https://ntp.niehs.nih.gov/go/3942

TDMS Study 93029-03 Pathology Tables

NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/18/03
Route: DOSED FEED                                            LEUKOMALACHITE GREEN                                 Time: 15:15:27
       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
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
                                                              Page   1
NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/18/03    
Route: DOSED FEED                                            LEUKOMALACHITE GREEN                                 Time: 15:15:27    
____________________________________________________________________________________________________________________________________
         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 [4.0]                                            
      Cecum, Lymphoid Tissue, Hyperplasia                           1 [2.0]                                                         
      Colon, Lymphoid Tissue, Hyperplasia                           1 [2.0]      1 [2.0]      1 [2.0]                               
      Rectum, Inflammation                             1 [2.0]                                                                      
   Intestine Small                                    (48)         (48)         (48)         (48)                                   
      Ileum, Dilatation                                                          1 [2.0]                                            
      Ileum, Inflammation                                                        1 [4.0]                                            
      Ileum, Lymphoid Tissue, Hyperplasia              1 [2.0]      2 [2.0]      1 [3.0]                                            
   Liver                                              (48)         (48)         (48)         (48)                                   
      Angiectasis                                                                             1 [2.0]                               
      Basophilic Focus                                 3            4            2            1                                     
      Basophilic Focus, Multiple                      20           26            2                                                  
      Degeneration, Cystic                             3 [2.0]      2 [1.0]      5 [1.6]      3 [2.0]                               
      Developmental Malformation                       7            5            3            5                                     
      Eosinophilic Focus                               3            4           13            5                                     
      Eosinophilic Focus, Multiple                                  8            7           11                                     
      Hematopoietic Cell Proliferation                 1 [1.0]      1 [1.0]      3 [1.0]      1 [1.0]                               
      Hepatodiaphragmatic Nodule                       4            1            5            1                                     
      Infiltration Cellular, Lymphocyte                2 [1.5]      3 [1.0]      7 [1.1]      4 [1.0]                               
      Inflammation, Focal, Granulomatous              10 [1.9]     19 [1.7]     20 [1.7]     13 [1.2]                               
      Mixed Cell Focus                                 1                                                                            
      Necrosis                                         4 [1.8]      2 [1.5]      1 [2.0]      3 [1.3]                               
      Tension Lipidosis                                1 [3.0]      2 [2.5]                                                         
      Tension Lipidosis, Multiple                                                             1 [2.0]                               
      Vacuolization Cytoplasmic                        5 [2.0]      5 [1.4]     17 [1.8]     22 [1.7]                               
      Bile Duct, Cyst                                                            2                                                  
      Bile Duct, Hyperplasia                          16 [1.5]     18 [1.2]     19 [1.5]     18 [1.3]                               
      Centrilobular, Necrosis                                                    1 [3.0]      2 [2.5]                               
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page    2                                                              
NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/18/03    
Route: DOSED FEED                                            LEUKOMALACHITE GREEN                                 Time: 15:15:27    
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS-NCTR FEMALE                 0 PPM        91 PPM       272 PPM      543 PPM                                
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT                                                                                                            
   Mesentery                                          (8)          (7)          (1)          (4)                                    
      Accessory Spleen                                              2                         1                                     
      Fat, Necrosis                                    6 [2.3]      5 [2.4]      1 [3.0]      3 [2.7]                               
   Pancreas                                           (48)         (48)         (47)         (48)                                   
      Infiltration Cellular, Lymphocyte                             2 [1.0]      3 [1.0]      1 [1.0]                               
      Inflammation                                     1 [2.0]                   1 [1.0]                                            
      Acinus, Atrophy                                 20 [2.1]     16 [1.3]     17 [1.9]     18 [1.9]                               
   Salivary Glands                                    (48)         (48)         (48)         (48)                                   
      Atrophy                                          2 [2.0]                                1 [2.0]                               
      Infiltration Cellular, Lymphocyte                                          1 [1.0]                                            
      Parotid Gland, Hypertrophy, Focal                             1 [2.0]                                                         
   Stomach                                            (48)         (48)         (48)         (48)                                   
      Forestomach, Edema                               1 [2.0]                                                                      
      Forestomach, Inflammation                        2 [3.0]                   1 [2.0]      1 [2.0]                               
      Forestomach, Epithelium, Hyperplasia             2 [3.0]                   1 [2.0]                                            
      Glandular, Edema                                 1 [3.0]                                                                      
   Tongue                                             (48)         (48)         (48)         (48)                                   
      Epithelium, Hyperplasia, Focal                                             1 [1.0]                                            
____________________________________________________________________________________________________________________________________
 CARDIOVASCULAR SYSTEM                                                                                                              
   Heart                                              (48)         (48)         (48)         (48)                                   
      Cardiomyopathy                                  35 [1.6]     35 [1.7]     33 [1.5]     30 [1.5]                               
____________________________________________________________________________________________________________________________________
 ENDOCRINE SYSTEM                                                                                                                   
   Adrenal Gland                                      (47)         (48)         (47)         (48)                                   
      Cortex, Accessory Adrenal Cortical Nodule                                  3                                                  
      Cortex, Angiectasis                              8 [1.6]     10 [1.9]      2 [2.0]      3 [1.3]                               
      Cortex, Atrophy                                               1 [2.0]                                                         
      Cortex, Degeneration                             1 [3.0]                                                                      
      Cortex, Hyperplasia, Focal                       4 [1.3]      2 [2.0]      4 [1.5]      5 [1.0]                               
