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TDMS Study 05067-09 Pathology Tables

NTP Experiment-Test: 05067-09         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                            THEOPHYLLINE                                       Date: 07/11/96
Route: GAVAGE                                                                                                     Time: 16:17:04

                                                           CORE STUDY




       Facility:  Southern Research Institute

       Chemical CAS #:  58-55-9

       Lock Date:  09/03/93

       Cage Range:  All

       Reasons For Removal:    All

       Removal Date Range:     All

       Treatment Groups:       Include All


































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

                                                              Page   1

NTP Experiment-Test: 05067-09         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                            THEOPHYLLINE                                       Date: 07/11/96  
Route: GAVAGE                                                                                                     Time: 16:17:04  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   VEHICLE      7.5          25 MG/KG     75 MG/KG                                  
                                                   CONTROL      MG/KG                                                               
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially In Study                          50           50           50           50                                     
  Early Deaths                                                                                                                      
    Moribund Sacrifice                                17           12           14            7                                     
    Natural Death                                      1            7            3            7                                     
    Dosing Accident                                                 1                         3                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                31           30           33           33                                     
    Natural Death                                      1                                                                            
  Animals Examined Microscopically                    50           50           50           50                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Esophagus                                          (50)         (50)         (50)         (50)                                   
      Inflammation, Focal                                           1 (2%)                                                          
      Perforation                                                   1 (2%)                                                          
   Intestine Large, Colon                             (50)         (47)         (50)         (50)                                   
      Parasite Metazoan                                                          4 (8%)       2 (4%)                                
   Intestine Large, Rectum                            (50)         (47)         (50)         (50)                                   
      Parasite Metazoan                                1 (2%)                    4 (8%)       2 (4%)                                
   Intestine Large, Cecum                             (50)         (47)         (50)         (50)                                   
      Parasite Metazoan                                                                       1 (2%)                                
   Liver                                              (50)         (50)         (50)         (50)                                   
      Angiectasis                                      1 (2%)                    2 (4%)       1 (2%)                                
      Basophilic Focus                                40 (80%)     37 (74%)     31 (62%)     32 (64%)                               
      Clear Cell Focus                                 3 (6%)                                 2 (4%)                                
      Eosinophilic Focus                               2 (4%)                                                                       
      Hemorrhage                                       1 (2%)                                                                       
      Hepatodiaphragmatic Nodule                       5 (10%)      4 (8%)       7 (14%)      7 (14%)                               
      Hyperplasia, Focal, Histiocytic                  6 (12%)      2 (4%)       1 (2%)       3 (6%)                                
      Hyperplasia, Focal, Lymphoid                     4 (8%)       2 (4%)       1 (2%)       4 (8%)                                
      Infiltration Cellular, Mixed Cell                1 (2%)                    5 (10%)      4 (8%)                                
      Mineralization, Focal                                                      1 (2%)                                             
      Mixed Cell Focus                                 2 (4%)       5 (10%)      5 (10%)      7 (14%)                               
      Vacuolization Cytoplasmic                        4 (8%)                                                                       
      Bile Duct, Hyperplasia                           8 (16%)      7 (14%)      4 (8%)       7 (14%)                               
      Centrilobular, Degeneration                                                1 (2%)                                             
      Centrilobular, Necrosis                          1 (2%)                                                                       
   Mesentery                                          (11)         (12)         (8)          (4)                                    
      Accessory Spleen                                 1 (9%)       1 (8%)                    1 (25%)                               
      Hemorrhage                                                                              1 (25%)                               
      Infiltration Cellular, Focal, Mixed Cell         1 (9%)                                                                       
      Inflammation, Chronic                            1 (9%)                                                                       
      Necrosis, Fatty                                               1 (8%)                                                          
      Artery, Inflammation, Chronic                    1 (9%)                    2 (25%)                                            
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    2                                                              
NTP Experiment-Test: 05067-09         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                            THEOPHYLLINE                                       Date: 07/11/96  
Route: GAVAGE                                                                                                     Time: 16:17:04  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   VEHICLE      7.5          25 MG/KG     75 MG/KG                                  
