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https://ntp.niehs.nih.gov/go/2764

TDMS Study 05019-04 Pathology Tables


                                     INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
                                                          CI PIGMENT RED 3


NTP Experiment-Test: 05019-04                                                                                     Report: PEIRPT03
Study Type: CHRONIC                                                                                               Date: 09/03/94
Route: DOSED FEED                                                                                                 Time: 16:33:55




       Facility:  Southern Research Institute

       Chemical CAS #:  2425-85-6

       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: 05019-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                          CI PIGMENT RED 3                                     Date: 09/03/94  
Route: DOSED FEED                                                                                                 Time: 16:33:55  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE FEMALE                        UNTREATD     1.25%        2.5%         5.0%                                      
                                                    CONTROL                                                                         
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially In Study                          60           60           60           60                                     
  Scheduled Sacrifice                                  9           10           10           10                                     
  Early Deaths                                                                                                                      
    Moribund                                           8            9           11           20                                     
    Accident                                           2                                                                            
    Dead                                               2            4            8            5                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                39           37           31           25                                     
  Animals Examined Microscopically                    50           50           50           50                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Liver                                              (50)         (50)         (49)         (50)                                   
      Angiectasis                                      1 (2%)       1 (2%)                                                          
      Basophilic Focus                                 1 (2%)       1 (2%)                    2 (4%)                                
      Cytologic Alterations                            1 (2%)       1 (2%)                   15 (30%)                               
      Eosinophilic Focus                                            3 (6%)       2 (4%)       2 (4%)                                
      Hematopoietic Cell Proliferation                 2 (4%)       2 (4%)       7 (14%)     15 (30%)                               
      Inflammation, Granulomatous                      1 (2%)       2 (4%)       2 (4%)      11 (22%)                               
      Mixed Cell Focus                                              1 (2%)                    2 (4%)                                
      Necrosis, Focal                                  4 (8%)       3 (6%)       1 (2%)       6 (12%)                               
      Necrosis, Multifocal                             2 (4%)                                 4 (8%)                                
      Kupffer Cell, Pigmentation                       2 (4%)       1 (2%)       1 (2%)      29 (58%)                               
      Sinusoid, Infiltration Cellular,                                                                                              
          Polymorphonuclear                            4 (8%)       2 (4%)      10 (20%)     18 (36%)                               
   Mesentery                                          (8)          (4)          (4)          (6)                                    
      Inflammation, Acute, Suppurative                 2 (25%)      1 (25%)      2 (50%)      3 (50%)                               
      Inflammation, Chronic                            1 (13%)                                                                      
      Artery, Inflammation                                                                    1 (17%)                               
      Fat, Necrosis, Focal                             4 (50%)      3 (75%)      2 (50%)      1 (17%)                               
   Pancreas                                           (50)         (12)         (19)         (50)                                   
      Cyst, Multiple                                   1 (2%)                                                                       
      Hemorrhage, Focal                                                                       1 (2%)                                
      Inflammation, Acute, Suppurative                 1 (2%)                    1 (5%)       2 (4%)                                
      Inflammation, Chronic                            1 (2%)                                                                       
      Inflammation, Subacute                           2 (4%)                                 3 (6%)                                
      Acinus, Atrophy, Multifocal                      3 (6%)       1 (8%)       5 (26%)      3 (6%)                                
      Acinus, Hyperplasia, Focal                                                              1 (2%)                                
      Acinus, Necrosis, Multifocal                     1 (2%)                                                                       
      Duct, Dilatation                                                           2 (11%)      1 (2%)                                
   Stomach, Forestomach                               (50)         (16)         (24)         (49)                                   
      Erosion                                          6 (12%)      5 (31%)      4 (17%)      4 (8%)                                
      Hyperplasia                                     11 (22%)      5 (31%)      5 (21%)     10 (20%)                               
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    2                                                              
NTP Experiment-Test: 05019-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                          CI PIGMENT RED 3                                     Date: 09/03/94  
