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https://ntp.niehs.nih.gov/go/1609

TDMS Study 05169-01 Pathology Tables


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


NTP Experiment-Test: 05169-01                                                                                     Report: PEIRPT03
Study Type: CHRONIC                                                                                               Date: 09/18/94
Route: DOSED WATER                                                                                                Time: 03:28:32




       Facility:  Hazleton Laboratories America, Inc.

       Chemical CAS #:  2429-74-5

       Lock Date:  None

       Cage Range:  All

       Reasons For Removal:    All

       Removal Date Range:     All

       Treatment Groups:       Include All
































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

                                                             Page   1

NTP Experiment-Test: 05169-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        C. I. DIRECT BLUE 15                                   Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 03:28:32  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   CONTROL      0.063        0.125        0.25                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially In Study                          70           45           75           70                                     
  Scheduled Sacrifice                                 20           10           10           20                                     
  Early Deaths                                                                                                                      
    Dead                                               4            4           12           15                                     
    Moribund                                           6           18           31           31                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                40           13           22            4                                     
  Animals Examined Microscopically                    50           35           65           50                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Esophagus                                          (50)         (35)         (65)         (50)                                   
      Hyperkeratosis                                   1 (2%)                                 1 (2%)                                
   Intestine Large, Cecum                             (50)         (35)         (65)         (50)                                   
      Edema                                                         1 (3%)                                                          
      Inflammation, Acute                                                        1 (2%)       1 (2%)                                
      Necrosis, Focal                                                                         1 (2%)                                
      Ulcer                                                                                   1 (2%)                                
   Intestine Large, Colon                             (50)         (35)         (65)         (50)                                   
      Descending Colon, Necrosis, Focal                                          1 (2%)                                             
   Intestine Large, Rectum                            (50)         (34)         (65)         (50)                                   
      Inflammation, Acute                                                                     1 (2%)                                
      Necrosis, Focal                                                                         1 (2%)                                
   Liver                                              (50)         (35)         (65)         (50)                                   
      Angiectasis, Focal                               3 (6%)       1 (3%)       2 (3%)                                             
      Angiectasis, Multifocal                          1 (2%)       2 (6%)                                                          
      Basophilic Focus                                34 (68%)     18 (51%)     33 (51%)     23 (46%)                               
      Clear Cell Focus                                 7 (14%)      3 (9%)       1 (2%)       1 (2%)                                
      Degeneration, Cystic, Focal                                   1 (3%)                    1 (2%)                                
      Eosinophilic Focus                               2 (4%)       2 (6%)       3 (5%)       6 (12%)                               
      Erythrophagocytosis                                                                     1 (2%)                                
      Fatty Change                                                               1 (2%)                                             
      Granuloma                                       11 (22%)      7 (20%)      5 (8%)       2 (4%)                                
      Hematopoietic Cell Proliferation                 5 (10%)      5 (14%)     14 (22%)     13 (26%)                               
      Hepatodiaphragmatic Nodule                      10 (20%)      1 (3%)       9 (14%)      2 (4%)                                
      Mixed Cell Focus                                 1 (2%)                                                                       
      Necrosis, Coagulative                                                      2 (3%)                                             
      Necrosis, Multifocal                                                       3 (5%)       2 (4%)                                
      Pigmentation                                                               1 (2%)                                             
      Regeneration, Diffuse                                                      1 (2%)                                             
      Regeneration, Focal                                                        2 (3%)       3 (6%)                                
      Regeneration, Multifocal                                                   7 (11%)      4 (8%)                                
      Vacuolization Cytoplasmic, Diffuse               2 (4%)       5 (14%)      6 (9%)       6 (12%)                               
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    2                                                              
NTP Experiment-Test: 05169-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        C. I. DIRECT BLUE 15                                   Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 03:28:32  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   CONTROL      0.063        0.125        0.25                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Vacuolization Cytoplasmic, Focal                                           2 (3%)       2 (4%)                                
      Vacuolization Cytoplasmic, Multifocal            2 (4%)       1 (3%)       1 (2%)       1 (2%)                                
      Bile Duct, Cyst                                                            2 (3%)                                             
      Bile Duct, Hyperplasia                                        1 (3%)                                                          
      Centrilobular, Degeneration, Diffuse                          1 (3%)       3 (5%)       3 (6%)                                
      Centrilobular, Necrosis                                                    1 (2%)       1 (2%)                                
      Centrilobular, Necrosis, Diffuse                 1 (2%)                                 2 (4%)                                
   Mesentery                                          (4)          (5)          (7)          (4)                                    
