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TDMS Study 93029-03 Pathology Tables

NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        LEUKOMALACHITE GREEN                                   Date: 06/18/03
Route: DOSED FEED                                                                                                 Time: 14:39:48




       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: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                        LEUKOMALACHITE GREEN                                   Date: 06/18/03    
Route: DOSED FEED                                                                                                 Time: 14:39:48    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS-NCTR FEMALE              0 PPM        91 PPM       272 PPM      543 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially In Study                          48           48           48           48                                     
  Early Deaths                                                                                                                      
    Moribund                                          12           11           12           10                                     
    Natural Death                                      3            1            1            4                                     
  Survivors                                                                                                                         
    Moribund                                                                                  1                                     
    Terminal Sacrifice                                33           36           35           33                                     
                                                                                                                                    
  Animals Examined Microscopically                    48           48           48           48                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large                                    (48)         (48)         (48)         (48)                                   
      Cecum, Inflammation                                                        1 (2%)                                             
      Cecum, Lymphoid Tissue, Hyperplasia                           1 (2%)                                                          
      Colon, Lymphoid Tissue, Hyperplasia                           1 (2%)       1 (2%)       1 (2%)                                
      Rectum, Inflammation                             1 (2%)                                                                       
   Intestine Small                                    (48)         (48)         (48)         (48)                                   
      Ileum, Dilatation                                                          1 (2%)                                             
      Ileum, Inflammation                                                        1 (2%)                                             
      Ileum, Lymphoid Tissue, Hyperplasia              1 (2%)       2 (4%)       1 (2%)                                             
   Liver                                              (48)         (48)         (48)         (48)                                   
      Angiectasis                                                                             1 (2%)                                
      Basophilic Focus                                 3 (6%)       4 (8%)       2 (4%)       1 (2%)                                
      Basophilic Focus, Multiple                      20 (42%)     26 (54%)      2 (4%)                                             
      Degeneration, Cystic                             3 (6%)       2 (4%)       5 (10%)      3 (6%)                                
      Developmental Malformation                       7 (15%)      5 (10%)      3 (6%)       5 (10%)                               
      Eosinophilic Focus                               3 (6%)       4 (8%)      13 (27%)      5 (10%)                               
      Eosinophilic Focus, Multiple                                  8 (17%)      7 (15%)     11 (23%)                               
      Hematopoietic Cell Proliferation                 1 (2%)       1 (2%)       3 (6%)       1 (2%)                                
      Hepatodiaphragmatic Nodule                       4 (8%)       1 (2%)       5 (10%)      1 (2%)                                
      Infiltration Cellular, Lymphocyte                2 (4%)       3 (6%)       7 (15%)      4 (8%)                                
      Inflammation, Focal, Granulomatous              10 (21%)     19 (40%)     20 (42%)     13 (27%)                               
      Mixed Cell Focus                                 1 (2%)                                                                       
      Necrosis                                         4 (8%)       2 (4%)       1 (2%)       3 (6%)                                
      Tension Lipidosis                                1 (2%)       2 (4%)                                                          
      Tension Lipidosis, Multiple                                                             1 (2%)                                
      Vacuolization Cytoplasmic                        5 (10%)      5 (10%)     17 (35%)     22 (46%)                               
      Bile Duct, Cyst                                                            2 (4%)                                             
      Bile Duct, Hyperplasia                          16 (33%)     18 (38%)     19 (40%)     18 (38%)                               
      Centrilobular, Necrosis                                                    1 (2%)       2 (4%)                                
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    2                                                              
                                                                                                                                   
NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                        LEUKOMALACHITE GREEN                                   Date: 06/18/03    
Route: DOSED FEED                                                                                                 Time: 14:39:48    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS-NCTR FEMALE              0 PPM        91 PPM       272 PPM      543 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
   Mesentery                                          (8)          (7)          (1)          (4)                                    
      Accessory Spleen                                              2 (29%)                   1 (25%)                               
      Fat, Necrosis                                    6 (75%)      5 (71%)      1 (100%)     3 (75%)                               
   Pancreas                                           (48)         (48)         (47)         (48)                                   
      Infiltration Cellular, Lymphocyte                             2 (4%)       3 (6%)       1 (2%)                                
      Inflammation                                     1 (2%)                    1 (2%)                                             
      Acinus, Atrophy                                 20 (42%)     16 (33%)     17 (36%)     18 (38%)                               
   Salivary Glands                                    (48)         (48)         (48)         (48)                                   
      Atrophy                                          2 (4%)                                 1 (2%)                                
      Infiltration Cellular, Lymphocyte                                          1 (2%)                                             
      Parotid Gland, Hypertrophy, Focal                             1 (2%)                                                          
   Stomach                                            (48)         (48)         (48)         (48)                                   
      Forestomach, Edema                               1 (2%)                                                                       
      Forestomach, Inflammation                        2 (4%)                    1 (2%)       1 (2%)                                
      Forestomach, Epithelium, Hyperplasia             2 (4%)                    1 (2%)                                             
      Glandular, Edema                                 1 (2%)                                                                       
   Tongue                                             (48)         (48)         (48)         (48)                                   
      Epithelium, Hyperplasia, Focal                                             1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (48)         (48)         (48)         (48)                                   
      Cardiomyopathy                                  35 (73%)     35 (73%)     33 (69%)     30 (63%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Gland                                      (47)         (48)         (47)         (48)                                   
      Cortex, Accessory Adrenal Cortical Nodule                                  3 (6%)                                             
      Cortex, Angiectasis                              8 (17%)     10 (21%)      2 (4%)       3 (6%)                                
      Cortex, Atrophy                                               1 (2%)                                                          
      Cortex, Degeneration                             1 (2%)                                                                       
      Cortex, Hyperplasia, Focal                       4 (9%)       2 (4%)       4 (9%)       5 (10%)                               
      Cortex, Hypertrophy, Focal                       2 (4%)                    2 (4%)                                             
      Cortex, Thrombosis                                                                      1 (2%)                                
      Cortex, Vacuolization Cytoplasmic                2 (4%)                                 1 (2%)                                
      Medulla, Hyperplasia                             1 (2%)                                                                       
   Pituitary Gland                                    (47)         (47)         (45)         (46)                                   
      Angiectasis                                      3 (6%)       1 (2%)       1 (2%)       2 (4%)                                
      Pars Distalis, Cyst                              8 (17%)      4 (9%)       6 (13%)      1 (2%)                                
      Pars Distalis, Hyperplasia                       2 (4%)       4 (9%)       4 (9%)       5 (11%)                               
   Thyroid Gland                                      (46)         (46)         (47)         (48)                                   
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    3                                                              
                                                                                                                                   
NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                        LEUKOMALACHITE GREEN                                   Date: 06/18/03    
Route: DOSED FEED                                                                                                 Time: 14:39:48    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS-NCTR FEMALE              0 PPM        91 PPM       272 PPM      543 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
      C-Cell, Hyperplasia                             13 (28%)      5 (11%)      6 (13%)      1 (2%)                                
      Follicle, Cyst                                                1 (2%)                    2 (4%)                                
      Follicular Cell, Hyperplasia                     1 (2%)                                 3 (6%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (47)         (47)         (46)         (47)                                   
      Hyperplasia                                      4 (9%)       4 (9%)       5 (11%)      3 (6%)                                
      Inflammation                                    23 (49%)     31 (66%)     22 (48%)     28 (60%)                               
      Duct, Dilatation                                25 (53%)     24 (51%)     18 (39%)     15 (32%)                               
      Duct, Hyperplasia                                                                       1 (2%)                                
   Ovary                                              (48)         (48)         (48)         (48)                                   
      Atrophy                                          6 (13%)      5 (10%)     10 (21%)      7 (15%)                               
      Cyst                                             8 (17%)      5 (10%)     10 (21%)      4 (8%)                                
      Infiltration Cellular, Lymphocyte                3 (6%)       3 (6%)       3 (6%)                                             
      Periovarian Tissue, Hemorrhage                                1 (2%)                                                          
   Uterus                                             (48)         (48)         (48)         (48)                                   
      Decidual Reaction                                             1 (2%)                    1 (2%)                                
      Hemorrhage                                                    1 (2%)                    1 (2%)                                
      Inflammation                                     1 (2%)                                                                       
      Thrombosis                                                                              1 (2%)                                
      Bilateral, Horn, Dilatation                                                             1 (2%)                                
      Cervix, Hypertrophy                              5 (10%)      5 (10%)      2 (4%)       5 (10%)                               
      Endometrium, Hyperplasia                                                                1 (2%)                                
      Endometrium, Hyperplasia, Cystic                 3 (6%)       3 (6%)       4 (8%)       7 (15%)                               
   Vagina                                             (48)         (48)         (48)         (48)                                   
      Cyst                                             1 (2%)                                                                       
      Exudate, Mucous                                  1 (2%)       1 (2%)                                                          
      Hemorrhage                                                                              1 (2%)                                
      Inflammation, Suppurative                        3 (6%)       2 (4%)       1 (2%)       2 (4%)                                
      Metaplasia, Squamous                                                       1 (2%)                                             
      Prolapse                                                                                1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 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: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                        LEUKOMALACHITE GREEN                                   Date: 06/18/03    
Route: DOSED FEED                                                                                                 Time: 14:39:48    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS-NCTR FEMALE              0 PPM        91 PPM       272 PPM      543 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Atrophy                                          4 (8%)       2 (4%)       4 (8%)       3 (6%)                                
      Myelostromal Proliferation                                                              1 (2%)                                
      Myeloid Cell, Hyperplasia                                     1 (2%)                                                          
   Lymph Node                                         (48)         (48)         (48)         (48)                                   
      Hyperplasia, Lymphoid                                                      1 (2%)                                             
      Bronchial, Hyperplasia, Lymphoid                              1 (2%)                                                          
      Lumbar, Ectasia                                  1 (2%)                                                                       
      Lumbar, Hyperplasia, Lymphoid                    1 (2%)                                                                       
      Mandibular, Ectasia                                                        2 (4%)       2 (4%)                                
      Mandibular, Hyperplasia, Lymphoid                1 (2%)       1 (2%)       4 (8%)       1 (2%)                                
      Mandibular, Infiltration Cellular, Plasma                                                                                     
        Cell                                           4 (8%)       8 (17%)      4 (8%)                                             
      Mediastinal, Ectasia                                          1 (2%)                    1 (2%)                                
      Mediastinal, Hemorrhage                          1 (2%)       3 (6%)                    1 (2%)                                
      Mediastinal, Hyperplasia, Lymphoid               1 (2%)       1 (2%)       1 (2%)                                             
      Mediastinal, Infiltration Cellular, Plasma                                                                                    
        Cell                                           1 (2%)                                                                       
      Mesenteric, Angiectasis                                                    1 (2%)                                             
      Mesenteric, Ectasia                              2 (4%)       1 (2%)       4 (8%)       2 (4%)                                
      Mesenteric, Hemorrhage                                        1 (2%)                    2 (4%)                                
      Mesenteric, Hyperplasia, Lymphoid                1 (2%)                    2 (4%)       2 (4%)                                
      Pancreatic, Ectasia                                                                     1 (2%)                                
      Pancreatic, Hemorrhage                                        1 (2%)                    1 (2%)                                
      Pancreatic, Hyperplasia, Lymphoid                             1 (2%)       2 (4%)       1 (2%)                                
      Renal, Ectasia                                   1 (2%)                                                                       
      Renal, Hemorrhage                                1 (2%)                                                                       
      Renal, Hyperplasia, Lymphoid                     2 (4%)                    1 (2%)                                             
   Spleen                                             (48)         (48)         (48)         (48)                                   
      Angiectasis                                                                             1 (2%)                                
      Fibrosis                                                                                1 (2%)                                
      Hematopoietic Cell Proliferation                 3 (6%)       4 (8%)       6 (13%)      5 (10%)                               
      Hyperplasia, Focal                                            1 (2%)                                                          
      Pigmentation                                     1 (2%)       2 (4%)       3 (6%)       1 (2%)                                
      Stromal Hyperplasia                                                        1 (2%)                                             
   Thymus                                             (41)         (47)         (44)         (42)                                   
      Cyst                                                          2 (4%)       1 (2%)       1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (48)         (46)         (48)         (48)                                   
      Galactocele                                      7 (15%)      2 (4%)                                                          
      Hyperplasia                                     25 (52%)     20 (43%)     19 (40%)     22 (46%)                               
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    5                                                              
                                                                                                                                   
NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                        LEUKOMALACHITE GREEN                                   Date: 06/18/03    
Route: DOSED FEED                                                                                                 Time: 14:39:48    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS-NCTR FEMALE              0 PPM        91 PPM       272 PPM      543 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
INTEGUMENTARY SYSTEM - CONT                                                                                                         
      Infiltration Cellular, Lymphocyte                             1 (2%)                                                          
      Duct, Dilatation                                10 (21%)     13 (28%)      7 (15%)      3 (6%)                                
   Skin                                               (48)         (48)         (48)         (48)                                   
      Abscess                                                       1 (2%)                                                          
      Hyperkeratosis, Multifocal                                                              1 (2%)                                
      Inflammation                                     2 (4%)                    1 (2%)       1 (2%)                                
      Epidermis, Hyperplasia                           3 (6%)       1 (2%)       3 (6%)       3 (6%)                                
      Epidermis, Necrosis                              1 (2%)       1 (2%)       2 (4%)       3 (6%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (48)         (48)         (48)         (48)                                   
      Cranium, Osteopetrosis                                                                  1 (2%)                                
      Femur, Fibrous Osteodystrophy                    2 (4%)                                                                       
      Femur, Fracture Healed                                                                  1 (2%)                                
      Femur, Osteopetrosis                             1 (2%)       4 (8%)       3 (6%)       1 (2%)                                
      Mandible, Osteopetrosis                                                                 1 (2%)                                
      Maxilla, Inflammation, Chronic                                1 (2%)                                                          
      Sternum, Fibrous Osteodystrophy                  1 (2%)       1 (2%)                                                          
      Sternum, Osteopetrosis                           1 (2%)       4 (8%)       4 (8%)       1 (2%)                                
      Turbinate, Osteopetrosis                         1 (2%)       3 (6%)       4 (8%)       1 (2%)                                
   Skeletal Muscle                                    (48)         (48)         (48)         (48)                                   
      Mineralization, Multifocal                       1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (48)         (48)         (48)         (48)                                   
      Brain Stem, Hemorrhage                           1 (2%)                                                                       
      Brain Stem, Hypothalamus, Compression           11 (23%)      6 (13%)      5 (10%)      5 (10%)                               
      Cerebrum, Hemorrhage                             1 (2%)                                 1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (48)         (48)         (48)         (48)                                   
      Infiltration Cellular, Lymphocyte                                          1 (2%)                                             
      Alveolar Epithelium, Hyperplasia                              3 (6%)       1 (2%)       2 (4%)                                
      Alveolar Epithelium, Metaplasia, Focal,                                                                                       
        Squamous                                                                              1 (2%)                                
      Alveolus, Infiltration Cellular, Multifocal                                             1 (2%)                                
      Alveolus, Infiltration Cellular, Histiocyte      4 (8%)       3 (6%)      10 (21%)      6 (13%)                               
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    6                                                              
                                                                                                                                   
NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                        LEUKOMALACHITE GREEN                                   Date: 06/18/03    
Route: DOSED FEED                                                                                                 Time: 14:39:48    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS-NCTR FEMALE              0 PPM        91 PPM       272 PPM      543 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
RESPIRATORY SYSTEM - CONT                                                                                                           
      Alveolus, Inflammation, Multifocal                            1 (2%)                    1 (2%)                                
   Nose                                               (48)         (48)         (48)         (48)                                   
      Inflammation, Suppurative                                     1 (2%)                                                          
      Nasolacrimal Duct, Cyst Epithelial Inclusion                  1 (2%)                                                          
      Nasolacrimal Duct, Inflammation                 21 (44%)     19 (40%)     18 (38%)     19 (40%)                               
      Respiratory Epithelium, Concretion                                                      1 (2%)                                
   Trachea                                            (48)         (48)         (48)         (48)                                   
      Inflammation, Chronic                                         1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (48)         (48)         (48)         (48)                                   
      Cataract                                         2 (4%)                                 5 (10%)                               
      Phthisis Bulbi                                                1 (2%)       1 (2%)       2 (4%)                                
      Bilateral, Cataract                              1 (2%)       1 (2%)                    2 (4%)                                
      Bilateral, Retina, Degeneration                  4 (8%)       4 (8%)       5 (10%)      7 (15%)                               
      Conjunctiva, Inflammation                        1 (2%)                                                                       
      Cornea, Neovascularization                                                              1 (2%)                                
      Retina, Autolysis                                5 (10%)      1 (2%)       1 (2%)       3 (6%)                                
      Retina, Degeneration                                          3 (6%)       6 (13%)      9 (19%)                               
      Sclera, Metaplasia, Osseous                      1 (2%)                                                                       
   Harderian Gland                                    (48)         (48)         (48)         (48)                                   
      Hyperplasia                                                                1 (2%)                                             
      Infiltration Cellular, Focal, Histiocyte                      1 (2%)                                                          
      Infiltration Cellular, Lymphocyte               19 (40%)     26 (54%)     22 (46%)     21 (44%)                               
      Inflammation                                                                            1 (2%)                                
   Lacrimal Gland                                     (10)         (6)          (8)          (4)                                    
      Infiltration Cellular, Lymphocyte                3 (30%)      1 (17%)                   2 (50%)                               
      Metaplasia                                      10 (100%)     6 (100%)     8 (100%)     4 (100%)                              
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (48)         (48)         (48)         (48)                                   
      Hydronephrosis                                                1 (2%)       1 (2%)                                             
      Infarct                                          1 (2%)                                                                       
      Infiltration Cellular, Lymphocyte                                          1 (2%)                                             
      Mineralization                                  47 (98%)     46 (96%)     47 (98%)     48 (100%)                              
      Necrosis, Focal                                  1 (2%)                                                                       
      Nephropathy                                     34 (71%)     31 (65%)     27 (56%)     29 (60%)                               
      Pigmentation                                     2 (4%)                                 2 (4%)                                
   Urinary Bladder                                    (47)         (47)         (48)         (48)                                   
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    7                                                              
                                                                                                                                   
NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                        LEUKOMALACHITE GREEN                                   Date: 06/18/03    
Route: DOSED FEED                                                                                                 Time: 14:39:48    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS-NCTR FEMALE              0 PPM        91 PPM       272 PPM      543 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
URINARY SYSTEM - CONT                                                                                                               
      Hemorrhage                                                    1 (2%)                                                          
      Infiltration Cellular, Lymphocyte                             1 (2%)       1 (2%)       2 (4%)                                
      Inflammation                                                  2 (4%)                                                          
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page    8                                                              
                                                                                                                                   
NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                        LEUKOMALACHITE GREEN                                   Date: 06/18/03    
Route: DOSED FEED                                                                                                 Time: 14:39:48    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS-NCTR MALE                0 PPM        91 PPM       272 PPM      543 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially In Study                          48           48           48           48                                     
  Early Deaths                                                                                                                      
    Moribund                                          20           12           11           10                                     
    Natural Death                                      4            5            3            7                                     
  Survivors                                                                                                                         
    Natural Death                                      1            1                                                               
    Terminal Sacrifice                                23           29           34           30                                     
  Wrong Sex                                                         1                         1                                     
                                                                                                                                    
