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TDMS Study 93005-04 Pathology Tables

NTP Experiment-Test: 93005-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                          MALACHITE GREEN                                      Date: 06/19/03
Route: DOSED FEED                                                                                                 Time: 07:15:44




       Facility:  National Center for Toxicological Research

       Chemical CAS #:  569-64-2

       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: 93005-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                          MALACHITE GREEN                                      Date: 06/19/03    
Route: DOSED FEED                                                                                                 Time: 07:15:44    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         C57BL/6N XC3H/HEN MTN-NCTR FEMALE         0 PPM        100 PPM      225 PPM      450 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially In Study                          48           48           48           48                                     
  Early Deaths                                                                                                                      
    Natural Death                                      4            1            4            3                                     
    Accidently Killed                                                            1                                                  
    Moribund Sacrifice                                 4            3            3            4                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                40           44           40           41                                     
                                                                                                                                    
  Animals Examined Microscopically                    48           48           48           48                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large, Cecum                             (46)         (47)         (45)         (46)                                   
      Hyperplasia, Lymphoid                                                                   1 (2%)                                
   Intestine Small, Jejunum                           (46)         (47)         (44)         (47)                                   
      Hyperplasia, Lymphoid                                                                   1 (2%)                                
   Liver                                              (48)         (48)         (46)         (48)                                   
      Basophilic Focus                                 1 (2%)       1 (2%)       3 (7%)                                             
      Fatty Change, Focal                                                        1 (2%)                                             
      Hematopoietic Cell Proliferation                 2 (4%)       1 (2%)                    2 (4%)                                
      Infiltration Cellular, Lymphocyte                4 (8%)       6 (13%)      8 (17%)     12 (25%)                               
      Infiltration Cellular, Histiocyte                             1 (2%)                                                          
      Inflammation, Chronic Active, Focal              5 (10%)      9 (19%)      8 (17%)      4 (8%)                                
      Necrosis                                                                                2 (4%)                                
      Tension Lipidosis                               10 (21%)      7 (15%)      8 (17%)      6 (13%)                               
      Bile Duct, Cyst                                                                         1 (2%)                                
   Mesentery                                          (2)          (5)          (1)                                                 
      Infiltration Cellular, Lymphocyte                             1 (20%)                                                         
      Fat, Necrosis, Focal                             2 (100%)     3 (60%)      1 (100%)                                           
   Pancreas                                           (47)         (47)         (44)         (47)                                   
      Cyst                                                                                    1 (2%)                                
      Cytoplasmic Alteration                                        1 (2%)       1 (2%)       1 (2%)                                
      Infiltration Cellular, Lymphocyte                6 (13%)      4 (9%)       2 (5%)       3 (6%)                                
      Necrosis, Focal                                               1 (2%)                                                          
      Acinus, Atrophy                                  2 (4%)                                                                       
   Salivary Glands                                    (48)         (48)         (48)         (48)                                   
      Infiltration Cellular, Mononuclear Cell                       1 (2%)                                                          
      Parotid Gland, Infiltration Cellular,                                                                                         
        Lymphocyte                                     5 (10%)     12 (25%)      4 (8%)       5 (10%)                               
      Sublingual Gland, Infiltration Cellular,                                                                                      
         Lymphocyte                                                 1 (2%)                                                          
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    2                                                              
                                                                                                                                   