                                                   CONTROL      MG/KG                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Fat, Necrosis                                    6 (55%)      9 (75%)      2 (25%)                                            
      Vein, Inflammation, Chronic                                                1 (13%)                                            
   Pancreas                                           (50)         (48)         (49)         (50)                                   
      Inflammation, Chronic                                                                   1 (2%)                                
      Acinus, Atrophy, Focal                           3 (6%)       9 (19%)     10 (20%)      9 (18%)                               
      Acinus, Hyperplasia, Focal                                    2 (4%)       1 (2%)                                             
   Salivary Glands                                    (50)         (49)         (50)         (50)                                   
      Duct, Cyst                                                                 1 (2%)                                             
   Stomach, Forestomach                               (50)         (50)         (50)         (50)                                   
      Inflammation, Chronic                            3 (6%)       1 (2%)                                                          
      Ulcer                                            1 (2%)                                                                       
      Epithelium, Hyperplasia                          2 (4%)                    1 (2%)                                             
   Tooth                                                           (1)                                                              
      Developmental Malformation                                    1 (100%)                                                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (50)         (50)         (50)         (50)                                   
      Thrombosis                                       1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (50)         (50)         (50)         (50)                                   
      Accessory Adrenal Cortical Nodule                1 (2%)       3 (6%)                    2 (4%)                                
      Angiectasis                                      1 (2%)                                                                       
      Cytoplasmic Alteration, Focal                    6 (12%)      2 (4%)       6 (12%)      5 (10%)                               
      Hematopoietic Cell Proliferation                                           1 (2%)                                             
      Hemorrhage                                       1 (2%)                                 1 (2%)                                
      Vacuolization Cytoplasmic                                                               1 (2%)                                
   Adrenal Medulla                                    (50)         (49)         (50)         (49)                                   
      Hyperplasia                                      3 (6%)       4 (8%)       3 (6%)       5 (10%)                               
   Pituitary Gland                                    (47)         (50)         (49)         (49)                                   
      Angiectasis                                      6 (13%)      5 (10%)      6 (12%)      2 (4%)                                
      Fibrosis, Focal                                                                         1 (2%)                                
      Metaplasia, Focal, Osseous                                    1 (2%)                                                          
      Pars Distalis, Angiectasis                       1 (2%)                                 3 (6%)                                
      Pars Distalis, Cyst                              8 (17%)     14 (28%)      7 (14%)      7 (14%)                               
      Pars Distalis, Cytoplasmic Alteration, Focal     2 (4%)       4 (8%)       2 (4%)       4 (8%)                                
      Pars Distalis, Hyperplasia                                    1 (2%)                                                          
      Pars Distalis, Hyperplasia, Focal                3 (6%)       1 (2%)       2 (4%)       3 (6%)                                
      Pars Distalis, Necrosis                                                                 1 (2%)                                
   Thyroid Gland                                      (50)         (50)         (50)         (50)                                   
      Ultimobranchial Cyst                                                       1 (2%)                                             
      C-Cell, Hyperplasia                              6 (12%)      3 (6%)       1 (2%)       5 (10%)                               
      Follicle, Cyst                                   1 (2%)       1 (2%)       1 (2%)       2 (4%)                                
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    3                                                              
NTP Experiment-Test: 05067-09         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                            THEOPHYLLINE                                       Date: 07/11/96  
Route: GAVAGE                                                                                                     Time: 16:17:04  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   VEHICLE      7.5          25 MG/KG     75 MG/KG                                  
                                                   CONTROL      MG/KG                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
      Follicular Cell, Hyperplasia                                               2 (4%)       1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (49)         (50)         (50)         (50)                                   
      Degeneration, Cystic                             8 (16%)      6 (12%)      8 (16%)      3 (6%)                                
      Hyperplasia                                      3 (6%)       1 (2%)       3 (6%)       2 (4%)                                
      Inflammation, Chronic                            2 (4%)                    2 (4%)       2 (4%)                                
   Ovary                                              (50)         (50)         (50)         (50)                                   
      Cyst                                             3 (6%)       2 (4%)       1 (2%)       2 (4%)                                
      Bilateral, Cyst                                               1 (2%)       1 (2%)                                             
   Uterus                                             (50)         (50)         (50)         (50)                                   
      Hemorrhage                                                    1 (2%)                                                          
      Hydrometra                                       1 (2%)       3 (6%)       2 (4%)       3 (6%)                                
      Hyperplasia, Cystic                              1 (2%)                                                                       
      Cervix, Hypertrophy                                                                     2 (4%)                                