Route: DOSED FEED                                                                                                 Time: 16:33:55  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE FEMALE                        UNTREATD     1.25%        2.5%         5.0%                                      
                                                    CONTROL                                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Hypertrophy                                      1 (2%)                                                                       
      Ulcer                                                                      1 (4%)       1 (2%)                                
   Stomach, Glandular                                 (50)         (12)         (18)         (49)                                   
      Erosion, Multiple                                1 (2%)                                 1 (2%)                                
      Hemorrhage                                       1 (2%)                                                                       
   Tooth                                              (1)                                                                           
      Dysplasia                                        1 (100%)                                                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (50)         (13)         (19)         (50)                                   
      Inflammation, Focal, Subacute                                 1 (8%)       1 (5%)       1 (2%)                                
      Inflammation, Multifocal, Subacute                            1 (8%)       2 (11%)      2 (4%)                                
      Artery, Inflammation, Subacute                   1 (2%)                                 1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Gland, Cortex                              (50)         (15)         (18)         (50)                                   
      Cyst                                             1 (2%)                                                                       
      Hyperplasia, Focal                               1 (2%)                                 2 (4%)                                
      Hyperplasia, Multifocal                          1 (2%)                                                                       
      Hypertrophy, Diffuse                             1 (2%)                                                                       
      Hypertrophy, Focal                               2 (4%)                                                                       
      Capsule, Accessory Adrenal Cortical Nodule       1 (2%)                    1 (6%)                                             
      X-Zone, Degeneration, Fatty                      2 (4%)                                                                       
   Adrenal Gland, Medulla                             (50)         (14)         (18)         (50)                                   
      Hyperplasia, Focal                               1 (2%)                                 1 (2%)                                
   Islets, Pancreatic                                 (50)         (12)         (18)         (50)                                   
      Hyperplasia                                                                1 (6%)                                             
   Pituitary Gland                                    (49)         (14)         (17)         (50)                                   
      Pars Distalis, Angiectasis                      10 (20%)                                2 (4%)                                
      Pars Distalis, Cyst                              1 (2%)                                                                       
      Pars Distalis, Hyperplasia                      16 (33%)      2 (14%)      3 (18%)     12 (24%)                               
      Pars Distalis, Pigmentation, Hemosiderin         1 (2%)                                                                       
   Thyroid Gland                                      (50)         (50)         (49)         (50)                                   
      Ultimobranchial Cyst                             1 (2%)                                                                       
      Artery, Inflammation                                                                    1 (2%)                                
      Follicle, Cyst                                   7 (14%)     12 (24%)     11 (22%)     21 (42%)                               
      Follicle, Hyperplasia, Cystic                                              1 (2%)       1 (2%)                                
      Follicular Cell, Hyperplasia                    11 (22%)     11 (22%)     24 (49%)     38 (76%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    3                                                              
NTP Experiment-Test: 05019-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                          CI PIGMENT RED 3                                     Date: 09/03/94  
Route: DOSED FEED                                                                                                 Time: 16:33:55  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE FEMALE                        UNTREATD     1.25%        2.5%         5.0%                                      
                                                    CONTROL                                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   Tissue NOS                                                      (1)                                                              
      Hemorrhage                                                    1 (100%)                                                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Ovary                                              (50)         (49)         (50)         (50)                                   
      Abscess                                                       2 (4%)       6 (12%)      9 (18%)                               
      Abscess, Multiple                                2 (4%)                    6 (12%)     10 (20%)                               
      Angiectasis                                      1 (2%)                                                                       
      Cyst                                            18 (36%)     14 (29%)     13 (26%)     16 (32%)                               
      Cyst, Multiple                                                2 (4%)       4 (8%)       4 (8%)                                
      Hemorrhage                                       1 (2%)                    2 (4%)                                             