      Cortex, Hypertrophy, Focal                       2 [1.5]                   2 [1.5]                                            
      Cortex, Thrombosis                                                                      1 [3.0]                               
      Cortex, Vacuolization Cytoplasmic                2 [2.5]                                1 [2.0]                               
      Medulla, Hyperplasia                             1 [2.0]                                                                      
   Pituitary Gland                                    (47)         (47)         (45)         (46)                                   
      Angiectasis                                      3 [1.3]      1 [3.0]      1 [4.0]      2 [2.0]                               
      Pars Distalis, Cyst                              8            4            6            1                                     
      Pars Distalis, Hyperplasia                       2 [2.0]      4 [2.3]      4 [2.0]      5 [2.0]                               
   Thyroid Gland                                      (46)         (46)         (47)         (48)                                   
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page    3                                                              
NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/18/03    
Route: DOSED FEED                                            LEUKOMALACHITE GREEN                                 Time: 15:15:27    
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS-NCTR FEMALE                 0 PPM        91 PPM       272 PPM      543 PPM                                
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT                                                                                                             
      C-Cell, Hyperplasia                             13 [1.4]      5 [1.0]      6 [1.8]      1 [2.0]                               
      Follicle, Cyst                                                1 [2.0]                   2 [1.0]                               
      Follicular Cell, Hyperplasia                     1 [2.0]                                3 [1.3]                               
____________________________________________________________________________________________________________________________________
 GENERAL BODY SYSTEM                                                                                                                
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
 GENITAL SYSTEM                                                                                                                     
   Clitoral Gland                                     (47)         (47)         (46)         (47)                                   
      Hyperplasia                                      4 [2.8]      4 [2.0]      5 [2.6]      3 [1.7]                               
      Inflammation                                    23 [1.9]     31 [1.9]     22 [1.9]     28 [2.1]                               
      Duct, Dilatation                                25 [2.4]     24 [2.4]     18 [2.3]     15 [2.1]                               
      Duct, Hyperplasia                                                                       1 [2.0]                               
   Ovary                                              (48)         (48)         (48)         (48)                                   
      Atrophy                                          6 [2.0]      5 [2.4]     10 [2.3]      7 [2.1]                               
      Cyst                                             8            5           10            4                                     
      Infiltration Cellular, Lymphocyte                3 [2.7]      3 [2.7]      3 [2.3]                                            
      Periovarian Tissue, Hemorrhage                                1 [2.0]                                                         
   Uterus                                             (48)         (48)         (48)         (48)                                   
      Decidual Reaction                                             1                         1                                     
      Hemorrhage                                                    1 [3.0]                   1 [3.0]                               
      Inflammation                                     1 [1.0]                                                                      
      Thrombosis                                                                              1                                     
      Bilateral, Horn, Dilatation                                                             1 [3.0]                               
      Cervix, Hypertrophy                              5            5            2            5                                     
      Endometrium, Hyperplasia                                                                1 [3.0]                               
      Endometrium, Hyperplasia, Cystic                 3 [1.7]      3 [2.3]      4 [2.0]      7 [2.1]                               
   Vagina                                             (48)         (48)         (48)         (48)                                   
      Cyst                                             1                                                                            
      Exudate, Mucous                                  1 [3.0]      1 [2.0]                                                         
      Hemorrhage                                                                              1 [3.0]                               
      Inflammation, Suppurative                        3 [3.0]      2 [2.0]      1 [3.0]      2 [2.0]                               
      Metaplasia, Squamous                                                       1 [2.0]                                            
      Prolapse                                                                                1                                     
____________________________________________________________________________________________________________________________________
 HEMATOPOIETIC SYSTEM                                                                                                               
   Bone Marrow                                        (48)         (48)         (48)         (48)                                   
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page    4                                                              
NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/18/03    
Route: DOSED FEED                                            LEUKOMALACHITE GREEN                                 Time: 15:15:27    
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS-NCTR FEMALE                 0 PPM        91 PPM       272 PPM      543 PPM                                
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Atrophy                                          4 [2.0]      2 [1.0]      4 [2.0]      3 [2.0]                               
      Myelostromal Proliferation                                                              1 [4.0]                               
      Myeloid Cell, Hyperplasia                                     1 [2.0]                                                         
   Lymph Node                                         (48)         (48)         (48)         (48)                                   
      Hyperplasia, Lymphoid                                                      1 [3.0]                                            
      Bronchial, Hyperplasia, Lymphoid                              1 [2.0]                                                         
      Lumbar, Ectasia                                  1 [3.0]                                                                      
      Lumbar, Hyperplasia, Lymphoid                    1 [2.0]                                                                      
      Mandibular, Ectasia                                                        2 [2.0]      2 [2.0]                               
      Mandibular, Hyperplasia, Lymphoid                1 [2.0]      1 [2.0]      4 [2.3]      1 [2.0]                               
      Mandibular, Infiltration Cellular, Plasma                                                                                     
        Cell                                           4 [2.0]      8 [2.3]      4 [2.0]                                            
      Mediastinal, Ectasia                                          1 [2.0]                   1 [2.0]                               
      Mediastinal, Hemorrhage                          1 [2.0]      3 [2.0]                   1 [3.0]                               
      Mediastinal, Hyperplasia, Lymphoid               1 [2.0]      1 [2.0]      1 [3.0]                                            
      Mediastinal, Infiltration Cellular, Plasma                                                                                    