      Endometrium, Hyperplasia, Cystic                 8 (16%)      7 (14%)      8 (16%)     11 (22%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (49)         (50)         (50)                                   
      Depletion Cellular                               1 (2%)       1 (2%)                                                          
      Hyperplasia                                                   1 (2%)                                                          
      Hyperplasia, Focal, Histiocytic                                            1 (2%)       4 (8%)                                
      Myelofibrosis                                                 1 (2%)       1 (2%)                                             
   Lymph Node                                         (9)          (10)         (9)          (8)                                    
      Iliac, Ectasia                                   1 (11%)                                                                      
      Inguinal, Pigmentation                                        1 (10%)                                                         
      Mediastinal, Ectasia                             1 (11%)                                                                      
      Mediastinal, Hemorrhage                                                    1 (11%)      2 (25%)                               
      Mediastinal, Pigmentation                        4 (44%)      3 (30%)      1 (11%)      2 (25%)                               
      Pancreatic, Ectasia                                                        1 (11%)                                            
      Pancreatic, Pigmentation                                                   1 (11%)                                            
      Renal, Hyperplasia                                            1 (10%)                                                         
   Lymph Node, Mandibular                             (49)         (48)         (50)         (50)                                   
      Congestion                                                                              2 (4%)                                
      Ectasia                                                                    1 (2%)       1 (2%)                                
      Hemorrhage                                                                 3 (6%)                                             
      Hyperplasia                                      1 (2%)                                                                       
      Hyperplasia, Lymphoid                                                      2 (4%)                                             
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    4                                                              
NTP Experiment-Test: 05067-09         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                            THEOPHYLLINE                                       Date: 07/11/96  
Route: GAVAGE                                                                                                     Time: 16:17:04  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   VEHICLE      7.5          25 MG/KG     75 MG/KG                                  
                                                   CONTROL      MG/KG                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
   Lymph Node, Mesenteric                             (50)         (50)         (50)         (50)                                   
      Hemorrhage                                                                 1 (2%)                                             
      Hyperplasia, Lymphoid                                                      1 (2%)                                             
      Pigmentation                                                  2 (4%)       1 (2%)       1 (2%)                                
   Spleen                                             (50)         (48)         (50)         (50)                                   
      Hematopoietic Cell Proliferation                 5 (10%)      7 (15%)     11 (22%)      3 (6%)                                
      Hemorrhage                                                                              1 (2%)                                
      Pigmentation                                                               2 (4%)                                             
   Thymus                                             (49)         (49)         (48)         (50)                                   
      Angiectasis                                                                             1 (2%)                                
      Cyst                                             1 (2%)       1 (2%)                    2 (4%)                                
      Hemorrhage                                                                              1 (2%)                                
      Hyperplasia, Lymphoid                                                                   1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (50)         (50)         (50)         (49)                                   
      Cyst                                             1 (2%)                                                                       
      Ectasia                                         26 (52%)     23 (46%)     23 (46%)     20 (41%)                               
      Hyperplasia                                      5 (10%)      3 (6%)       4 (8%)       6 (12%)                               
   Skin                                               (50)         (50)         (50)         (50)                                   
      Inflammation, Chronic, Focal                     2 (4%)       1 (2%)       2 (4%)                                             
      Ulcer                                            1 (2%)       3 (6%)       1 (2%)                                             
      Subcutaneous Tissue, Fibrosis, Focal             1 (2%)                                                                       
      Subcutaneous Tissue, Hemorrhage, Focal           1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (50)         (50)         (50)         (50)                                   
      Hyperostosis                                     5 (10%)      3 (6%)       2 (4%)       2 (4%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (50)         (50)         (50)                                   
      Atrophy, Focal                                  10 (20%)      7 (14%)      7 (14%)      8 (16%)                               
      Hemorrhage, Focal                                3 (6%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (50)         (50)         (50)                                   
      Congestion                                                    2 (4%)       1 (2%)       5 (10%)                               
      Hemorrhage                                                    1 (2%)       1 (2%)                                             
      Hyperplasia, Histiocytic                                                   1 (2%)       1 (2%)                                
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    5                                                              