      Hyperplasia, Cystic                              2 (4%)       1 (2%)                                                          
      Inflammation, Chronic                            2 (4%)                    2 (4%)                                             
      Pigmentation, Hemosiderin                        1 (2%)                                                                       
      Fat, Necrosis, Focal                             1 (2%)                                                                       
   Uterus                                             (50)         (38)         (43)         (50)                                   
      Angiectasis                                                                             1 (2%)                                
      Hemorrhage                                       1 (2%)                                                                       
      Hydrometra                                       5 (10%)      3 (8%)       4 (9%)                                             
      Inflammation, Acute, Suppurative                 3 (6%)                    1 (2%)       1 (2%)                                
      Endometrium, Hyperplasia                         1 (2%)                                                                       
      Endometrium, Hyperplasia, Cystic                47 (94%)     33 (87%)     39 (91%)     48 (96%)                               
      Serosa, Inflammation, Acute, Suppurative                                                1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Blood                                                                        (2)          (1)                                    
      Leukocytosis                                                                            1 (100%)                              
   Bone Marrow                                        (50)         (50)         (49)         (50)                                   
      Fibrosis                                         1 (2%)                                                                       
      Infiltration Cellular, Lipocyte                  1 (2%)                                                                       
      Myeloid Cell, Hypercellularity                   1 (2%)       2 (4%)      11 (22%)     15 (30%)                               
   Lymph Node                                         (50)         (20)         (23)         (50)                                   
      Deep Cervical, Hyperplasia, Lymphoid             1 (2%)                                                                       
      Iliac, Hyperplasia, Lymphoid                     1 (2%)       1 (5%)       4 (17%)      9 (18%)                               
      Inguinal, Hyperplasia, Lymphoid                               1 (5%)       1 (4%)       1 (2%)                                
      Inguinal, Infiltration Cellular,                                                                                              
          Polymorphonuclear                                                                   1 (2%)                                
      Mediastinal, Abscess                             1 (2%)                    1 (4%)       1 (2%)                                
      Mediastinal, Hyperplasia, Lymphoid               3 (6%)       2 (10%)      3 (13%)     11 (22%)                               
      Mesenteric, Angiectasis                          5 (10%)      1 (5%)       2 (9%)       5 (10%)                               
      Mesenteric, Hyperplasia, Lymphoid                4 (8%)       2 (10%)      1 (4%)       6 (12%)                               
      Mesenteric, Infiltration Cellular,                                                                                            
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    4                                                              
NTP Experiment-Test: 05019-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                          CI PIGMENT RED 3                                     Date: 09/03/94  
Route: DOSED FEED                                                                                                 Time: 16:33:55  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE FEMALE                        UNTREATD     1.25%        2.5%         5.0%                                      
                                                    CONTROL                                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
          Polymorphonuclear                                                                   3 (6%)                                
      Pancreatic, Hyperplasia, Lymphoid                1 (2%)       1 (5%)       1 (4%)       2 (4%)                                
      Renal, Hyperplasia, Lymphoid                     1 (2%)       1 (5%)       6 (26%)     12 (24%)                               
   Lymph Node, Mandibular                             (50)         (15)         (18)         (49)                                   
      Hyperplasia, Lymphoid                                         1 (7%)                                                          
   Spleen                                             (50)         (49)         (49)         (50)                                   
      Fibrosis, Focal                                  2 (4%)       1 (2%)       1 (2%)                                             
      Hematopoietic Cell Proliferation                16 (32%)     14 (29%)     18 (37%)     21 (42%)                               
      Pigmentation                                                               4 (8%)      10 (20%)                               
      Thrombosis                                       1 (2%)                                                                       
   Thymus                                             (50)         (13)         (19)         (50)                                   
      Cyst                                             1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (50)         (14)         (19)         (50)                                   
      Inflammation, Subacute                                                                  1 (2%)                                
      Duct, Cyst                                       2 (4%)                                 3 (6%)                                
   Skin                                               (50)         (29)         (33)         (50)                                   
      Cyst Epithelial Inclusion                        1 (2%)                                                                       
      Subcutaneous Tissue, Fibrosis, Focal                                                    2 (4%)                                