        Cell                                           1 [2.0]                                                                      
      Mesenteric, Angiectasis                                                    1 [2.0]                                            
      Mesenteric, Ectasia                              2 [2.0]      1 [3.0]      4 [2.5]      2 [2.5]                               
      Mesenteric, Hemorrhage                                        1 [2.0]                   2 [2.0]                               
      Mesenteric, Hyperplasia, Lymphoid                1 [2.0]                   2 [2.0]      2 [2.0]                               
      Pancreatic, Ectasia                                                                     1 [3.0]                               
      Pancreatic, Hemorrhage                                        1 [2.0]                   1 [2.0]                               
      Pancreatic, Hyperplasia, Lymphoid                             1 [2.0]      2 [2.0]      1 [3.0]                               
      Renal, Ectasia                                   1 [2.0]                                                                      
      Renal, Hemorrhage                                1 [2.0]                                                                      
      Renal, Hyperplasia, Lymphoid                     2 [2.0]                   1 [2.0]                                            
   Spleen                                             (48)         (48)         (48)         (48)                                   
      Angiectasis                                                                             1 [2.0]                               
      Fibrosis                                                                                1 [1.0]                               
      Hematopoietic Cell Proliferation                 3 [3.0]      4 [2.0]      6 [2.5]      5 [2.4]                               
      Hyperplasia, Focal                                            1 [4.0]                                                         
      Pigmentation                                     1 [3.0]      2 [2.5]      3 [2.7]      1 [2.0]                               
      Stromal Hyperplasia                                                        1 [2.0]                                            
   Thymus                                             (41)         (47)         (44)         (42)                                   
      Cyst                                                          2            1            1                                     
____________________________________________________________________________________________________________________________________
 INTEGUMENTARY SYSTEM                                                                                                               
   Mammary Gland                                      (48)         (46)         (48)         (48)                                   
      Galactocele                                      7            2                                                               
      Hyperplasia                                     25 [2.0]     20 [2.0]     19 [1.8]     22 [2.0]                               
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page    5                                                              
NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/18/03    
Route: DOSED FEED                                            LEUKOMALACHITE GREEN                                 Time: 15:15:27    
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS-NCTR FEMALE                 0 PPM        91 PPM       272 PPM      543 PPM                                
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT                                                                                                         
      Infiltration Cellular, Lymphocyte                             1 [2.0]                                                         
      Duct, Dilatation                                10 [2.0]     13 [2.2]      7 [1.9]      3 [2.0]                               
   Skin                                               (48)         (48)         (48)         (48)                                   
      Abscess                                                       1 [3.0]                                                         
      Hyperkeratosis, Multifocal                                                              1 [2.0]                               
      Inflammation                                     2 [2.5]                   1 [2.0]      1 [2.0]                               
      Epidermis, Hyperplasia                           3 [2.3]      1 [2.0]      3 [2.0]      3 [2.0]                               
      Epidermis, Necrosis                              1 [1.0]      1 [2.0]      2 [1.5]      3 [2.0]                               
____________________________________________________________________________________________________________________________________
 MUSCULOSKELETAL SYSTEM                                                                                                             
   Bone                                               (48)         (48)         (48)         (48)                                   
      Cranium, Osteopetrosis                                                                  1 [3.0]                               
      Femur, Fibrous Osteodystrophy                    2 [2.5]                                                                      
      Femur, Fracture Healed                                                                  1                                     
      Femur, Osteopetrosis                             1 [3.0]      4 [3.3]      3 [2.7]      1 [3.0]                               
      Mandible, Osteopetrosis                                                                 1 [3.0]                               
      Maxilla, Inflammation, Chronic                                1 [3.0]                                                         
      Sternum, Fibrous Osteodystrophy                  1 [3.0]      1 [1.0]                                                         
      Sternum, Osteopetrosis                           1 [3.0]      4 [3.3]      4 [2.5]      1 [3.0]                               
      Turbinate, Osteopetrosis                         1 [2.0]      3 [3.0]      4 [2.3]      1 [3.0]                               
   Skeletal Muscle                                    (48)         (48)         (48)         (48)                                   
      Mineralization, Multifocal                       1 [2.0]                                                                      
____________________________________________________________________________________________________________________________________
 NERVOUS SYSTEM                                                                                                                     
   Brain                                              (48)         (48)         (48)         (48)                                   
      Brain Stem, Hemorrhage                           1 [2.0]                                                                      
      Brain Stem, Hypothalamus, Compression           11 [2.2]      6 [2.0]      5 [2.2]      5 [2.0]                               
      Cerebrum, Hemorrhage                             1 [1.0]                                1 [1.0]                               
____________________________________________________________________________________________________________________________________
 RESPIRATORY SYSTEM                                                                                                                 
   Lung                                               (48)         (48)         (48)         (48)                                   
      Infiltration Cellular, Lymphocyte                                          1 [1.0]                                            
      Alveolar Epithelium, Hyperplasia                              3 [1.3]      1 [1.0]      2 [2.0]                               
      Alveolar Epithelium, Metaplasia, Focal,                                                                                       
        Squamous                                                                              1 [1.0]                               
      Alveolus, Infiltration Cellular, Multifocal                                             1 [1.0]                               
      Alveolus, Infiltration Cellular, Histiocyte      4 [1.0]      3 [1.0]     10 [1.0]      6 [1.5]                               
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page    6                                                              
NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/18/03    
