National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/2383

TDMS Study 05002-05 Pathology Tables


                                     INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
                                                        GAMMA-BUTYROLACTONE


NTP Experiment-Test: 05002-05                                                                                     Report: PEIRPT03
Study Type: CHRONIC                                                                                               Date: 09/02/94
Route: GAVAGE                                                                                                     Time: 17:49:23




       Facility:  Southern Research Institute

       Chemical CAS #:  96-48-0

       Lock Date:  None

       Cage Range:  All

       Reasons For Removal:    All

       Removal Date Range:     All

       Treatment Groups:       Include All
































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

                                                             Page   1

NTP Experiment-Test: 05002-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        GAMMA-BUTYROLACTONE                                    Date: 09/02/94  
Route: GAVAGE                                                                                                     Time: 17:49:23  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   VEHICLE      225.         450.                                                   
                                                   CONTROL      MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially In Study                          50           50           50                                                  
  Early Deaths                                                                                                                      
    Moribund                                          19           16           14                                                  
    Dead                                               3            7            6                                                  
    Dosing Accident                                                              2                                                  
  Survivors                                                                                                                         
    Terminal Sacrifice                                28           26           28                                                  
    Dead                                                            1                                                               
  Animals Examined Microscopically                    50           50           50                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Esophagus                                          (50)         (24)         (50)                                                
      Serosa, Inflammation, Chronic                    1 (2%)                                                                       
   Intestine Large, Colon                             (48)         (20)         (49)                                                
      Infiltration Cellular, Lipocyte                  1 (2%)                                                                       
      Parasite Metazoan                                6 (13%)      2 (10%)      7 (14%)                                            
   Intestine Large, Rectum                            (48)         (20)         (43)                                                
      Parasite Metazoan                                                          1 (2%)                                             
   Intestine Small, Ileum                             (47)         (20)         (45)                                                
      Hyperplasia, Lymphoid                                                      1 (2%)                                             
   Liver                                              (50)         (50)         (50)                                                
      Angiectasis                                      1 (2%)                    1 (2%)                                             
      Basophilic Focus                                 1 (2%)                    1 (2%)                                             
      Basophilic Focus, Multiple                      35 (70%)     40 (80%)     32 (64%)                                            
      Clear Cell Focus                                                           2 (4%)                                             
      Cyst                                                          1 (2%)                                                          
      Eosinophilic Focus                               1 (2%)       3 (6%)       1 (2%)                                             
      Eosinophilic Focus, Multiple                                  2 (4%)                                                          
      Fibrosis, Focal                                                            1 (2%)                                             
      Hematopoietic Cell Proliferation                 2 (4%)       2 (4%)       1 (2%)                                             
      Hepatodiaphragmatic Nodule                       4 (8%)       5 (10%)      6 (12%)                                            
      Hyperplasia, Nodular                             4 (8%)       4 (8%)       3 (6%)                                             
      Inflammation, Granulomatous, Multiple            5 (10%)      9 (18%)     10 (20%)                                            
      Mixed Cell Focus                                 1 (2%)       2 (4%)       4 (8%)                                             
      Necrosis, Focal                                  1 (2%)       1 (2%)                                                          
      Vacuolization Cytoplasmic                        4 (8%)       2 (4%)       1 (2%)                                             
      Bile Duct, Dilatation                                         1 (2%)                                                          
      Bile Duct, Hyperplasia                          14 (28%)     15 (30%)     10 (20%)                                            
      Centrilobular, Necrosis, Multiple                1 (2%)                                                                       
      Serosa, Hemorrhage                               1 (2%)                                                                       
      Serosa, Inflammation, Suppurative                             1 (2%)                                                          
   Mesentery                                          (5)          (3)          (4)                                                 
      Fat, Inflammation, Chronic                       3 (60%)      1 (33%)                                                         
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    2                                                              
NTP Experiment-Test: 05002-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        GAMMA-BUTYROLACTONE                                    Date: 09/02/94  
Route: GAVAGE                                                                                                     Time: 17:49:23  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   VEHICLE      225.         450.                                                   
                                                   CONTROL      MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Fat, Inflammation, Focal, Granulomatous                                    1 (25%)                                            
      Fat, Necrosis, Focal                             4 (80%)      2 (67%)      2 (50%)                                            