      Subcutaneous Tissue, Inflammation, Focal,                                                                                     
           Subacute                                    1 (2%)                                 1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (14)         (18)         (50)                                   
      Compression                                      3 (6%)       1 (7%)                                                          
      Hemorrhage                                       1 (2%)                                 1 (2%)                                
      Mineralization, Multifocal                      39 (78%)      6 (43%)     12 (67%)     30 (60%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (13)         (21)         (50)                                   
      Hemorrhage                                       2 (4%)                    1 (5%)                                             
      Infiltration Cellular, Multifocal, Histiocyte                                           1 (2%)                                
      Inflammation, Acute, Suppurative                                           1 (5%)                                             
      Alveolar Epithelium, Hyperplasia, Focal                                    1 (5%)                                             
   Nose                                               (50)         (13)         (19)         (50)                                   
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    5                                                              
NTP Experiment-Test: 05019-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                          CI PIGMENT RED 3                                     Date: 09/03/94  
Route: DOSED FEED                                                                                                 Time: 16:33:55  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE FEMALE                        UNTREATD     1.25%        2.5%         5.0%                                      
                                                    CONTROL                                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
RESPIRATORY SYSTEM - CONT                                                                                                           
      Nasolacrimal Duct, Inflammation, Subacute        1 (2%)                                 1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (1)                                    (1)                                    
      Cornea, Fibrosis                                 1 (100%)                                                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (49)         (49)         (50)                                   
      Hydronephrosis                                                                          1 (2%)                                
      Nephropathy, Chronic                            33 (66%)     45 (92%)     46 (94%)     45 (90%)                               
      Capsule, Inflammation, Subacute                                                         1 (2%)                                
      Cortex, Cyst                                     1 (2%)                                 1 (2%)                                
      Cortex, Fibrosis, Focal                          2 (4%)                                                                       
      Cortex, Metaplasia, Focal, Osseous               1 (2%)                                 3 (6%)                                
      Glomerulus, Inflammation                                                                2 (4%)                                
      Papilla, Necrosis                                                          1 (2%)                                             
      Pelvis, Inflammation, Acute, Suppurative                                   1 (2%)                                             
      Renal Tubule, Degeneration, Multifocal                                                  2 (4%)                                
      Renal Tubule, Dilatation, Multifocal             1 (2%)                                                                       
      Renal Tubule, Necrosis, Multifocal               1 (2%)                                                                       
   Urinary Bladder                                    (50)         (12)         (18)         (50)                                   
      Inflammation, Subacute                                                                  1 (2%)                                
      Serosa, Inflammation, Subacute                                                          1 (2%)                                
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    6                                                              
NTP Experiment-Test: 05019-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                          CI PIGMENT RED 3                                     Date: 09/03/94  
Route: DOSED FEED                                                                                                 Time: 16:33:55  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE MALE                          UNTREATD     1.25%        2.5%         5.0%                                      
                                                    CONTROL                                                                         
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially In Study                          60           60           60           60                                     
  Scheduled Sacrifice                                 10           10            9            8                                     
  Early Deaths                                                                                                                      
    Moribund                                           8           13           10           10                                     
    Dead                                               8            9           10            9                                     
    Natural Death                                      1                                                                            
  Survivors                                                                                                                         
    Terminal Sacrifice                                33           28           31           33                                     
  Animals Examined Microscopically                    50           50           50           50                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Gallbladder                                        (47)         (15)         (15)         (48)                                   