NTP Experiment-Test: 05067-09         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                            THEOPHYLLINE                                       Date: 07/11/96  
Route: GAVAGE                                                                                                     Time: 16:17:04  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   VEHICLE      7.5          25 MG/KG     75 MG/KG                                  
                                                   CONTROL      MG/KG                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
RESPIRATORY SYSTEM - CONT                                                                                                           
      Inflammation, Chronic                                         1 (2%)                                                          
      Alveolar Epithelium, Hyperplasia                 1 (2%)       1 (2%)       1 (2%)       3 (6%)                                
      Interstitium, Edema                                                        1 (2%)                                             
   Nose                                               (50)         (50)         (50)         (50)                                   
      Foreign Body                                     1 (2%)                                                                       
      Inflammation, Suppurative                        3 (6%)       3 (6%)       1 (2%)       2 (4%)                                
      Mucosa, Glands, Dilatation, Focal                             1 (2%)                                                          
      Nasolacrimal Duct, Inflammation, Suppurative     1 (2%)       1 (2%)                    1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (2)          (3)          (9)          (11)                                   
      Cataract                                                                                2 (18%)                               
      Inflammation, Chronic                                                                   1 (9%)                                
      Cornea, Inflammation, Chronic                                                           2 (18%)                               
      Cornea, Pigmentation                                                                    1 (9%)                                
      Retina, Degeneration                                                                    1 (9%)                                
      Sclera, Metaplasia, Focal, Osseous                            1 (33%)      3 (33%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (48)         (50)         (49)                                   
      Angiectasis                                                                             1 (2%)                                
      Cyst                                                          1 (2%)       2 (4%)                                             
      Fibrosis, Focal                                                                         1 (2%)                                
      Inflammation, Chronic                                                      1 (2%)                                             
      Inflammation, Suppurative                                                               1 (2%)                                
      Nephropathy                                     43 (86%)     36 (75%)     41 (82%)     41 (84%)                               
      Papilla, Mineralization, Focal                                1 (2%)                                                          
      Pelvis, Dilatation                                            1 (2%)                                                          
      Pelvis, Mineralization                                                     2 (4%)                                             
      Pelvis, Transitional Epithelium, Hyperplasia     1 (2%)       1 (2%)       2 (4%)                                             
      Renal Tubule, Pigmentation                                    1 (2%)                                                          
   Ureter                                             (1)                                                                           
      Inflammation, Chronic                            1 (100%)                                                                     
      Transitional Epithelium, Hyperplasia             1 (100%)                                                                     
   Urinary Bladder                                    (50)         (49)         (50)         (50)                                   
      Calculus Gross Observation                       1 (2%)                    1 (2%)                                             
      Calculus Micro Observation Only                  1 (2%)                                                                       
      Inflammation, Chronic                            1 (2%)                                                                       
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    6                                                              
NTP Experiment-Test: 05067-09         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                            THEOPHYLLINE                                       Date: 07/11/96  
Route: GAVAGE                                                                                                     Time: 16:17:04  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   VEHICLE      7.5          25 MG/KG     75 MG/KG                                  
                                                   CONTROL      MG/KG                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
URINARY SYSTEM - CONT                                                                                                               
      Transitional Epithelium, Hyperplasia             1 (2%)                    1 (2%)                                             
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    7                                                              
NTP Experiment-Test: 05067-09         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                            THEOPHYLLINE                                       Date: 07/11/96  
Route: GAVAGE                                                                                                     Time: 16:17:04  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     VEHICLE      7.5          25 MG/KG     75 MG/KG                                  
                                                   CONTROL      MG/KG                                                               
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially In Study                          50           50           50           50                                     
  Early Deaths                                                                                                                      
    Moribund Sacrifice                                21           11           18           13                                     
    Natural Death                                      5            5            2           13                                     
    Dosing Accident                                    1            1            1                                                  
