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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: 11:19:17

                                                           CORE STUDY




       Facility:  Battelle Columbus Laboratory

       Chemical CAS #:  434-07-01

       Lock Date:  01/02/96

       Cage Range:  All

       Reasons For Removal:    25018 Dosing Accident                   25019 Moribund Sacrifice
                               25020 Natural Death                     25026 Other
                               25021 Terminal Sacrifice

       Removal Date Range:     All

       Treatment Groups:       Include All
































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

                                                              Page   1


NTP Experiment-Test: 88032-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                            OXYMETHOLONE                                       Date: 11/24/97  
Route: GAVAGE                                                                                                     Time: 11:19:17  
____________________________________________________________________________________________________________________________________

         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                                     
  Early Deaths                                                                                                                      
    Natural Death                                     15           10            9            8                                     
    Moribund Sacrifice                                 9           11           10           10                                     
    Dosing Accident                                    1                         1            1                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                25           29           30           31                                     

  Animals Examined Microscopically                    50           50           50           50                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Esophagus                                          (50)         (50)         (50)         (49)                                   
      Hemorrhage                                                                 1 (2%)                                             
      Inflammation, Chronic Active                     1 (2%)       1 (2%)                    1 (2%)                                
      Ulcer                                                                                   1 (2%)                                
   Intestine Large, Colon                             (46)         (46)         (49)         (48)                                   
      Parasite Metazoan                                1 (2%)                    3 (6%)                                             
   Intestine Large, Rectum                            (44)         (47)         (46)         (50)                                   
      Parasite Metazoan                                2 (5%)       5 (11%)      5 (11%)     10 (20%)                               
   Intestine Small, Duodenum                          (47)         (48)         (49)         (49)                                   
      Inflammation, Chronic Active                                               1 (2%)                                             
   Intestine Small, Jejunum                           (43)         (45)         (43)         (44)                                   
      Inflammation, Chronic Active                                                            1 (2%)                                
   Intestine Small, Ileum                             (40)         (44)         (44)         (46)                                   
      Inflammation, Chronic Active                                                            1 (2%)                                
   Liver                                              (50)         (50)         (50)         (49)                                   
      Basophilic Focus                                37 (74%)     40 (80%)     37 (74%)     41 (84%)                               
      Clear Cell Focus                                 5 (10%)     11 (22%)      6 (12%)     14 (29%)                               
      Cyst                                                          1 (2%)                                                          
      Degeneration, Cystic                                                       1 (2%)       3 (6%)                                
      Eosinophilic Focus                               8 (16%)      6 (12%)      3 (6%)       3 (6%)                                
      Fibrosis                                         1 (2%)                                                                       
      Hematopoietic Cell Proliferation                 2 (4%)       1 (2%)                                                          
      Hepatodiaphragmatic Nodule                      12 (24%)      6 (12%)      4 (8%)       9 (18%)                               
      Inflammation, Chronic Active                    17 (34%)     13 (26%)     10 (20%)      5 (10%)                               
      Mixed Cell Focus                                 2 (4%)       7 (14%)      9 (18%)      7 (14%)                               
      Necrosis                                         1 (2%)       2 (4%)                    1 (2%)                                
      Regeneration                                                  1 (2%)                    2 (4%)                                
      Vacuolization Cytoplasmic, Focal                 1 (2%)                    1 (2%)                                             
      Bile Duct, Hyperplasia                           1 (2%)       3 (6%)       6 (12%)                                            
      Centrilobular, Necrosis                                                                 1 (2%)                                
      Centrilobular, Vacuolization Cytoplasmic         7 (14%)      8 (16%)      6 (12%)      3 (6%)                                
   Mesentery                                          (5)          (3)          (12)         (10)                                   
      Mineralization                                                             1 (8%)                                             

