https://ntp.niehs.nih.gov/go/3199

TDMS Study 93005-03 Pathology Tables

NTP Experiment-Test: 93005-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                          MALACHITE GREEN                                      Date: 06/18/03
Route: DOSED FEED                                                                                                 Time: 14:23:36
       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: 93005-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                          MALACHITE GREEN                                      Date: 06/18/03    
Route: DOSED FEED                                                                                                 Time: 14:23:36    
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   0 PPM        100 PPM      300 PPM      600 PPM                                   
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially In Study                          48           48           48           48                                     
  Early Deaths                                                                                                                      
    Natural Death                                      1            3            1            6                                     
    Moribund Sacrifice                                18           22           15           17                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                29           23           32           25                                     
  Animals Examined Microscopically                    48           48           48           48                                     
____________________________________________________________________________________________________________________________________
 ALIMENTARY SYSTEM                                                                                                                  
   Esophagus                                          (48)         (48)         (48)         (48)                                   
      Dilatation                                                                              1 (2%)                                
      Foreign Body                                                                            1 (2%)                                
   Intestine Small, Ileum                             (47)         (46)         (48)         (47)                                   
      Dilatation                                                    1 (2%)                                                          
   Liver                                              (48)         (48)         (48)         (48)                                   
      Angiectasis                                      1 (2%)                                                                       
      Basophilic Focus                                 2 (4%)       3 (6%)       2 (4%)       7 (15%)                               
      Basophilic Focus, Multiple                      19 (40%)     14 (29%)     18 (38%)      8 (17%)                               
      Clear Cell Focus                                              2 (4%)                                                          
      Clear Cell Focus, Multiple                                                 1 (2%)                                             
      Cyst                                                          1 (2%)                                                          
      Degeneration, Cystic                                                       1 (2%)                                             
      Developmental Malformation                       4 (8%)       7 (15%)      2 (4%)       5 (10%)                               
      Eosinophilic Focus                               3 (6%)       9 (19%)      3 (6%)      11 (23%)                               
      Eosinophilic Focus, Multiple                     2 (4%)       1 (2%)      10 (21%)      3 (6%)                                
      Fatty Change                                                                            1 (2%)                                
      Hematopoietic Cell Proliferation                 2 (4%)       3 (6%)       4 (8%)       5 (10%)                               
      Hepatodiaphragmatic Nodule                       3 (6%)       6 (13%)      2 (4%)       3 (6%)                                
      Infiltration Cellular, Lymphocyte                2 (4%)       3 (6%)       3 (6%)       8 (17%)                               
      Inflammation, Focal, Granulomatous              18 (38%)     15 (31%)     23 (48%)     19 (40%)                               
      Inflammation, Focal, Suppurative                 1 (2%)       2 (4%)                                                          
      Mixed Cell Focus                                              2 (4%)                                                          
      Mixed Cell Focus, Multiple                                                              1 (2%)                                
      Necrosis                                                      2 (4%)       2 (4%)       1 (2%)                                
      Vacuolization Cytoplasmic                        4 (8%)       4 (8%)       1 (2%)       6 (13%)                               
      Bile Duct, Cyst                                                            1 (2%)                                             
      Bile Duct, Hyperplasia                          10 (21%)     10 (21%)      9 (19%)      5 (10%)                               
      Centrilobular, Necrosis                                                                 4 (8%)                                
   Mesentery                                          (9)          (5)          (2)          (4)                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    2                                                              
NTP Experiment-Test: 93005-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                          MALACHITE GREEN                                      Date: 06/18/03    
Route: DOSED FEED                                                                                                 Time: 14:23:36    
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   0 PPM        100 PPM      300 PPM      600 PPM                                   
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT                                                                                                            
      Fat, Necrosis                                    7 (78%)      4 (80%)      2 (100%)     3 (75%)                               
   Pancreas                                           (48)         (48)         (48)         (48)                                   
      Infiltration Cellular, Lymphocyte                                          1 (2%)       2 (4%)                                
      Inflammation                                                                            1 (2%)                                
      Acinus, Atrophy                                 13 (27%)     14 (29%)     12 (25%)      7 (15%)                               
