https://ntp.niehs.nih.gov/go/3944

TDMS Study 93029-04 Pathology Tables

NTP Experiment-Test: 93029-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        LEUKOMALACHITE GREEN                                   Date: 06/19/03
Route: DOSED FEED                                                                                                 Time: 07:04:42
       Facility:  National Center for Toxicological Research
       Chemical CAS #:  129-73-7
       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: 93029-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                        LEUKOMALACHITE GREEN                                   Date: 06/19/03    
Route: DOSED FEED                                                                                                 Time: 07:04:42    
____________________________________________________________________________________________________________________________________
         C57BL/6N XC3H/HEN MTN-NCTR FEMALE         0 PPM        91 PPM       204 PPM      408 PPM                                   
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DISPOSITION SUMMARY                                                                                                                 
  Animals Initially In Study                          48           48           48           48                                     
  Early Deaths                                                                                                                      
    Natural Death                                      7            2            2            5                                     
    Moribund                                           4            5            7            4                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                37           41           39           39                                     
  Animals Examined Microscopically                    47           48           47           47                                     
____________________________________________________________________________________________________________________________________
 ALIMENTARY SYSTEM                                                                                                                  
   Gallbladder                                        (44)         (47)         (44)         (46)                                   
      Infiltration Cellular, Lymphocytic                            1 (2%)                                                          
      Inflammation, Acute                                                                     1 (2%)                                
      Polyarteritis                                    1 (2%)                                                                       
      Mucosa, Hyperplasia, Focal                                                              2 (4%)                                
   Intestine Large                                    (46)         (48)         (47)         (46)                                   
      Cecum, Polyarteritis                                                       1 (2%)                                             
      Colon, Angiectasis                                                         1 (2%)                                             
      Colon, Proliferation Connective Tissue                                                  1 (2%)                                
      Rectum, Inflammation, Chronic                    1 (2%)       1 (2%)                                                          
      Rectum, Polyarteritis                                                      1 (2%)                                             
   Intestine Small                                    (44)         (47)         (47)         (46)                                   
      Ileum, Hyperplasia, Lymphoid                     1 (2%)       1 (2%)       3 (6%)       1 (2%)                                
      Jejunum, Hyperplasia, Lymphoid                                             2 (4%)       1 (2%)                                
   Liver                                              (47)         (48)         (47)         (47)                                   
      Basophilic Focus                                 1 (2%)       2 (4%)                    2 (4%)                                
      Basophilic Focus, Two                                                                   1 (2%)                                
      Clear Cell Focus                                              1 (2%)       1 (2%)                                             
      Eosinophilic Focus, Single                                                 1 (2%)       1 (2%)                                
      Hematopoietic Cell Proliferation                 2 (4%)       2 (4%)       3 (6%)       3 (6%)                                
      Infarct                                                                    1 (2%)                                             
      Infiltration Cellular, Lymphocytic               8 (17%)      2 (4%)       2 (4%)       8 (17%)                               
      Inflammation, Chronic Active, Focal             15 (32%)     13 (27%)     16 (34%)     11 (23%)                               
      Leukocytosis                                                                            1 (2%)                                
      Mineralization, Focal                            1 (2%)                                                                       
      Necrosis                                         1 (2%)                                                                       
      Tension Lipidosis                               10 (21%)     12 (25%)      9 (19%)      9 (19%)                               
      Vacuolization Cytoplasmic                        2 (4%)       1 (2%)                                                          
      Bile Duct, Cyst                                  3 (6%)       1 (2%)       1 (2%)       1 (2%)                                
      Oval Cell, Hyperplasia                           1 (2%)                                                                       
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    2                                                              
NTP Experiment-Test: 93029-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                        LEUKOMALACHITE GREEN                                   Date: 06/19/03    
Route: DOSED FEED                                                                                                 Time: 07:04:42    
____________________________________________________________________________________________________________________________________
         C57BL/6N XC3H/HEN MTN-NCTR FEMALE         0 PPM        91 PPM       204 PPM      408 PPM                                   
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT                                                                                                            
      Serosa, Fibrosis                                                                        1 (2%)                                
   Mesentery                                          (1)          (2)          (1)          (3)                                    
      Fat, Necrosis, Focal                             1 (100%)     2 (100%)     1 (100%)     3 (100%)                              