  Survivors                                                                                                                         
    Terminal Sacrifice                                23           33           29           24                                     
  Animals Examined Microscopically                    50           50           50           50                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Esophagus                                          (50)         (50)         (50)         (50)                                   
      Hemorrhage                                                    1 (2%)                                                          
      Inflammation, Focal                                           1 (2%)       1 (2%)                                             
      Perforation                                      1 (2%)                    1 (2%)                                             
      Periesophageal Tissue, Inflammation, Focal       1 (2%)                                                                       
   Intestine Large, Rectum                            (49)         (48)         (50)         (49)                                   
      Parasite Metazoan                                             1 (2%)                                                          
   Liver                                              (50)         (50)         (50)         (50)                                   
      Angiectasis                                      1 (2%)       1 (2%)       1 (2%)                                             
      Basophilic Focus                                25 (50%)     20 (40%)     26 (52%)     14 (28%)                               
      Clear Cell Focus                                 4 (8%)       2 (4%)       1 (2%)       1 (2%)                                
      Congestion                                       1 (2%)                    2 (4%)       1 (2%)                                
      Degeneration, Cystic                             2 (4%)                                                                       
      Hemorrhage                                                                              1 (2%)                                
      Hepatodiaphragmatic Nodule                       6 (12%)      2 (4%)       3 (6%)       4 (8%)                                
      Hyperplasia, Focal, Histiocytic                                            1 (2%)                                             
      Infiltration Cellular, Mixed Cell                4 (8%)       3 (6%)       1 (2%)       1 (2%)                                
      Mineralization, Focal                                         1 (2%)                    1 (2%)                                
      Mixed Cell Focus                                 3 (6%)       3 (6%)       7 (14%)      3 (6%)                                
      Necrosis, Focal                                                                         2 (4%)                                
      Vacuolization Cytoplasmic                        2 (4%)                    1 (2%)                                             
      Bile Duct, Hyperplasia                          39 (78%)     39 (78%)     31 (62%)     29 (58%)                               
   Mesentery                                          (16)         (16)         (17)         (27)                                   
      Accessory Spleen                                                           1 (6%)                                             
      Artery, Inflammation, Chronic                    2 (13%)      2 (13%)      3 (18%)     15 (56%)                               
      Fat, Necrosis                                   15 (94%)     12 (75%)     15 (88%)     15 (56%)                               
      Lymphatic, Angiectasis                                                                  1 (4%)                                
   Pancreas                                           (50)         (50)         (50)         (50)                                   
      Acinus, Atrophy, Focal                          19 (38%)     13 (26%)     12 (24%)      9 (18%)                               
      Acinus, Hyperplasia                              1 (2%)                                                                       
      Acinus, Hyperplasia, Focal                       9 (18%)      5 (10%)      2 (4%)                                             
   Stomach, Forestomach                               (50)         (50)         (50)         (50)                                   
      Diverticulum                                     1 (2%)                                                                       
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    8                                                              
NTP Experiment-Test: 05067-09         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                            THEOPHYLLINE                                       Date: 07/11/96  
Route: GAVAGE                                                                                                     Time: 16:17:04  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     VEHICLE      7.5          25 MG/KG     75 MG/KG                                  
                                                   CONTROL      MG/KG                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Edema                                                                      1 (2%)                                             
      Erosion                                          1 (2%)                                                                       
      Inflammation, Chronic                            5 (10%)                                3 (6%)                                
      Ulcer                                            2 (4%)                                                                       
      Epithelium, Hyperplasia                          6 (12%)                                3 (6%)                                
   Stomach, Glandular                                 (50)         (49)         (50)         (50)                                   
      Erosion                                          1 (2%)                                                                       
      Inflammation, Chronic                            2 (4%)                                                                       
      Mineralization                                                1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (50)         (50)         (50)         (50)                                   
      Fibrosis, Focal                                                                         1 (2%)                                
      Hypertrophy                                                   1 (2%)                                                          
      Inflammation, Chronic, Focal                                               1 (2%)                                             
      Mineralization                                                1 (2%)                    1 (2%)                                
      Pericardium, Inflammation, Suppurative                                     1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (50)         (50)         (50)         (50)                                   