   Pancreas                                           (49)         (24)         (50)                                                
      Polyarteritis, Multiple                                       1 (4%)                                                          
      Acinar Cell, Atrophy                             5 (10%)      4 (17%)      6 (12%)                                            
      Acinar Cell, Hyperplasia                         2 (4%)                    5 (10%)                                            
      Acinar Cell, Hyperplasia, Multiple                                         1 (2%)                                             
      Duct, Cyst                                                                 1 (2%)                                             
   Stomach                                            (49)         (24)         (50)                                                
      Forestomach, Edema                               1 (2%)       2 (8%)       2 (4%)                                             
      Forestomach, Inflammation, Chronic               1 (2%)                    1 (2%)                                             
      Forestomach, Ulcer                               1 (2%)       2 (8%)       3 (6%)                                             
      Forestomach, Ulcer, Multiple                                               2 (4%)                                             
      Glandular, Cyst, Multiple                                                  1 (2%)                                             
      Glandular, Mineralization                                     1 (4%)       4 (8%)                                             
      Glandular, Epithelium, Hyperplasia                                         1 (2%)                                             
   Tongue                                                                       (1)                                                 
      Hyperplasia, Squamous                                                      1 (100%)                                           
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Blood Vessel                                                    (1)          (1)                                                 
      Aorta, Media, Hypertrophy                                     1 (100%)                                                        
   Heart                                              (50)         (25)         (50)                                                
      Congestion                                                                 1 (2%)                                             
      Fibrosis, Focal                                               1 (4%)                                                          
      Fibrosis, Multiple                                            1 (4%)       1 (2%)                                             
      Inflammation, Chronic                           35 (70%)     13 (52%)     29 (58%)                                            
      Atrium, Congestion                                                         1 (2%)                                             
      Atrium, Thrombosis                                            1 (4%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Gland, Cortex                              (50)         (25)         (50)                                                
      Accessory Adrenal Cortical Nodule                4 (8%)       4 (16%)      2 (4%)                                             
      Angiectasis                                      1 (2%)                                                                       
      Congestion                                                                 1 (2%)                                             
      Degeneration, Cystic                             4 (8%)                    2 (4%)                                             
      Hematopoietic Cell Proliferation                 1 (2%)                                                                       
      Hypertrophy, Focal                               3 (6%)       3 (12%)      6 (12%)                                            
      Vacuolization Cytoplasmic                        5 (10%)      3 (12%)      3 (6%)                                             
   Adrenal Gland, Medulla                             (50)         (25)         (49)                                                
      Angiectasis                                                                1 (2%)                                             
      Congestion                                                                 1 (2%)                                             
      Hyperplasia, Focal                               4 (8%)       1 (4%)       1 (2%)                                             
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    3                                                              
NTP Experiment-Test: 05002-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        GAMMA-BUTYROLACTONE                                    Date: 09/02/94  
Route: GAVAGE                                                                                                     Time: 17:49:23  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   VEHICLE      225.         450.                                                   
                                                   CONTROL      MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
   Pituitary Gland                                    (49)         (37)         (48)                                                
      Cyst                                             1 (2%)                                                                       
      Cyst, Multiple                                   2 (4%)                                                                       
      Pars Distalis, Angiectasis                       4 (8%)       9 (24%)      4 (8%)                                             
      Pars Distalis, Cyst                              9 (18%)      6 (16%)      5 (10%)                                            
      Pars Distalis, Cyst, Multiple                   16 (33%)      7 (19%)      6 (13%)                                            
      Pars Distalis, Hemorrhage                                     3 (8%)                                                          
      Pars Distalis, Hyperplasia, Focal                7 (14%)      7 (19%)      6 (13%)                                            
      Pars Distalis, Inflammation, Focal,                                                                                           
          Granulomatous                                                          1 (2%)                                             
   Thyroid Gland                                      (50)         (27)         (50)                                                
      Angiectasis                                                   1 (4%)                                                          
      Degeneration, Cystic                                          1 (4%)                                                          
      Ultimobranchial Cyst                             2 (4%)                                                                       
      C-Cell, Hyperplasia                             10 (20%)      2 (7%)       3 (6%)                                             
      Follicle, Cyst                                   1 (2%)                                                                       
      Follicular Cell, Hyperplasia                     1 (2%)       1 (4%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (48)         (22)         (46)                                                