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: 11:19:17  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 MG/KG      3 MG/KG      30 MG/KG     100                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Fat, Inflammation, Chronic Active                2 (40%)      3 (100%)    10 (83%)     10 (100%)                              
      Fat, Mineralization                              1 (20%)                   3 (25%)      5 (50%)                               
      Fat, Necrosis                                    2 (40%)                   2 (17%)      1 (10%)                               
   Pancreas                                           (50)         (49)         (49)         (49)                                   
      Atrophy                                                       1 (2%)                                                          
      Inflammation, Chronic Active                                               2 (4%)                                             
      Acinus, Atrophy                                  8 (16%)      7 (14%)      5 (10%)      3 (6%)                                
   Salivary Glands                                    (50)         (49)         (50)         (49)                                   
      Inflammation, Chronic Active                                               1 (2%)                                             
   Stomach, Forestomach                               (50)         (50)         (50)         (50)                                   
      Hyperkeratosis                                   1 (2%)                                 1 (2%)                                
      Inflammation, Chronic Active                     1 (2%)       1 (2%)                                                          
      Perforation                                      1 (2%)                                                                       
      Ulcer                                            2 (4%)       2 (4%)       1 (2%)                                             
      Epithelium, Hyperplasia                                                                 1 (2%)                                
   Stomach, Glandular                                 (50)         (50)         (50)         (50)                                   
      Erosion                                                       1 (2%)                                                          
      Mineralization                                                1 (2%)       1 (2%)                                             
      Ulcer                                                                      3 (6%)                                             
   Tongue                                                          (1)                       (1)                                    
      Angiectasis                                                                             1 (100%)                              
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (50)         (50)         (50)         (49)                                   
      Thrombosis                                                                 1 (2%)                                             
      Epicardium, Inflammation, Chronic Active                                                2 (4%)                                
      Myocardium, Degeneration, Chronic               29 (58%)     34 (68%)     40 (80%)     45 (92%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (50)         (50)         (50)         (49)                                   
      Accessory Adrenal Cortical Nodule                1 (2%)                                                                       
      Angiectasis                                     21 (42%)     26 (52%)     15 (30%)      3 (6%)                                
      Hematopoietic Cell Proliferation                              1 (2%)                                                          
      Hypertrophy                                                   5 (10%)                                                         
      Metaplasia, Osseous                                           1 (2%)                                                          
      Mineralization                                   1 (2%)                                                                       
      Necrosis                                         1 (2%)                                 1 (2%)                                
      Pigmentation                                                               2 (4%)                                             
      Vacuolization Cytoplasmic                        4 (8%)       5 (10%)     21 (42%)     36 (73%)                               
   Adrenal Medulla                                    (50)         (50)         (50)         (49)                                   
      Hyperplasia                                      5 (10%)      1 (2%)       3 (6%)      13 (27%)                               
      Vacuolization Cytoplasmic                                                               1 (2%)                                
   Islets, Pancreatic                                 (49)         (49)         (49)         (49)                                   

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: 11:19:17  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 MG/KG      3 MG/KG      30 MG/KG     100                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
      Hyperplasia                                      1 (2%)                                                                       
   Parathyroid Gland                                  (47)         (46)         (42)         (38)                                   
      Hyperplasia                                                                2 (5%)                                             
   Pituitary Gland                                    (50)         (50)         (49)         (50)                                   
      Angiectasis                                      1 (2%)                                                                       
      Cyst                                            10 (20%)      9 (18%)      4 (8%)       1 (2%)                                
      Hemorrhage                                       1 (2%)                    2 (4%)                                             
      Hyperplasia                                      3 (6%)       2 (4%)       2 (4%)       1 (2%)                                
      Mineralization                                                             1 (2%)       1 (2%)                                
      Pars Distalis, Angiectasis                       1 (2%)       1 (2%)       1 (2%)                                             
      Pars Distalis, Hyperplasia                       1 (2%)       2 (4%)       2 (4%)                                             
      Pars Nervosa, Developmental Malformation                                   1 (2%)       1 (2%)                                
   Thyroid Gland                                      (50)         (49)         (50)         (49)                                   
      Cyst                                                          1 (2%)                    1 (2%)                                
      Hyperplasia                                                   1 (2%)                                                          
      Ultimobranchial Cyst                             2 (4%)       1 (2%)                    2 (4%)                                
      C-Cell, Hyperplasia                                                        2 (4%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (50)         (48)         (50)         (50)                                   
      Cyst                                             6 (12%)      6 (13%)      5 (10%)      2 (4%)                                
      Inflammation                                                               1 (2%)                                             
      Inflammation, Chronic Active                     7 (14%)      8 (17%)     11 (22%)     18 (36%)                               
   Ovary                                              (50)         (49)         (50)         (49)                                   
      DYSGENESIS                                                    1 (2%)      43 (86%)     49 (100%)                              
      Corpus Luteum, Cyst                                           1 (2%)                                                          
      Follicle, Cyst                                                2 (4%)       1 (2%)       1 (2%)                                
      Periovarian Tissue, Cyst                         4 (8%)                    4 (8%)       2 (4%)                                
   Uterus                                             (50)         (50)         (50)         (50)                                   
      Hemorrhage                                       1 (2%)       1 (2%)       2 (4%)                                             
      Hydrometra                                       3 (6%)       4 (8%)       5 (10%)      6 (12%)                               
      Inflammation, Chronic Active                     1 (2%)                                                                       
      Cervix, Angiectasis                                                                     1 (2%)                                
      Cervix, Cyst                                     1 (2%)                                 1 (2%)                                
      Endometrium, Cyst                                1 (2%)       1 (2%)       9 (18%)      3 (6%)                                
      Endometrium, Hyperplasia, Cystic                 1 (2%)                    4 (8%)       3 (6%)                                
      Endometrium, Inflammation, Chronic Active                     1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    