Route: DOSED FEED                                            LEUKOMALACHITE GREEN                                 Time: 15:15:27    
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS-NCTR FEMALE                 0 PPM        91 PPM       272 PPM      543 PPM                                
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT                                                                                                           
      Alveolus, Inflammation, Multifocal                            1 [2.0]                   1 [1.0]                               
   Nose                                               (48)         (48)         (48)         (48)                                   
      Inflammation, Suppurative                                     1 [2.0]                                                         
      Nasolacrimal Duct, Cyst Epithelial Inclusion                  1                                                               
      Nasolacrimal Duct, Inflammation                 21 [1.8]     19 [1.7]     18 [1.6]     19 [1.5]                               
      Respiratory Epithelium, Concretion                                                      1 [1.0]                               
   Trachea                                            (48)         (48)         (48)         (48)                                   
      Inflammation, Chronic                                         1 [2.0]                                                         
____________________________________________________________________________________________________________________________________
 SPECIAL SENSES SYSTEM                                                                                                              
   Eye                                                (48)         (48)         (48)         (48)                                   
      Cataract                                         2 [2.0]                                5 [1.6]                               
      Phthisis Bulbi                                                1            1            2                                     
      Bilateral, Cataract                              1 [2.0]      1 [2.0]                   2 [1.0]                               
      Bilateral, Retina, Degeneration                  4 [2.0]      4 [2.0]      5 [1.8]      7 [2.1]                               
      Conjunctiva, Inflammation                        1 [2.0]                                                                      
      Cornea, Neovascularization                                                              1 [2.0]                               
      Retina, Autolysis                                5            1            1            3                                     
      Retina, Degeneration                                          3 [1.3]      6 [1.7]      9 [2.1]                               
      Sclera, Metaplasia, Osseous                      1 [1.0]                                                                      
   Harderian Gland                                    (48)         (48)         (48)         (48)                                   
      Hyperplasia                                                                1 [3.0]                                            
      Infiltration Cellular, Focal, Histiocyte                      1 [1.0]                                                         
      Infiltration Cellular, Lymphocyte               19 [1.3]     26 [1.3]     22 [1.4]     21 [1.2]                               
      Inflammation                                                                            1 [1.0]                               
   Lacrimal Gland                                     (10)         (6)          (8)          (4)                                    
      Infiltration Cellular, Lymphocyte                3 [1.7]      1 [1.0]                   2 [2.0]                               
      Metaplasia                                      10 [2.0]      6 [1.8]      8 [2.1]      4 [2.0]                               
____________________________________________________________________________________________________________________________________
 URINARY SYSTEM                                                                                                                     
   Kidney                                             (48)         (48)         (48)         (48)                                   
      Hydronephrosis                                                1 [1.0]      1 [2.0]                                            
      Infarct                                          1 [2.0]                                                                      
      Infiltration Cellular, Lymphocyte                                          1 [1.0]                                            
      Mineralization                                  47 [1.9]     46 [1.9]     47 [1.9]     48 [1.9]                               
      Necrosis, Focal                                  1 [1.0]                                                                      
      Nephropathy                                     34 [1.2]     31 [1.2]     27 [1.2]     29 [1.2]                               
      Pigmentation                                     2 [2.0]                                2 [2.0]                               
   Urinary Bladder                                    (47)         (47)         (48)         (48)                                   
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page    7                                                              
NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/18/03    
Route: DOSED FEED                                            LEUKOMALACHITE GREEN                                 Time: 15:15:27    
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS-NCTR FEMALE                 0 PPM        91 PPM       272 PPM      543 PPM                                
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT                                                                                                               
      Hemorrhage                                                    1 [3.0]                                                         
      Infiltration Cellular, Lymphocyte                             1 [1.0]      1 [1.0]      2 [1.0]                               
      Inflammation                                                  2 [1.5]                                                         
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page    8                                                              
NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/18/03    
Route: DOSED FEED                                            LEUKOMALACHITE GREEN                                 Time: 15:15:27    
____________________________________________________________________________________________________________________________________
         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                                                  
      Cecum, Lymphoid Tissue, Hyperplasia              3 [2.3]      1 [2.0]                                                         
      Colon, Lymphoid Tissue, Hyperplasia                                        2 [2.5]      1 [3.0]                               
   Intestine Small                                    (47)         (47)         (48)         (47)                                   
      Duodenum, Autolysis                                           1 [3.0]                                                         
      Ileum, Hyperplasia                                                         1 [3.0]                                            
      Ileum, Inflammation                                                        1 [2.0]                                            
      Ileum, Lymphoid Tissue, Hyperplasia              4 [2.0]      1 [2.0]      1 [2.0]      3 [2.3]                               
      Jejunum, Autolysis                                            1 [3.0]                                                         
      Jejunum, Diverticulum                                                                   1                                     
      Jejunum, Lymphoid Tissue, Hyperplasia            1 [2.0]                                2 [2.0]                               
   Liver                                              (48)         (47)         (48)         (47)                                   
      Basophilic Focus                                              2                         2                                     
      Degeneration, Cystic                             4 [2.0]     18 [1.3]     13 [1.5]     19 [1.4]                               
      Developmental Malformation                       1            1                         1                                     
