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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: 11/25/97
Route: GAVAGE                                                                                                     Time: 07:20:55

                                                          53 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:     04/21/94 - 04/22/94

       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: 11/25/97  
Route: GAVAGE                                                                                                     Time: 07:20:55  
____________________________________________________________________________________________________________________________________

         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                                2 (20%)                                3 (30%)                               
   Intestine Large, Cecum                             (10)         (10)         (10)         (10)                                   
      Inflammation, Chronic Active                     1 (10%)                                                                      
   Liver                                              (10)         (10)         (10)         (10)                                   
      Basophilic Focus                                 4 (40%)      8 (80%)      2 (20%)      7 (70%)                               
      Clear Cell Focus                                                           1 (10%)      1 (10%)                               
      Eosinophilic Focus                                            1 (10%)                                                         
      Hepatodiaphragmatic Nodule                       1 (10%)      2 (20%)      2 (20%)      1 (10%)                               
      Inflammation, Chronic Active                     7 (70%)      5 (50%)      6 (60%)      3 (30%)                               
      Bile Duct, Hyperplasia                                                     1 (10%)                                            
      Centrilobular, Vacuolization Cytoplasmic                                   7 (70%)                                            
   Mesentery                                          (1)          (3)          (3)          (1)                                    
      Fat, Inflammation, Chronic Active                1 (100%)     3 (100%)     3 (100%)     1 (100%)                              
   Pancreas                                           (10)         (10)         (10)         (10)                                   
      Inflammation, Chronic Active                     1 (10%)                                                                      
      Acinus, Atrophy                                  2 (20%)      1 (10%)      1 (10%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (10)         (10)         (10)         (10)                                   
      Myocardium, Degeneration, Chronic                7 (70%)      8 (80%)      9 (90%)      9 (90%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (10)         (10)         (10)         (10)                                   
      Accessory Adrenal Cortical Nodule                3 (30%)      2 (20%)                   1 (10%)                               
      Hyperplasia                                      1 (10%)                                                                      
      Inflammation, Chronic Active                                                            1 (10%)                               
      Vacuolization Cytoplasmic                                                              10 (100%)                              
   Pituitary Gland                                    (10)         (10)         (10)         (10)                                   

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: 11/25/97  
Route: GAVAGE                                                                                                     Time: 07:20:55  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 MG/KG      3 MG/KG      30 MG/KG     100                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
      Cyst                                                          2 (20%)                   1 (10%)                               
      Pars Distalis, Angiectasis                                    1 (10%)                                                         
   Thyroid Gland                                      (10)         (10)         (10)         (10)                                   
      Ultimobranchial Cyst                                                       1 (10%)                                            
      Follicle, Cyst                                                                          1 (10%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (10)         (10)         (10)         (10)                                   
      Cyst                                                                       1 (10%)                                            
      Inflammation, Chronic Active                     4 (40%)      6 (60%)      6 (60%)      3 (30%)                               
   Ovary                                              (10)         (10)         (10)         (10)                                   
      DYSGENESIS                                                                10 (100%)    10 (100%)                              
      Follicle, Cyst                                                             1 (10%)                                            
      Periovarian Tissue, Cyst                         1 (10%)                                                                      
   Uterus                                             (10)         (10)         (10)         (10)                                   
      Hydrometra                                                    1 (10%)                   1 (10%)                               
      Endometrium, Cyst                                1 (10%)                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (10)         (10)         (10)         (10)                                   
      Myelofibrosis                                    1 (10%)                                                                      
   Spleen                                             (10)         (10)         (10)         (10)                                   
      Lymphoid Follicle, Depletion Cellular                                      1 (10%)                                            
   Thymus                                             (10)         (10)         (9)          (10)                                   
      Atrophy                                                                                 2 (20%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (10)         (10)         (10)         (10)                                   
      Dilatation                                                                 1 (10%)      8 (80%)                               
      Lobular, Hyperplasia                                                      10 (100%)     8 (80%)                               
____________________________________________________________________________________________________________________________________

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: 11/25/97  
Route: GAVAGE                                                                                                     Time: 07:20:55  
____________________________________________________________________________________________________________________________________

         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)                                   
      Hemorrhage                                                    1 (10%)      1 (10%)                                            
      Inflammation, Chronic Active                     1 (10%)      4 (40%)      3 (30%)                                            
      Mineralization                                   2 (20%)                   2 (20%)      2 (20%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (10)         (10)         (10)         (10)                                   
      Mineralization                                   9 (90%)     10 (100%)    10 (100%)    10 (100%)                              
      Nephropathy                                      5 (50%)      6 (60%)      9 (90%)     10 (100%)                              
   Urinary Bladder                                    (10)         (10)         (10)         (10)                                   
      Inflammation, Chronic Active                                  1 (10%)                                                         
                                                                                                                                    

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: 11/25/97  
Route: GAVAGE                                                                                                     Time: 07:20:55  
____________________________________________________________________________________________________________________________________

         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                                  9           10           10           10                                     
  Early Deaths                                                                                                                      
  Survivors                                                                                                                         