      Fat, Necrosis                                    3 (75%)      4 (80%)      6 (86%)      4 (100%)                              
   Pancreas                                           (49)         (35)         (65)         (49)                                   
      Atrophy                                          9 (18%)      4 (11%)      6 (9%)                                             
   Pharynx                                                         (4)          (21)         (12)                                   
      Palate, Hyperkeratosis, Focal                                              1 (5%)       2 (17%)                               
      Palate, Hyperplasia, Focal                                    2 (50%)      2 (10%)                                            
      Palate, Hyperplasia, Focal, Squamous                                       1 (5%)                                             
      Palate, Hyperplasia, Squamous                                              1 (5%)                                             
   Salivary Glands                                    (50)         (35)         (65)         (50)                                   
      Atrophy                                                                                 2 (4%)                                
   Stomach, Forestomach                               (50)         (35)         (65)         (50)                                   
      Acanthosis                                       1 (2%)       1 (3%)       4 (6%)       3 (6%)                                
      Inflammation, Chronic                            1 (2%)                    1 (2%)                                             
      Ulcer, Focal                                     1 (2%)                    2 (3%)       1 (2%)                                
   Stomach, Glandular                                 (50)         (35)         (65)         (50)                                   
      Erosion, Diffuse                                              1 (3%)                                                          
      Erosion, Focal                                   1 (2%)                    1 (2%)                                             
      Erosion, Multifocal                              1 (2%)                    1 (2%)       1 (2%)                                
      Inflammation, Chronic                                                      1 (2%)                                             
      Mineralization, Diffuse                                       1 (3%)                                                          
      Ulcer, Focal                                                                            1 (2%)                                
   Tongue                                             (2)          (3)          (6)          (9)                                    
      Hyperkeratosis, Focal                                                                   1 (11%)                               
      Epithelium, Hyperplasia, Focal                                                          1 (11%)                               
   Tooth                                                                        (1)          (1)                                    
      Gingiva, Hyperplasia, Focal                                                             1 (100%)                              
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (50)         (35)         (65)         (50)                                   
      Cardiomyopathy, Chronic                         23 (46%)     14 (40%)     29 (45%)     20 (40%)                               
      Mineralization, Multifocal                                    1 (3%)                                                          
      Atrium, Thrombosis                                            1 (3%)       3 (5%)       5 (10%)                               
      Endocardium, Hyperplasia                                                   1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    3                                                              
NTP Experiment-Test: 05169-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        C. I. DIRECT BLUE 15                                   Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 03:28:32  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   CONTROL      0.063        0.125        0.25                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Gland, Cortex                              (50)         (35)         (65)         (50)                                   
      Angiectasis                                      2 (4%)                                                                       
      Congestion                                                                 1 (2%)                                             
      Hyperplasia, Focal                               3 (6%)       1 (3%)       2 (3%)                                             
      Hyperplasia, Multifocal                                                    2 (3%)                                             
      Hypertrophy, Focal                                            1 (3%)                    1 (2%)                                
      Necrosis, Multifocal                                                                    1 (2%)                                
      Vacuolization Cytoplasmic, Diffuse               1 (2%)       2 (6%)       1 (2%)       2 (4%)                                
      Vacuolization Cytoplasmic, Focal                 2 (4%)       3 (9%)       1 (2%)                                             
      Vacuolization Cytoplasmic, Multifocal            1 (2%)                    1 (2%)                                             
   Adrenal Gland, Medulla                             (50)         (35)         (65)         (50)                                   
      Hematopoietic Cell Proliferation                                                        1 (2%)                                
      Hemorrhage                                       1 (2%)                                                                       
      Hyperplasia, Focal                                            1 (3%)       1 (2%)                                             
      Hyperplasia, Multifocal                                       1 (3%)                    1 (2%)                                
   Pituitary Gland                                    (49)         (35)         (65)         (49)                                   
      Hemorrhage                                       1 (2%)       1 (3%)       1 (2%)                                             
      Pars Distalis, Angiectasis, Focal                2 (4%)       4 (11%)      6 (9%)       4 (8%)                                
      Pars Distalis, Cyst                             10 (20%)      9 (26%)     15 (23%)      6 (12%)                               
      Pars Distalis, Cyst, Multiple                    1 (2%)                                                                       
      Pars Distalis, Hyperplasia, Focal                2 (4%)       2 (6%)                    1 (2%)                                
   Thyroid Gland                                      (49)         (35)         (65)         (50)                                   
      Cyst                                                                                    1 (2%)                                
      C-Cell, Hyperplasia, Focal                       2 (4%)       5 (14%)      4 (6%)       2 (4%)                                
      Follicular Cell, Hyperplasia, Focal                                                     1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (50)         (31)         (64)         (50)                                   
      Atrophy                                                                    1 (2%)                                             
      Ectasia                                         10 (20%)      4 (13%)     10 (16%)     12 (24%)                               