      Eosinophilic Focus                               2            8            9            8                                     
      Eosinophilic Focus, Multiple                     1            6           10           25                                     
      Hematopoietic Cell Proliferation                 1 [1.0]                                                                      
      Hepatodiaphragmatic Nodule                       2            2            3                                                  
      Infiltration Cellular, Lymphocyte                                                       1 [1.0]                               
      Inflammation, Focal, Granulomatous               3 [2.0]      1 [1.0]      1 [2.0]      1 [2.0]                               
      Mixed Cell Focus                                 1                                      2                                     
      Necrosis                                         1 [2.0]                   1 [2.0]                                            
      Pigmentation                                                               1 [1.0]                                            
      Vacuolization Cytoplasmic                        9 [2.0]     21 [1.9]     10 [1.9]     13 [1.8]                               
      Bile Duct, Cyst                                  1                         1                                                  
      Bile Duct, Hyperplasia                          41 [2.2]     42 [2.1]     42 [1.9]     38 [1.9]                               
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page    9                                                              
NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/18/03    
Route: DOSED FEED                                            LEUKOMALACHITE GREEN                                 Time: 15:15:27    
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS-NCTR MALE                   0 PPM        91 PPM       272 PPM      543 PPM                                
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT                                                                                                            
      Centrilobular, Necrosis                                       1 [2.0]      1 [3.0]      3 [2.7]                               
   Mesentery                                          (5)          (3)          (6)          (3)                                    
      Accessory Spleen                                                           2                                                  
      Polyarteritis                                                              2 [2.5]      1 [3.0]                               
      Fat, Necrosis                                    3 [2.3]      3 [2.3]      2 [2.5]      2 [3.0]                               
   Pancreas                                           (48)         (47)         (48)         (47)                                   
      Accessory Spleen                                                           1            1                                     
      Hyperplasia                                                                1 [3.0]                                            
      Infiltration Cellular, Lymphocyte                1 [1.0]      2 [1.0]      2 [1.5]      1 [2.0]                               
      Polyarteritis                                                                           1 [3.0]                               
      Acinus, Atrophy                                 28 [1.9]     16 [1.9]     24 [1.7]     22 [1.9]                               
      Artery, Inflammation, Chronic                                 1 [3.0]      2 [2.0]      4 [3.0]                               
      Artery, Media, Hypertrophy                                    1 [3.0]                   1 [3.0]                               
   Salivary Glands                                    (48)         (47)         (48)         (47)                                   
      Atrophy                                                                    1 [2.0]                                            
   Stomach                                            (48)         (47)         (47)         (47)                                   
      Forestomach, Edema                               2 [3.0]      1 [3.0]      2 [2.5]                                            
      Forestomach, Inflammation                        2 [2.0]      1 [2.0]      1 [2.0]      2 [2.0]                               
      Forestomach, Necrosis                                         1 [2.0]                                                         
      Forestomach, Epithelium, Hyperplasia             1 [1.0]                   1 [2.0]      2 [2.5]                               
      Glandular, Edema                                 1 [3.0]      1 [3.0]                                                         
      Glandular, Erosion                               1 [2.0]      1 [2.0]                                                         
      Glandular, Mineralization                                                               1 [2.0]                               
   Tooth                                                                        (1)                                                 
      Gingiva, Hyperplasia                                                       1 [3.0]                                            
      Gingiva, Inflammation                                                      1 [2.0]                                            
____________________________________________________________________________________________________________________________________
 CARDIOVASCULAR SYSTEM                                                                                                              
   Heart                                              (48)         (47)         (48)         (47)                                   
      Cardiomyopathy                                  37 [1.9]     36 [1.9]     40 [1.9]     40 [1.9]                               
      Atrium, Thrombosis                               1            2                         3                                     
      Myocardium, Infarct                                                                     1 [2.0]                               
      Ventricle Right, Dilatation                      1 [3.0]                                                                      
____________________________________________________________________________________________________________________________________
 ENDOCRINE SYSTEM                                                                                                                   
   Adrenal Gland                                      (48)         (47)         (48)         (47)                                   
      Degeneration                                                                            1 [3.0]                               
      Cortex, Accessory Adrenal Cortical Nodule                                  2            1                                     
      Cortex, Cytoplasmic Alteration                                                          1 [3.0]                               
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page   10                                                              
NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/18/03    
Route: DOSED FEED                                            LEUKOMALACHITE GREEN                                 Time: 15:15:27    
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS-NCTR MALE                   0 PPM        91 PPM       272 PPM      543 PPM                                
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT                                                                                                             
      Cortex, Hyperplasia, Focal                                    5 [1.6]      3 [1.7]      5 [1.2]                               
      Cortex, Hypertrophy, Focal                                    1 [1.0]                   1 [1.0]                               
      Cortex, Vacuolization Cytoplasmic                1 [2.0]      2 [2.0]      4 [1.5]      2 [2.5]                               
      Medulla, Hyperplasia                             1 [1.0]                   3 [2.0]      2 [2.0]                               
   Islets, Pancreatic                                 (48)         (47)         (48)         (47)                                   
      Hyperplasia                                                   1 [2.0]      1 [1.0]      1 [2.0]                               
   Parathyroid Gland                                  (38)         (41)         (40)         (42)                                   
      Hyperplasia, Focal                               2 [2.5]      2 [3.0]                   1 [3.0]                               
