                                            1 (2%)                                
      Pigmentation, Focal                                                                     1 (2%)                                
   Skin                                               (50)         (50)         (50)         (50)                                   
      Acanthosis, Focal                                                          1 (2%)                                             
      Subcutaneous Tissue, Inflammation, Acute                                                1 (2%)                                
      Subcutaneous Tissue, Inflammation, Chronic                                                                                    
          Active, Focal                                1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (50)         (50)         (50)         (50)                                   
      Fibrous Osteodystrophy                                                     1 (2%)       1 (2%)                                
      Hyperostosis                                     1 (2%)                                                                       
      Hyperplasia, Focal                                                                      1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (50)         (50)         (50)                                   
      Gliosis, Focal                                                                          1 (2%)                                
      Hemorrhage, Focal                                1 (2%)                                                                       
      Hydrocephalus                                    4 (8%)       4 (8%)       1 (2%)       1 (2%)                                
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   12                                                              
NTP Experiment-Test: 05130-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                       C. I. DIRECT BLUE 218                                   Date: 09/17/94  
Route: DOSED FEED                                                                                                 Time: 01:29:33  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     0 PPM        1000 PPM     3000 PPM     10000PPM                                  
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
NERVOUS SYSTEM - CONT                                                                                                               
      Infiltration Cellular, Focal, Lymphocyte         1 (2%)                                                                       
      Mineralization, Focal                                                      1 (2%)                                             
      Necrosis, Focal                                  1 (2%)       1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (50)         (50)         (50)                                   
      Congestion                                       6 (12%)      1 (2%)       1 (2%)       3 (6%)                                
      Hemorrhage, Focal                                                                       1 (2%)                                
      Infiltration Cellular, Focal, Lymphocyte                      3 (6%)       3 (6%)                                             
      Infiltration Cellular, Focal, Histiocyte         6 (12%)      4 (8%)       6 (12%)      4 (8%)                                
      Inflammation, Focal                              7 (14%)      2 (4%)       7 (14%)      7 (14%)                               
      Alveolar Epithelium, Hyperplasia, Focal          2 (4%)       1 (2%)       3 (6%)       2 (4%)                                
   Nose                                               (50)         (50)         (49)         (50)                                   
      Congestion                                       1 (2%)                    1 (2%)                                             
      Foreign Body                                     5 (10%)      2 (4%)       3 (6%)       3 (6%)                                
      Fungus                                           7 (14%)      6 (12%)     16 (33%)     11 (22%)                               
      Hemorrhage                                       2 (4%)       1 (2%)       1 (2%)       1 (2%)                                
      Inflammation, Acute                              7 (14%)      2 (4%)       1 (2%)                                             
      Inflammation, Chronic Active                     9 (18%)     10 (20%)     20 (41%)     14 (28%)                               
      Inflammation, Subacute                           5 (10%)      1 (2%)       3 (6%)       3 (6%)                                
      Glands, Dilatation, Focal                                                               1 (2%)                                
      Olfactory Epithelium, Necrosis, Focal                         1 (2%)                                                          
   Trachea                                            (50)         (50)         (50)         (50)                                   
      Inflammation, Chronic Active, Focal                                        1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (5)          (4)          (3)          (2)                                    
      Inflammation, Chronic                                         1 (25%)                                                         
      Phthisis Bulbi                                   1 (20%)      1 (25%)                                                         
      Cornea, Degeneration, Focal                                                1 (33%)                                            
      Cornea, Inflammation                             1 (20%)                                                                      
      Lens, Cataract                                   3 (60%)      1 (25%)      1 (33%)      1 (50%)                               
      Lens, Inflammation, Focal, Subacute              1 (20%)                                                                      
      Retina, Atrophy                                  1 (20%)      2 (50%)                   1 (50%)                               
   Zymbal's Gland                                     (48)         (48)         (48)         (48)                                   
      Hyperplasia                                      1 (2%)                                                                       
      Inflammation, Chronic Active                                                            1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   13                                                              
NTP Experiment-Test: 05130-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                       C. I. DIRECT BLUE 218                                   Date: 09/17/94  
Route: DOSED FEED                                                                                                 Time: 01:29:33  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     0 PPM        1000 PPM     3000 PPM     10000PPM                                  
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (50)         (50)         (50)                                   
      Cyst                                                                       2 (4%)       2 (4%)                                
      Hydronephrosis                                                             1 (2%)                                             
      Infarct                                                                                 1 (2%)                                
      Mineralization, Focal                                                                   1 (2%)                                
      Nephropathy                                     48 (96%)     50 (100%)    50 (100%)    46 (92%)                               
      Pigmentation, Focal                             12 (24%)     11 (22%)     15 (30%)     23 (46%)                               
      Pelvis, Inflammation, Suppurative                                                       1 (2%)                                
   Urinary Bladder                                    (50)         (50)         (50)         (50)                                   
      Abscess                                                                                 1 (2%)                                
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   14                                                              
                             ------------------------------------------------------------                                           
                             ----------              END OF REPORT             ----------                                           
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