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: 11:19:17  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 MG/KG      3 MG/KG      30 MG/KG     100                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (50)         (49)         (49)                                   
      Hyperplasia                                                   1 (2%)                                                          
      Infiltration Cellular                                                      1 (2%)                                             
      Myelofibrosis                                                 2 (4%)       2 (4%)                                             
   Lymph Node                                         (4)          (1)          (1)          (1)                                    
      Ectasia                                          1 (25%)                                                                      
   Lymph Node, Mandibular                             (49)         (48)         (48)         (48)                                   
      Congestion                                       2 (4%)                                                                       
      Ectasia                                                       1 (2%)       1 (2%)       2 (4%)                                
   Lymph Node, Mesenteric                             (50)         (48)         (49)         (49)                                   
      Atrophy                                          1 (2%)                    1 (2%)                                             
      Ectasia                                                       1 (2%)       3 (6%)       4 (8%)                                
      Hemorrhage                                                    1 (2%)                                                          
      Inflammation, Granulomatous                                                             1 (2%)                                
      Inflammation, Suppurative                                     1 (2%)                                                          
   Spleen                                             (50)         (49)         (50)         (49)                                   
      Accessory Spleen                                              1 (2%)                    1 (2%)                                
      Angiectasis                                                                             1 (2%)                                
      Congestion                                                    1 (2%)                                                          
      Fibrosis                                         1 (2%)       1 (2%)       3 (6%)                                             
      Hematopoietic Cell Proliferation                 2 (4%)       6 (12%)                   3 (6%)                                
      Hyperplasia, Focal                               1 (2%)                    1 (2%)                                             
      Necrosis                                                                   1 (2%)       1 (2%)                                
      Pigmentation, Hemosiderin                                     1 (2%)                                                          
      Capsule, Fibrosis                                                          1 (2%)                                             
      Lymphoid Follicle, Depletion Cellular            1 (2%)       1 (2%)       1 (2%)       2 (4%)                                
   Thymus                                             (45)         (47)         (44)         (42)                                   
      Atrophy                                          3 (7%)       2 (4%)       7 (16%)      6 (14%)                               
      Inflammation                                                                            1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (50)         (50)         (49)         (50)                                   
      Dilatation                                      27 (54%)     34 (68%)     13 (27%)     17 (34%)                               
      Galactocele                                      2 (4%)       1 (2%)       3 (6%)       2 (4%)                                
      Hyperplasia, Focal                               3 (6%)                    1 (2%)       1 (2%)                                
      Lobular, Hyperplasia                                          1 (2%)                    1 (2%)                                
   Skin                                               (50)         (50)         (50)         (50)                                   
      Inflammation, Chronic Active                                                            1 (2%)                                
      Parakeratosis                                                                           1 (2%)                                
      Ulcer                                                                                   1 (2%)                                
      Epidermis, Cyst                                                            1 (2%)       1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    

