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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: PEIRPT18
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/19/03
Route: DOSED FEED                                              MALACHITE GREEN                                    Time: 07:29:07
       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
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
                                                              Page   1
NTP Experiment-Test: 93005-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/19/03    
Route: DOSED FEED                                              MALACHITE GREEN                                    Time: 07:29:07    
____________________________________________________________________________________________________________________________________
         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 [2.0]                               
   Intestine Small, Jejunum                           (46)         (47)         (44)         (47)                                   
      Hyperplasia, Lymphoid                                                                   1 [4.0]                               
   Liver                                              (48)         (48)         (46)         (48)                                   
      Basophilic Focus                                 1            1            3                                                  
      Fatty Change, Focal                                                        1 [2.0]                                            
      Hematopoietic Cell Proliferation                 2 [1.0]      1 [2.0]                   2 [1.0]                               
      Infiltration Cellular, Lymphocyte                4 [1.0]      6 [1.3]      8 [1.6]     12 [1.2]                               
      Infiltration Cellular, Histiocyte                             1 [2.0]                                                         
      Inflammation, Chronic Active, Focal              5 [1.4]      9 [1.1]      8 [1.0]      4 [1.0]                               
      Necrosis                                                                                2 [2.5]                               
      Tension Lipidosis                               10 [1.2]      7 [1.3]      8 [1.5]      6 [1.5]                               
      Bile Duct, Cyst                                                                         1 [3.0]                               
   Mesentery                                          (2)          (5)          (1)                                                 
      Infiltration Cellular, Lymphocyte                             1 [3.0]                                                         
      Fat, Necrosis, Focal                             2 [2.5]      3 [1.7]      1 [2.0]                                            
   Pancreas                                           (47)         (47)         (44)         (47)                                   
      Cyst                                                                                    1 [2.0]                               
      Cytoplasmic Alteration                                        1 [1.0]      1 [1.0]      1 [1.0]                               
      Infiltration Cellular, Lymphocyte                6 [1.7]      4 [1.5]      2 [1.5]      3 [1.7]                               
      Necrosis, Focal                                               1 [2.0]                                                         
      Acinus, Atrophy                                  2 [2.5]                                                                      
   Salivary Glands                                    (48)         (48)         (48)         (48)                                   
      Infiltration Cellular, Mononuclear Cell                       1 [1.0]                                                         
      Parotid Gland, Infiltration Cellular,                                                                                         
        Lymphocyte                                     5 [1.6]     12 [1.6]      4 [1.3]      5 [1.4]                               
      Sublingual Gland, Infiltration Cellular,                                                                                      
         Lymphocyte                                                 1 [1.0]                                                         
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page    2                                                              
NTP Experiment-Test: 93005-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/19/03    
Route: DOSED FEED                                              MALACHITE GREEN                                    Time: 07:29:07    
____________________________________________________________________________________________________________________________________
         C57BL/6N XC3H/HEN MTN-NCTR FEMALE            0 PPM        100 PPM      225 PPM      450 PPM                                
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT                                                                                                            
      Submandibular Gland, Infiltration Cellular,                                                                                   
         Lymphocyte                                   35 [1.5]     28 [1.6]     28 [1.8]     28 [1.8]                               
   Stomach, Forestomach                               (47)         (47)         (46)         (48)                                   
      Hyperkeratosis, Focal                            1 [1.0]                                                                      
      Infiltration Cellular, Mast Cell                                                        1 [2.0]                               
      Inflammation, Chronic Active                     2 [1.0]      3 [1.0]      2 [1.5]      1 [2.0]                               
      Ulcer                                                                                   1 [2.0]                               
      Epithelium, Hyperplasia, Diffuse                 2 [2.0]      2 [1.0]      1 [1.0]                                            
      Epithelium, Hyperplasia, Focal                  11 [1.5]      8 [1.8]      4 [1.8]      7 [1.7]                               
   Stomach, Glandular                                 (47)         (47)         (46)         (48)                                   
      Erosion                                                       1 [2.0]                   1 [2.0]                               
      Ulcer                                            1 [2.0]                   1 [2.0]      1 [1.0]                               
   Tongue                                             (48)         (48)         (48)         (48)                                   
      Artery, Inflammation, Chronic                    2 [2.0]                                                                      
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 CARDIOVASCULAR SYSTEM                                                                                                              