  Animals Examined Microscopically                     9           10           10           10                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large, Rectum                            (9)          (10)         (10)         (10)                                   
      Parasite Metazoan                                                          4 (40%)      1 (10%)                               
   Intestine Large, Cecum                             (9)          (10)         (10)         (10)                                   
      Parasite Metazoan                                                                       1 (10%)                               
   Intestine Small, Ileum                             (9)          (10)         (10)         (10)                                   
      Peyer's Patch, Mineralization                                                           1 (10%)                               
   Liver                                              (9)          (10)         (9)          (10)                                   
      Basophilic Focus                                              2 (20%)      2 (22%)                                            
      Clear Cell Focus                                                                        1 (10%)                               
      Cyst                                             1 (11%)                                                                      
      Hepatodiaphragmatic Nodule                       2 (22%)      1 (10%)      1 (11%)      1 (10%)                               
      Inflammation, Chronic Active                     6 (67%)      7 (70%)      6 (67%)                                            
      Necrosis                                                      4 (40%)      2 (22%)                                            
      Bile Duct, Hyperplasia                           3 (33%)      5 (50%)      3 (33%)                                            
      Centrilobular, Vacuolization Cytoplasmic         2 (22%)      3 (30%)      1 (11%)                                            
   Mesentery                                                       (1)                                                              
      Fat, Inflammation, Chronic Active                             1 (100%)                                                        
   Pancreas                                           (9)          (10)         (10)         (10)                                   
      Acinus, Atrophy                                  1 (11%)      3 (30%)      4 (40%)      3 (30%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (9)          (10)         (10)         (10)                                   
      Myocardium, Degeneration, Chronic                8 (89%)      9 (90%)     10 (100%)    10 (100%)                              
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (9)          (10)         (10)         (10)                                   
      Accessory Adrenal Cortical Nodule                1 (11%)      1 (10%)                                                         
      Hypertrophy                                      1 (11%)                                                                      
      Vacuolization Cytoplasmic                        9 (100%)     7 (70%)      9 (90%)      8 (80%)                               
   Pituitary Gland                                    (9)          (10)         (10)         (10)                                   
      Cyst                                             1 (11%)                                                                      

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: 11/25/97  
Route: GAVAGE                                                                                                     Time: 07:20:55  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      3 MG/KG      30 MG/KG     150                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
      Hyperplasia                                      1 (11%)      4 (40%)      3 (30%)      1 (10%)                               
      Pars Nervosa, Developmental Malformation         1 (11%)                                                                      
   Thyroid Gland                                      (9)          (10)         (10)         (10)                                   
      Ultimobranchial Cyst                                          1 (10%)      1 (10%)      1 (10%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Preputial Gland                                    (9)          (10)         (10)         (10)                                   
      Inflammation, Chronic Active                     6 (67%)      6 (60%)      9 (90%)      7 (70%)                               
   Testes                                             (9)          (10)         (10)         (10)                                   
      Degeneration                                                                            1 (10%)                               
      Mineralization                                                2 (20%)      3 (30%)      6 (60%)                               
      Interstitial Cell, Hyperplasia                   8 (89%)      7 (70%)                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Lymph Node, Mandibular                             (9)          (10)         (10)         (10)                                   
      Congestion                                       1 (11%)      1 (10%)                   1 (10%)                               
      Ectasia                                          1 (11%)                                                                      
   Lymph Node, Mesenteric                             (9)          (10)         (10)         (10)                                   
      Atrophy                                                                                 1 (10%)                               
   Spleen                                             (9)          (10)         (10)         (10)                                   
      Red Pulp, Depletion Cellular                     1 (11%)                                                                      
   Thymus                                             (9)          (10)         (10)         (10)                                   
      Atrophy                                                                                 7 (70%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (8)          (9)          (10)         (10)                                   
      Dilatation                                       4 (50%)      1 (11%)      5 (50%)     10 (100%)                              
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________

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: 11/25/97  
Route: GAVAGE                                                                                                     Time: 07:20:55  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      3 MG/KG      30 MG/KG     150                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (9)          (10)         (10)         (10)                                   
      Hemorrhage                                       1 (11%)      1 (10%)      1 (10%)                                            
      Inflammation, Chronic Active                     1 (11%)      3 (30%)      1 (10%)      2 (20%)                               
      Mineralization                                   2 (22%)      1 (10%)      4 (40%)      4 (40%)                               
      Vacuolization Cytoplasmic                                     1 (10%)      2 (20%)                                            
   Nose                                               (9)          (10)         (10)         (10)                                   
      Inflammation, Chronic Active                     2 (22%)      1 (10%)                                                         
      Inflammation, Suppurative                        1 (11%)                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (9)          (10)         (10)         (10)                                   
      Mineralization                                   1 (11%)                                9 (90%)                               
      Necrosis                                                                   1 (10%)                                            
      Nephropathy                                      9 (100%)    10 (100%)    10 (100%)    10 (100%)                              
                                                                                                                                    

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

                                                             Page    7                                                              
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