   Pituitary Gland                                    (45)         (46)         (48)         (45)                                   
      Angiectasis                                                   2 [1.5]      1 [2.0]                                            
      Infiltration Cellular, Histiocytic                            1 [2.0]                                                         
      Pigmentation                                                  1 [2.0]                                                         
      Pars Distalis, Cyst                              2            3            5            3                                     
      Pars Distalis, Hyperplasia                       1 [2.0]      7 [1.7]      2 [2.0]      7 [2.4]                               
      Pars Intermedia, Cyst                                                                   1                                     
   Thyroid Gland                                      (47)         (47)         (48)         (46)                                   
      Ultimobranchial Cyst                                                       1                                                  
      C-Cell, Hyperplasia                              8 [1.8]      6 [1.7]      3 [2.0]      3 [2.0]                               
      Follicle, Cyst                                                                          3 [1.3]                               
      Follicular Cell, Hyperplasia                     2 [1.0]      1 [4.0]      3 [2.3]      3 [2.0]                               
____________________________________________________________________________________________________________________________________
 GENERAL BODY SYSTEM                                                                                                                
   Tissue NOS                                         (1)                                    (1)                                    
      Abdominal, Pigmentation                          1 [2.0]                                                                      
      Abdominal, Fat, Necrosis                                                                1                                     
____________________________________________________________________________________________________________________________________
 GENITAL SYSTEM                                                                                                                     
   Coagulating Gland                                  (46)         (45)         (47)         (46)                                   
      Decreased Secretory Fluid                        2 [2.5]                                3 [2.3]                               
      Inflammation, Suppurative                                     1 [2.0]                                                         
   Epididymis                                         (48)         (47)         (48)         (47)                                   
      Atrophy                                                                                 1 [2.0]                               
      Granuloma Sperm                                               1 [3.0]                                                         
      Inflammation, Chronic                                                                   1 [2.0]                               
      Serosa, Cyst                                     1                                                                            
   Penis                                                           (1)                                                              
      Thrombosis                                                    1 [3.0]                                                         
   Preputial Gland                                    (48)         (47)         (48)         (47)                                   
      Atrophy                                          1 [2.0]                                3 [1.7]                               
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page   11                                                              
NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/18/03    
Route: DOSED FEED                                            LEUKOMALACHITE GREEN                                 Time: 15:15:27    
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS-NCTR MALE                   0 PPM        91 PPM       272 PPM      543 PPM                                
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT                                                                                                               
      Hyperplasia                                      1 [1.0]      1 [2.0]                   3 [2.3]                               
      Infiltration Cellular, Chronic                   1 [2.0]                                                                      
      Inflammation                                    35 [2.1]     36 [2.0]     38 [1.9]     29 [2.1]                               
      Duct, Ectasia                                    7 [2.4]      8 [2.8]     11 [2.5]      9 [2.6]                               
   Prostate                                           (48)         (47)         (48)         (47)                                   
      Decreased Secretory Fluid                        1 [2.0]      1 [2.0]                   1 [2.0]                               
      Inflammation                                    29 [2.1]     21 [1.8]     22 [1.9]     18 [1.8]                               
      Ventral, Hyperplasia                             1 [2.0]      3 [1.3]      1 [2.0]      6 [1.7]                               
   Seminal Vesicle                                    (48)         (47)         (48)         (47)                                   
      Atrophy                                                                    1 [3.0]      1 [3.0]                               
      Decreased Secretory Fluid                       28 [2.3]     31 [2.2]     33 [2.4]     36 [2.2]                               
      Lumen, Distended                                 1 [3.0]                                                                      
      Serosa, Inflammation, Chronic                    1 [3.0]                                                                      
   Testes                                             (48)         (47)         (48)         (47)                                   
      Mineralization                                   1 [1.0]                   1 [1.0]                                            
      Interstitial Cell, Hyperplasia                  17 [1.7]     11 [1.7]      5 [1.6]      3 [1.7]                               
      Seminiferous Tubule, Atrophy                    11 [2.5]      7 [2.4]      3 [1.7]      8 [2.8]                               
____________________________________________________________________________________________________________________________________
 HEMATOPOIETIC SYSTEM                                                                                                               
   Bone Marrow                                        (48)         (47)         (48)         (47)                                   
      Atrophy                                          1 [1.0]      1 [2.0]                   1 [2.0]                               
      Hyperplasia                                      2 [2.0]                                2 [3.0]                               
      Myeloid Cell, Hyperplasia                                     1 [2.0]      2 [2.0]      1 [2.0]                               
   Lymph Node                                         (48)         (47)         (48)         (47)                                   
      Infiltration Cellular, Plasma Cell               1 [2.0]                                                                      
      Axillary, Hyperplasia, Lymphoid                                            1 [2.0]                                            
      Deep Cervical, Infiltration Cellular, Plasma                                                                                  
        Cell                                                                     1 [3.0]                                            
      Lumbar, Hematopoietic Cell Proliferation                                   1 [2.0]                                            
      Lumbar, Hyperplasia, Lymphoid                    2 [2.0]      1 [2.0]      2 [2.5]                                            
      Lumbar, Pigmentation                                          1 [3.0]                                                         
      Mandibular, Ectasia                              3 [2.7]      5 [2.4]      6 [2.3]      4 [2.5]                               
      Mandibular, Hemorrhage                           1 [2.0]                                1 [2.0]                               