      Hyperplasia, Focal                               4 (8%)       2 (6%)       4 (6%)       3 (6%)                                
      Hyperplasia, Focal, Squamous                                  1 (3%)       2 (3%)       1 (2%)                                
      Hyperplasia, Multifocal, Squamous                             1 (3%)       2 (3%)                                             
      Inflammation, Acute                                                        1 (2%)                                             
      Inflammation, Chronic                            1 (2%)                                                                       
   Ovary                                              (50)         (35)         (64)         (50)                                   
      Cyst                                             6 (12%)      5 (14%)      6 (9%)       3 (6%)                                
   Uterus                                             (50)         (35)         (65)         (50)                                   
      Ectasia, Focal                                                1 (3%)       1 (2%)                                             
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    4                                                              
NTP Experiment-Test: 05169-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        C. I. DIRECT BLUE 15                                   Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 03:28:32  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   CONTROL      0.063        0.125        0.25                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
GENITAL SYSTEM - CONT                                                                                                               
      Hydrometra                                       1 (2%)                    1 (2%)                                             
      Prolapse                                                                   1 (2%)                                             
      Cervix, Cyst                                     2 (4%)                                                                       
      Cervix, Fibrosis                                 3 (6%)       1 (3%)       2 (3%)                                             
      Endometrium, Cyst                                3 (6%)       3 (9%)       6 (9%)       2 (4%)                                
      Endometrium, Hyperplasia, Cystic                              2 (6%)       2 (3%)                                             
   Vagina                                             (2)          (1)          (1)          (1)                                    
      Cyst                                             1 (50%)      1 (100%)     1 (100%)                                           
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (35)         (64)         (49)                                   
      Hyperplasia                                                   2 (6%)       2 (3%)       2 (4%)                                
      Hypoplasia                                                                 3 (5%)                                             
      Myelofibrosis                                                                           2 (4%)                                
      Necrosis, Multifocal                                          1 (3%)                                                          
   Lymph Node                                         (50)         (35)         (65)         (50)                                   
      Axillary, Hyperplasia, Lymphoid                                            1 (2%)                                             
      Mediastinal, Congestion                                                                 2 (4%)                                
      Mediastinal, Erythrophagocytosis                 2 (4%)                                                                       
      Mediastinal, Hemorrhage                                       1 (3%)                    1 (2%)                                
      Mediastinal, Hyperplasia, Re Cell                                          1 (2%)                                             
   Lymph Node, Mandibular                             (50)         (33)         (65)         (50)                                   
      Angiectasis                                                                1 (2%)                                             
      Hyperplasia, Lymphoid                                         1 (3%)       1 (2%)       3 (6%)                                
      Hyperplasia, Re Cell                             1 (2%)       1 (3%)                                                          
   Lymph Node, Mesenteric                             (50)         (34)         (65)         (50)                                   
      Angiectasis                                      1 (2%)                    1 (2%)                                             
      Hemorrhage                                                                              1 (2%)                                
      Hyperplasia, Lymphoid                                                      1 (2%)                                             
      Hyperplasia, Re Cell                            11 (22%)      7 (21%)      5 (8%)       4 (8%)                                
      Inflammation, Acute                                                                     1 (2%)                                
   Spleen                                             (50)         (35)         (65)         (50)                                   
      Atrophy                                          2 (4%)       3 (9%)       1 (2%)       2 (4%)                                
      Hematopoietic Cell Proliferation                 5 (10%)     12 (34%)     20 (31%)     18 (36%)                               
      Hyperplasia, Reticulum Cell                                   1 (3%)       3 (5%)                                             
      Necrosis, Multifocal                                                                    1 (2%)                                
      Pigmentation                                     4 (8%)       1 (3%)       5 (8%)       4 (8%)                                
   Thymus                                             (47)         (31)         (63)         (45)                                   
      Congestion                                                                              1 (2%)                                
      Cyst                                             1 (2%)                                                                       
      Fibrosis                                                      1 (3%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    5                                                              
NTP Experiment-Test: 05169-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        C. I. DIRECT BLUE 15                                   Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 03:28:32  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   CONTROL      0.063        0.125        0.25                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (49)         (34)         (63)         (44)                                   
      Ectasia                                          1 (2%)                                                                       
      Galactocele                                      2 (4%)                    2 (3%)       2 (5%)                                
      Hyperplasia, Diffuse                                                                    1 (2%)                                
      Hyperplasia, Multifocal                          1 (2%)                                                                       
      Duct, Ectasia                                   15 (31%)      6 (18%)     11 (17%)      2 (5%)                                
