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TDMS Study 88032-05 Pathology Tables

NTP Experiment-Test: 88032-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                            OXYMETHOLONE                                       Date: 11/24/97
Route: GAVAGE                                                                                                     Time: 11:06:56

                                                          79 WEEK SSAC




       Facility:  Battelle Columbus Laboratory

       Chemical CAS #:  434-07-01

       Lock Date:  01/02/96

       Cage Range:  All

       Reasons For Removal:    25017 Scheduled Sacrifice

       Removal Date Range:     10/20/94 - 10/21/94

       Treatment Groups:       Include 002    0 MG/KG
                               Include 004    3 MG/KG
                               Include 006    30 MG/KG
                               Include 008    100     MG/KG
                               Include 001    0 MG/KG
                               Include 003    3 MG/KG
                               Include 005    30 MG/KG
                               Include 007    150     MG/KG



























a  Number of animals examined microscopically at site and number of animals with lesion

                                                              Page   1


NTP Experiment-Test: 88032-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                            OXYMETHOLONE                                       Date: 11/24/97  
Route: GAVAGE                                                                                                     Time: 11:06:56  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 MG/KG      3 MG/KG      30 MG/KG     100                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________

DISPOSITION SUMMARY                                                                                                                 

  Animals Initially In Study                          90           90           90           90                                     

  Scheduled Sacrifice                                 10           10           10           10                                     
  Early Deaths                                                                                                                      
  Survivors                                                                                                                         

  Animals Examined Microscopically                    10           10           10           10                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large, Colon                             (10)         (10)         (10)         (10)                                   
      Parasite Metazoan                                                                       1 (10%)                               
   Intestine Large, Rectum                            (10)         (10)         (10)         (10)                                   
      Parasite Metazoan                                4 (40%)      4 (40%)      4 (40%)                                            
   Liver                                              (10)         (10)         (10)         (10)                                   
      Basophilic Focus                                 7 (70%)     10 (100%)    10 (100%)     9 (90%)                               
      Clear Cell Focus                                              1 (10%)                   3 (30%)                               
      Hepatodiaphragmatic Nodule                       2 (20%)      1 (10%)      2 (20%)      1 (10%)                               
      Inflammation, Chronic Active                     7 (70%)      6 (60%)      7 (70%)      1 (10%)                               
      Mixed Cell Focus                                                           2 (20%)                                            
      Bile Duct, Hyperplasia                                                                  1 (10%)                               
      Centrilobular, Vacuolization Cytoplasmic                                   9 (90%)      1 (10%)                               
   Mesentery                                          (4)          (3)          (2)          (1)                                    
      Fat, Inflammation, Chronic Active                4 (100%)     3 (100%)     2 (100%)     1 (100%)                              
      Fat, Mineralization                              1 (25%)                                                                      
   Pancreas                                           (10)         (10)         (10)         (10)                                   
      Acinus, Atrophy                                  1 (10%)                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (10)         (10)         (10)         (10)                                   
      Myocardium, Degeneration, Chronic                6 (60%)      7 (70%)      8 (80%)      9 (90%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (10)         (10)         (10)         (10)                                   
      Angiectasis                                                   3 (30%)                                                         
      Vacuolization Cytoplasmic                                                  1 (10%)      9 (90%)                               
   Adrenal Medulla                                    (10)         (10)         (10)         (10)                                   
      Hyperplasia                                                                1 (10%)                                            
   Pituitary Gland                                    (10)         (9)          (10)         (10)                                   
      Cyst                                             2 (20%)      1 (11%)      2 (20%)      1 (10%)                               
      Hyperplasia                                      1 (10%)      1 (11%)                   2 (20%)                               

a  Number of animals examined microscopically at site and number of animals with lesion                                             

                                                             Page    2                                                              
NTP Experiment-Test: 88032-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                            OXYMETHOLONE                                       Date: 11/24/97  
Route: GAVAGE                                                                                                     Time: 11:06:56  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 MG/KG      3 MG/KG      30 MG/KG     100                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
   Thyroid Gland                                      (10)         (10)         (10)         (10)                                   
      C-Cell, Hyperplasia                                                                     1 (10%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (9)          (10)         (8)          (10)                                   
      Cyst                                                                                    3 (30%)                               
      Inflammation, Chronic Active                     5 (56%)      3 (30%)      2 (25%)      4 (40%)                               
   Ovary                                              (10)         (10)         (10)         (10)                                   
      DYSGENESIS                                                                 8 (80%)     10 (100%)                              
      Periovarian Tissue, Cyst                         3 (30%)      1 (10%)      1 (10%)      1 (10%)                               
   Uterus                                             (10)         (10)         (10)         (10)                                   
      Hydrometra                                       3 (30%)                                2 (20%)                               
      Endometrium, Cyst                                             1 (10%)                                                         
      Endometrium, Hyperplasia                                                                1 (10%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Lymph Node, Mandibular                             (10)         (10)         (10)         (10)                                   
      Ectasia                                                                    1 (10%)                                            
   Lymph Node, Mesenteric                             (10)         (10)         (10)         (10)                                   
      Ectasia                                                       1 (10%)                                                         
   Spleen                                             (10)         (10)         (10)         (10)                                   
      Hematopoietic Cell Proliferation                 1 (10%)                                                                      
      Pigmentation, Hemosiderin                        1 (10%)                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (10)         (10)         (10)         (10)                                   
      Dilatation                                       4 (40%)      1 (10%)                   1 (10%)                               
      Galactocele                                      1 (10%)      1 (10%)                                                         
      Lobular, Hyperplasia                             1 (10%)                   9 (90%)      9 (90%)                               
   Skin                                               (10)         (10)         (10)         (10)                                   
      Epidermis, Cyst                                  1 (10%)                                                                      
____________________________________________________________________________________________________________________________________