  Animals Examined Microscopically                    48           47           48           47                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large                                    (48)         (47)         (48)         (47)                                   
      Artery, Colon, Serosa, Dilatation                                          1 (2%)                                             
      Cecum, Lymphoid Tissue, Hyperplasia              3 (6%)       1 (2%)                                                          
      Colon, Lymphoid Tissue, Hyperplasia                                        2 (4%)       1 (2%)                                
   Intestine Small                                    (47)         (47)         (48)         (47)                                   
      Duodenum, Autolysis                                           1 (2%)                                                          
      Ileum, Hyperplasia                                                         1 (2%)                                             
      Ileum, Inflammation                                                        1 (2%)                                             
      Ileum, Lymphoid Tissue, Hyperplasia              4 (9%)       1 (2%)       1 (2%)       3 (6%)                                
      Jejunum, Autolysis                                            1 (2%)                                                          
      Jejunum, Diverticulum                                                                   1 (2%)                                
      Jejunum, Lymphoid Tissue, Hyperplasia            1 (2%)                                 2 (4%)                                
   Liver                                              (48)         (47)         (48)         (47)                                   
      Basophilic Focus                                              2 (4%)                    2 (4%)                                
      Degeneration, Cystic                             4 (8%)      18 (38%)     13 (27%)     19 (40%)                               
      Developmental Malformation                       1 (2%)       1 (2%)                    1 (2%)                                
      Eosinophilic Focus                               2 (4%)       8 (17%)      9 (19%)      8 (17%)                               
      Eosinophilic Focus, Multiple                     1 (2%)       6 (13%)     10 (21%)     25 (53%)                               
      Hematopoietic Cell Proliferation                 1 (2%)                                                                       
      Hepatodiaphragmatic Nodule                       2 (4%)       2 (4%)       3 (6%)                                             
      Infiltration Cellular, Lymphocyte                                                       1 (2%)                                
      Inflammation, Focal, Granulomatous               3 (6%)       1 (2%)       1 (2%)       1 (2%)                                
      Mixed Cell Focus                                 1 (2%)                                 2 (4%)                                
      Necrosis                                         1 (2%)                    1 (2%)                                             
      Pigmentation                                                               1 (2%)                                             
      Vacuolization Cytoplasmic                        9 (19%)     21 (45%)     10 (21%)     13 (28%)                               
      Bile Duct, Cyst                                  1 (2%)                    1 (2%)                                             
      Bile Duct, Hyperplasia                          41 (85%)     42 (89%)     42 (88%)     38 (81%)                               
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    9                                                              
                                                                                                                                   
NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                        LEUKOMALACHITE GREEN                                   Date: 06/18/03    
Route: DOSED FEED                                                                                                 Time: 14:39:48    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS-NCTR MALE                0 PPM        91 PPM       272 PPM      543 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Centrilobular, Necrosis                                       1 (2%)       1 (2%)       3 (6%)                                
   Mesentery                                          (5)          (3)          (6)          (3)                                    
      Accessory Spleen                                                           2 (33%)                                            
      Polyarteritis                                                              2 (33%)      1 (33%)                               
      Fat, Necrosis                                    3 (60%)      3 (100%)     2 (33%)      2 (67%)                               
   Pancreas                                           (48)         (47)         (48)         (47)                                   
      Accessory Spleen                                                           1 (2%)       1 (2%)                                
      Hyperplasia                                                                1 (2%)                                             
      Infiltration Cellular, Lymphocyte                1 (2%)       2 (4%)       2 (4%)       1 (2%)                                
      Polyarteritis                                                                           1 (2%)                                
      Acinus, Atrophy                                 28 (58%)     16 (34%)     24 (50%)     22 (47%)                               
      Artery, Inflammation, Chronic                                 1 (2%)       2 (4%)       4 (9%)                                
      Artery, Media, Hypertrophy                                    1 (2%)                    1 (2%)                                
   Salivary Glands                                    (48)         (47)         (48)         (47)                                   
      Atrophy                                                                    1 (2%)                                             
   Stomach                                            (48)         (47)         (47)         (47)                                   
      Forestomach, Edema                               2 (4%)       1 (2%)       2 (4%)                                             
      Forestomach, Inflammation                        2 (4%)       1 (2%)       1 (2%)       2 (4%)                                
      Forestomach, Necrosis                                         1 (2%)                                                          
      Forestomach, Epithelium, Hyperplasia             1 (2%)                    1 (2%)       2 (4%)                                
      Glandular, Edema                                 1 (2%)       1 (2%)                                                          
      Glandular, Erosion                               1 (2%)       1 (2%)                                                          
      Glandular, Mineralization                                                               1 (2%)                                
   Tooth                                                                        (1)                                                 
      Gingiva, Hyperplasia                                                       1 (100%)                                           
      Gingiva, Inflammation                                                      1 (100%)                                           
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (48)         (47)         (48)         (47)                                   
      Cardiomyopathy                                  37 (77%)     36 (77%)     40 (83%)     40 (85%)                               
      Atrium, Thrombosis                               1 (2%)       2 (4%)                    3 (6%)                                
      Myocardium, Infarct                                                                     1 (2%)                                
      Ventricle Right, Dilatation                      1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Gland                                      (48)         (47)         (48)         (47)                                   
      Degeneration                                                                            1 (2%)                                
      Cortex, Accessory Adrenal Cortical Nodule                                  2 (4%)       1 (2%)                                
      Cortex, Cytoplasmic Alteration                                                          1 (2%)                                
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page   10                                                              
                                                                                                                                   
NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                        LEUKOMALACHITE GREEN                                   Date: 06/18/03    
Route: DOSED FEED                                                                                                 Time: 14:39:48    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS-NCTR MALE                0 PPM        91 PPM       272 PPM      543 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
      Cortex, Hyperplasia, Focal                                    5 (11%)      3 (6%)       5 (11%)                               
      Cortex, Hypertrophy, Focal                                    1 (2%)                    1 (2%)                                
      Cortex, Vacuolization Cytoplasmic                1 (2%)       2 (4%)       4 (8%)       2 (4%)                                
      Medulla, Hyperplasia                             1 (2%)                    3 (6%)       2 (4%)                                
   Islets, Pancreatic                                 (48)         (47)         (48)         (47)                                   
      Hyperplasia                                                   1 (2%)       1 (2%)       1 (2%)                                
   Parathyroid Gland                                  (38)         (41)         (40)         (42)                                   
      Hyperplasia, Focal                               2 (5%)       2 (5%)                    1 (2%)                                
   Pituitary Gland                                    (45)         (46)         (48)         (45)                                   
      Angiectasis                                                   2 (4%)       1 (2%)                                             
      Infiltration Cellular, Histiocytic                            1 (2%)                                                          
      Pigmentation                                                  1 (2%)                                                          
      Pars Distalis, Cyst                              2 (4%)       3 (7%)       5 (10%)      3 (7%)                                
      Pars Distalis, Hyperplasia                       1 (2%)       7 (15%)      2 (4%)       7 (16%)                               
      Pars Intermedia, Cyst                                                                   1 (2%)                                
   Thyroid Gland                                      (47)         (47)         (48)         (46)                                   
      Ultimobranchial Cyst                                                       1 (2%)                                             
      C-Cell, Hyperplasia                              8 (17%)      6 (13%)      3 (6%)       3 (7%)                                
      Follicle, Cyst                                                                          3 (7%)                                
      Follicular Cell, Hyperplasia                     2 (4%)       1 (2%)       3 (6%)       3 (7%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   Tissue NOS                                         (1)                                    (1)                                    
      Abdominal, Pigmentation                          1 (100%)                                                                     
      Abdominal, Fat, Necrosis                                                                1 (100%)                              
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Coagulating Gland                                  (46)         (45)         (47)         (46)                                   
      Decreased Secretory Fluid                        2 (4%)                                 3 (7%)                                
      Inflammation, Suppurative                                     1 (2%)                                                          
   Epididymis                                         (48)         (47)         (48)         (47)                                   
      Atrophy                                                                                 1 (2%)                                
      Granuloma Sperm                                               1 (2%)                                                          
      Inflammation, Chronic                                                                   1 (2%)                                
      Serosa, Cyst                                     1 (2%)                                                                       
   Penis                                                           (1)                                                              
      Thrombosis                                                    1 (100%)                                                        
   Preputial Gland                                    (48)         (47)         (48)         (47)                                   
      Atrophy                                          1 (2%)                                 3 (6%)                                
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page   11                                                              
                                                                                                                                   
NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                        LEUKOMALACHITE GREEN                                   Date: 06/18/03    
Route: DOSED FEED                                                                                                 Time: 14:39:48    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS-NCTR MALE                0 PPM        91 PPM       272 PPM      543 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
GENITAL SYSTEM - CONT                                                                                                               
      Hyperplasia                                      1 (2%)       1 (2%)                    3 (6%)                                
      Infiltration Cellular, Chronic                   1 (2%)                                                                       
      Inflammation                                    35 (73%)     36 (77%)     38 (79%)     29 (62%)                               
      Duct, Ectasia                                    7 (15%)      8 (17%)     11 (23%)      9 (19%)                               
   Prostate                                           (48)         (47)         (48)         (47)                                   
      Decreased Secretory Fluid                        1 (2%)       1 (2%)                    1 (2%)                                
      Inflammation                                    29 (60%)     21 (45%)     22 (46%)     18 (38%)                               
      Ventral, Hyperplasia                             1 (2%)       3 (6%)       1 (2%)       6 (13%)                               
   Seminal Vesicle                                    (48)         (47)         (48)         (47)                                   
      Atrophy                                                                    1 (2%)       1 (2%)                                
      Decreased Secretory Fluid                       28 (58%)     31 (66%)     33 (69%)     36 (77%)                               
      Lumen, Distended                                 1 (2%)                                                                       
      Serosa, Inflammation, Chronic                    1 (2%)                                                                       
   Testes                                             (48)         (47)         (48)         (47)                                   
      Mineralization                                   1 (2%)                    1 (2%)                                             
      Interstitial Cell, Hyperplasia                  17 (35%)     11 (23%)      5 (10%)      3 (6%)                                
      Seminiferous Tubule, Atrophy                    11 (23%)      7 (15%)      3 (6%)       8 (17%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (48)         (47)         (48)         (47)                                   
      Atrophy                                          1 (2%)       1 (2%)                    1 (2%)                                
      Hyperplasia                                      2 (4%)                                 2 (4%)                                
      Myeloid Cell, Hyperplasia                                     1 (2%)       2 (4%)       1 (2%)                                
   Lymph Node                                         (48)         (47)         (48)         (47)                                   
      Infiltration Cellular, Plasma Cell               1 (2%)                                                                       
      Axillary, Hyperplasia, Lymphoid                                            1 (2%)                                             
      Deep Cervical, Infiltration Cellular, Plasma                                                                                  
        Cell                                                                     1 (2%)                                             
      Lumbar, Hematopoietic Cell Proliferation                                   1 (2%)                                             
      Lumbar, Hyperplasia, Lymphoid                    2 (4%)       1 (2%)       2 (4%)                                             
      Lumbar, Pigmentation                                          1 (2%)                                                          
      Mandibular, Ectasia                              3 (6%)       5 (11%)      6 (13%)      4 (9%)                                
      Mandibular, Hemorrhage                           1 (2%)                                 1 (2%)                                
      Mandibular, Hyperplasia, Lymphoid                             2 (4%)       3 (6%)       1 (2%)                                
      Mandibular, Infiltration Cellular, Plasma                                                                                     
        Cell                                           5 (10%)      6 (13%)     11 (23%)      7 (15%)                               
      Mediastinal, Ectasia                             1 (2%)                                                                       
      Mediastinal, Hemorrhage                                       1 (2%)       1 (2%)       1 (2%)                                
      Mesenteric, Congestion                                        1 (2%)                                                          
      Mesenteric, Ectasia                              4 (8%)       6 (13%)      6 (13%)      1 (2%)                                
      Mesenteric, Hemorrhage                           1 (2%)       3 (6%)       2 (4%)       1 (2%)                                
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page   12                                                              
                                                                                                                                   
NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                        LEUKOMALACHITE GREEN                                   Date: 06/18/03    
Route: DOSED FEED                                                                                                 Time: 14:39:48    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS-NCTR MALE                0 PPM        91 PPM       272 PPM      543 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Mesenteric, Hyperplasia, Lymphoid                1 (2%)                    1 (2%)       1 (2%)                                
      Mesenteric, Infiltration Cellular, Plasma                                                                                     
        Cell                                           2 (4%)                                 1 (2%)                                
      Pancreatic, Hyperplasia, Lymphoid                1 (2%)       1 (2%)                                                          
      Pancreatic, Infiltration Cellular, Plasma                                                                                     
        Cell                                           1 (2%)                                                                       
      Pancreatic, Pigmentation                                      1 (2%)                                                          
      Renal, Hemorrhage                                1 (2%)       2 (4%)                                                          
      Renal, Hyperplasia, Lymphoid                                  2 (4%)                                                          
      Renal, Infiltration Cellular, Diffuse,                                                                                        
        Histiocytic                                                 1 (2%)                                                          
   Spleen                                             (48)         (47)         (48)         (47)                                   
      Angiectasis                                                   1 (2%)                                                          
      Fibrosis                                         5 (10%)      6 (13%)      1 (2%)       5 (11%)                               
      Hematopoietic Cell Proliferation                 2 (4%)       3 (6%)       1 (2%)       8 (17%)                               
      Hyperplasia, Focal                                                         1 (2%)                                             
      Hyperplasia, Lymphoid                                         1 (2%)       2 (4%)       4 (9%)                                
      Infarct                                                       1 (2%)                    2 (4%)                                
      Pigmentation                                     3 (6%)       2 (4%)                    2 (4%)                                
      Stromal Hyperplasia                              1 (2%)                                                                       
   Thymus                                             (43)         (42)         (43)         (42)                                   
      Ectopic Parathyroid Gland                        1 (2%)                                                                       
      Epithelial Cell, Hyperplasia                                                            1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (43)         (41)         (46)         (41)                                   
      Galactocele                                      6 (14%)      1 (2%)       6 (13%)      2 (5%)                                
      Hyperplasia                                      5 (12%)      4 (10%)      4 (9%)       5 (12%)                               
      Duct, Dilatation                                12 (28%)      6 (15%)      3 (7%)       4 (10%)                               
   Skin                                               (48)         (47)         (47)         (47)                                   
      Abscess                                          1 (2%)                                                                       
      Cyst                                                                                    1 (2%)                                
      Cyst Epithelial Inclusion                        2 (4%)       2 (4%)                    1 (2%)                                
      Hyperkeratosis                                   1 (2%)                                                                       
      Inflammation                                                               1 (2%)                                             
      Inflammation, Chronic                                                      1 (2%)                                             
      Epidermis, Hyperplasia                           1 (2%)                                 1 (2%)                                
      Epidermis, Necrosis                                                                     1 (2%)                                
      Epithelium, Hyperplasia                                                                 2 (4%)                                
      Foot, Inflammation, Chronic                                   1 (2%)       1 (2%)       1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page   13                                                              
                                                                                                                                   
NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                        LEUKOMALACHITE GREEN                                   Date: 06/18/03    
Route: DOSED FEED                                                                                                 Time: 14:39:48    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS-NCTR MALE                0 PPM        91 PPM       272 PPM      543 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (48)         (47)         (48)         (47)                                   
      Femur, Fibrous Osteodystrophy                    1 (2%)                                 2 (4%)                                
      Sternum, Fibrous Osteodystrophy                               1 (2%)                                                          
   Skeletal Muscle                                    (48)         (47)         (48)         (47)                                   
      Arteriole, Mandibular, Proliferation                                       1 (2%)                                             
      Fiber, Mandibular, Hypertrophy                                             1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (48)         (47)         (48)         (47)                                   
      Brain Stem, Hemorrhage                           1 (2%)       2 (4%)                                                          
      Brain Stem, Hypothalamus, Compression            9 (19%)      4 (9%)       6 (13%)      1 (2%)                                
      Cerebrum, Compression                                                                   1 (2%)                                
      Cerebrum, Hemorrhage                                                                    1 (2%)                                
      Cerebrum, Hydrocephalus                                       1 (2%)                                                          
      Cerebrum, Hypothalamus, Compression                           1 (2%)                                                          
   Spinal Cord                                        (48)         (47)         (48)         (47)                                   
      Thoracic, Hemorrhage                                          1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (48)         (47)         (48)         (47)                                   
      Granuloma                                                     1 (2%)                                                          
      Hemorrhage                                       1 (2%)                    2 (4%)                                             
      Alveolar Epithelium, Hyperplasia                 2 (4%)       2 (4%)       4 (8%)       6 (13%)                               
      Alveolus, Infiltration Cellular, Histiocytic                                            1 (2%)                                
      Alveolus, Infiltration Cellular, Histiocyte      3 (6%)       4 (9%)       2 (4%)       4 (9%)                                
      Alveolus, Inflammation, Multifocal                                         1 (2%)                                             
      Mediastinum, Hemorrhage                                       1 (2%)                                                          
   Nose                                               (48)         (47)         (48)         (47)                                   
      Inflammation, Suppurative                                     1 (2%)                                                          
      Nasolacrimal Duct, Inflammation                 10 (21%)     15 (32%)     16 (33%)     12 (26%)                               
      Nasolacrimal Duct, Mineralization                                                       1 (2%)                                
      Respiratory Epithelium, Hyperplasia              1 (2%)       1 (2%)       1 (2%)                                             
      Respiratory Epithelium, Inflammation, Chronic    1 (2%)                                                                       
      Septum, Inflammation, Chronic                    1 (2%)                    1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                                                                                                    
                                                             Page   14                                                              
                                                                                                                                   
NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                        LEUKOMALACHITE GREEN                                   Date: 06/18/03    
Route: DOSED FEED                                                                                                 Time: 14:39:48    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS-NCTR MALE                0 PPM        91 PPM       272 PPM      543 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Ear                                                (1)                       (2)                                                 
      Canal, External Ear, Exudate                                               1 (50%)                                            
   Eye                                                (48)         (47)         (48)         (47)                                   
      Cataract                                         3 (6%)       3 (6%)       2 (4%)       1 (2%)                                
      Hemorrhage                                       2 (4%)                                                                       
      Inflammation                                     1 (2%)                                                                       
      Bilateral, Cataract                              2 (4%)                    1 (2%)       3 (6%)                                
      Bilateral, Retina, Degeneration                  1 (2%)                                 5 (11%)                               
      Cornea, Edema                                    1 (2%)                                                                       
      Retina, Autolysis                                4 (8%)       5 (11%)      3 (6%)       3 (6%)                                
      Retina, Degeneration                             8 (17%)      3 (6%)       3 (6%)       2 (4%)                                
      Sclera, Metaplasia, Osseous                      2 (4%)                    1 (2%)       1 (2%)                                
   Harderian Gland                                    (48)         (47)         (48)         (47)                                   
      Hyperplasia                                                   1 (2%)                                                          
      Infiltration Cellular, Lymphocyte               16 (33%)     16 (34%)     16 (33%)     18 (38%)                               
      Inflammation                                     1 (2%)       1 (2%)                    1 (2%)                                
   Zymbal's Gland                                     (46)         (43)         (47)         (47)                                   
      Hyperplasia                                                                1 (2%)                                             
      Inflammation, Chronic                            1 (2%)                                                                       
      Duct, Ectasia                                                                           1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (48)         (47)         (48)         (47)                                   
      Accumulation, Hyaline Droplet                                                           1 (2%)                                
      Infiltration Cellular, Lymphocyte                1 (2%)                                                                       
      Nephropathy                                     43 (90%)     45 (96%)     46 (96%)     47 (100%)                              
      Pigmentation                                     3 (6%)       1 (2%)       1 (2%)                                             
      Thrombosis                                                                              1 (2%)                                
      Cortex, Cyst                                                               1 (2%)       1 (2%)                                
      Renal Tubule, Hyperplasia                                                  1 (2%)                                             
   Urinary Bladder                                    (48)         (47)         (48)         (47)                                   
      Calculus Micro Observation Only                                                         1 (2%)                                
      Hemorrhage                                                    1 (2%)                                                          
      Inflammation                                                  1 (2%)                                                          
      Artery, Inflammation                                                                    1 (2%)                                
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   15                                                              
                                                                                                                                   
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                             ----------              END OF REPORT             ----------                                           
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