   Salivary Glands                                    (48)         (47)         (48)         (48)                                   
      Atrophy                                                       2 (4%)       1 (2%)       1 (2%)                                
      Infiltration Cellular, Lymphocyte                1 (2%)                                 1 (2%)                                
   Stomach, Forestomach                               (48)         (48)         (48)         (48)                                   
      Edema                                                         1 (2%)                                                          
      Erosion                                                                    1 (2%)                                             
      Inflammation                                     1 (2%)       2 (4%)       1 (2%)                                             
      Necrosis                                                      1 (2%)                                                          
      Epithelium, Hyperplasia                                       1 (2%)                    1 (2%)                                
____________________________________________________________________________________________________________________________________
 CARDIOVASCULAR SYSTEM                                                                                                              
   Heart                                              (48)         (48)         (48)         (48)                                   
      Cardiomyopathy                                  13 (27%)     22 (46%)     19 (40%)     14 (29%)                               
      Atrium, Thrombosis                               1 (2%)                                                                       
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 ENDOCRINE SYSTEM                                                                                                                   
   Adrenal Cortex                                     (48)         (48)         (48)         (48)                                   
      Accessory Adrenal Cortical Nodule                1 (2%)                    1 (2%)                                             
      Angiectasis                                     10 (21%)     11 (23%)     17 (35%)     16 (33%)                               
      Atrophy                                                                                 2 (4%)                                
      Hematopoietic Cell Proliferation                                                        1 (2%)                                
      Hyperplasia, Focal                                            1 (2%)       1 (2%)       1 (2%)                                
      Hypertrophy, Focal                               1 (2%)       4 (8%)       1 (2%)       4 (8%)                                
      Infiltration Cellular, Lymphocyte                                                       1 (2%)                                
      Vacuolization Cytoplasmic                        6 (13%)      5 (10%)      2 (4%)       3 (6%)                                
   Adrenal Medulla                                    (47)         (47)         (48)         (48)                                   
      Hyperplasia                                      1 (2%)       3 (6%)       1 (2%)       1 (2%)                                
   Islets, Pancreatic                                 (48)         (48)         (48)         (48)                                   
      Hyperplasia                                      1 (2%)                                                                       
   Parathyroid Gland                                  (43)         (43)         (45)         (39)                                   
      Hyperplasia, Focal                               1 (2%)                                                                       
   Pituitary Gland                                    (48)         (47)         (46)         (45)                                   
      Angiectasis                                      5 (10%)      2 (4%)       2 (4%)       2 (4%)                                
      Pars Distalis, Cyst                              8 (17%)      5 (11%)      9 (20%)      9 (20%)                               
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    3                                                              
NTP Experiment-Test: 93005-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                          MALACHITE GREEN                                      Date: 06/18/03    
Route: DOSED FEED                                                                                                 Time: 14:23:36    
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   0 PPM        100 PPM      300 PPM      600 PPM                                   
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT                                                                                                             
      Pars Distalis, Hyperplasia                       5 (10%)                  11 (24%)      6 (13%)                               
      Pars Intermedia, Cyst                                                                   1 (2%)                                
   Thyroid Gland                                      (46)         (48)         (47)         (46)                                   
      C-Cell, Hyperplasia                              8 (17%)      5 (10%)     11 (23%)      6 (13%)                               
      Follicle, Cyst                                                1 (2%)       1 (2%)       3 (7%)                                
      Follicular Cell, Hyperplasia                                               1 (2%)       2 (4%)                                
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 GENERAL BODY SYSTEM                                                                                                                
   None                                                                                                                             
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 GENITAL SYSTEM                                                                                                                     
   Clitoral Gland                                     (48)         (48)         (47)         (47)                                   
      Hyperplasia                                      5 (10%)      4 (8%)       2 (4%)       6 (13%)                               
      Inflammation                                    21 (44%)     30 (63%)     23 (49%)     26 (55%)                               
      Metaplasia, Squamous                                                                    1 (2%)                                
      Duct, Dilatation                                 6 (13%)      5 (10%)      7 (15%)      6 (13%)                               
   Ovary                                              (48)         (48)         (47)         (48)                                   