      Atrophy                                                       1 (5%)       1 (2%)                                             
      Fibrosis                                                                   1 (2%)                                             
      Hemorrhage                                       1 (2%)                                                                       
      Hyperplasia                                      2 (4%)       1 (5%)                                                          
      Inflammation, Suppurative                        4 (8%)       2 (9%)       3 (7%)                                             
      Metaplasia, Squamous                                                       1 (2%)                                             
      Necrosis                                         1 (2%)                                                                       
      Duct, Cyst                                      19 (40%)      4 (18%)     11 (24%)                                            
   Ovary                                              (50)         (24)         (50)                                                
      Cyst                                             5 (10%)                   3 (6%)                                             
      Hyperplasia, Tubular                                                       1 (2%)                                             
   Uterus                                             (50)         (32)         (50)                                                
      Decidual Reaction                                1 (2%)                    1 (2%)                                             
      Dilatation                                       4 (8%)       1 (3%)       2 (4%)                                             
      Inflammation, Suppurative                        1 (2%)                                                                       
      Cervix, Cyst                                     2 (4%)       1 (3%)                                                          
      Endometrium, Fibrosis                            1 (2%)                                                                       
      Endometrium, Fibrosis, Focal                     1 (2%)                                                                       
      Endometrium, Hyperplasia, Cystic                 6 (12%)      3 (9%)       7 (14%)                                            
      Endometrium, Hyperplasia, Glandular                           1 (3%)       2 (4%)                                             
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    4                                                              
NTP Experiment-Test: 05002-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        GAMMA-BUTYROLACTONE                                    Date: 09/02/94  
Route: GAVAGE                                                                                                     Time: 17:49:23  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   VEHICLE      225.         450.                                                   
                                                   CONTROL      MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
GENITAL SYSTEM - CONT                                                                                                               
   Vagina                                             (2)                       (4)                                                 
      Cyst                                             1 (50%)                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (49)         (24)         (50)                                                
      Hyperplasia, Reticulum Cell                                                2 (4%)                                             
      Myelofibrosis                                    3 (6%)                    1 (2%)                                             
      Myeloid Cell, Hyperplasia                        1 (2%)       1 (4%)                                                          
   Lymph Node                                         (50)         (26)         (50)                                                
      Mediastinal, Hyperplasia, Lymphoid                            1 (4%)                                                          
      Pancreatic, Inflammation, Granulomatous                                    1 (2%)                                             
   Lymph Node, Mandibular                             (49)         (23)         (50)                                                
      Hyperplasia, Lymphoid                            1 (2%)       1 (4%)       1 (2%)                                             
   Lymph Node, Mesenteric                             (49)         (24)         (49)                                                
      Depletion Lymphoid                               1 (2%)       1 (4%)                                                          
      Hyperplasia, Lymphoid                            1 (2%)       1 (4%)                                                          
      Pigmentation                                     1 (2%)       1 (4%)                                                          
   Spleen                                             (48)         (49)         (50)                                                
      Atrophy                                                       2 (4%)       1 (2%)                                             
      Fibrosis                                                      1 (2%)       1 (2%)                                             
      Hematopoietic Cell Proliferation                 3 (6%)       8 (16%)      3 (6%)                                             
      Necrosis                                                      1 (2%)                                                          
      Pigmentation                                     7 (15%)      9 (18%)      3 (6%)                                             
   Thymus                                             (48)         (21)         (47)                                                
      Atrophy                                                       1 (5%)                                                          
      Cyst, Multiple                                                             2 (4%)                                             
      Hemorrhage                                                                 1 (2%)                                             
      Hyperplasia, Lymphoid                            1 (2%)                                                                       
      Mediastinum, Hemorrhage                                                    1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (50)         (50)         (50)                                                
      Hyperplasia, Lobular                             6 (12%)      7 (14%)      3 (6%)                                             
      Duct, Cyst                                      42 (84%)     35 (70%)     23 (46%)                                            
   Skin                                               (50)         (28)         (50)                                                
      Cyst Epithelial Inclusion                        1 (2%)                                                                       
      Hemorrhage                                       1 (2%)                                                                       
      Ulcer                                                         1 (4%)                                                          