      Mineralization, Focal                                                                   1 (2%)                                
      Epithelium, Hyperplasia                          1 (2%)                                                                       
   Intestine Small, Duodenum                          (46)         (18)         (16)         (45)                                   
      Lymphoid Tissue, Hyperplasia, Lymphoid                        1 (6%)                                                          
   Liver                                              (50)         (48)         (50)         (49)                                   
      Angiectasis                                      1 (2%)       1 (2%)                                                          
      Basophilic Focus                                 3 (6%)       2 (4%)       3 (6%)       8 (16%)                               
      Clear Cell Focus                                                                        1 (2%)                                
      Cytologic Alterations                                        21 (44%)     41 (82%)     43 (88%)                               
      Eosinophilic Focus                                            4 (8%)                    3 (6%)                                
      Hematopoietic Cell Proliferation                 1 (2%)                    2 (4%)                                             
      Inflammation, Granulomatous                                   1 (2%)      10 (20%)     38 (78%)                               
      Inflammation, Multifocal, Subacute               2 (4%)                    1 (2%)                                             
      Mixed Cell Focus                                 2 (4%)       3 (6%)       1 (2%)       2 (4%)                                
      Necrosis, Focal                                  4 (8%)       3 (6%)       2 (4%)                                             
      Necrosis, Multifocal                             1 (2%)                                 1 (2%)                                
      Centrilobular, Necrosis                          1 (2%)       1 (2%)                                                          
      Kupffer Cell, Pigmentation                                    5 (10%)     30 (60%)     41 (84%)                               
      Sinusoid, Amyloid Deposition                     1 (2%)                                                                       
      Sinusoid, Infiltration Cellular,                                                                                              
          Polymorphonuclear                            1 (2%)                                 1 (2%)                                
   Mesentery                                          (2)          (3)          (2)          (1)                                    
      Cyst                                                          1 (33%)                                                         
      Fat, Mineralization, Focal                                                              1 (100%)                              
      Fat, Necrosis, Focal                             2 (100%)     2 (67%)      2 (100%)     1 (100%)                              
   Pancreas                                           (50)         (20)         (18)         (50)                                   
      Inflammation, Acute, Suppurative                 1 (2%)                                                                       
      Acinus, Atrophy, Focal                           1 (2%)                                 1 (2%)                                
      Acinus, Atrophy, Multifocal                                   1 (5%)                                                          
      Acinus, Hyperplasia, Focal                       1 (2%)                                                                       
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    7                                                              
NTP Experiment-Test: 05019-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                          CI PIGMENT RED 3                                     Date: 09/03/94  
Route: DOSED FEED                                                                                                 Time: 16:33:55  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE MALE                          UNTREATD     1.25%        2.5%         5.0%                                      
                                                    CONTROL                                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Acinus, Inflammation, Focal, Subacute                                                   1 (2%)                                
      Acinus, Necrosis                                 1 (2%)                                                                       
   Stomach, Forestomach                               (49)         (21)         (22)         (50)                                   
      Erosion                                                                    3 (14%)                                            
      Hyperplasia                                                   1 (5%)       5 (23%)      2 (4%)                                
      Inflammation, Subacute                                        2 (10%)                                                         
      Ulcer                                                                      1 (5%)                                             
   Stomach, Glandular                                 (49)         (20)         (18)         (50)                                   
      Erosion                                                       1 (5%)                                                          
      Inflammation, Subacute                                        1 (5%)                                                          
      Mineralization                                                                          1 (2%)                                
   Tooth                                              (16)         (3)          (4)          (24)                                   
      Dysplasia                                       15 (94%)      3 (100%)     4 (100%)    24 (100%)                              
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Blood Vessel                                                    (1)                                                              
      Abdominal, Inflammation, Subacute                             1 (100%)                                                        
   Heart                                              (50)         (22)         (19)         (50)                                   