      Atrophy                                         18 (38%)     14 (29%)     11 (23%)     10 (21%)                               
      Congestion                                                                              1 (2%)                                
      Cyst                                             5 (10%)      4 (8%)       7 (15%)     10 (21%)                               
      Cyst, Multiple                                                                          1 (2%)                                
      Infiltration Cellular, Lymphocyte                1 (2%)                                                                       
      Interstitial Cell, Hyperplasia                                1 (2%)                                                          
   Uterus                                             (48)         (48)         (48)         (48)                                   
      Decidual Reaction                                                                       1 (2%)                                
      Hemorrhage                                                                              1 (2%)                                
      Inflammation, Suppurative                        1 (2%)                                                                       
      Thrombosis                                                                 1 (2%)       1 (2%)                                
      Cervix, Hypertrophy                              1 (2%)       1 (2%)       1 (2%)                                             
      Cervix, Serosa, Cyst                             1 (2%)                                                                       
      Endometrium, Hyperplasia, Cystic                 6 (13%)      3 (6%)      11 (23%)      8 (17%)                               
   Vagina                                             (48)         (48)         (48)         (48)                                   
      Inflammation, Suppurative                        3 (6%)       3 (6%)       5 (10%)      1 (2%)                                
      Prolapse                                                                                2 (4%)                                
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 HEMATOPOIETIC SYSTEM                                                                                                               
   Bone Marrow                                        (48)         (48)         (48)         (48)                                   
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    4                                                              
NTP Experiment-Test: 93005-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                          MALACHITE GREEN                                      Date: 06/18/03    
Route: DOSED FEED                                                                                                 Time: 14:23:36    
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   0 PPM        100 PPM      300 PPM      600 PPM                                   
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Atrophy                                          1 (2%)       3 (6%)       2 (4%)       2 (4%)                                
      Myelofibrosis                                                              2 (4%)                                             
      Myelostromal Proliferation                       1 (2%)                                                                       
      Myeloid Cell, Hyperplasia                        5 (10%)                   5 (10%)      4 (8%)                                
   Lymph Node                                         (10)         (7)          (7)          (5)                                    
      Pigmentation                                                  1 (14%)                                                         
      Deep Cervical, Hemorrhage                        1 (10%)                                                                      
      Deep Cervical, Hyperplasia, Lymphoid             1 (10%)                                1 (20%)                               
      Iliac, Hyperplasia, Lymphoid                     1 (10%)                                                                      
      Lumbar, Ectasia                                                                         2 (40%)                               
      Lumbar, Hematopoietic Cell Proliferation                      1 (14%)                                                         
      Lumbar, Hemorrhage                                            1 (14%)                   1 (20%)                               
      Lumbar, Hyperplasia, Lymphoid                    2 (20%)                                1 (20%)                               
      Mediastinal, Hemorrhage                          1 (10%)      1 (14%)      3 (43%)                                            
      Mediastinal, Hyperplasia, Lymphoid               2 (20%)                                                                      
      Pancreatic, Hematopoietic Cell Proliferation                               1 (14%)                                            
      Pancreatic, Hemorrhage                           1 (10%)                                                                      
      Pancreatic, Hyperplasia, Lymphoid                1 (10%)                                1 (20%)                               
      Renal, Ectasia                                   1 (10%)                                                                      
      Renal, Hemorrhage                                2 (20%)                   1 (14%)                                            
      Renal, Hyperplasia, Lymphoid                                  1 (14%)      1 (14%)                                            
   Lymph Node, Mandibular                             (47)         (46)         (47)         (48)                                   
      Ectasia                                                       1 (2%)                                                          
      Hemorrhage                                                                 2 (4%)                                             
      Hyperplasia, Lymphoid                            1 (2%)       3 (7%)       2 (4%)       5 (10%)                               
      Infiltration Cellular, Plasma Cell               5 (11%)      5 (11%)      5 (11%)      7 (15%)                               
   Lymph Node, Mesenteric                             (47)         (47)         (48)         (48)                                   
      Ectasia                                                                    1 (2%)                                             
      Hemorrhage                                                    1 (2%)       1 (2%)                                             
      Hyperplasia, Lymphoid                            2 (4%)                                                                       
      Infiltration Cellular, Plasma Cell                            1 (2%)                    1 (2%)                                