   Pancreas                                           (45)         (48)         (47)         (45)                                   
      Cyst                                                          2 (4%)                                                          
      Cytoplasmic Alteration                           1 (2%)       1 (2%)       1 (2%)       2 (4%)                                
      Infiltration Cellular, Lymphocytic               7 (16%)      9 (19%)      4 (9%)       6 (13%)                               
      Polyarteritis                                                              1 (2%)                                             
      Acinus, Atrophy                                  1 (2%)       2 (4%)       1 (2%)       2 (4%)                                
   Salivary Glands                                    (47)         (48)         (47)         (47)                                   
      Acinus, Parotid Gland, Atrophy                   1 (2%)       3 (6%)                    1 (2%)                                
      Acinus, Parotid Gland, Necrosis, Focal                                     3 (6%)       2 (4%)                                
      Acinus, Submandibular Gland, Atrophy             1 (2%)       1 (2%)                    1 (2%)                                
      Parotid Gland, Infiltration Cellular,                                                                                         
        Lymphocytic                                    9 (19%)      9 (19%)      8 (17%)     11 (23%)                               
      Parotid Gland, Vacuolization Cytoplasmic         2 (4%)                    1 (2%)                                             
      Sublingual Gland, Infiltration Cellular,                                                                                      
         Lymphocytic                                                             2 (4%)       1 (2%)                                
      Submandibular Gland, Infiltration Cellular,                                                                                   
         Lymphocytic                                  33 (70%)     30 (63%)     35 (74%)     31 (66%)                               
   Stomach                                            (46)         (48)         (47)         (46)                                   
      Forestomach, Foreign Body                                                  1 (2%)                                             
      Forestomach, Hyperkeratosis, Focal               1 (2%)                                                                       
      Forestomach, Infiltration Cellular,                                                                                           
        Lymphocytic                                    1 (2%)                                                                       
      Forestomach, Inflammation, Chronic Active                                  2 (4%)                                             
      Forestomach, Epithelium, Hyperplasia, Diffuse    1 (2%)                                                                       
      Forestomach, Epithelium, Hyperplasia, Focal      3 (7%)       4 (8%)       8 (17%)      6 (13%)                               
      Glandular, Infiltration Cellular, Lymphocytic    1 (2%)       2 (4%)       1 (2%)                                             
      Glandular, Polyarteritis                                                   1 (2%)                                             
      Glandular, Ulcer                                 1 (2%)                                                                       
   Tongue                                             (47)         (48)         (47)         (47)                                   
      Foreign Body                                                  3 (6%)       1 (2%)       3 (6%)                                
      Artery, Inflammation, Chronic                    1 (2%)       2 (4%)       2 (4%)                                             
____________________________________________________________________________________________________________________________________
 CARDIOVASCULAR SYSTEM                                                                                                              
   Blood Vessel                                       (47)         (48)         (46)         (46)                                   
      Aorta, Embolus Bacterial                                      1 (2%)                                                          
   Heart                                              (47)         (48)         (47)         (47)                                   
      Cardiomyopathy                                                1 (2%)                                                          
      Inflammation, Acute, Focal                                    1 (2%)                    1 (2%)                                
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    3                                                              
NTP Experiment-Test: 93029-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                        LEUKOMALACHITE GREEN                                   Date: 06/19/03    
Route: DOSED FEED                                                                                                 Time: 07:04:42    
____________________________________________________________________________________________________________________________________
         C57BL/6N XC3H/HEN MTN-NCTR FEMALE         0 PPM        91 PPM       204 PPM      408 PPM                                   
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM - CONT                                                                                                        
      Mineralization                                                                          1 (2%)                                
      Polyarteritis                                    1 (2%)                                                                       
      Atrium Left, Thrombosis                          1 (2%)                                                                       
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 ENDOCRINE SYSTEM                                                                                                                   
   Adrenal Gland                                      (46)         (48)         (47)         (47)                                   
      Bilateral, Cortex, Hypertrophy, Focal                                      1 (2%)                                             
      Cortex, Accessory Adrenal Cortical Nodule        3 (7%)       1 (2%)       1 (2%)       1 (2%)                                
      Cortex, Cyst                                     1 (2%)                                                                       
      Cortex, Hematopoietic Cell Proliferation                                   1 (2%)       1 (2%)                                
      Cortex, Hyperplasia, Focal                       2 (4%)                    2 (4%)                                             
      Cortex, Hypertrophy, Focal                       2 (4%)       2 (4%)       1 (2%)                                             
      Cortex, Polyarteritis                                                      1 (2%)                                             
      Cortex, Subcapsular, Hyperplasia                42 (91%)     47 (98%)     46 (98%)     47 (100%)                              