      Accessory Adrenal Cortical Nodule                1 (2%)                    3 (6%)       3 (6%)                                
      Cytoplasmic Alteration, Focal                    3 (6%)       1 (2%)       1 (2%)                                             
      Hemorrhage                                       1 (2%)                    1 (2%)       1 (2%)                                
      Hyperplasia, Focal                               1 (2%)                                                                       
      Infiltration Cellular, Focal, Mixed Cell                                                1 (2%)                                
      Necrosis, Focal                                  1 (2%)                                                                       
   Adrenal Medulla                                    (50)         (49)         (50)         (50)                                   
      Angiectasis                                                                1 (2%)                                             
      Hyperplasia                                      5 (10%)      9 (18%)      8 (16%)      4 (8%)                                
   Islets, Pancreatic                                 (50)         (50)         (50)         (50)                                   
      Hyperplasia                                      1 (2%)                                                                       
   Pituitary Gland                                    (50)         (49)         (50)         (48)                                   
      Angiectasis                                      2 (4%)       3 (6%)       1 (2%)       1 (2%)                                
      Pars Distalis, Angiectasis                                                 1 (2%)                                             
      Pars Distalis, Cyst                              2 (4%)       4 (8%)       3 (6%)       2 (4%)                                
      Pars Distalis, Cytoplasmic Alteration, Focal     2 (4%)       3 (6%)       2 (4%)       2 (4%)                                
      Pars Distalis, Degeneration, Focal                                         1 (2%)                                             
      Pars Distalis, Hyperplasia, Focal                4 (8%)       3 (6%)       1 (2%)       3 (6%)                                
   Thyroid Gland                                      (50)         (50)         (50)         (50)                                   
      C-Cell, Hyperplasia                              6 (12%)      5 (10%)      5 (10%)      2 (4%)                                
      Follicle, Cyst                                   2 (4%)       4 (8%)       2 (4%)       2 (4%)                                
      Follicle, Pigmentation, Focal                                 1 (2%)       1 (2%)                                             
      Follicular Cell, Hyperplasia                                               5 (10%)                                            
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    9                                                              
NTP Experiment-Test: 05067-09         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                            THEOPHYLLINE                                       Date: 07/11/96  
Route: GAVAGE                                                                                                     Time: 16:17:04  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     VEHICLE      7.5          25 MG/KG     75 MG/KG                                  
                                                   CONTROL      MG/KG                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (50)         (50)         (50)         (50)                                   
      Granuloma Sperm                                  1 (2%)                                                                       
      Inflammation, Chronic                                         3 (6%)                    1 (2%)                                
   Preputial Gland                                    (50)         (49)         (50)         (50)                                   
      Cyst                                             1 (2%)                                                                       
      Degeneration, Cystic                            10 (20%)      7 (14%)     10 (20%)      4 (8%)                                
      Hyperplasia                                                   3 (6%)                    4 (8%)                                
      Inflammation, Chronic                            5 (10%)      5 (10%)      8 (16%)      3 (6%)                                
   Prostate                                           (50)         (50)         (50)         (50)                                   
      Cyst                                             1 (2%)                                                                       
      Inflammation, Chronic                           30 (60%)     33 (66%)     31 (62%)     20 (40%)                               
      Epithelium, Hyperplasia, Focal                                             5 (10%)      2 (4%)                                
   Seminal Vesicle                                    (50)         (50)         (50)         (50)                                   
      Inflammation, Chronic                            1 (2%)                                                                       
   Testes                                             (50)         (50)         (50)         (50)                                   
      Cyst                                                          1 (2%)                                                          
      Germinal Epithelium, Degeneration                2 (4%)       4 (8%)       1 (2%)                                             
      Interstitial Cell, Hyperplasia                   2 (4%)       1 (2%)                    1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (50)         (50)         (50)                                   
      Myelofibrosis                                    2 (4%)                                                                       
      Necrosis, Focal                                               1 (2%)                                                          
   Lymph Node                                         (13)         (11)         (12)         (9)                                    
      Deep Cervical, Hyperplasia                                                              1 (11%)                               
      Iliac, Ectasia                                                1 (9%)                                                          
      Iliac, Hyperplasia                                                         1 (8%)                                             
      Inguinal, Hyperplasia                                         1 (9%)       1 (8%)                                             
      Inguinal, Hyperplasia, Lymphoid                                                         1 (11%)                               
      Inguinal, Pigmentation                                        1 (9%)                                                          
      Mediastinal, Ectasia                                          1 (9%)                                                          