      Fibrosis, Focal                                                                         1 (2%)                                
      Inflammation, Subacute                                        1 (5%)                                                          
      Atrium, Thrombosis                               1 (2%)       1 (5%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Gland                                      (50)         (23)         (19)         (50)                                   
      Capsule, Hyperplasia                             1 (2%)                                 1 (2%)                                
   Adrenal Gland, Cortex                              (50)         (23)         (19)         (50)                                   
      Angiectasis                                      1 (2%)                                                                       
      Cyst                                             1 (2%)       1 (4%)                                                          
      Fibrosis, Focal                                  1 (2%)                                                                       
      Hyperplasia, Focal                               1 (2%)                                                                       
      Hypertrophy, Focal                               5 (10%)                                8 (16%)                               
      Hypertrophy, Multifocal                          1 (2%)                                                                       
      Mineralization, Focal                            1 (2%)                                                                       
      Necrosis                                         1 (2%)                                                                       
      Pigmentation, Focal, Hematoidin                  1 (2%)                                                                       
      Capsule, Accessory Adrenal Cortical Nodule       2 (4%)       1 (4%)                    1 (2%)                                
      Spindle Cell, Hyperplasia                        4 (8%)                    1 (5%)       2 (4%)                                
   Adrenal Gland, Medulla                             (50)         (21)         (18)         (50)                                   
      Hyperplasia, Focal                                                                      1 (2%)                                
   Islets, Pancreatic                                 (50)         (22)         (17)         (50)                                   
      Hyperplasia                                      1 (2%)       1 (5%)       2 (12%)      1 (2%)                                
      Necrosis                                         1 (2%)                                                                       
   Pituitary Gland                                    (46)         (20)         (18)         (49)                                   
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    8                                                              
NTP Experiment-Test: 05019-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                          CI PIGMENT RED 3                                     Date: 09/03/94  
Route: DOSED FEED                                                                                                 Time: 16:33:55  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE MALE                          UNTREATD     1.25%        2.5%         5.0%                                      
                                                    CONTROL                                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
      Pars Distalis, Cyst                              3 (7%)                                 1 (2%)                                
   Thyroid Gland                                      (50)         (49)         (50)         (50)                                   
      Follicle, Cyst                                   3 (6%)       4 (8%)      19 (38%)     38 (76%)                               
      Follicle, Degeneration, Cystic                   1 (2%)                                                                       
      Follicular Cell, Hyperplasia                     2 (4%)      10 (20%)     24 (48%)     41 (82%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   Tissue NOS                                         (1)                                                                           
      Hemorrhage                                       1 (100%)                                                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (50)         (22)         (19)         (50)                                   
      Granuloma Sperm                                               1 (5%)                    2 (4%)                                
      Inflammation, Subacute                           3 (6%)                    2 (11%)      4 (8%)                                
   Penis                                                           (3)                                                              
      Developmental Malformation                                    1 (33%)                                                         
   Preputial Gland                                    (16)         (14)         (7)          (4)                                    
      Inflammation, Subacute                           9 (56%)     10 (71%)      4 (57%)      2 (50%)                               
      Duct, Cyst                                       3 (19%)      6 (43%)      2 (29%)      2 (50%)                               
   Prostate                                           (50)         (22)         (19)         (50)                                   
      Hemorrhage                                       1 (2%)       1 (5%)                                                          
      Inflammation, Subacute                           6 (12%)      7 (32%)      2 (11%)      8 (16%)                               
   Seminal Vesicle                                    (50)         (21)         (18)         (50)                                   
      Dilatation                                                                 1 (6%)                                             
      Fibrosis                                         1 (2%)                                                                       
      Inflammation, Subacute                           2 (4%)       1 (5%)       2 (11%)      2 (4%)                                
   Testes                                             (50)         (22)         (19)         (50)                                   
      Interstitial Cell, Hyperplasia                                                          1 (2%)                                