   Skin                                               (49)         (34)         (65)         (50)                                   
      Hyperkeratosis, Focal                            1 (2%)                                                                       
      Necrosis, Focal                                                            1 (2%)                                             
      Epidermis, Hypoplasia, Focal                                                            1 (2%)                                
      Hair Follicle, Hyperplasia, Basal Cell,                                                                                       
          Multifocal                                                1 (3%)                                                          
      Subcutaneous Tissue, Inflammation, Acute                                                1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (13)         (4)          (12)         (7)                                    
      Sternum, Osteopetrosis                          13 (100%)     4 (100%)    10 (83%)      6 (86%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (35)         (65)         (50)                                   
      Compression                                      3 (6%)       2 (6%)       4 (6%)       2 (4%)                                
      Hemorrhage                                                    1 (3%)                    1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (35)         (65)         (50)                                   
      Congestion                                       1 (2%)       1 (3%)       1 (2%)       2 (4%)                                
      Foreign Body                                     1 (2%)                                                                       
      Hemorrhage                                                    1 (3%)                                                          
      Hyperplasia, Lymphoid                           42 (84%)     22 (63%)     41 (63%)     35 (70%)                               
      Infiltration Cellular, Histiocyte                6 (12%)      4 (11%)     11 (17%)      6 (12%)                               
      Inflammation, Chronic                            1 (2%)                                 1 (2%)                                
      Alveolar Epithelium, Hyperplasia, Focal          1 (2%)                    2 (3%)       1 (2%)                                
   Nose                                               (50)         (35)         (65)         (50)                                   
      Foreign Body                                     1 (2%)                                                                       
      Fungus                                                        2 (6%)       2 (3%)       2 (4%)                                
      Inflammation, Acute                              2 (4%)       2 (6%)       4 (6%)       1 (2%)                                
      Metaplasia, Squamous                                          1 (3%)       1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    6                                                              
NTP Experiment-Test: 05169-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        C. I. DIRECT BLUE 15                                   Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 03:28:32  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   CONTROL      0.063        0.125        0.25                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                             (3)          (4)          (1)                                    
      Cataract                                                      2 (67%)      2 (50%)                                            
      Degeneration                                                                            1 (100%)                              
      Cornea, Inflammation, Chronic Active                                       1 (25%)                                            
      Retina, Degeneration                                          3 (100%)     2 (50%)                                            
   Zymbal's Gland                                     (49)         (35)         (64)         (50)                                   
      Ectasia                                          1 (2%)       5 (14%)     13 (20%)      9 (18%)                               
      Hyperplasia, Focal                                            1 (3%)                    2 (4%)                                
      Hyperplasia, Focal, Squamous                                  2 (6%)       4 (6%)       3 (6%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (35)         (65)         (50)                                   
      Hydronephrosis                                   1 (2%)                    1 (2%)       1 (2%)                                
      Infarct, Acute                                                             1 (2%)                                             
      Infarct, Chronic                                              1 (3%)                                                          
      Nephropathy, Chronic                            45 (90%)     22 (63%)     48 (74%)     29 (58%)                               
      Cortex, Cyst                                                  1 (3%)       1 (2%)                                             
      Renal Tubule, Degeneration                                                 1 (2%)                                             
      Renal Tubule, Dilatation                                                                1 (2%)                                
      Renal Tubule, Mineralization                                  1 (3%)                                                          
      Renal Tubule, Pigmentation                       3 (6%)       2 (6%)       4 (6%)       2 (4%)                                
      Transitional Epithelium, Hyperplasia                                                    1 (2%)                                
   Urinary Bladder                                    (50)         (35)         (65)         (50)                                   
      Pigmentation, Hemosiderin                        1 (2%)                                                                       
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    7                                                              
NTP Experiment-Test: 05169-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        C. I. DIRECT BLUE 15                                   Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 03:28:32  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     CONTROL      0.063        0.125        0.25                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially In Study                          70           45           75           70                                     
  Scheduled Sacrifice                                 20           10           10           20                                     
  Early Deaths                                                                                                                      
    Dead                                               5           12           24           12                                     
    Moribund                                           8           15           30           34                                     
    Accident                                                                                  2                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                37            8           11            2                                     
  Animals Examined Microscopically                    50           35           65           50                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large, Cecum                             (50)         (35)         (61)         (50)                                   