      Mediastinal, Hemorrhage                          3 (23%)      3 (27%)      5 (42%)      5 (56%)                               
      Mediastinal, Hyperplasia, Lymphoid               1 (8%)                    1 (8%)                                             
      Mediastinal, Pigmentation                        4 (31%)      3 (27%)      2 (17%)      2 (22%)                               
      Pancreatic, Ectasia                                                        1 (8%)                                             
      Pancreatic, Hyperplasia, Histiocytic             1 (8%)                                                                       
      Pancreatic, Pigmentation                                                   1 (8%)                                             
   Lymph Node, Mandibular                             (48)         (49)         (50)         (50)                                   
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   10                                                              
NTP Experiment-Test: 05067-09         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                            THEOPHYLLINE                                       Date: 07/11/96  
Route: GAVAGE                                                                                                     Time: 16:17:04  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     VEHICLE      7.5          25 MG/KG     75 MG/KG                                  
                                                   CONTROL      MG/KG                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Congestion                                                                              1 (2%)                                
      Ectasia                                                                    2 (4%)       1 (2%)                                
      Hemorrhage                                                    3 (6%)       6 (12%)      2 (4%)                                
      Hyperplasia                                                   1 (2%)       4 (8%)       1 (2%)                                
      Hyperplasia, Lymphoid                            1 (2%)                                                                       
   Lymph Node, Mesenteric                             (50)         (49)         (50)         (49)                                   
      Hyperplasia                                                                1 (2%)                                             
      Pigmentation                                     1 (2%)                                                                       
   Spleen                                             (49)         (50)         (50)         (49)                                   
      Fibrosis, Focal                                  4 (8%)       2 (4%)       2 (4%)                                             
      Hematopoietic Cell Proliferation                 4 (8%)       1 (2%)       2 (4%)                                             
      Hemorrhage                                       1 (2%)                                                                       
      Necrosis, Focal                                               1 (2%)                                                          
   Thymus                                             (49)         (47)         (47)         (50)                                   
      Angiectasis                                                                1 (2%)       3 (6%)                                
      Cyst                                                                                    2 (4%)                                
      Hemorrhage                                       1 (2%)       1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (48)         (49)         (47)         (48)                                   
      Cyst                                                                       1 (2%)       1 (2%)                                
      Ectasia                                         13 (27%)     10 (20%)      8 (17%)      6 (13%)                               
      Hyperplasia                                      1 (2%)       1 (2%)                    2 (4%)                                
      Inflammation, Chronic, Focal                                               1 (2%)                                             
   Skin                                               (50)         (50)         (50)         (50)                                   
      Cyst Epithelial Inclusion                                     1 (2%)                                                          
      Hyperkeratosis                                                                          1 (2%)                                
      Inflammation, Chronic, Focal                                                            2 (4%)                                
      Ulcer                                                                                   1 (2%)                                
      Dermis, Atrophy, Focal                                        1 (2%)                                                          
      Epidermis, Hyperplasia, Focal                                 1 (2%)       1 (2%)       2 (4%)                                
      Hair Follicle, Atrophy                                                     1 (2%)                                             
      Subcutaneous Tissue, Edema                       1 (2%)                                 2 (4%)                                
      Subcutaneous Tissue, Hemorrhage, Focal           2 (4%)                    1 (2%)       1 (2%)                                
      Subcutaneous Tissue, Inflammation, Chronic,                                                                                   
           Focal                                                                              4 (8%)                                
      Subcutaneous Tissue, Necrosis, Focal                                       1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (50)         (50)         (50)         (50)                                   
      Callus                                                        1 (2%)                                                          
      Cranium, Hemorrhage                              1 (2%)                                                                       
   Skeletal Muscle                                    (4)          (1)          (1)                                                 
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   11                                                              
NTP Experiment-Test: 05067-09         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                            THEOPHYLLINE                                       Date: 07/11/96  
Route: GAVAGE                                                                                                     Time: 16:17:04  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     VEHICLE      7.5          25 MG/KG     75 MG/KG                                  
                                                   CONTROL      MG/KG                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
MUSCULOSKELETAL SYSTEM - CONT                                                                                                       