      Seminiferous Tubule, Degeneration                                                       2 (4%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Blood                                              (1)          (1)          (1)          (3)                                    
      Leukocytosis                                     1 (100%)     1 (100%)     1 (100%)     1 (33%)                               
   Bone Marrow                                        (50)         (22)         (19)         (49)                                   
      Hyperplasia, Histiocytic                                                   1 (5%)                                             
      Myeloid Cell, Hypercellularity                   9 (18%)      2 (9%)       5 (26%)      6 (12%)                               
   Lymph Node                                         (49)         (27)         (26)         (50)                                   
      Axillary, Hyperplasia, Lymphoid                                            1 (4%)       1 (2%)                                
      Iliac, Hyperplasia, Lymphoid                                               1 (4%)                                             
      Inguinal, Ectasia                                1 (2%)                                                                       
      Inguinal, Hyperplasia, Lymphoid                  6 (12%)      4 (15%)      3 (12%)      8 (16%)                               
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    9                                                              
NTP Experiment-Test: 05019-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                          CI PIGMENT RED 3                                     Date: 09/03/94  
Route: DOSED FEED                                                                                                 Time: 16:33:55  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE MALE                          UNTREATD     1.25%        2.5%         5.0%                                      
                                                    CONTROL                                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Mediastinal, Hyperplasia, Lymphoid                            1 (4%)                                                          
      Mesenteric, Angiectasis                         14 (29%)      7 (26%)      4 (15%)     14 (28%)                               
      Mesenteric, Hyperplasia, Lymphoid                                                       4 (8%)                                
      Renal, Hyperplasia, Lymphoid                                               1 (4%)                                             
   Spleen                                             (48)         (47)         (49)         (48)                                   
      Atrophy                                                       2 (4%)                                                          
      Congestion                                       1 (2%)                                                                       
      Hematopoietic Cell Proliferation                12 (25%)      9 (19%)     11 (22%)      5 (10%)                               
      Hemorrhage                                                                 1 (2%)                                             
      Necrosis                                         1 (2%)                                                                       
      Pigmentation                                                  6 (13%)     23 (47%)     39 (81%)                               
   Thymus                                             (46)         (18)         (19)         (45)                                   
      Atrophy                                          1 (2%)       1 (6%)                    2 (4%)                                
      Cyst                                             4 (9%)                                                                       
      Necrosis                                                      1 (6%)       1 (5%)       3 (7%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (49)         (39)         (45)         (50)                                   
      Inflammation, Focal, Subacute                    6 (12%)      8 (21%)      5 (11%)      1 (2%)                                
      Inflammation, Multifocal, Subacute               3 (6%)                                                                       
      Ulcer                                            3 (6%)       6 (15%)      4 (9%)                                             
      Epidermis, Hyperplasia                                        1 (3%)                                                          
      Epidermis, Hyperplasia, Focal                    5 (10%)      4 (10%)      3 (7%)       4 (8%)                                
      Epidermis, Hyperplasia, Multifocal               3 (6%)                                                                       
      Subcutaneous Tissue, Edema, Focal                1 (2%)                                                                       
      Subcutaneous Tissue, Fibrosis, Focal             6 (12%)      6 (15%)      8 (18%)      7 (14%)                               
      Subcutaneous Tissue, Fibrosis, Multifocal        3 (6%)       1 (3%)       1 (2%)                                             
      Subcutaneous Tissue, Hemorrhage                                                         1 (2%)                                
      Subcutaneous Tissue, Inflammation, Focal,                                                                                     
           Subacute                                    1 (2%)                    1 (2%)       3 (6%)                                
      Subcutaneous Tissue, Mineralization, Focal       2 (4%)                                 2 (4%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (22)         (19)         (50)                                   
      Hemorrhage                                       1 (2%)                    1 (5%)                                             
      Mineralization, Multifocal                      31 (62%)     11 (50%)     15 (79%)     36 (72%)                               
      Necrosis, Multifocal                                          1 (5%)                                                          
____________________________________________________________________________________________________________________________________
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   10                                                              
NTP Experiment-Test: 05019-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                          CI PIGMENT RED 3                                     Date: 09/03/94  