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: 11:19:17  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 MG/KG      3 MG/KG      30 MG/KG     100                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (50)         (50)         (49)         (50)                                   
      Osteosclerosis                                   2 (4%)       2 (4%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (50)         (50)         (50)                                   
      Thrombosis                                                    1 (2%)                                                          
      Vacuolization Cytoplasmic                                     1 (2%)                                                          
   Spinal Cord                                        (1)          (1)          (1)          (2)                                    
      Hemorrhage                                                                              1 (50%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (50)         (50)         (49)                                   
      Congestion                                                                 1 (2%)                                             
      Cyst, Squamous                                                             1 (2%)                                             
      Inflammation, Chronic Active                     8 (16%)     12 (24%)      7 (14%)     17 (35%)                               
      Mineralization                                  15 (30%)     23 (46%)     33 (66%)     33 (67%)                               
      Necrosis                                                      1 (2%)                                                          
      Pigmentation                                     2 (4%)       1 (2%)       1 (2%)                                             
      Alveolar Epithelium, Hyperplasia                 4 (8%)      10 (20%)      4 (8%)       9 (18%)                               
      Alveolar Epithelium, Metaplasia, Squamous                     1 (2%)                                                          
      Interstitium, Fibrosis                           1 (2%)                                                                       
   Nose                                               (49)         (50)         (49)         (50)                                   
      Inflammation, Suppurative                        1 (2%)       3 (6%)                                                          
   Trachea                                            (50)         (50)         (50)         (49)                                   
      Inflammation, Chronic Active                     1 (2%)                                 1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (2)          (1)                                                              
      Lens, Mineralization                             1 (50%)      1 (100%)                                                        
      Retina, Degeneration                             1 (50%)      1 (100%)                                                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (50)         (50)         (49)                                   
      Congestion                                                                 1 (2%)                                             
      Cyst                                                                                    1 (2%)                                
      Developmental Malformation                                                              1 (2%)                                
      Hydronephrosis                                                1 (2%)                                                          
      Inflammation, Chronic Active                     1 (2%)                                 1 (2%)                                

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: 11:19:17  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 MG/KG      3 MG/KG      30 MG/KG     100                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
URINARY SYSTEM - CONT                                                                                                               
      Metaplasia, Osseous                                                        1 (2%)                                             
      Mineralization                                  27 (54%)     31 (62%)     35 (70%)     36 (73%)                               
      Necrosis                                                      1 (2%)                                                          
      Nephropathy                                     32 (64%)     26 (52%)     38 (76%)     41 (84%)                               
      Pigmentation, Hemosiderin                        5 (10%)      7 (14%)      4 (8%)       3 (6%)                                
   Urinary Bladder                                    (50)         (50)         (49)         (50)                                   
      Hemorrhage                                                    1 (2%)                                                          
      Inflammation, Chronic Active                                  3 (6%)       1 (2%)                                             
      Transitional Epithelium, Hyperplasia                                       2 (4%)       1 (2%)                                
                                                                                                                                    

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: 11:19:17  
____________________________________________________________________________________________________________________________________

         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                                     
  Early Deaths                                                                                                                      
    Moribund Sacrifice                                24           22           25           15                                     
    Natural Death                                     12           12           11           12                                     
    Dosing Accident                                                 1                         3                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                15           15           14           20                                     
  Other                                                                                       1                                     