NTP Experiment-Test: 93005-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                          MALACHITE GREEN                                      Date: 06/19/03    
Route: DOSED FEED                                                                                                 Time: 07:15:44    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         C57BL/6N XC3H/HEN MTN-NCTR FEMALE         0 PPM        100 PPM      225 PPM      450 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Submandibular Gland, Infiltration Cellular,                                                                                   
         Lymphocyte                                   35 (73%)     28 (58%)     28 (58%)     28 (58%)                               
   Stomach, Forestomach                               (47)         (47)         (46)         (48)                                   
      Hyperkeratosis, Focal                            1 (2%)                                                                       
      Infiltration Cellular, Mast Cell                                                        1 (2%)                                
      Inflammation, Chronic Active                     2 (4%)       3 (6%)       2 (4%)       1 (2%)                                
      Ulcer                                                                                   1 (2%)                                
      Epithelium, Hyperplasia, Diffuse                 2 (4%)       2 (4%)       1 (2%)                                             
      Epithelium, Hyperplasia, Focal                  11 (23%)      8 (17%)      4 (9%)       7 (15%)                               
   Stomach, Glandular                                 (47)         (47)         (46)         (48)                                   
      Erosion                                                       1 (2%)                    1 (2%)                                
      Ulcer                                            1 (2%)                    1 (2%)       1 (2%)                                
   Tongue                                             (48)         (48)         (48)         (48)                                   
      Artery, Inflammation, Chronic                    2 (4%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (48)         (48)         (48)         (48)                                   
      Infiltration Cellular, Lymphocyte                                          2 (4%)                                             
      Artery, Inflammation, Chronic                    1 (2%)                                 1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (47)         (47)         (45)         (47)                                   
      Accessory Adrenal Cortical Nodule                             1 (2%)       1 (2%)       1 (2%)                                
      Hematopoietic Cell Proliferation                 1 (2%)                                                                       
      Hyperplasia, Focal                               1 (2%)                    1 (2%)                                             
      Hypertrophy, Focal                                                         1 (2%)       2 (4%)                                
      Mineralization, Focal                                                      1 (2%)                                             
      Vacuolization Cytoplasmic                        1 (2%)                                                                       
      Bilateral, Hypertrophy, Focal                                                           1 (2%)                                
      Subcapsular, Hyperplasia                        46 (98%)     46 (98%)     44 (98%)     45 (96%)                               
   Adrenal Medulla                                    (47)         (46)         (44)         (46)                                   
      Hyperplasia, Focal                                            1 (2%)       1 (2%)                                             
   Pituitary Gland                                    (48)         (47)         (46)         (45)                                   
      Pars Distalis, Hyperplasia, Focal                1 (2%)       2 (4%)       5 (11%)                                            
      Pars Intermedia, Hyperplasia, Focal                           1 (2%)                                                          
   Thyroid Gland                                      (47)         (46)         (46)         (48)                                   
      Hyperplasia, Focal                                                         1 (2%)                                             
      Infiltration Cellular, Lymphocyte                1 (2%)                    1 (2%)                                             
      Ultimobranchial Cyst                                                       2 (4%)       2 (4%)                                
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    3                                                              
                                                                                                                                   
NTP Experiment-Test: 93005-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                          MALACHITE GREEN                                      Date: 06/19/03    
Route: DOSED FEED                                                                                                 Time: 07:15:44    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         C57BL/6N XC3H/HEN MTN-NCTR FEMALE         0 PPM        100 PPM      225 PPM      450 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
      Follicular Cell, Cyst                            2 (4%)       2 (4%)       3 (7%)       1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   Tissue NOS                                         (1)                       (1)                                                 
      Hemorrhage                                                                 1 (100%)                                           
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (48)         (47)         (46)         (44)                                   
      Inflammation, Chronic                                                      1 (2%)                                             
      Duct, Cyst                                      44 (92%)     47 (100%)    45 (98%)     44 (100%)                              
   Ovary                                              (48)         (46)         (46)         (45)                                   
      Angiectasis                                      1 (2%)       1 (2%)       1 (2%)                                             
      Atrophy                                         28 (58%)     33 (72%)     36 (78%)     36 (80%)                               
      Cyst                                            15 (31%)     18 (39%)     11 (24%)     11 (24%)                               
      Hemorrhage                                       3 (6%)                    1 (2%)       1 (2%)                                
      Inflammation, Acute                                           1 (2%)                                                          
      Inflammation, Chronic Active                                               1 (2%)                                             
      Mineralization                                   1 (2%)                                                                       
      Thrombosis                                                    1 (2%)                                                          
      Bilateral, Cyst                                  4 (8%)       3 (7%)       3 (7%)       2 (4%)                                
      Germinal Epithelium, Hyperplasia                                           2 (4%)                                             
   Uterus                                             (48)         (48)         (47)         (48)                                   
      Angiectasis                                      1 (2%)                                 1 (2%)                                
      Hyperplasia, Cystic                             42 (88%)     46 (96%)     44 (94%)     42 (88%)                               
      Inflammation, Acute                                                        1 (2%)                                             
      Thrombosis                                       1 (2%)                                                                       
   Vagina                                             (48)         (48)         (46)         (48)                                   
      Inflammation, Chronic                            1 (2%)                                                                       
      Artery, Inflammation, Chronic                                              1 (2%)                                             
      Epithelium, Hyperplasia                                                    1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (47)         (47)         (47)         (48)                                   
      Fibrosis                                                                   1 (2%)                                             
   Lymph Node                                         (13)         (13)         (6)          (9)                                    
      Inguinal, Hyperplasia, Lymphoid                                            1 (17%)                                            
      Lumbar, Hyperplasia, Lymphoid                    4 (31%)      4 (31%)      2 (33%)      1 (11%)                               
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    4                                                              
                                                                                                                                   