   Heart                                              (48)         (48)         (48)         (48)                                   
      Infiltration Cellular, Lymphocyte                                          2 [1.0]                                            
      Artery, Inflammation, Chronic                    1 [2.0]                                1 [3.0]                               
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 ENDOCRINE SYSTEM                                                                                                                   
   Adrenal Cortex                                     (47)         (47)         (45)         (47)                                   
      Accessory Adrenal Cortical Nodule                             1 [1.0]      1 [1.0]      1 [1.0]                               
      Hematopoietic Cell Proliferation                 1 [1.0]                                                                      
      Hyperplasia, Focal                               1 [1.0]                   1 [1.0]                                            
      Hypertrophy, Focal                                                         1 [2.0]      2 [2.5]                               
      Mineralization, Focal                                                      1 [4.0]                                            
      Vacuolization Cytoplasmic                        1 [4.0]                                                                      
      Bilateral, Hypertrophy, Focal                                                           1 [3.0]                               
      Subcapsular, Hyperplasia                        46 [1.9]     46 [2.0]     44 [1.9]     45 [2.0]                               
   Adrenal Medulla                                    (47)         (46)         (44)         (46)                                   
      Hyperplasia, Focal                                            1 [1.0]      1 [1.0]                                            
   Pituitary Gland                                    (48)         (47)         (46)         (45)                                   
      Pars Distalis, Hyperplasia, Focal                1 [1.0]      2 [1.0]      5 [1.6]                                            
      Pars Intermedia, Hyperplasia, Focal                           1 [2.0]                                                         
   Thyroid Gland                                      (47)         (46)         (46)         (48)                                   
      Hyperplasia, Focal                                                         1 [1.0]                                            
      Infiltration Cellular, Lymphocyte                1 [1.0]                   1 [1.0]                                            
      Ultimobranchial Cyst                                                       2 [1.0]      2 [1.0]                               
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page    3                                                              
NTP Experiment-Test: 93005-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/19/03    
Route: DOSED FEED                                              MALACHITE GREEN                                    Time: 07:29:07    
____________________________________________________________________________________________________________________________________
         C57BL/6N XC3H/HEN MTN-NCTR FEMALE            0 PPM        100 PPM      225 PPM      450 PPM                                
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT                                                                                                             
      Follicular Cell, Cyst                            2 [1.0]      2 [1.0]      3 [1.0]      1 [1.0]                               
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 GENERAL BODY SYSTEM                                                                                                                
   Tissue NOS                                         (1)                       (1)                                                 
      Hemorrhage                                                                 1 [4.0]                                            
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 GENITAL SYSTEM                                                                                                                     
   Clitoral Gland                                     (48)         (47)         (46)         (44)                                   
      Inflammation, Chronic                                                      1 [2.0]                                            
      Duct, Cyst                                      44 [1.9]     47 [1.9]     45 [2.0]     44 [1.9]                               
   Ovary                                              (48)         (46)         (46)         (45)                                   
      Angiectasis                                      1 [2.0]      1 [3.0]      1 [2.0]                                            
      Atrophy                                         28 [2.1]     33 [2.3]     36 [2.5]     36 [2.6]                               
      Cyst                                            15 [1.0]     18 [1.0]     11 [1.0]     11 [1.0]                               
      Hemorrhage                                       3 [1.0]                   1 [2.0]      1 [1.0]                               
      Inflammation, Acute                                           1 [3.0]                                                         
      Inflammation, Chronic Active                                               1 [3.0]                                            
      Mineralization                                   1 [2.0]                                                                      
      Thrombosis                                                    1 [4.0]                                                         
      Bilateral, Cyst                                  4 [1.0]      3 [1.0]      3 [1.0]      2 [1.0]                               
      Germinal Epithelium, Hyperplasia                                           2 [2.0]                                            
   Uterus                                             (48)         (48)         (47)         (48)                                   
      Angiectasis                                      1 [2.0]                                1 [2.0]                               
      Hyperplasia, Cystic                             42 [2.3]     46 [2.5]     44 [2.4]     42 [2.2]                               
      Inflammation, Acute                                                        1 [3.0]                                            
      Thrombosis                                       1 [2.0]                                                                      
   Vagina                                             (48)         (48)         (46)         (48)                                   