  Animals Examined Microscopically                    51           50           50           50                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Esophagus                                          (50)         (49)         (50)         (49)                                   
      Periesophageal Tissue, Hemorrhage                                                       1 (2%)                                
   Intestine Large, Colon                             (48)         (49)         (46)         (47)                                   
      Inflammation, Chronic Active                                  1 (2%)                                                          
      Mineralization                                   1 (2%)       2 (4%)                                                          
      Parasite Metazoan                                3 (6%)                    2 (4%)       3 (6%)                                
   Intestine Large, Rectum                            (49)         (47)         (47)         (46)                                   
      Parasite Metazoan                                1 (2%)       3 (6%)       1 (2%)       1 (2%)                                
   Intestine Large, Cecum                             (43)         (40)         (41)         (44)                                   
      Inflammation, Granulomatous                      1 (2%)                                                                       
   Intestine Small, Duodenum                          (48)         (49)         (49)         (47)                                   
      Inflammation, Chronic Active                                  1 (2%)                                                          
      Mineralization                                   2 (4%)       1 (2%)                                                          
   Liver                                              (51)         (50)         (50)         (49)                                   
      Angiectasis                                      1 (2%)       2 (4%)                                                          
      Basophilic Focus                                23 (45%)     29 (58%)     41 (82%)     38 (78%)                               
      Clear Cell Focus                                 2 (4%)       2 (4%)       6 (12%)     12 (24%)                               
      Degeneration, Cystic                                          4 (8%)                                                          
      Eosinophilic Focus                               6 (12%)      4 (8%)       4 (8%)       2 (4%)                                
      Fatty Change                                                               1 (2%)                                             
      Hematopoietic Cell Proliferation                              2 (4%)       2 (4%)                                             
      Hemorrhage                                       1 (2%)                                                                       
      Hepatodiaphragmatic Nodule                       7 (14%)      3 (6%)       2 (4%)       6 (12%)                               
      Inflammation, Chronic Active                     9 (18%)      4 (8%)       3 (6%)       1 (2%)                                
      Mixed Cell Focus                                 2 (4%)       1 (2%)       4 (8%)       4 (8%)                                
      Necrosis                                         3 (6%)       1 (2%)       1 (2%)       1 (2%)                                
      Bile Duct, Fibrosis                                                                     1 (2%)                                
      Bile Duct, Hyperplasia                          29 (57%)     27 (54%)     24 (48%)                                            
      Centrilobular, Congestion                        1 (2%)                                 1 (2%)                                
      Centrilobular, Degeneration                                                1 (2%)                                             
      Centrilobular, Necrosis                          1 (2%)       3 (6%)       1 (2%)       1 (2%)                                
      Centrilobular, Vacuolization Cytoplasmic         9 (18%)      6 (12%)     10 (20%)      2 (4%)                                

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

                                                             Page    8                                                              
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: 11:19:17  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      3 MG/KG      30 MG/KG     150                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
   Mesentery                                          (14)         (6)          (5)          (3)                                    
      Fat, Inflammation, Chronic Active               10 (71%)      4 (67%)      5 (100%)     3 (100%)                              
      Fat, Mineralization                              5 (36%)      2 (33%)      3 (60%)                                            
      Fat, Necrosis                                    2 (14%)      2 (33%)      1 (20%)                                            
   Oral Mucosa                                        (3)          (1)                                                              
      Hyperplasia                                      1 (33%)                                                                      
   Pancreas                                           (49)         (48)         (50)         (48)                                   
      Inflammation, Chronic Active                     2 (4%)                                                                       
      Acinus, Atrophy                                 11 (22%)      7 (15%)     11 (22%)      4 (8%)                                
   Salivary Glands                                    (51)         (49)         (50)         (49)                                   
      Atrophy                                                       2 (4%)                                                          
   Stomach, Forestomach                               (51)         (50)         (49)         (48)                                   
      Edema                                            2 (4%)                                                                       
      Erosion                                                       1 (2%)       1 (2%)                                             
      Hyperkeratosis                                   1 (2%)                                 2 (4%)                                
      Inflammation, Chronic Active                     3 (6%)       3 (6%)       9 (18%)      4 (8%)                                
      Mineralization                                   1 (2%)       2 (4%)       2 (4%)       2 (4%)                                
      Perforation                                                                2 (4%)                                             
      Ulcer                                            6 (12%)      2 (4%)       4 (8%)       5 (10%)                               
      Epithelium, Hyperplasia                                                    2 (4%)       2 (4%)                                
   Stomach, Glandular                                 (51)         (50)         (49)         (48)                                   
      Erosion                                          2 (4%)                    1 (2%)                                             
      Hemorrhage                                                    1 (2%)                                                          
      Mineralization                                   6 (12%)      6 (12%)      7 (14%)      7 (15%)                               
      Ulcer                                                                                   1 (2%)                                
   Tongue                                             (1)                       (1)          (1)                                    
      Vacuolization Cytoplasmic                                                  1 (100%)                                           
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Blood Vessel                                       (51)         (50)         (50)         (48)                                   
      Mineralization                                   3 (6%)       5 (10%)      6 (12%)      7 (15%)                               
      Thrombosis                                                    1 (2%)                                                          
   Heart                                              (51)         (49)         (50)         (47)                                   
      Mineralization                                   3 (6%)       5 (10%)      8 (16%)      5 (11%)                               
      Thrombosis                                                    1 (2%)                    2 (4%)                                
      Myocardium, Degeneration, Chronic               43 (84%)     43 (88%)     48 (96%)     42 (89%)                               
      Pericardium, Inflammation, Chronic Active        1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (51)         (50)         (50)         (49)                                   
      Hematopoietic Cell Proliferation                                           1 (2%)                                             
      Hemorrhage                                                    2 (4%)                                                          
      Vacuolization Cytoplasmic                       22 (43%)     23 (46%)     40 (80%)     33 (67%)                               