a  Number of animals examined microscopically at site and number of animals with lesion                                             

                                                             Page    3                                                              
NTP Experiment-Test: 88032-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                            OXYMETHOLONE                                       Date: 11/24/97  
Route: GAVAGE                                                                                                     Time: 11:06:56  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 MG/KG      3 MG/KG      30 MG/KG     100                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (10)         (10)         (10)         (10)                                   
      Inflammation, Chronic Active                     1 (10%)      4 (40%)      4 (40%)      3 (30%)                               
      Mineralization                                   2 (20%)      1 (10%)      5 (50%)      3 (30%)                               
   Nose                                               (10)         (10)         (10)         (10)                                   
      Inflammation, Suppurative                                                  1 (10%)                                            
      Glands, Hyperplasia                                                        1 (10%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (10)         (10)         (10)         (10)                                   
      Mineralization                                   8 (80%)      9 (90%)     10 (100%)     9 (90%)                               
      Nephropathy                                      8 (80%)      4 (40%)      9 (90%)     10 (100%)                              
      Renal Tubule, Hyperplasia                                                               1 (10%)                               
   Urinary Bladder                                    (10)         (10)         (10)         (10)                                   
      Inflammation, Chronic Active                     1 (10%)                   2 (20%)                                            
                                                                                                                                    

a  Number of animals examined microscopically at site and number of animals with lesion                                             

                                                             Page    4                                                              
NTP Experiment-Test: 88032-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                            OXYMETHOLONE                                       Date: 11/24/97  
Route: GAVAGE                                                                                                     Time: 11:06:56  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      3 MG/KG      30 MG/KG     150                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________

DISPOSITION SUMMARY                                                                                                                 

  Animals Initially In Study                          90           90           90           90                                     

  Scheduled Sacrifice                                 10           10           10           10                                     
  Early Deaths                                                                                                                      
  Survivors                                                                                                                         

  Animals Examined Microscopically                    10           10           10           10                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large, Colon                             (10)         (10)         (10)         (10)                                   
      Parasite Metazoan                                             1 (10%)      1 (10%)                                            
   Intestine Large, Rectum                            (10)         (10)         (10)         (10)                                   
      Parasite Metazoan                                2 (20%)      4 (40%)      1 (10%)      1 (10%)                               
   Intestine Small, Ileum                             (10)         (10)         (10)         (10)                                   
      Fibrosis                                                                   1 (10%)                                            
   Liver                                              (10)         (10)         (10)         (10)                                   
      Basophilic Focus                                 4 (40%)      8 (80%)      9 (90%)      8 (80%)                               
      Clear Cell Focus                                 2 (20%)                   2 (20%)      2 (20%)                               
      Degeneration, Cystic                                          1 (10%)                                                         
      Eosinophilic Focus                               1 (10%)      1 (10%)      1 (10%)                                            
      Hepatodiaphragmatic Nodule                                    2 (20%)      1 (10%)      1 (10%)                               
      Inflammation, Chronic Active                     8 (80%)      5 (50%)      1 (10%)                                            
      Mixed Cell Focus                                              1 (10%)                   3 (30%)                               
      Necrosis                                                      1 (10%)                                                         
      Bile Duct, Hyperplasia                          10 (100%)     6 (60%)      6 (60%)                                            
      Centrilobular, Vacuolization Cytoplasmic         3 (30%)      5 (50%)      2 (20%)      1 (10%)                               
   Mesentery                                          (3)          (1)          (3)                                                 
      Fat, Congestion                                  1 (33%)                                                                      
      Fat, Inflammation, Chronic Active                2 (67%)      1 (100%)     3 (100%)                                           
      Fat, Mineralization                                                        1 (33%)                                            
   Pancreas                                           (10)         (10)         (10)         (10)                                   
      Acinus, Atrophy                                  1 (10%)      2 (20%)      2 (20%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (10)         (10)         (10)         (10)                                   
      Myocardium, Degeneration, Chronic               10 (100%)    10 (100%)    10 (100%)    10 (100%)                              
____________________________________________________________________________________________________________________________________
                                                                                                                                    

a  Number of animals examined microscopically at site and number of animals with lesion                                             