      Subcutaneous Tissue, Thrombosis, Multiple                     1 (4%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    5                                                              
NTP Experiment-Test: 05002-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        GAMMA-BUTYROLACTONE                                    Date: 09/02/94  
Route: GAVAGE                                                                                                     Time: 17:49:23  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   VEHICLE      225.         450.                                                   
                                                   CONTROL      MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (50)         (28)         (50)                                                
      Calvarium, Hyperostosis                          2 (4%)       4 (14%)      2 (4%)                                             
      Femur, Fracture                                                            1 (2%)                                             
   Skeletal Muscle                                    (2)                       (1)                                                 
      Diaphragm, Inflammation, Chronic                 1 (50%)                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (24)         (50)                                                
      Compression                                      5 (10%)      6 (25%)      1 (2%)                                             
      Hydrocephalus                                                 1 (4%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (30)         (50)                                                
      Congestion                                       2 (4%)       5 (17%)      6 (12%)                                            
      Hemorrhage                                       1 (2%)                                                                       
      Alveolar Epithelium, Hyperplasia                 3 (6%)                    1 (2%)                                             
      Alveolus, Pigmentation                                        1 (3%)       2 (4%)                                             
      Bronchus, Foreign Body                                                     1 (2%)                                             
      Lymphatic, Foreign Body                          1 (2%)       2 (7%)       1 (2%)                                             
      Mediastinum, Edema                                                         1 (2%)                                             
      Mediastinum, Foreign Body                                     1 (3%)       2 (4%)                                             
      Mediastinum, Hemorrhage                                                    2 (4%)                                             
      Peribronchial, Infiltration Cellular,                                                                                         
          Lymphocyte                                                             1 (2%)                                             
   Nose                                               (50)         (24)         (50)                                                
      Nasolacrimal Duct, Inflammation, Suppurative     2 (4%)                    1 (2%)                                             
   Trachea                                            (50)         (24)         (50)                                                
      Inflammation, Suppurative                                                  1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Ear                                                             (1)          (5)                                                 
      Inflammation, Suppurative                                     1 (100%)                                                        
   Eye                                                (1)          (1)          (3)                                                 
      Cataract                                                                   2 (67%)                                            
      Cataract, Multiple                               1 (100%)                                                                     
      Cornea, Edema                                                 1 (100%)                                                        
      Retina, Degeneration                             1 (100%)     1 (100%)     2 (67%)                                            
   Zymbal's Gland                                                  (2)          (1)                                                 
      Inflammation, Suppurative                                     1 (50%)                                                         
____________________________________________________________________________________________________________________________________
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    6                                                              
NTP Experiment-Test: 05002-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        GAMMA-BUTYROLACTONE                                    Date: 09/02/94  
Route: GAVAGE                                                                                                     Time: 17:49:23  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   VEHICLE      225.         450.                                                   
                                                   CONTROL      MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (49)         (24)         (49)                                                
      Fibrosis, Focal                                  1 (2%)                                                                       
      Infarct, Multiple                                                          1 (2%)                                             
      Nephropathy, Chronic                            23 (47%)      7 (29%)     19 (39%)                                            
      Cortex, Cyst                                     1 (2%)                                                                       
      Medulla, Cyst                                    1 (2%)                                                                       
      Renal Tubule, Degeneration                                    1 (4%)                                                          
      Renal Tubule, Dilatation                         1 (2%)                    1 (2%)                                             
      Renal Tubule, Mineralization                    10 (20%)      2 (8%)      19 (39%)                                            
      Renal Tubule, Pigmentation                       4 (8%)                    3 (6%)                                             
   Urinary Bladder                                    (50)         (24)         (50)                                                
      Inflammation, Chronic, Focal                     1 (2%)                                                                       
      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: 05002-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        GAMMA-BUTYROLACTONE                                    Date: 09/02/94  
Route: GAVAGE                                                                                                     Time: 17:49:23  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     VEHICLE      112.         225.                                                   
                                                   CONTROL      MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially In Study                          50           50           50                                                  
  Early Deaths                                                                                                                      