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

                                                             Page    9                                                              
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: 11:19:17  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      3 MG/KG      30 MG/KG     150                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
   Adrenal Medulla                                    (51)         (50)         (50)         (49)                                   
      Hyperplasia                                     15 (29%)     17 (34%)     20 (40%)     15 (31%)                               
      Inflammation, Chronic Active                                               1 (2%)                                             
      Mineralization                                                                          1 (2%)                                
      Necrosis                                         1 (2%)                                                                       
   Islets, Pancreatic                                 (49)         (48)         (50)         (48)                                   
      Hyperplasia                                      1 (2%)                                 1 (2%)                                
      Pigmentation, Hemosiderin                                                  1 (2%)                                             
   Parathyroid Gland                                  (46)         (44)         (48)         (43)                                   
      Hyperplasia                                     10 (22%)     14 (32%)     17 (35%)     15 (35%)                               
   Pituitary Gland                                    (51)         (50)         (50)         (49)                                   
      Angiectasis                                                                             1 (2%)                                
      Cyst                                             2 (4%)       2 (4%)       3 (6%)       3 (6%)                                
      Hyperplasia                                      2 (4%)       2 (4%)                    1 (2%)                                
      Mineralization                                   2 (4%)       1 (2%)                                                          
      Necrosis                                         2 (4%)                                                                       
      Vacuolization Cytoplasmic                                                               1 (2%)                                
      Pars Distalis, Fibrosis                          1 (2%)                                                                       
      Pars Distalis, Hyperplasia                                                              1 (2%)                                
      Pars Nervosa, Developmental Malformation         1 (2%)                                 1 (2%)                                
   Thyroid Gland                                      (51)         (48)         (50)         (49)                                   
      Mineralization                                                1 (2%)                                                          
      Ultimobranchial Cyst                             1 (2%)       6 (13%)      3 (6%)                                             
      C-Cell, Hyperplasia                              1 (2%)                                                                       
      Follicle, Cyst                                   1 (2%)       1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (51)         (50)         (50)         (49)                                   
      Atypia Cellular                                               2 (4%)       1 (2%)                                             
      Degeneration                                     1 (2%)       1 (2%)       1 (2%)                                             
      Inflammation, Chronic Active                                  1 (2%)                                                          
      Inflammation, Granulomatous                      1 (2%)                                                                       
   Preputial Gland                                    (51)         (49)         (50)         (49)                                   
      Cyst                                             3 (6%)       2 (4%)                                                          
      Hyperplasia                                      1 (2%)       1 (2%)                                                          
      Inflammation, Chronic Active                    45 (88%)     37 (76%)     42 (84%)     36 (73%)                               
      Mineralization                                                2 (4%)                                                          
   Prostate                                           (51)         (50)         (50)         (49)                                   
      Atrophy                                                       1 (2%)                                                          
      Inflammation, Chronic Active                    10 (20%)      5 (10%)                                                         