   Spleen                                             (48)         (48)         (48)         (48)                                   
      Atrophy                                                                                 1 (2%)                                
      Fibrosis                                                                                1 (2%)                                
      Hematopoietic Cell Proliferation                 6 (13%)      2 (4%)       7 (15%)     12 (25%)                               
      Hyperplasia, Focal                               1 (2%)                                                                       
      Pigmentation                                     1 (2%)       2 (4%)       2 (4%)       3 (6%)                                
      Thrombosis                                                                 1 (2%)                                             
      Capsule, Hemorrhage                                           1 (2%)                                                          
   Thymus                                             (40)         (42)         (43)         (40)                                   
      Cyst                                             1 (3%)                                                                       
      Ectopic Parathyroid Gland                                     1 (2%)                                                          
      Hemorrhage                                                                 1 (2%)                                             
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    5                                                              
NTP Experiment-Test: 93005-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                          MALACHITE GREEN                                      Date: 06/18/03    
Route: DOSED FEED                                                                                                 Time: 14:23:36    
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   0 PPM        100 PPM      300 PPM      600 PPM                                   
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Hyperplasia, Reticulum Cell                                                             1 (3%)                                
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 INTEGUMENTARY SYSTEM                                                                                                               
   Mammary Gland                                      (46)         (48)         (48)         (48)                                   
      Galactocele                                      4 (9%)       8 (17%)      2 (4%)       2 (4%)                                
      Hyperplasia                                     28 (61%)     33 (69%)     29 (60%)     35 (73%)                               
      Inflammation                                                  1 (2%)                                                          
      Duct, Dilatation                                12 (26%)     22 (46%)     18 (38%)     11 (23%)                               
   Skin                                               (48)         (48)         (48)         (48)                                   
      Hyperkeratosis                                   2 (4%)                                                                       
      Inflammation                                                  1 (2%)                                                          
      Epidermis, Hyperplasia                                        1 (2%)                                                          
      Epidermis, Necrosis                                           2 (4%)                                                          
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 MUSCULOSKELETAL SYSTEM                                                                                                             
   Bone                                               (48)         (48)         (48)         (48)                                   
      Femur, Fibrous Osteodystrophy                    1 (2%)       1 (2%)                    3 (6%)                                
      Femur, Osteopetrosis                             8 (17%)      3 (6%)       3 (6%)       3 (6%)                                
      Sternum, Fibrous Osteodystrophy                               1 (2%)                                                          
      Sternum, Osteopetrosis                           8 (17%)      3 (6%)       3 (6%)       3 (6%)                                
      Turbinate, Osteopetrosis                         7 (15%)      2 (4%)       2 (4%)       2 (4%)                                
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 NERVOUS SYSTEM                                                                                                                     
   Brain                                              (48)         (48)         (48)         (48)                                   
      Hemorrhage                                       1 (2%)       1 (2%)                                                          
      Hypothalamus, Compression                        5 (10%)     14 (29%)     10 (21%)      7 (15%)                               
   Spinal Cord                                        (48)         (48)         (48)         (48)                                   
      Hemorrhage                                       1 (2%)                                                                       
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 RESPIRATORY SYSTEM                                                                                                                 
   Lung                                               (48)         (48)         (48)         (48)                                   
      Foreign Body                                                               1 (2%)       4 (8%)                                
      Hemorrhage                                                                              2 (4%)                                
      Inflammation, Chronic, Diffuse                                1 (2%)                                                          
      Inflammation, Chronic, Focal                     1 (2%)       3 (6%)       4 (8%)       8 (17%)                               
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    6                                                              
NTP Experiment-Test: 93005-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                          MALACHITE GREEN                                      Date: 06/18/03    
Route: DOSED FEED                                                                                                 Time: 14:23:36    
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   0 PPM        100 PPM      300 PPM      600 PPM                                   
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT                                                                                                           
      Alveolar Epithelium, Hyperplasia, Focal          1 (2%)       1 (2%)       2 (4%)                                             