      Erosion                                                                    1 (2%)                                             
      Inflammation, Acute                                           1 (3%)       2 (3%)                                             
      Necrosis, Focal                                  1 (2%)       1 (3%)                    1 (2%)                                
   Intestine Large, Colon                             (50)         (35)         (62)         (50)                                   
      Necrosis                                                                                1 (2%)                                
      Parasite Metazoan                                                                       1 (2%)                                
      Thrombosis                                                                 1 (2%)                                             
   Intestine Large, Rectum                            (50)         (35)         (61)         (50)                                   
      Inflammation, Acute, Multifocal                                                         1 (2%)                                
   Intestine Small, Jejunum                           (49)         (35)         (60)         (50)                                   
      Diverticulum                                                                            1 (2%)                                
   Liver                                              (50)         (35)         (65)         (50)                                   
      Basophilic Focus                                27 (54%)      9 (26%)     19 (29%)     21 (42%)                               
      Clear Cell Focus                                 1 (2%)       2 (6%)       4 (6%)       3 (6%)                                
      Congestion                                                    1 (3%)       3 (5%)                                             
      Degeneration, Cystic, Focal                      1 (2%)       3 (9%)       2 (3%)       5 (10%)                               
      Degeneration, Cystic, Multifocal                              2 (6%)       8 (12%)      2 (4%)                                
      Eosinophilic Focus                               2 (4%)       7 (20%)     15 (23%)     23 (46%)                               
      Granuloma                                        1 (2%)       1 (3%)       1 (2%)       3 (6%)                                
      Hematopoietic Cell Proliferation                              4 (11%)      6 (9%)      13 (26%)                               
      Hepatodiaphragmatic Nodule                       7 (14%)                                2 (4%)                                
      Infarct, Acute                                                1 (3%)       1 (2%)                                             
      Infarct, Focal                                                                          1 (2%)                                
      Infarct, Subacute                                                                       1 (2%)                                
      Mixed Cell Focus                                 1 (2%)                    1 (2%)       1 (2%)                                
      Necrosis                                                                                1 (2%)                                
      Necrosis, Coagulative                            2 (4%)                    2 (3%)                                             
      Necrosis, Focal                                  1 (2%)                    3 (5%)       2 (4%)                                
      Necrosis, Multifocal                                                       1 (2%)       1 (2%)                                
      Pigmentation                                     1 (2%)                    1 (2%)                                             
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    8                                                              
NTP Experiment-Test: 05169-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        C. I. DIRECT BLUE 15                                   Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 03:28:32  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     CONTROL      0.063        0.125        0.25                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Regeneration, Diffuse                                                      1 (2%)       3 (6%)                                
      Regeneration, Focal                                           2 (6%)       1 (2%)       1 (2%)                                
      Regeneration, Multifocal                         1 (2%)       3 (9%)       3 (5%)      11 (22%)                               
      Thrombosis                                                                 2 (3%)       1 (2%)                                
      Vacuolization Cytoplasmic                                                               1 (2%)                                
      Vacuolization Cytoplasmic, Diffuse               1 (2%)                                                                       
      Vacuolization Cytoplasmic, Focal                 1 (2%)                    3 (5%)       1 (2%)                                
      Vacuolization Cytoplasmic, Multifocal            1 (2%)                    3 (5%)       6 (12%)                               
      Bile Duct, Cyst                                                                         1 (2%)                                
      Bile Duct, Hyperplasia                           6 (12%)      2 (6%)       2 (3%)                                             
      Centrilobular, Degeneration, Diffuse             1 (2%)       1 (3%)       7 (11%)      4 (8%)                                
      Centrilobular, Necrosis                                       1 (3%)                                                          
      Centrilobular, Necrosis, Diffuse                 1 (2%)       3 (9%)       4 (6%)       2 (4%)                                
   Mesentery                                          (8)          (6)          (11)         (6)                                    
      Inflammation, Chronic, Diffuse                   1 (13%)                                                                      
      Thrombosis                                                                 1 (9%)                                             
      Fat, Necrosis                                    6 (75%)      3 (50%)      7 (64%)      6 (100%)                              
   Pancreas                                           (49)         (35)         (65)         (50)                                   
      Accessory Spleen                                 1 (2%)                                                                       
      Atrophy                                          7 (14%)      5 (14%)      4 (6%)       3 (6%)                                
      Acinus, Hyperplasia, Focal                       1 (2%)                                 1 (2%)                                
   Pharynx                                            (1)          (9)          (23)         (20)                                   
      Palate, Hyperkeratosis, Diffuse                                            1 (4%)                                             
      Palate, Hyperkeratosis, Focal                                                           3 (15%)                               
      Palate, Hyperplasia, Focal                                                 1 (4%)                                             
   Salivary Glands                                    (50)         (35)         (65)         (50)                                   
      Atrophy                                                                                 1 (2%)                                