                                                             Page    5                                                              
NTP Experiment-Test: 88032-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                            OXYMETHOLONE                                       Date: 11/24/97  
Route: GAVAGE                                                                                                     Time: 11:06:56  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      3 MG/KG      30 MG/KG     150                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (10)         (10)         (10)         (10)                                   
      Vacuolization Cytoplasmic                        4 (40%)      8 (80%)     10 (100%)    10 (100%)                              
   Adrenal Medulla                                    (10)         (10)         (10)         (10)                                   
      Hyperplasia                                      3 (30%)      1 (10%)      2 (20%)                                            
   Islets, Pancreatic                                 (10)         (10)         (10)         (10)                                   
      Pigmentation, Hemosiderin                                                               1 (10%)                               
   Pituitary Gland                                    (10)         (10)         (10)         (9)                                    
      Atrophy                                          1 (10%)                                                                      
      Cyst                                             2 (20%)                                                                      
      Hyperplasia                                      2 (20%)      3 (30%)      2 (20%)      1 (11%)                               
   Thyroid Gland                                      (10)         (10)         (10)         (10)                                   
      C-Cell, Hyperplasia                                                                     1 (10%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (10)         (10)         (10)         (10)                                   
      Degeneration                                     1 (10%)                                                                      
   Preputial Gland                                    (10)         (10)         (10)         (10)                                   
      Inflammation, Chronic Active                    10 (100%)     8 (80%)      9 (90%)      8 (80%)                               
   Prostate                                           (10)         (10)         (10)         (10)                                   
      Inflammation, Chronic Active                     2 (20%)      2 (20%)                                                         
   Seminal Vesicle                                    (10)         (10)         (10)         (10)                                   
      Cyst                                                                                    1 (10%)                               
   Testes                                             (10)         (10)         (10)         (10)                                   
      Degeneration                                     2 (20%)      1 (10%)      2 (20%)      3 (30%)                               
      Mineralization                                   3 (30%)      1 (10%)      7 (70%)      4 (40%)                               
      Interstitial Cell, Hyperplasia                   3 (30%)      4 (40%)                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (10)         (10)         (10)         (10)                                   
      Myelofibrosis                                                 1 (10%)                   1 (10%)                               
   Lymph Node, Mandibular                             (10)         (10)         (10)         (10)                                   
      Ectasia                                                                    1 (10%)                                            
   Spleen                                             (10)         (10)         (10)         (10)                                   
      Hematopoietic Cell Proliferation                                           1 (10%)                                            
   Thymus                                             (10)         (10)         (9)          (10)                                   
      Atrophy                                          2 (20%)                                1 (10%)                               
____________________________________________________________________________________________________________________________________

a  Number of animals examined microscopically at site and number of animals with lesion                                             

                                                             Page    6                                                              
NTP Experiment-Test: 88032-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                            OXYMETHOLONE                                       Date: 11/24/97  
Route: GAVAGE                                                                                                     Time: 11:06:56  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      3 MG/KG      30 MG/KG     150                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (10)         (10)         (10)         (10)                                   
      Dilatation                                       2 (20%)      3 (30%)      1 (10%)      7 (70%)                               
      Galactocele                                      2 (20%)      1 (10%)                                                         
      Lobular, Hyperplasia                                                                    6 (60%)                               
   Skin                                               (10)         (10)         (10)         (10)                                   
      Parakeratosis                                                 1 (10%)                                                         
      Ulcer                                                         1 (10%)                                                         
      Epidermis, Cyst                                                            1 (10%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (10)         (10)         (9)          (10)                                   
      Inflammation, Chronic Active                                  4 (40%)      3 (33%)                                            
      Mineralization                                   1 (10%)      4 (40%)      6 (67%)      3 (30%)                               
      Vacuolization Cytoplasmic                        1 (10%)      3 (30%)      1 (11%)      2 (20%)                               
      Alveolar Epithelium, Hyperplasia                 1 (10%)                                                                      
   Nose                                               (10)         (10)         (10)         (10)                                   
      Inflammation, Chronic Active                     1 (10%)                                                                      
      Inflammation, Suppurative                        1 (10%)      2 (20%)      1 (10%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (10)         (10)         (10)         (10)                                   
      Mineralization                                                                          4 (40%)                               
      Nephropathy                                     10 (100%)    10 (100%)     9 (90%)     10 (100%)                              
      Pigmentation, Hemosiderin                                                               1 (10%)                               
   Urinary Bladder                                    (10)         (10)         (10)         (10)                                   

a  Number of animals examined microscopically at site and number of animals with lesion                                             

                                                             Page    7                                                              
NTP Experiment-Test: 88032-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                            OXYMETHOLONE                                       Date: 11/24/97  
Route: GAVAGE                                                                                                     Time: 11:06:56  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      3 MG/KG      30 MG/KG     150                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
URINARY SYSTEM - CONT                                                                                                               
      Inflammation, Chronic Active                                                            1 (10%)                               
                                                                                                                                    

a  Number of animals examined microscopically at site and number of animals with lesion                                             

                                                             Page    8                                                              
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