      Inflammation, Chronic                            1 [2.0]                                                                      
      Artery, Inflammation, Chronic                                              1 [2.0]                                            
      Epithelium, Hyperplasia                                                    1 [1.0]                                            
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 HEMATOPOIETIC SYSTEM                                                                                                               
   Bone Marrow                                        (47)         (47)         (47)         (48)                                   
      Fibrosis                                                                   1 [1.0]                                            
   Lymph Node                                         (13)         (13)         (6)          (9)                                    
      Inguinal, Hyperplasia, Lymphoid                                            1 [2.0]                                            
      Lumbar, Hyperplasia, Lymphoid                    4 [2.0]      4 [2.0]      2 [2.0]      1 [2.0]                               
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
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NTP Experiment-Test: 93005-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/19/03    
Route: DOSED FEED                                              MALACHITE GREEN                                    Time: 07:29:07    
____________________________________________________________________________________________________________________________________
         C57BL/6N XC3H/HEN MTN-NCTR FEMALE            0 PPM        100 PPM      225 PPM      450 PPM                                
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Mediastinal, Hemorrhage                                       2 [2.0]                                                         
      Mediastinal, Infiltration Cellular,                                                                                           
        Mononuclear Cell                                            1 [2.0]                                                         
      Pancreatic, Infiltration Cellular,                                                                                            
        Mononuclear Cell                                            1 [3.0]                                                         
      Renal, Hemorrhage                                1 [3.0]                                                                      
      Renal, Hyperplasia, Lymphoid                     2 [2.0]      1 [2.0]      2 [2.0]      1 [2.0]                               
   Lymph Node, Mandibular                             (48)         (48)         (47)         (48)                                   
      Hemorrhage                                                                 1 [2.0]                                            
      Hyperplasia, Lymphoid                            2 [2.0]      1 [3.0]      2 [2.5]      1 [2.0]                               
      Infiltration Cellular, Mast Cell                                                        1 [2.0]                               
   Lymph Node, Mesenteric                             (45)         (46)         (44)         (46)                                   
      Hemorrhage                                                    1 [1.0]                                                         
      Hyperplasia, Lymphoid                            8 [2.0]      8 [2.0]      5 [2.2]      5 [2.2]                               
   Spleen                                             (47)         (47)         (45)         (47)                                   
      Angiectasis                                      1 [1.0]                                1 [2.0]                               
      Depletion Cellular                                                         1 [2.0]                                            
      Hematopoietic Cell Proliferation                 9 [2.4]      8 [2.5]      3 [2.0]      5 [3.0]                               
      Hyperplasia, Lymphoid                            6 [2.2]      6 [2.3]      7 [2.1]      2 [1.5]                               
      Infiltration Cellular, Mononuclear Cell                       1 [3.0]                                                         
      Necrosis, Focal                                               1 [3.0]                                                         
   Thymus                                             (43)         (44)         (43)         (47)                                   
      Angiectasis                                                                             1 [2.0]                               
      Cyst                                             4 [1.0]      2 [1.0]      3 [1.0]      3 [1.0]                               
      Ectopic Parathyroid Gland                        3 [1.0]      1 [1.0]      2 [1.0]      3 [1.0]                               
      Hyperplasia, Lymphoid                            3 [1.3]      5 [2.2]      6 [2.3]      2 [2.5]                               
      Infiltration Cellular, Mononuclear Cell                       1 [3.0]                                                         
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 INTEGUMENTARY SYSTEM                                                                                                               
   Mammary Gland                                      (46)         (48)         (45)         (46)                                   
      Infiltration Cellular, Lymphocyte                             1 [2.0]                                                         
   Skin                                               (48)         (48)         (46)         (48)                                   
      Fibrosis                                                      1 [2.0]                                                         
      Hyperplasia                                                                             1 [3.0]                               
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 MUSCULOSKELETAL SYSTEM                                                                                                             
   Bone                                               (48)         (48)         (48)         (48)                                   
      Hyperostosis                                     1 [2.0]                                                                      
      Cranium, Fibrous Osteodystrophy                  1 [2.0]                                                                      
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page    5                                                              
NTP Experiment-Test: 93005-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/19/03    
Route: DOSED FEED                                              MALACHITE GREEN                                    Time: 07:29:07    