      Edema                                                                      1 (2%)                                             
   Stomach, Forestomach                               (49)         (35)         (65)         (50)                                   
      Acanthosis                                       1 (2%)                    1 (2%)       1 (2%)                                
      Erosion, Focal                                                             1 (2%)                                             
      Erosion, Multifocal                                                        1 (2%)                                             
      Hyperplasia, Focal                                                                      1 (2%)                                
      Inflammation, Multifocal, Membranous                                       1 (2%)                                             
      Ulcer                                            1 (2%)                                 1 (2%)                                
   Stomach, Glandular                                 (49)         (34)         (65)         (50)                                   
      Erosion, Focal                                                             3 (5%)       1 (2%)                                
      Erosion, Multifocal                                                        3 (5%)       2 (4%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (50)         (35)         (65)         (50)                                   
      Cardiomyopathy, Chronic                         35 (70%)     25 (71%)     49 (75%)     39 (78%)                               
      Embolus                                                                                 1 (2%)                                
      Inflammation, Acute, Multifocal                                                         1 (2%)                                
      Atrium, Thrombosis                               2 (4%)       3 (9%)      17 (26%)     12 (24%)                               
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    9                                                              
NTP Experiment-Test: 05169-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        C. I. DIRECT BLUE 15                                   Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 03:28:32  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     CONTROL      0.063        0.125        0.25                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
CARDIOVASCULAR SYSTEM - CONT                                                                                                        
      Epicardium, Hemorrhage, Chronic                                            1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Gland, Cortex                              (50)         (35)         (65)         (50)                                   
      Hyperplasia, Focal                               1 (2%)       1 (3%)       2 (3%)                                             
      Hypertrophy, Focal                               1 (2%)                    1 (2%)                                             
      Vacuolization Cytoplasmic, Diffuse                                         1 (2%)       1 (2%)                                
      Vacuolization Cytoplasmic, Focal                                           1 (2%)       1 (2%)                                
   Adrenal Gland, Medulla                             (50)         (35)         (65)         (50)                                   
      Hyperplasia, Focal                               2 (4%)       2 (6%)       1 (2%)       2 (4%)                                
      Hyperplasia, Multifocal                          2 (4%)       3 (9%)       1 (2%)       3 (6%)                                
      Necrosis, Acute                                                            1 (2%)                                             
   Parathyroid Gland                                  (49)         (35)         (63)         (49)                                   
      Hyperplasia                                      1 (2%)                                 1 (2%)                                
   Pituitary Gland                                    (49)         (34)         (63)         (50)                                   
      Pars Distalis, Cyst                              1 (2%)                    1 (2%)       1 (2%)                                
      Pars Distalis, Hyperplasia, Focal                             1 (3%)       2 (3%)                                             
   Thyroid Gland                                      (50)         (35)         (65)         (50)                                   
      C-Cell, Hyperplasia, Focal                       2 (4%)                    2 (3%)       3 (6%)                                
      Follicular Cell, Hyperplasia, Focal                           1 (3%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Preputial Gland                                    (49)         (35)         (64)         (48)                                   
      Atrophy                                         10 (20%)      6 (17%)     12 (19%)     10 (21%)                               
      Ectasia                                          5 (10%)      4 (11%)     15 (23%)     14 (29%)                               
      Granuloma                                        1 (2%)                                                                       
      Hyperplasia                                                                             1 (2%)                                
      Hyperplasia, Focal                               2 (4%)                                 2 (4%)                                
      Hyperplasia, Focal, Squamous                     3 (6%)       1 (3%)       2 (3%)       2 (4%)                                
      Inflammation, Chronic                                                                   1 (2%)                                
      Inflammation, Chronic Active                                               1 (2%)       2 (4%)                                
   Prostate                                           (50)         (35)         (64)         (49)                                   
      Hemorrhage                                       1 (2%)                                                                       
      Hyperplasia, Focal, Glandular                    7 (14%)      4 (11%)      6 (9%)       1 (2%)                                
      Hyperplasia, Glandular, Multifocal               3 (6%)       3 (9%)       2 (3%)                                             
      Inflammation, Acute                              1 (2%)       1 (3%)                                                          
      Inflammation, Chronic                            1 (2%)                    1 (2%)                                             
      Inflammation, Chronic Active                     2 (4%)       1 (3%)       4 (6%)       3 (6%)                                
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   10                                                              
NTP Experiment-Test: 05169-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        C. I. DIRECT BLUE 15                                   Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 03:28:32  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     CONTROL      0.063        0.125        0.25                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
GENITAL SYSTEM - CONT                                                                                                               
   Seminal Vesicle                                    (47)         (32)         (57)         (42)                                   
      Dilatation                                       1 (2%)                                                                       