      Mandibular, Hyperplasia, Lymphoid                             2 [2.0]      3 [2.0]      1 [2.0]                               
      Mandibular, Infiltration Cellular, Plasma                                                                                     
        Cell                                           5 [2.0]      6 [2.0]     11 [2.1]      7 [2.3]                               
      Mediastinal, Ectasia                             1 [2.0]                                                                      
      Mediastinal, Hemorrhage                                       1 [2.0]      1 [2.0]      1 [2.0]                               
      Mesenteric, Congestion                                        1 [2.0]                                                         
      Mesenteric, Ectasia                              4 [2.5]      6 [2.5]      6 [2.7]      1 [2.0]                               
      Mesenteric, Hemorrhage                           1 [2.0]      3 [2.3]      2 [2.0]      1 [2.0]                               
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page   12                                                              
NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/18/03    
Route: DOSED FEED                                            LEUKOMALACHITE GREEN                                 Time: 15:15:27    
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS-NCTR MALE                   0 PPM        91 PPM       272 PPM      543 PPM                                
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Mesenteric, Hyperplasia, Lymphoid                1 [2.0]                   1 [2.0]      1 [2.0]                               
      Mesenteric, Infiltration Cellular, Plasma                                                                                     
        Cell                                           2 [2.0]                                1 [2.0]                               
      Pancreatic, Hyperplasia, Lymphoid                1 [3.0]      1 [2.0]                                                         
      Pancreatic, Infiltration Cellular, Plasma                                                                                     
        Cell                                           1 [2.0]                                                                      
      Pancreatic, Pigmentation                                      1 [3.0]                                                         
      Renal, Hemorrhage                                1 [2.0]      2 [2.0]                                                         
      Renal, Hyperplasia, Lymphoid                                  2 [2.0]                                                         
      Renal, Infiltration Cellular, Diffuse,                                                                                        
        Histiocytic                                                 1 [3.0]                                                         
   Spleen                                             (48)         (47)         (48)         (47)                                   
      Angiectasis                                                   1 [2.0]                                                         
      Fibrosis                                         5 [2.0]      6 [2.7]      1 [2.0]      5 [2.2]                               
      Hematopoietic Cell Proliferation                 2 [2.0]      3 [2.0]      1 [3.0]      8 [2.1]                               
      Hyperplasia, Focal                                                         1 [3.0]                                            
      Hyperplasia, Lymphoid                                         1 [2.0]      2 [2.0]      4 [2.0]                               
      Infarct                                                       1                         2                                     
      Pigmentation                                     3 [2.7]      2 [2.5]                   2 [2.0]                               
      Stromal Hyperplasia                              1 [3.0]                                                                      
   Thymus                                             (43)         (42)         (43)         (42)                                   
      Ectopic Parathyroid Gland                        1 [3.0]                                                                      
      Epithelial Cell, Hyperplasia                                                            1 [2.0]                               
____________________________________________________________________________________________________________________________________
 INTEGUMENTARY SYSTEM                                                                                                               
   Mammary Gland                                      (43)         (41)         (46)         (41)                                   
      Galactocele                                      6            1            6            2                                     
      Hyperplasia                                      5 [1.8]      4 [2.3]      4 [2.0]      5 [2.0]                               
      Duct, Dilatation                                12 [2.1]      6 [2.3]      3 [2.0]      4 [2.0]                               
   Skin                                               (48)         (47)         (47)         (47)                                   
      Abscess                                          1 [3.0]                                                                      
      Cyst                                                                                    1                                     
      Cyst Epithelial Inclusion                        2            2                         1                                     
      Hyperkeratosis                                   1 [3.0]                                                                      
      Inflammation                                                               1 [3.0]                                            
      Inflammation, Chronic                                                      1 [3.0]                                            
      Epidermis, Hyperplasia                           1 [3.0]                                1 [3.0]                               
      Epidermis, Necrosis                                                                     1 [2.0]                               
      Epithelium, Hyperplasia                                                                 2 [2.0]                               
      Foot, Inflammation, Chronic                                   1 [2.0]      1 [2.0]      1 [2.0]                               
____________________________________________________________________________________________________________________________________
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page   13                                                              
NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/18/03    
Route: DOSED FEED                                            LEUKOMALACHITE GREEN                                 Time: 15:15:27    
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS-NCTR MALE                   0 PPM        91 PPM       272 PPM      543 PPM                                
____________________________________________________________________________________________________________________________________
 MUSCULOSKELETAL SYSTEM                                                                                                             
   Bone                                               (48)         (47)         (48)         (47)                                   
      Femur, Fibrous Osteodystrophy                    1 [3.0]                                2 [1.5]                               
      Sternum, Fibrous Osteodystrophy                               1 [2.0]                                                         
   Skeletal Muscle                                    (48)         (47)         (48)         (47)                                   
      Arteriole, Mandibular, Proliferation                                       1                                                  
      Fiber, Mandibular, Hypertrophy                                             1                                                  
____________________________________________________________________________________________________________________________________
 NERVOUS SYSTEM                                                                                                                     
   Brain                                              (48)         (47)         (48)         (47)                                   
      Brain Stem, Hemorrhage                           1 [2.0]      2 [3.0]                                                         