Route: DOSED FEED                                                                                                 Time: 16:33:55  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE MALE                          UNTREATD     1.25%        2.5%         5.0%                                      
                                                    CONTROL                                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (25)         (26)         (50)                                   
      Congestion                                       1 (2%)       1 (4%)                    1 (2%)                                
      Hemorrhage, Multifocal                           1 (2%)                                                                       
      Infiltration Cellular, Multifocal, Histiocyte                 2 (8%)                                                          
      Alveolar Epithelium, Hyperplasia                                           4 (15%)                                            
   Nose                                               (50)         (21)         (20)         (50)                                   
      Foreign Body                                     1 (2%)                                                                       
      Inflammation, Acute, Suppurative                                                        1 (2%)                                
      Nasolacrimal Duct, Inflammation, Suppurative     1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (2)                                                                           
      Cataract                                         1 (50%)                                                                      
      Conjunctiva, Inflammation, Subacute              1 (50%)                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (50)         (50)         (50)                                   
      Bacterium                                        1 (2%)                                                                       
      Hydronephrosis                                   1 (2%)       1 (2%)       1 (2%)                                             
      Inflammation, Chronic, Focal                                               1 (2%)                                             
      Inflammation, Suppurative                        2 (4%)       1 (2%)       1 (2%)       1 (2%)                                
      Nephropathy, Chronic                            34 (68%)     39 (78%)     42 (84%)     45 (90%)                               
      Artery, Inflammation                                          1 (2%)                    1 (2%)                                
      Cortex, Cyst                                                  2 (4%)       4 (8%)       9 (18%)                               
      Glomerulus, Amyloid Deposition                   1 (2%)                                                                       
      Left, Fibrosis, Focal                                                                   1 (2%)                                
      Papilla, Necrosis                                1 (2%)                    1 (2%)                                             
      Renal Tubule, Dilatation, Multifocal                                                    1 (2%)                                
      Renal Tubule, Hyperplasia                                     1 (2%)       7 (14%)      7 (14%)                               
      Renal Tubule, Hyperplasia, Cystic                                                       4 (8%)                                
      Renal Tubule, Mineralization, Multifocal         1 (2%)       6 (12%)      5 (10%)      4 (8%)                                
      Renal Tubule, Epithelium, Cytomegaly                         40 (80%)     47 (94%)     46 (92%)                               
      Right, Atrophy                                   1 (2%)                                                                       
   Urethra                                            (1)          (2)          (3)          (2)                                    
      Dilatation                                                    1 (50%)                   1 (50%)                               
      Inflammation, Suppurative                        1 (100%)     1 (50%)                   1 (50%)                               
      Bulbourethral Gland, Cyst                                                               1 (50%)                               
      Bulbourethral Gland, Hemorrhage                                            2 (67%)                                            
      Bulbourethral Gland, Inflammation, Subacute                                             1 (50%)                               
   Urinary Bladder                                    (49)         (22)         (18)         (50)                                   
      Hemorrhage                                                    2 (9%)                                                          
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   11                                                              
NTP Experiment-Test: 05019-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                          CI PIGMENT RED 3                                     Date: 09/03/94  
Route: DOSED FEED                                                                                                 Time: 16:33:55  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE MALE                          UNTREATD     1.25%        2.5%         5.0%                                      
                                                    CONTROL                                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
URINARY SYSTEM - CONT                                                                                                               
      Hyperplasia                                                                             1 (2%)                                
      Inflammation, Subacute                           2 (4%)       2 (9%)       1 (6%)       1 (2%)                                
      Inflammation, Suppurative                        1 (2%)       1 (5%)                                                          
      Mineralization                                                                          1 (2%)                                
      Wall, Mineralization, Focal                      1 (2%)                                                                       
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   12                                                              
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