    Dead                                               6            7            3                                                  
    Moribund                                          19           13           12                                                  
    Dosing Accident                                    1            3            3                                                  
  Survivors                                                                                                                         
    Terminal Sacrifice                                24           27           32                                                  
  Animals Examined Microscopically                    50           50           50                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large, Cecum                             (48)         (17)         (49)                                                
      Parasite Metazoan                                1 (2%)                                                                       
   Intestine Large, Colon                             (47)         (21)         (50)                                                
      Fibrosis, Focal                                                            1 (2%)                                             
      Parasite Metazoan                                7 (15%)      1 (5%)       8 (16%)                                            
      Ulcer                                                                      1 (2%)                                             
   Intestine Large, Rectum                            (47)         (19)         (49)                                                
      Parasite Metazoan                                             2 (11%)      1 (2%)                                             
   Intestine Small, Ileum                             (46)         (18)         (49)                                                
      Hyperplasia, Lymphoid                            2 (4%)                    5 (10%)                                            
   Intestine Small, Jejunum                           (46)         (17)         (50)                                                
      Hyperplasia, Lymphoid                            1 (2%)                                                                       
      Metaplasia, Osseous                                           1 (6%)                                                          
   Liver                                              (50)         (50)         (50)                                                
      Basophilic Focus                                 7 (14%)      2 (4%)       5 (10%)                                            
      Basophilic Focus, Multiple                      13 (26%)     20 (40%)     18 (36%)                                            
      Clear Cell Focus                                 4 (8%)                    2 (4%)                                             
      Clear Cell Focus, Multiple                                                 3 (6%)                                             
      Congestion                                                    1 (2%)       1 (2%)                                             
      Degeneration, Cystic                             1 (2%)       1 (2%)       4 (8%)                                             
      Eosinophilic Focus                               4 (8%)                    1 (2%)                                             
      Eosinophilic Focus, Multiple                                               1 (2%)                                             
      Fibrosis                                                      1 (2%)                                                          
      Hematopoietic Cell Proliferation                 1 (2%)       1 (2%)       1 (2%)                                             
      Hemorrhage                                       1 (2%)       1 (2%)                                                          
      Hepatodiaphragmatic Nodule                       5 (10%)      4 (8%)       7 (14%)                                            
      Hyperplasia, Nodular                             4 (8%)       4 (8%)       6 (12%)                                            
      Inflammation, Granulomatous, Multiple            1 (2%)       1 (2%)       3 (6%)                                             
      Mixed Cell Focus                                 3 (6%)                    4 (8%)                                             
      Mixed Cell Focus, Multiple                       1 (2%)       2 (4%)                                                          
      Necrosis, Focal                                               1 (2%)                                                          
      Vacuolization Cytoplasmic                        6 (12%)      8 (16%)     11 (22%)                                            
      Bile Duct, Hyperplasia                          45 (90%)     35 (70%)     38 (76%)                                            
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    8                                                              
NTP Experiment-Test: 05002-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        GAMMA-BUTYROLACTONE                                    Date: 09/02/94  
Route: GAVAGE                                                                                                     Time: 17:49:23  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     VEHICLE      112.         225.                                                   
                                                   CONTROL      MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Centrilobular, Degeneration                      2 (4%)       1 (2%)       3 (6%)                                             
      Centrilobular, Necrosis                          1 (2%)                    1 (2%)                                             
   Mesentery                                          (11)         (10)         (19)                                                
      Inflammation, Chronic                                         2 (20%)                                                         
      Metaplasia, Osseous                              1 (9%)                                                                       
      Polyarteritis                                                              1 (5%)                                             
      Fat, Inflammation, Focal, Granulomatous                       1 (10%)      2 (11%)                                            
      Fat, Mineralization, Focal                       1 (9%)       1 (10%)                                                         
      Fat, Necrosis, Focal                             9 (82%)      9 (90%)     13 (68%)                                            
   Pancreas                                           (50)         (22)         (50)                                                
      Polyarteritis                                    3 (6%)                    6 (12%)                                            
      Acinar Cell, Atrophy                            18 (36%)      7 (32%)     21 (42%)                                            
      Acinar Cell, Hyperplasia                         2 (4%)       2 (9%)       4 (8%)                                             
      Acinar Cell, Hyperplasia, Multiple                                         1 (2%)                                             
   Pharynx                                            (1)                                                                           
      Palate, Hyperplasia, Squamous                    1 (100%)                                                                     