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

                                                             Page   10                                                              
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: 11:19:17  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      3 MG/KG      30 MG/KG     150                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
GENITAL SYSTEM - CONT                                                                                                               
      Inflammation, Granulomatous                      1 (2%)                                                                       
      Mineralization                                                1 (2%)                    2 (4%)                                
   Seminal Vesicle                                    (51)         (49)         (50)         (48)                                   
      Inflammation, Chronic Active                     1 (2%)                                                                       
      Inflammation, Granulomatous                      1 (2%)                                                                       
      Mineralization                                   1 (2%)       1 (2%)                    1 (2%)                                
      Epithelium, Hyperplasia                          1 (2%)                                                                       
   Testes                                             (51)         (50)         (50)         (49)                                   
      Cyst                                             1 (2%)                                                                       
      Degeneration                                     9 (18%)      9 (18%)     37 (74%)     28 (57%)                               
      Mineralization                                  17 (33%)     10 (20%)     33 (66%)     19 (39%)                               
      Necrosis                                         1 (2%)                                                                       
      Interstitial Cell, Hyperplasia                  16 (31%)     22 (44%)                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (48)         (49)         (50)         (49)                                   
      Myelofibrosis                                    1 (2%)       2 (4%)                                                          
      Necrosis                                         1 (2%)                                                                       
   Lymph Node                                         (4)          (4)                       (2)                                    
      Ectasia                                          1 (25%)      2 (50%)                                                         
      Hemorrhage                                                    1 (25%)                                                         
      Pigmentation, Hemosiderin                        1 (25%)                                                                      
   Lymph Node, Mandibular                             (51)         (47)         (50)         (49)                                   
      Amyloid Deposition                               1 (2%)                                                                       
      Ectasia                                          2 (4%)       2 (4%)       2 (4%)       1 (2%)                                
      Inflammation, Chronic Active                                               1 (2%)                                             
   Lymph Node, Mesenteric                             (50)         (49)         (49)         (48)                                   
      Atrophy                                                       1 (2%)       1 (2%)       1 (2%)                                
      Congestion                                       1 (2%)                                                                       
      Ectasia                                          3 (6%)       5 (10%)      3 (6%)       5 (10%)                               
      Necrosis                                                                   1 (2%)                                             
   Spleen                                             (51)         (50)         (50)         (48)                                   
      Accessory Spleen                                                                        1 (2%)                                
      Angiectasis                                                   1 (2%)                                                          
      Congestion                                                    2 (4%)                                                          
      Fibrosis                                         7 (14%)      3 (6%)       2 (4%)                                             
      Hematopoietic Cell Proliferation                 3 (6%)       3 (6%)       2 (4%)       3 (6%)                                
      Necrosis                                         1 (2%)                                                                       
      Pigmentation, Hemosiderin                                     1 (2%)                                                          
      Thrombosis                                                                 1 (2%)                                             
      Lymphoid Follicle, Depletion Cellular            1 (2%)       1 (2%)       1 (2%)       2 (4%)                                
   Thymus                                             (42)         (42)         (38)         (39)                                   
      Atrophy                                          6 (14%)      3 (7%)       7 (18%)      7 (18%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    