NTP Experiment-Test: 93005-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                          MALACHITE GREEN                                      Date: 06/19/03    
Route: DOSED FEED                                                                                                 Time: 07:15:44    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         C57BL/6N XC3H/HEN MTN-NCTR FEMALE         0 PPM        100 PPM      225 PPM      450 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Mediastinal, Hemorrhage                                       2 (15%)                                                         
      Mediastinal, Infiltration Cellular,                                                                                           
        Mononuclear Cell                                            1 (8%)                                                          
      Pancreatic, Infiltration Cellular,                                                                                            
        Mononuclear Cell                                            1 (8%)                                                          
      Renal, Hemorrhage                                1 (8%)                                                                       
      Renal, Hyperplasia, Lymphoid                     2 (15%)      1 (8%)       2 (33%)      1 (11%)                               
   Lymph Node, Mandibular                             (48)         (48)         (47)         (48)                                   
      Hemorrhage                                                                 1 (2%)                                             
      Hyperplasia, Lymphoid                            2 (4%)       1 (2%)       2 (4%)       1 (2%)                                
      Infiltration Cellular, Mast Cell                                                        1 (2%)                                
   Lymph Node, Mesenteric                             (45)         (46)         (44)         (46)                                   
      Hemorrhage                                                    1 (2%)                                                          
      Hyperplasia, Lymphoid                            8 (18%)      8 (17%)      5 (11%)      5 (11%)                               
   Spleen                                             (47)         (47)         (45)         (47)                                   
      Angiectasis                                      1 (2%)                                 1 (2%)                                
      Depletion Cellular                                                         1 (2%)                                             
      Hematopoietic Cell Proliferation                 9 (19%)      8 (17%)      3 (7%)       5 (11%)                               
      Hyperplasia, Lymphoid                            6 (13%)      6 (13%)      7 (16%)      2 (4%)                                
      Infiltration Cellular, Mononuclear Cell                       1 (2%)                                                          
      Necrosis, Focal                                               1 (2%)                                                          
   Thymus                                             (43)         (44)         (43)         (47)                                   
      Angiectasis                                                                             1 (2%)                                
      Cyst                                             4 (9%)       2 (5%)       3 (7%)       3 (6%)                                
      Ectopic Parathyroid Gland                        3 (7%)       1 (2%)       2 (5%)       3 (6%)                                
      Hyperplasia, Lymphoid                            3 (7%)       5 (11%)      6 (14%)      2 (4%)                                
      Infiltration Cellular, Mononuclear Cell                       1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (46)         (48)         (45)         (46)                                   
      Infiltration Cellular, Lymphocyte                             1 (2%)                                                          
   Skin                                               (48)         (48)         (46)         (48)                                   
      Fibrosis                                                      1 (2%)                                                          
      Hyperplasia                                                                             1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (48)         (48)         (48)         (48)                                   
      Hyperostosis                                     1 (2%)                                                                       
      Cranium, Fibrous Osteodystrophy                  1 (2%)                                                                       
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    5                                                              
                                                                                                                                   