      Medulla, Hyperplasia, Focal                                   1 (2%)                                                          
   Parathyroid Gland                                  (42)         (42)         (41)         (44)                                   
      Infiltration Cellular, Lymphocytic                            1 (2%)                                                          
   Pituitary Gland                                    (41)         (45)         (44)         (46)                                   
      Pars Distalis, Hyperplasia, Focal                3 (7%)       1 (2%)       3 (7%)       2 (4%)                                
   Thyroid Gland                                      (46)         (48)         (47)         (47)                                   
      Ectopic Thymus                                                                          1 (2%)                                
      Polyarteritis                                                              1 (2%)                                             
      Ultimobranchial Cyst                                          2 (4%)       2 (4%)                                             
      Follicular Cell, Cyst                            7 (15%)     10 (21%)      6 (13%)      9 (19%)                               
____________________________________________________________________________________________________________________________________
 GENERAL BODY SYSTEM                                                                                                                
   None                                                                                                                             
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 GENITAL SYSTEM                                                                                                                     
   Clitoral Gland                                     (45)         (46)         (44)         (45)                                   
      Inflammation, Chronic                                         1 (2%)                                                          
      Inflammation, Subacute                                                     1 (2%)                                             
      Duct, Cyst                                      44 (98%)     46 (100%)    41 (93%)     45 (100%)                              
   Ovary                                              (46)         (48)         (47)         (44)                                   
      Abscess                                                       1 (2%)                                                          
      Angiectasis                                      1 (2%)       1 (2%)       2 (4%)                                             
      Atrophy                                         42 (91%)     45 (94%)     44 (94%)     41 (93%)                               
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    4                                                              
NTP Experiment-Test: 93029-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                        LEUKOMALACHITE GREEN                                   Date: 06/19/03    
Route: DOSED FEED                                                                                                 Time: 07:04:42    
____________________________________________________________________________________________________________________________________
         C57BL/6N XC3H/HEN MTN-NCTR FEMALE         0 PPM        91 PPM       204 PPM      408 PPM                                   
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT                                                                                                               
      Cyst                                            14 (30%)     16 (33%)     17 (36%)     10 (23%)                               
      Hemorrhage                                       4 (9%)       2 (4%)       2 (4%)       2 (5%)                                
      Mineralization                                                             1 (2%)                                             
      Thrombosis                                       3 (7%)                                                                       
      Bilateral, Cyst                                  7 (15%)      3 (6%)       2 (4%)       3 (7%)                                
   Uterus                                             (46)         (48)         (47)         (46)                                   
      Adenomyosis, Focal                               1 (2%)                                                                       
      Angiectasis                                                   4 (8%)       3 (6%)       1 (2%)                                
      Hyperplasia, Cystic                             42 (91%)     46 (96%)     47 (100%)    43 (93%)                               
      Inflammation, Acute                                                                     1 (2%)                                
      Polyarteritis                                                              1 (2%)                                             
      Thrombosis                                                    1 (2%)       3 (6%)                                             
      Endometrium, Metaplasia                                       1 (2%)                                                          
      Stroma, Fibrosis                                                           1 (2%)                                             
      Stroma, Hyperplasia                                                        1 (2%)                                             
   Vagina                                             (45)         (47)         (47)         (46)                                   
      Epithelium, Hyperplasia                          1 (2%)                                 3 (7%)                                
____________________________________________________________________________________________________________________________________
 HEMATOPOIETIC SYSTEM                                                                                                               
   Bone Marrow                                        (46)         (48)         (47)         (46)                                   
      Angiectasis, Focal                               1 (2%)                                                                       
      Fibrosis                                                      1 (2%)       1 (2%)                                             
      Femoral, Infarct                                 1 (2%)                                                                       
      Myeloid Cell, Hyperplasia                        4 (9%)       1 (2%)       4 (9%)       6 (13%)                               
   Lymph Node                                         (47)         (48)         (47)         (47)                                   
      Inguinal, Hyperplasia, Lymphoid                               1 (2%)                                                          
      Lumbar, Cyst                                     1 (2%)                                                                       
      Lumbar, Hematopoietic Cell Proliferation         1 (2%)                                                                       