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

                                                             Page   11                                                              
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: 11:19:17  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      3 MG/KG      30 MG/KG     150                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (51)         (48)         (49)         (50)                                   
      Angiectasis                                      1 (2%)                                                                       
      Dilatation                                      31 (61%)     24 (50%)     23 (47%)     23 (46%)                               
      Galactocele                                      1 (2%)       4 (8%)       1 (2%)       7 (14%)                               
      Hyperplasia                                                   1 (2%)                                                          
      Hyperplasia, Focal                                                         1 (2%)       1 (2%)                                
      Mineralization                                   2 (4%)       4 (8%)       3 (6%)       2 (4%)                                
      Pigmentation, Hemosiderin                        1 (2%)                                                                       
      Lobular, Hyperplasia                                                       4 (8%)      35 (70%)                               
   Skin                                               (51)         (50)         (49)         (50)                                   
      Inflammation, Chronic Active                                                            1 (2%)                                
      Parakeratosis                                    1 (2%)       1 (2%)                    1 (2%)                                
      Ulcer                                                         1 (2%)                                                          
      Epidermis, Cyst                                  2 (4%)       1 (2%)                                                          
      Hair Follicle, Cyst                                                                     1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (51)         (49)         (50)         (50)                                   
      Fibrous Osteodystrophy                           2 (4%)       8 (16%)     13 (26%)     15 (30%)                               
      Osteosclerosis                                   1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (51)         (50)         (50)         (50)                                   
      Hemorrhage                                                                 2 (4%)                                             
      Necrosis                                         2 (4%)                                                                       
      Meninges, Infiltration Cellular, Histiocyte                                1 (2%)                                             
   Spinal Cord                                        (5)          (1)          (4)                                                 
      Demyelination                                                              1 (25%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (51)         (50)         (50)         (47)                                   
      Congestion                                                                 1 (2%)       1 (2%)                                
      Edema                                                         1 (2%)                    1 (2%)                                
      Hemorrhage                                       1 (2%)       1 (2%)                    1 (2%)                                
      Inflammation, Chronic Active                    12 (24%)     13 (26%)     11 (22%)     14 (30%)                               
      Mineralization                                  19 (37%)     25 (50%)     27 (54%)     28 (60%)                               
      Necrosis                                         1 (2%)                    1 (2%)                                             
      Proteinosis                                                   1 (2%)                                                          
      Vacuolization Cytoplasmic                        6 (12%)      7 (14%)      7 (14%)      4 (9%)                                
      Alveolar Epithelium, Hyperplasia                 1 (2%)       1 (2%)       3 (6%)       2 (4%)                                

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

                                                             Page   12                                                              
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: 11:19:17  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      3 MG/KG      30 MG/KG     150                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
RESPIRATORY SYSTEM - CONT                                                                                                           
      Interstitium, Fibrosis                           1 (2%)       2 (4%)                                                          
   Nose                                               (50)         (49)         (50)         (50)                                   
      Inflammation, Chronic Active                     3 (6%)                    2 (4%)       1 (2%)                                
      Inflammation, Suppurative                        4 (8%)       6 (12%)      3 (6%)       2 (4%)                                
   Trachea                                            (50)         (49)         (50)         (49)                                   
      Inflammation, Chronic Active                     1 (2%)                                                                       
      Mineralization                                   1 (2%)       1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (1)          (2)          (2)          (3)                                    
      Degeneration                                                  1 (50%)                                                         
      Cornea, Inflammation, Suppurative                                          1 (50%)                                            
      Cornea, Mineralization                                                     1 (50%)                                            
      Cornea, Necrosis                                                           1 (50%)                                            
      Lens, Mineralization                                          1 (50%)                   2 (67%)                               
      Retina, Degeneration                             1 (100%)     1 (50%)                   2 (67%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (51)         (50)         (50)         (49)                                   
      Cyst                                             1 (2%)       7 (14%)      4 (8%)       6 (12%)                               
      Degeneration                                     1 (2%)                                                                       
      Hyperplasia, Oncocytic                                        1 (2%)                                                          
      Inflammation, Chronic Active                                  1 (2%)                                                          
      Mineralization                                   6 (12%)      6 (12%)      9 (18%)     25 (51%)                               
      Nephropathy                                     43 (84%)     47 (94%)     50 (100%)    48 (98%)                               
      Pigmentation, Hemosiderin                        4 (8%)       4 (8%)       2 (4%)       4 (8%)                                
      Renal Tubule, Accumulation, Hyaline Droplet      2 (4%)                                                                       
      Renal Tubule, Hyperplasia                        3 (6%)       2 (4%)       3 (6%)       1 (2%)                                
   Urinary Bladder                                    (51)         (50)         (50)         (49)                                   
      Hemorrhage                                                    1 (2%)                                                          
      Inflammation, Chronic Active                     1 (2%)       1 (2%)                    2 (4%)                                
      Mineralization                                   1 (2%)                                                                       
      Muscularis, Inflammation, Suppurative            1 (2%)                                                                       
      Transitional Epithelium, Hyperplasia                                                    1 (2%)                                
                                                                                                                                    

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

                                                             Page   13                                                              
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