      Alveolus, Infiltration Cellular, Histiocyte      1 (2%)       1 (2%)                                                          
   Nose                                               (48)         (48)         (48)         (48)                                   
      Foreign Body                                                               1 (2%)       2 (4%)                                
      Inflammation, Chronic                            1 (2%)                                                                       
      Inflammation, Suppurative                                                  1 (2%)       2 (4%)                                
      Nasolacrimal Duct, Inflammation                 19 (40%)     10 (21%)     11 (23%)     13 (27%)                               
      Olfactory Epithelium, Cytoplasmic Alteration     2 (4%)       3 (6%)       6 (13%)      1 (2%)                                
      Olfactory Epithelium, Respiratory Epithelium,                                                                                 
         Cytoplasmic Alteration                        1 (2%)                    2 (4%)                                             
      Respiratory Epithelium, Cytoplasmic                                                                                           
        Alteration                                                                            1 (2%)                                
   Trachea                                            (48)         (48)         (48)         (48)                                   
      Inflammation                                                               3 (6%)       1 (2%)                                
      Epithelium, Hyperplasia                                                    1 (2%)       2 (4%)                                
____________________________________________________________________________________________________________________________________
 SPECIAL SENSES SYSTEM                                                                                                              
   Eye                                                (47)         (48)         (48)         (48)                                   
      Cataract                                         7 (15%)      2 (4%)                    7 (15%)                               
      Hemorrhage                                                                 1 (2%)                                             
      Phthisis Bulbi                                                             2 (4%)                                             
      Bilateral, Cataract                              1 (2%)       1 (2%)       2 (4%)       2 (4%)                                
      Bilateral, Retina, Degeneration                 13 (28%)     14 (29%)     20 (42%)     18 (38%)                               
      Cornea, Inflammation                                                                    1 (2%)                                
      Retina, Autolysis                                1 (2%)       4 (8%)                    2 (4%)                                
      Retina, Degeneration                             8 (17%)      8 (17%)      9 (19%)      9 (19%)                               
      Sclera, Metaplasia, Osseous                      1 (2%)                                                                       
   Harderian Gland                                    (47)         (48)         (48)         (48)                                   
      Atrophy                                          1 (2%)                                                                       
      Infiltration Cellular, Lymphocyte               34 (72%)     37 (77%)     36 (75%)     32 (67%)                               
      Inflammation                                     1 (2%)                                                                       
      Pigmentation                                                                            1 (2%)                                
   Lacrimal Gland                                     (18)         (14)         (15)         (9)                                    
      Infiltration Cellular, Lymphocyte                2 (11%)      2 (14%)      2 (13%)      3 (33%)                               
      Metaplasia                                      18 (100%)    14 (100%)    15 (100%)     9 (100%)                              
   Zymbal's Gland                                     (47)         (48)         (48)         (46)                                   
      Hyperplasia                                      1 (2%)       1 (2%)                                                          
      Metaplasia, Squamous                                          1 (2%)                                                          
____________________________________________________________________________________________________________________________________
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    7                                                              
NTP Experiment-Test: 93005-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                          MALACHITE GREEN                                      Date: 06/18/03    
Route: DOSED FEED                                                                                                 Time: 14:23:36    
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   0 PPM        100 PPM      300 PPM      600 PPM                                   
____________________________________________________________________________________________________________________________________
 URINARY SYSTEM                                                                                                                     
   Kidney                                             (48)         (48)         (48)         (48)                                   
      Hydronephrosis                                                             1 (2%)                                             
      Mineralization                                  33 (69%)     31 (65%)     30 (63%)     30 (63%)                               
      Nephropathy                                     39 (81%)     38 (79%)     41 (85%)     40 (83%)                               
      Pelvis, Inflammation                                          1 (2%)                                                          
      Pelvis, Transitional Epithelium, Hyperplasia                  1 (2%)                                                          
      Renal Tubule, Necrosis                                                                  1 (2%)                                
   Urinary Bladder                                    (47)         (48)         (47)         (47)                                   
      Infiltration Cellular, Lymphocyte                1 (2%)                    1 (2%)       1 (2%)                                
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    8                                                              
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