      Hemorrhage, Focal                                1 (25%)      1 (100%)                                                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (49)         (50)         (49)                                   
      Atrophy, Focal                                  10 (20%)     10 (20%)      8 (16%)      4 (8%)                                
      Hemorrhage, Focal                                3 (6%)                    3 (6%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (50)         (50)         (50)                                   
      Congestion                                       1 (2%)       1 (2%)                    8 (16%)                               
      Fibrosis, Focal                                               1 (2%)                                                          
      Foreign Body                                                               1 (2%)       2 (4%)                                
      Hemorrhage                                                                 2 (4%)       3 (6%)                                
      Hyperplasia, Histiocytic                                                                1 (2%)                                
      Inflammation, Chronic                                         1 (2%)       1 (2%)       2 (4%)                                
      Inflammation, Suppurative                        2 (4%)                                                                       
      Necrosis, Focal                                               1 (2%)                                                          
      Alveolar Epithelium, Hyperplasia                 7 (14%)      2 (4%)       2 (4%)       1 (2%)                                
      Interstitium, Edema                                                        1 (2%)                                             
      Mediastinum, Inflammation, Acute                                           1 (2%)                                             
      Serosa, Foreign Body                                                       1 (2%)       1 (2%)                                
      Serosa, Inflammation                                                       1 (2%)                                             
   Nose                                               (50)         (49)         (50)         (50)                                   
      Inflammation, Suppurative                        5 (10%)      3 (6%)       7 (14%)      3 (6%)                                
      Nasolacrimal Duct, Inflammation, Suppurative                  1 (2%)       1 (2%)                                             
      Respiratory Epithelium, Hyperplasia, Focal       1 (2%)       1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Ear                                                                                       (1)                                    
      External Ear, Inflammation, Chronic, Focal                                              1 (100%)                              
   Eye                                                (8)          (7)          (15)                                                
      Cataract                                         1 (13%)      1 (14%)                                                         
      Hemorrhage                                       2 (25%)                                                                      
      Retinal Detachment                               1 (13%)                                                                      
      Cornea, Pigmentation                             1 (13%)                                                                      
      Retina, Degeneration                                          1 (14%)                                                         
      Sclera, Metaplasia, Focal, Osseous               1 (13%)      2 (29%)      8 (53%)                                            
   Harderian Gland                                    (1)                                                                           
      Hypertrophy                                      1 (100%)                                                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   12                                                              
NTP Experiment-Test: 05067-09         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                            THEOPHYLLINE                                       Date: 07/11/96  
Route: GAVAGE                                                                                                     Time: 16:17:04  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     VEHICLE      7.5          25 MG/KG     75 MG/KG                                  
                                                   CONTROL      MG/KG                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (49)         (49)         (50)         (49)                                   
      Congestion                                       1 (2%)                                                                       
      Cyst                                             2 (4%)                    1 (2%)       1 (2%)                                
      Infarct                                                       1 (2%)                    1 (2%)                                
      Inflammation, Suppurative                                     1 (2%)                                                          
      Nephropathy                                     46 (94%)     44 (90%)     49 (98%)     48 (98%)                               
      Papilla, Mineralization, Focal                                1 (2%)                                                          
      Papilla, Necrosis                                             1 (2%)                                                          
      Renal Tubule, Accumulation, Hyaline Droplet      1 (2%)       1 (2%)                                                          
      Renal Tubule, Dilatation                                      2 (4%)                                                          
      Renal Tubule, Hyperplasia, Focal                                           1 (2%)                                             
      Renal Tubule, Pigmentation                                    1 (2%)       1 (2%)                                             
   Ureter                                                          (1)                                                              
      Inflammation, Chronic                                         1 (100%)                                                        
      Transitional Epithelium, Hyperplasia                          1 (100%)                                                        
   Urinary Bladder                                    (50)         (50)         (50)         (49)                                   
      Inflammation, Chronic                                         1 (2%)                                                          
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   13                                                              
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                             ----------              END OF REPORT             ----------                                           
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