   Stomach                                            (50)         (29)         (50)                                                
      Forestomach, Cyst                                             1 (3%)                                                          
      Forestomach, Edema                               1 (2%)       3 (10%)      1 (2%)                                             
      Forestomach, Fibrosis, Chronic                                1 (3%)                                                          
      Forestomach, Hyperkeratosis                                   1 (3%)                                                          
      Forestomach, Inflammation, Chronic               2 (4%)       3 (10%)      1 (2%)                                             
      Forestomach, Mineralization                      1 (2%)                                                                       
      Forestomach, Polyarteritis                       1 (2%)                    1 (2%)                                             
      Forestomach, Ulcer                               1 (2%)       2 (7%)       1 (2%)                                             
      Forestomach, Epithelium, Hyperplasia             1 (2%)       3 (10%)      2 (4%)                                             
      Glandular, Mineralization                        2 (4%)                                                                       
      Glandular, Polyarteritis                                                   2 (4%)                                             
   Tongue                                             (3)          (4)                                                              
      Hemorrhage, Focal                                             1 (25%)                                                         
      Hyperkeratosis                                                1 (25%)                                                         
      Inflammation, Focal                              1 (33%)                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Blood Vessel                                       (1)                                                                           
      Mesenteric Artery, Polyarteritis                 1 (100%)                                                                     
   Heart                                              (50)         (25)         (50)                                                
      Congestion                                                    1 (4%)                                                          
      Fibrosis, Focal                                                            1 (2%)                                             
      Inflammation, Chronic                           46 (92%)     21 (84%)     43 (86%)                                            
      Mineralization                                                1 (4%)                                                          
      Atrium, Congestion                                            1 (4%)       4 (8%)                                             
      Atrium, Fibrosis                                                           1 (2%)                                             
      Atrium, Thrombosis                                            1 (4%)       4 (8%)                                             
      Valve, Bacterium                                 1 (2%)                                                                       
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    9                                                              
NTP Experiment-Test: 05002-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        GAMMA-BUTYROLACTONE                                    Date: 09/02/94  
Route: GAVAGE                                                                                                     Time: 17:49:23  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     VEHICLE      112.         225.                                                   
                                                   CONTROL      MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
CARDIOVASCULAR SYSTEM - CONT                                                                                                        
      Valve, Thrombosis                                1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Gland, Cortex                              (48)         (24)         (49)                                                
      Accessory Adrenal Cortical Nodule                                          2 (4%)                                             
      Degeneration, Cystic                                                       4 (8%)                                             
      Hyperplasia, Focal                               5 (10%)                   3 (6%)                                             
      Hypertrophy, Focal                               2 (4%)       1 (4%)                                                          
      Vacuolization Cytoplasmic                       11 (23%)      5 (21%)      5 (10%)                                            
   Adrenal Gland, Medulla                             (48)         (23)         (49)                                                
      Hemorrhage                                                    1 (4%)                                                          
      Hyperplasia, Focal                               5 (10%)      1 (4%)       1 (2%)                                             
      Hyperplasia, Focal, Multiple                                               2 (4%)                                             
      Mineralization                                                             1 (2%)                                             
      Thrombosis                                                                 1 (2%)                                             
      Vacuolization Cytoplasmic                        1 (2%)                                                                       
   Parathyroid Gland                                  (46)         (22)         (48)                                                
      Hyperplasia                                      1 (2%)       1 (5%)                                                          
   Pituitary Gland                                    (48)         (28)         (49)                                                
      Pars Distalis, Angiectasis                       3 (6%)       1 (4%)       2 (4%)                                             
      Pars Distalis, Cyst                              4 (8%)       2 (7%)       1 (2%)                                             
      Pars Distalis, Cyst, Multiple                    1 (2%)       1 (4%)                                                          
      Pars Distalis, Hemorrhage                                     1 (4%)       1 (2%)                                             
      Pars Distalis, Hyperplasia, Focal                8 (17%)      4 (14%)      3 (6%)                                             
      Pars Intermedia, Hemorrhage                                   1 (4%)                                                          
   Thyroid Gland                                      (50)         (25)         (50)                                                
      Hyperplasia, Cystic                              1 (2%)                                                                       
      Ultimobranchial Cyst                                                       1 (2%)                                             
      C-Cell, Hyperplasia                              9 (18%)      5 (20%)     13 (26%)                                            