      Hyperplasia, Diffuse, Glandular                               1 (3%)       2 (4%)       1 (2%)                                
      Hyperplasia, Focal, Glandular                                 1 (3%)                                                          
      Hyperplasia, Glandular, Multifocal                            1 (3%)                                                          
      Inflammation, Acute                                           1 (3%)                                                          
      Inflammation, Chronic                                                      1 (2%)                                             
      Inflammation, Chronic Active                     2 (4%)                    1 (2%)       1 (2%)                                
   Testes                                             (50)         (35)         (65)         (50)                                   
      Atrophy                                          3 (6%)       2 (6%)       8 (12%)      4 (8%)                                
      Interstitial Cell, Hyperplasia                   2 (4%)       1 (3%)       9 (14%)      9 (18%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (49)         (35)         (63)         (50)                                   
      Hyperplasia                                      1 (2%)      14 (40%)     20 (32%)     16 (32%)                               
      Hypoplasia                                                                 2 (3%)                                             
      Myelofibrosis                                    1 (2%)                    2 (3%)       1 (2%)                                
   Lymph Node                                         (50)         (35)         (64)         (50)                                   
      Mediastinal, Angiectasis                                      1 (3%)                                                          
      Mediastinal, Congestion                                                    2 (3%)                                             
      Mediastinal, Hemorrhage                                       1 (3%)       2 (3%)       2 (4%)                                
      Mediastinal, Pigmentation                                     1 (3%)       2 (3%)                                             
      Pancreatic, Angiectasis                                       1 (3%)                                                          
      Renal, Angiectasis                                            1 (3%)                                                          
   Lymph Node, Mandibular                             (50)         (35)         (62)         (50)                                   
      Angiectasis                                                   1 (3%)       1 (2%)                                             
      Congestion                                                                              1 (2%)                                
      Hemorrhage                                                    1 (3%)                                                          
      Hyperplasia, Lymphoid                                         1 (3%)       2 (3%)       2 (4%)                                
      Hyperplasia, Re Cell                                                                    1 (2%)                                
   Lymph Node, Mesenteric                             (50)         (35)         (64)         (50)                                   
      Angiectasis                                      1 (2%)       1 (3%)       1 (2%)                                             
      Atrophy                                                       1 (3%)                                                          
      Hemorrhage                                       1 (2%)       2 (6%)                    1 (2%)                                
      Hyperplasia, Re Cell                            10 (20%)      3 (9%)       7 (11%)      4 (8%)                                
   Spleen                                             (50)         (35)         (64)         (50)                                   
      Atrophy                                          1 (2%)       3 (9%)       4 (6%)       3 (6%)                                
      Congestion                                                                 1 (2%)                                             
      Fibrosis, Multifocal                                                       1 (2%)                                             
      Hematopoietic Cell Proliferation                 1 (2%)       3 (9%)      10 (16%)     17 (34%)                               
      Hemorrhage                                       1 (2%)                                                                       
      Hyperplasia, Diffuse, Reticulum Cell                          1 (3%)                                                          
      Hyperplasia, Focal, Reticulum Cell               1 (2%)       1 (3%)       1 (2%)                                             
      Hyperplasia, Multifocal, Reticulum Cell                                    1 (2%)                                             
      Necrosis, Multifocal                             1 (2%)                                                                       
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   11                                                              
NTP Experiment-Test: 05169-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        C. I. DIRECT BLUE 15                                   Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 03:28:32  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     CONTROL      0.063        0.125        0.25                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Pigmentation                                     1 (2%)                                                                       
   Thymus                                             (43)         (34)         (51)         (43)                                   
      Atrophy                                                       1 (3%)       1 (2%)                                             
      Congestion                                                    1 (3%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (48)         (34)         (59)         (42)                                   
      Duct, Ectasia                                                              1 (2%)                                             
   Skin                                               (50)         (35)         (65)         (50)                                   
      Cyst Epithelial Inclusion                                     1 (3%)       4 (6%)       1 (2%)                                
      Hemorrhage, Focal                                1 (2%)                                                                       
      Hair Follicle, Hyperplasia, Basal Cell, Focal    1 (2%)       1 (3%)       3 (5%)                                             
      Hair Follicle, Hyperplasia, Basal Cell,                                                                                       
          Multifocal                                                                          3 (6%)                                
      Subcutaneous Tissue, Edema                                    1 (3%)       4 (6%)       1 (2%)                                
      Subcutaneous Tissue, Fibrosis, Focal                                                    1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (1)          (1)          (1)                                                 
      Carpal, Osteopetrosis                            1 (100%)                                                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (35)         (65)         (50)                                   
      Compression                                                   1 (3%)                                                          