      Lumbar, Hyperplasia, Lymphoid                    1 (2%)                                                                       
      Lumbar, Hyperplasia, Plasma Cell                                                        1 (2%)                                
      Mandibular, Hyperplasia, Lymphoid                1 (2%)       3 (6%)       8 (17%)      2 (4%)                                
      Mediastinal, Hyperplasia, Lymphoid               1 (2%)                                                                       
      Mesenteric, Hematopoietic Cell Proliferation     1 (2%)                    1 (2%)                                             
      Mesenteric, Hemorrhage                           1 (2%)       1 (2%)       1 (2%)       1 (2%)                                
      Mesenteric, Hyperplasia, Lymphoid                5 (11%)      2 (4%)       3 (6%)       6 (13%)                               
      Mesenteric, Infiltration Cellular, Plasma                                                                                     
        Cell                                                                     2 (4%)       1 (2%)                                
      Renal, Hyperplasia, Lymphoid                     2 (4%)                                                                       
      Thoracic, Hyperplasia, Plasma Cell                                                      1 (2%)                                
   Spleen                                             (45)         (48)         (47)         (45)                                   
      Angiectasis                                                   1 (2%)                                                          
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    5                                                              
NTP Experiment-Test: 93029-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                        LEUKOMALACHITE GREEN                                   Date: 06/19/03    
Route: DOSED FEED                                                                                                 Time: 07:04:42    
____________________________________________________________________________________________________________________________________
         C57BL/6N XC3H/HEN MTN-NCTR FEMALE         0 PPM        91 PPM       204 PPM      408 PPM                                   
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Hematopoietic Cell Proliferation                11 (24%)      9 (19%)     17 (36%)     17 (38%)                               
      Hyperplasia, Lymphoid                           14 (31%)      4 (8%)       8 (17%)      9 (20%)                               
      Infiltration Cellular, Plasma Cell                            1 (2%)                    1 (2%)                                
      Proliferation Connective Tissue, Focal           1 (2%)                                                                       
   Thymus                                             (43)         (45)         (45)         (43)                                   
      Atrophy                                          2 (5%)       2 (4%)       1 (2%)                                             
      Cyst                                             2 (5%)       1 (2%)       2 (4%)       2 (5%)                                
      Ectopic Parathyroid Gland                        4 (9%)       7 (16%)      4 (9%)       7 (16%)                               
      Hyperplasia, Lymphoid                            2 (5%)       3 (7%)       5 (11%)      6 (14%)                               
____________________________________________________________________________________________________________________________________
 INTEGUMENTARY SYSTEM                                                                                                               
   Mammary Gland                                      (46)         (48)         (47)         (45)                                   
      Infiltration Cellular, Lymphocytic                                                      1 (2%)                                
   Skin                                               (46)         (48)         (45)         (45)                                   
      Face, Ulcer                                      1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
 MUSCULOSKELETAL SYSTEM                                                                                                             
   Bone                                               (47)         (48)         (47)         (47)                                   
      Femur, Fibrous Osteodystrophy                    8 (17%)      2 (4%)       5 (11%)      3 (6%)                                
      Sternum, Degeneration, Cystic                    1 (2%)       3 (6%)       1 (2%)       5 (11%)                               
      Sternum, Fibrous Osteodystrophy                 26 (55%)     21 (44%)     19 (40%)     21 (45%)                               
   Skeletal Muscle                                    (47)         (48)         (47)         (46)                                   
      Mineralization                                                                          2 (4%)                                
____________________________________________________________________________________________________________________________________
 NERVOUS SYSTEM                                                                                                                     
   Brain                                              (47)         (48)         (47)         (47)                                   
      Cerebellum, Infiltration Cellular,                                                                                            
        Lymphocytic                                                                           1 (2%)                                
      Cerebrum, Mineralization                        15 (32%)     18 (38%)     21 (45%)     21 (45%)                               
      Cerebrum, Polyarteritis                                                    1 (2%)                                             
   Spinal Cord                                        (47)         (48)         (47)         (47)                                   
      Thoracic, Infiltration Cellular, Lymphocytic                                            1 (2%)                                
      Thoracic, Axon, Degeneration                    12 (26%)     11 (23%)      9 (19%)     14 (30%)                               
____________________________________________________________________________________________________________________________________
 RESPIRATORY SYSTEM                                                                                                                 
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    6                                                              
NTP Experiment-Test: 93029-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                        LEUKOMALACHITE GREEN                                   Date: 06/19/03    
Route: DOSED FEED                                                                                                 Time: 07:04:42    
____________________________________________________________________________________________________________________________________
         C57BL/6N XC3H/HEN MTN-NCTR FEMALE         0 PPM        91 PPM       204 PPM      408 PPM                                   