      Follicle, Cyst                                   2 (4%)                    1 (2%)                                             
      Follicle, Hyperplasia, Cystic                                              1 (2%)                                             
      Follicular Cell, Hyperplasia                     1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (50)         (23)         (50)                                                
      Edema                                                                      1 (2%)                                             
   Preputial Gland                                    (48)         (24)         (50)                                                
      Atrophy                                         12 (25%)      3 (13%)     13 (26%)                                            
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   10                                                              
NTP Experiment-Test: 05002-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        GAMMA-BUTYROLACTONE                                    Date: 09/02/94  
Route: GAVAGE                                                                                                     Time: 17:49:23  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     VEHICLE      112.         225.                                                   
                                                   CONTROL      MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
GENITAL SYSTEM - CONT                                                                                                               
      Fibrosis                                         1 (2%)       2 (8%)                                                          
      Hyperplasia                                                   1 (4%)       1 (2%)                                             
      Inflammation, Chronic                            4 (8%)                    1 (2%)                                             
      Inflammation, Suppurative                        8 (17%)      9 (38%)      2 (4%)                                             
      Necrosis                                                                   1 (2%)                                             
      Duct, Cyst                                      10 (21%)      5 (21%)      7 (14%)                                            
   Prostate                                           (49)         (24)         (49)                                                
      Cyst                                                          1 (4%)                                                          
      Cyst, Multiple                                                2 (8%)                                                          
      Fibrosis                                                                   1 (2%)                                             
      Inflammation, Chronic                                         2 (8%)       2 (4%)                                             
      Inflammation, Suppurative                       16 (33%)     11 (46%)     17 (35%)                                            
      Epithelium, Hyperplasia                                                    1 (2%)                                             
   Seminal Vesicle                                    (50)         (25)         (50)                                                
      Atrophy                                                       1 (4%)                                                          
      Dilatation                                                    2 (8%)                                                          
      Inflammation, Chronic                                         1 (4%)                                                          
      Epithelium, Hyperplasia                                       1 (4%)                                                          
   Testes                                             (50)         (50)         (50)                                                
      Atrophy                                         15 (30%)     19 (38%)     22 (44%)                                            
      Mineralization                                                             1 (2%)                                             
      Necrosis                                         1 (2%)                                                                       
      Bilateral, Atrophy                                                         1 (2%)                                             
      Bilateral, Interstitial Cell, Hyperplasia        8 (16%)      2 (4%)       2 (4%)                                             
      Interstitial Cell, Atrophy                       2 (4%)                                                                       
      Interstitial Cell, Hyperplasia                   7 (14%)      8 (16%)     14 (28%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Blood                                              (2)          (2)                                                              
      Leukocytosis                                     1 (50%)                                                                      
   Bone Marrow                                        (50)         (23)         (50)                                                
      Atrophy                                          1 (2%)                                                                       
      Myelofibrosis                                    1 (2%)                                                                       
      Myeloid Cell, Hyperplasia                        1 (2%)       1 (4%)       1 (2%)                                             
   Lymph Node                                         (50)         (25)         (50)                                                
      Axillary, Hyperplasia, Lymphoid                                            1 (2%)                                             
      Inguinal, Cyst                                                1 (4%)                                                          
      Inguinal, Hyperplasia, Lymphoid                  1 (2%)                    1 (2%)                                             
      Mediastinal, Hemorrhage                                       2 (8%)                                                          
      Mediastinal, Hyperplasia, Histiocytic                         1 (4%)                                                          
      Mediastinal, Hyperplasia, Lymphoid               1 (2%)       1 (4%)                                                          
      Mediastinal, Necrosis                                         1 (4%)                                                          
      Mediastinal, Pigmentation                                                  1 (2%)                                             
      Pancreatic, Hyperplasia, Lymphoid                1 (2%)                                                                       
   Lymph Node, Mandibular                             (48)         (21)         (49)                                                
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   11                                                              
NTP Experiment-Test: 05002-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        GAMMA-BUTYROLACTONE                                    Date: 09/02/94  
Route: GAVAGE                                                                                                     Time: 17:49:23  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     VEHICLE      112.         225.                                                   