____________________________________________________________________________________________________________________________________
         C57BL/6N XC3H/HEN MTN-NCTR FEMALE            0 PPM        100 PPM      225 PPM      450 PPM                                
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM - CONT                                                                                                       
      Femur, Fibrous Osteodystrophy                    4 [2.0]      5 [1.2]      2 [2.0]      2 [2.0]                               
      Sternum, Degeneration, Cystic                                 2 [1.0]      4 [1.3]      3 [1.0]                               
      Sternum, Fibrous Osteodystrophy                 12 [1.8]     14 [1.5]      5 [1.4]      5 [1.0]                               
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 NERVOUS SYSTEM                                                                                                                     
   Brain                                              (48)         (48)         (48)         (48)                                   
      Infiltration Cellular, Lymphocyte                1 [1.0]                                                                      
      Cerebrum, Mineralization                        25 [1.0]     18 [1.0]     17 [1.0]     17 [1.0]                               
   Spinal Cord                                        (48)         (48)         (48)         (48)                                   
      Thoracic, Axon, Degeneration                    13 [1.2]     14 [1.1]     19 [1.2]     19 [1.1]                               
____________________________________________________________________________________________________________________________________
 RESPIRATORY SYSTEM                                                                                                                 
   Lung                                               (48)         (48)         (48)         (48)                                   
      Hemorrhage, Focal                                                                       1 [2.0]                               
      Infiltration Cellular, Lymphocyte                6 [1.7]      6 [1.8]      6 [1.7]      2 [1.5]                               
      Infiltration Cellular, Histiocyte                2 [2.0]      3 [1.0]      2 [1.0]                                            
      Inflammation, Chronic, Focal                     1 [1.0]                                                                      
      Pigmentation                                                  1 [2.0]                                                         
      Proteinosis                                      3 [2.0]                                                                      
      Thrombosis                                                                 1 [2.0]                                            
      Alveolar Epithelium, Hyperplasia                 1 [1.0]      3 [1.3]                   1 [1.0]                               
____________________________________________________________________________________________________________________________________
 SPECIAL SENSES SYSTEM                                                                                                              
   Eye                                                (48)         (48)         (47)         (48)                                   
      Bilateral, Lens, Cataract                        4 [2.0]      2 [2.0]      5 [2.2]      2 [1.0]                               
      Cornea, Mineralization                           1 [3.0]                                                                      
      Lens, Cataract                                   1 [1.0]      2 [1.5]      1 [1.0]      6 [1.8]                               
   Harderian Gland                                    (48)         (48)         (48)         (48)                                   
      Atrophy                                                       1 [2.0]                                                         
      Hyperplasia                                                                1 [2.0]      1 [2.0]                               
      Infiltration Cellular, Lymphocyte                4 [1.0]      5 [1.0]      5 [1.2]      4 [1.0]                               
   Zymbal's Gland                                     (48)         (48)         (47)         (47)                                   
      Atrophy                                                       1 [2.0]                   1 [1.0]                               
      Inflammation, Chronic                                                      1 [4.0]                                            
____________________________________________________________________________________________________________________________________
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page    6                                                              
NTP Experiment-Test: 93005-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/19/03    
Route: DOSED FEED                                              MALACHITE GREEN                                    Time: 07:29:07    
____________________________________________________________________________________________________________________________________
         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 [1.5]      7 [1.4]      3 [1.0]      2 [1.5]                               
      Metaplasia, Focal                                             1 [1.0]                                                         
      Nephropathy                                                                1 [1.0]      1 [1.0]                               
      Glomerulus, Amyloid Deposition                                                          2 [4.0]                               
      Glomerulus, Casts Protein                        1 [3.0]      1 [3.0]                                                         
      Glomerulus, Hypertrophy                                                                 1 [2.0]                               
      Glomerulus, Inflammation, Acute                                                         1 [2.0]                               
      Pelvis, Dilatation                               2 [2.5]                                                                      
      Renal Tubule, Accumulation, Hyaline Droplet      4 [1.8]                   1 [3.0]      1 [3.0]                               
      Renal Tubule, Hyperplasia                        1 [1.0]                                                                      
   Urinary Bladder                                    (47)         (46)         (45)         (48)                                   
      Inclusion Body Intracytoplasmic                  7 [1.1]     15 [1.1]     34 [1.4]     39 [1.4]                               
      Infiltration Cellular, Lymphocyte               36 [1.4]     34 [1.2]     33 [1.3]     25 [1.2]                               
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
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