      Gliosis, Focal                                                                          1 (2%)                                
      Hemorrhage                                       1 (2%)                                                                       
      Inflammation, Acute, Multifocal                                                         1 (2%)                                
      Cerebellum, Necrosis, Focal                                   1 (3%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (35)         (65)         (50)                                   
      Congestion                                       4 (8%)       2 (6%)       3 (5%)       1 (2%)                                
      Hemorrhage                                                                 1 (2%)       3 (6%)                                
      Hyperplasia, Lymphoid                           36 (72%)     18 (51%)     39 (60%)     26 (52%)                               
      Infiltration Cellular, Histiocyte                1 (2%)       1 (3%)       4 (6%)       8 (16%)                               
      Inflammation, Acute                                           1 (3%)       1 (2%)                                             
      Alveolar Epithelium, Hyperplasia, Focal                                    5 (8%)       4 (8%)                                
      Alveolar Epithelium, Hyperplasia, Multifocal                               1 (2%)                                             
   Nose                                               (50)         (35)         (65)         (49)                                   
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   12                                                              
NTP Experiment-Test: 05169-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        C. I. DIRECT BLUE 15                                   Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 03:28:32  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     CONTROL      0.063        0.125        0.25                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
RESPIRATORY SYSTEM - CONT                                                                                                           
      Fungus                                          13 (26%)      9 (26%)     13 (20%)      4 (8%)                                
      Hyperkeratosis                                   2 (4%)       4 (11%)      2 (3%)       1 (2%)                                
      Hyperplasia, Glandular                           1 (2%)                    1 (2%)                                             
      Inflammation, Acute                             15 (30%)      8 (23%)     18 (28%)      3 (6%)                                
      Metaplasia, Squamous                             1 (2%)       3 (9%)       1 (2%)                                             
      Necrosis, Diffuse                                                          1 (2%)                                             
      Necrosis, Focal                                                            1 (2%)                                             
      Necrosis, Multifocal                                          1 (3%)                                                          
   Trachea                                            (50)         (35)         (65)         (50)                                   
      Inflammation, Acute                              1 (2%)                                                                       
      Inflammation, Chronic                            1 (2%)                                                                       
      Necrosis                                         2 (4%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (1)          (1)          (2)                                                 
      Atrophy                                                                    1 (50%)                                            
      Cataract                                         1 (100%)                                                                     
      Synechia                                         1 (100%)                                                                     
      Retina, Degeneration                             1 (100%)                                                                     
   Harderian Gland                                                 (1)          (2)                                                 
      Inflammation, Chronic                                                      2 (100%)                                           
   Zymbal's Gland                                     (50)         (35)         (64)         (50)                                   
      Abscess                                          1 (2%)                                                                       
      Ectasia                                          2 (4%)      11 (31%)      8 (13%)     12 (24%)                               
      Hyperplasia, Focal, Squamous                                  1 (3%)       5 (8%)       5 (10%)                               
      Hyperplasia, Squamous                                                      1 (2%)                                             
      Hypertrophy, Diffuse                                                                    1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (35)         (65)         (50)                                   
      Hydronephrosis                                   1 (2%)                                                                       
      Inflammation, Acute, Multifocal                                                         1 (2%)                                
      Nephropathy, Chronic                            44 (88%)     28 (80%)     56 (86%)     41 (82%)                               
      Cortex, Cyst                                     1 (2%)                                                                       
      Pelvis, Inflammation, Acute                      1 (2%)                                                                       
      Renal Tubule, Degeneration                                                              2 (4%)                                
      Renal Tubule, Hyperplasia, Focal                              1 (3%)                    1 (2%)                                
      Renal Tubule, Pigmentation                       1 (2%)       3 (9%)                    1 (2%)                                
   Urinary Bladder                                    (50)         (35)         (65)         (50)                                   
      Hemorrhage                                       2 (4%)       1 (3%)       1 (2%)                                             
      Inflammation, Acute                              1 (2%)                                                                       
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   13                                                              
NTP Experiment-Test: 05169-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        C. I. DIRECT BLUE 15                                   Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 03:28:32  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     CONTROL      0.063        0.125        0.25                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
URINARY SYSTEM - CONT                                                                                                               
      Transitional Epithelium, Hyperplasia             1 (2%)       1 (3%)       1 (2%)       1 (2%)                                
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   14                                                              
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                             ----------              END OF REPORT             ----------                                           
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