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT                                                                                                           
   Lung                                               (47)         (48)         (47)         (47)                                   
      Crystals                                                      1 (2%)                    1 (2%)                                
      Hemorrhage, Focal                                1 (2%)                                                                       
      Infarct                                                                                 1 (2%)                                
      Infiltration Cellular, Histiocytic               1 (2%)       2 (4%)                    2 (4%)                                
      Infiltration Cellular, Lymphocytic              13 (28%)      7 (15%)      9 (19%)     12 (26%)                               
      Inflammation, Chronic, Focal                     1 (2%)       1 (2%)                    1 (2%)                                
      Inflammation, Granulomatous                                                             1 (2%)                                
      Leukocytosis                                                  2 (4%)                    1 (2%)                                
      Alveolar Epithelium, Hyperplasia                 1 (2%)       1 (2%)       1 (2%)       1 (2%)                                
      Artery, Mineralization                                                                  1 (2%)                                
      Vein, Thrombosis                                 1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
 SPECIAL SENSES SYSTEM                                                                                                              
   Eye                                                (47)         (48)         (47)         (47)                                   
      Phthisis Bulbi                                                                          1 (2%)                                
      Bilateral, Lens, Cataract                        4 (9%)       5 (10%)      3 (6%)       7 (15%)                               
      Conjunctiva, Polyarteritis                                                              1 (2%)                                
      Cornea, Inflammation, Chronic                    1 (2%)                                                                       
      Lens, Cataract                                   5 (11%)      4 (8%)       4 (9%)       4 (9%)                                
   Harderian Gland                                    (47)         (48)         (47)         (47)                                   
      Atrophy                                                       1 (2%)                                                          
      Hyperplasia                                                   1 (2%)       1 (2%)       3 (6%)                                
      Infiltration Cellular, Lymphocytic               4 (9%)       9 (19%)      8 (17%)      5 (11%)                               
      Acinus, Dilatation                                            1 (2%)                                                          
   Zymbal's Gland                                     (47)         (47)         (46)         (47)                                   
      Atrophy                                                       1 (2%)                    1 (2%)                                
____________________________________________________________________________________________________________________________________
 URINARY SYSTEM                                                                                                                     
   Kidney                                             (47)         (48)         (47)         (47)                                   
      Glomerulosclerosis                               1 (2%)                                 1 (2%)                                
      Hematopoietic Cell Proliferation                              1 (2%)                                                          
      Infarct                                          2 (4%)                    1 (2%)       1 (2%)                                
      Infiltration Cellular, Lymphocytic               9 (19%)      5 (10%)     15 (32%)     11 (23%)                               
      Nephropathy                                      1 (2%)       2 (4%)       3 (6%)       1 (2%)                                
      Polyarteritis                                                              1 (2%)                                             
      Glomerulus, Casts Protein                                     1 (2%)                    1 (2%)                                
      Papilla, Casts Protein                           1 (2%)                                                                       
      Pelvis, Dilatation                               2 (4%)       1 (2%)                                                          
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    7                                                              
NTP Experiment-Test: 93029-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                        LEUKOMALACHITE GREEN                                   Date: 06/19/03    
Route: DOSED FEED                                                                                                 Time: 07:04:42    
____________________________________________________________________________________________________________________________________
         C57BL/6N XC3H/HEN MTN-NCTR FEMALE         0 PPM        91 PPM       204 PPM      408 PPM                                   
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT                                                                                                               
      Renal Tubule, Accumulation, Hyaline Droplet      1 (2%)       2 (4%)       1 (2%)       3 (6%)                                
      Renal Tubule, Hyperplasia                                     1 (2%)                                                          
      Renal Tubule, Hypertrophy                                     1 (2%)                                                          
      Renal Tubule, Necrosis                                                     1 (2%)                                             
      Renal Tubule, Pigmentation                                                 1 (2%)                                             
   Urinary Bladder                                    (46)         (48)         (47)         (44)                                   
      Inclusion Body Intracytoplasmic                 14 (30%)     33 (69%)     44 (94%)     44 (100%)                              
      Infiltration Cellular, Lymphocytic              29 (63%)     22 (46%)     24 (51%)     26 (59%)                               
      Polyarteritis                                                              1 (2%)                                             
      Submucosa, Edema                                                           1 (2%)                                             
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    8                                                              
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