      Brain Stem, Hypothalamus, Compression            9 [2.3]      4 [3.0]      6 [2.2]      1 [3.0]                               
      Cerebrum, Compression                                                                   1 [2.0]                               
      Cerebrum, Hemorrhage                                                                    1 [3.0]                               
      Cerebrum, Hydrocephalus                                       1 [3.0]                                                         
      Cerebrum, Hypothalamus, Compression                           1 [3.0]                                                         
   Spinal Cord                                        (48)         (47)         (48)         (47)                                   
      Thoracic, Hemorrhage                                          1 [2.0]                                                         
____________________________________________________________________________________________________________________________________
 RESPIRATORY SYSTEM                                                                                                                 
   Lung                                               (48)         (47)         (48)         (47)                                   
      Granuloma                                                     1 [1.0]                                                         
      Hemorrhage                                       1 [2.0]                   2 [1.5]                                            
      Alveolar Epithelium, Hyperplasia                 2 [2.5]      2 [2.5]      4 [2.5]      6 [2.5]                               
      Alveolus, Infiltration Cellular, Histiocytic                                            1 [1.0]                               
      Alveolus, Infiltration Cellular, Histiocyte      3 [1.7]      4 [1.8]      2 [1.0]      4 [1.8]                               
      Alveolus, Inflammation, Multifocal                                         1 [2.0]                                            
      Mediastinum, Hemorrhage                                       1 [2.0]                                                         
   Nose                                               (48)         (47)         (48)         (47)                                   
      Inflammation, Suppurative                                     1 [1.0]                                                         
      Nasolacrimal Duct, Inflammation                 10 [1.7]     15 [1.8]     16 [1.8]     12 [1.7]                               
      Nasolacrimal Duct, Mineralization                                                       1 [2.0]                               
      Respiratory Epithelium, Hyperplasia              1 [2.0]      1 [2.0]      1 [2.0]                                            
      Respiratory Epithelium, Inflammation, Chronic    1 [2.0]                                                                      
      Septum, Inflammation, Chronic                    1 [2.0]                   1 [2.0]                                            
____________________________________________________________________________________________________________________________________
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page   14                                                              
NTP Experiment-Test: 93029-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/18/03    
Route: DOSED FEED                                            LEUKOMALACHITE GREEN                                 Time: 15:15:27    
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS-NCTR MALE                   0 PPM        91 PPM       272 PPM      543 PPM                                
____________________________________________________________________________________________________________________________________
 SPECIAL SENSES SYSTEM                                                                                                              
   Ear                                                (1)                       (2)                                                 
      Canal, External Ear, Exudate                                               1 [2.0]                                            
   Eye                                                (48)         (47)         (48)         (47)                                   
      Cataract                                         3 [2.3]      3 [1.3]      2 [2.0]      1 [3.0]                               
      Hemorrhage                                       2 [2.5]                                                                      
      Inflammation                                     1 [3.0]                                                                      
      Bilateral, Cataract                              2 [2.0]                   1 [2.0]      3 [1.7]                               
      Bilateral, Retina, Degeneration                  1 [1.0]                                5 [2.0]                               
      Cornea, Edema                                    1                                                                            
      Retina, Autolysis                                4            5            3            3                                     
      Retina, Degeneration                             8 [2.4]      3 [1.7]      3 [1.7]      2 [2.0]                               
      Sclera, Metaplasia, Osseous                      2 [2.0]                   1 [2.0]      1 [2.0]                               
   Harderian Gland                                    (48)         (47)         (48)         (47)                                   
      Hyperplasia                                                   1 [2.0]                                                         
      Infiltration Cellular, Lymphocyte               16 [1.2]     16 [1.3]     16 [1.1]     18 [1.3]                               
      Inflammation                                     1 [2.0]      1 [1.0]                   1 [2.0]                               
   Zymbal's Gland                                     (46)         (43)         (47)         (47)                                   
      Hyperplasia                                                                1 [3.0]                                            
      Inflammation, Chronic                            1 [1.0]                                                                      
      Duct, Ectasia                                                                           1 [2.0]                               
____________________________________________________________________________________________________________________________________
 URINARY SYSTEM                                                                                                                     
   Kidney                                             (48)         (47)         (48)         (47)                                   
      Accumulation, Hyaline Droplet                                                           1 [2.0]                               
      Infiltration Cellular, Lymphocyte                1 [2.0]                                                                      
      Nephropathy                                     43 [1.9]     45 [2.0]     46 [2.2]     47 [2.4]                               
      Pigmentation                                     3 [2.0]      1 [3.0]      1 [2.0]                                            
      Thrombosis                                                                              1 [4.0]                               
      Cortex, Cyst                                                               1            1                                     
      Renal Tubule, Hyperplasia                                                  1 [2.0]                                            
   Urinary Bladder                                    (48)         (47)         (48)         (47)                                   
      Calculus Micro Observation Only                                                         1                                     
      Hemorrhage                                                    1 [3.0]                                                         
      Inflammation                                                  1 [3.0]                                                         
      Artery, Inflammation                                                                    1 [2.0]                               
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page   15                                                              
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                             ----------              END OF REPORT             ----------                                           
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