NTP Experiment-Test: 93005-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                          MALACHITE GREEN                                      Date: 06/19/03    
Route: DOSED FEED                                                                                                 Time: 07:15:44    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         C57BL/6N XC3H/HEN MTN-NCTR FEMALE         0 PPM        100 PPM      225 PPM      450 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
MUSCULOSKELETAL SYSTEM - CONT                                                                                                       
      Femur, Fibrous Osteodystrophy                    4 (8%)       5 (10%)      2 (4%)       2 (4%)                                
      Sternum, Degeneration, Cystic                                 2 (4%)       4 (8%)       3 (6%)                                
      Sternum, Fibrous Osteodystrophy                 12 (25%)     14 (29%)      5 (10%)      5 (10%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (48)         (48)         (48)         (48)                                   
      Infiltration Cellular, Lymphocyte                1 (2%)                                                                       
      Cerebrum, Mineralization                        25 (52%)     18 (38%)     17 (35%)     17 (35%)                               
   Spinal Cord                                        (48)         (48)         (48)         (48)                                   
      Thoracic, Axon, Degeneration                    13 (27%)     14 (29%)     19 (40%)     19 (40%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (48)         (48)         (48)         (48)                                   
      Hemorrhage, Focal                                                                       1 (2%)                                
      Infiltration Cellular, Lymphocyte                6 (13%)      6 (13%)      6 (13%)      2 (4%)                                
      Infiltration Cellular, Histiocyte                2 (4%)       3 (6%)       2 (4%)                                             
      Inflammation, Chronic, Focal                     1 (2%)                                                                       
      Pigmentation                                                  1 (2%)                                                          
      Proteinosis                                      3 (6%)                                                                       
      Thrombosis                                                                 1 (2%)                                             
      Alveolar Epithelium, Hyperplasia                 1 (2%)       3 (6%)                    1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (48)         (48)         (47)         (48)                                   
      Bilateral, Lens, Cataract                        4 (8%)       2 (4%)       5 (11%)      2 (4%)                                
      Cornea, Mineralization                           1 (2%)                                                                       
      Lens, Cataract                                   1 (2%)       2 (4%)       1 (2%)       6 (13%)                               
   Harderian Gland                                    (48)         (48)         (48)         (48)                                   
      Atrophy                                                       1 (2%)                                                          
      Hyperplasia                                                                1 (2%)       1 (2%)                                
      Infiltration Cellular, Lymphocyte                4 (8%)       5 (10%)      5 (10%)      4 (8%)                                
   Zymbal's Gland                                     (48)         (48)         (47)         (47)                                   
      Atrophy                                                       1 (2%)                    1 (2%)                                
      Inflammation, Chronic                                                      1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                                                                                                    
                                                             Page    6                                                              
                                                                                                                                   
NTP Experiment-Test: 93005-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                          MALACHITE GREEN                                      Date: 06/19/03    
Route: DOSED FEED                                                                                                 Time: 07:15:44    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         C57BL/6N XC3H/HEN MTN-NCTR FEMALE         0 PPM        100 PPM      225 PPM      450 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (48)         (47)         (48)         (47)                                   
      Infiltration Cellular, Lymphocyte                2 (4%)       7 (15%)      3 (6%)       2 (4%)                                
      Metaplasia, Focal                                             1 (2%)                                                          
      Nephropathy                                                                1 (2%)       1 (2%)                                
      Glomerulus, Amyloid Deposition                                                          2 (4%)                                
      Glomerulus, Casts Protein                        1 (2%)       1 (2%)                                                          
      Glomerulus, Hypertrophy                                                                 1 (2%)                                
      Glomerulus, Inflammation, Acute                                                         1 (2%)                                
      Pelvis, Dilatation                               2 (4%)                                                                       
      Renal Tubule, Accumulation, Hyaline Droplet      4 (8%)                    1 (2%)       1 (2%)                                
      Renal Tubule, Hyperplasia                        1 (2%)                                                                       
   Urinary Bladder                                    (47)         (46)         (45)         (48)                                   
      Inclusion Body Intracytoplasmic                  7 (15%)     15 (33%)     34 (76%)     39 (81%)                               
      Infiltration Cellular, Lymphocyte               36 (77%)     34 (74%)     33 (73%)     25 (52%)                               
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page    7                                                              
                                                                                                                                   
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