                                                   CONTROL      MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Cyst                                                          1 (5%)       1 (2%)                                             
      Cyst, Multiple                                                             2 (4%)                                             
      Hyperplasia, Lymphoid                            5 (10%)      1 (5%)       2 (4%)                                             
      Lymphocyte, Necrosis                                                       1 (2%)                                             
   Lymph Node, Mesenteric                             (48)         (23)         (50)                                                
      Angiectasis                                      1 (2%)       1 (4%)                                                          
      Cyst, Multiple                                   1 (2%)                                                                       
      Hyperplasia, Lymphoid                            1 (2%)                    1 (2%)                                             
      Lymphocyte, Necrosis                                                       1 (2%)                                             
   Spleen                                             (50)         (45)         (50)                                                
      Atrophy                                                       1 (2%)       1 (2%)                                             
      Atrophy, Focal                                                             1 (2%)                                             
      Congestion                                                    1 (2%)                                                          
      Developmental Malformation                                                 1 (2%)                                             
      Fibrosis                                         1 (2%)                                                                       
      Hematopoietic Cell Proliferation                 2 (4%)       2 (4%)       1 (2%)                                             
      Hemorrhage                                                    1 (2%)                                                          
      Hyperplasia, Lymphoid                            2 (4%)                                                                       
      Necrosis                                                      2 (4%)                                                          
      Pigmentation                                                  1 (2%)                                                          
   Thymus                                             (43)         (20)         (49)                                                
      Hyperplasia, Lymphoid                                                      1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (44)         (23)         (48)                                                
      Hyperplasia, Lobular                             1 (2%)       1 (4%)       1 (2%)                                             
      Duct, Cyst                                       6 (14%)      8 (35%)     10 (21%)                                            
   Skin                                               (50)         (37)         (50)                                                
      Cyst                                             1 (2%)                                                                       
      Cyst Epithelial Inclusion                                     1 (3%)       4 (8%)                                             
      Fibrosis                                         1 (2%)       1 (3%)                                                          
      Ulcer                                            1 (2%)                                                                       
      Epidermis, Hyperplasia                           1 (2%)                                                                       
      Epidermis, Hyperplasia, Focal                    1 (2%)       3 (8%)       1 (2%)                                             
      Subcutaneous Tissue, Hemorrhage, Chronic         1 (2%)                                                                       
      Subcutaneous Tissue, Inflammation,                                                                                            
          Granulomatous                                                          1 (2%)                                             
      Subcutaneous Tissue, Necrosis                    1 (2%)                    1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   12                                                              
NTP Experiment-Test: 05002-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        GAMMA-BUTYROLACTONE                                    Date: 09/02/94  
Route: GAVAGE                                                                                                     Time: 17:49:23  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     VEHICLE      112.         225.                                                   
                                                   CONTROL      MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Skeletal Muscle                                    (1)          (1)          (3)                                                 
      Abdominal, Metaplasia, Osseous                   1 (100%)                                                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (24)         (50)                                                
      Compression                                      1 (2%)       2 (8%)       1 (2%)                                             
      Hemorrhage                                       5 (10%)      1 (4%)       1 (2%)                                             
      Hippocampus, Vacuolization Cytoplasmic           1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (29)         (50)                                                
      Congestion                                       6 (12%)      9 (31%)      5 (10%)                                            
      Edema                                            1 (2%)                                                                       
      Foreign Body                                     2 (4%)                                                                       
      Hemorrhage                                       1 (2%)       1 (3%)       2 (4%)                                             
      Inflammation, Granulomatous                                   1 (3%)                                                          
      Inflammation, Suppurative                        1 (2%)                                                                       
      Alveolar Epithelium, Hyperplasia                 1 (2%)       1 (3%)       1 (2%)                                             
      Alveolus, Edema                                               1 (3%)                                                          
      Alveolus, Foreign Body                                        1 (3%)       2 (4%)                                             
      Alveolus, Pigmentation                                        2 (7%)                                                          
      Artery, Embolus Tumor                                                      1 (2%)                                             
      Artery, Embolus Tumor, Multiple                               1 (3%)                                                          
      Artery, Mineralization, Multiple                              1 (3%)                                                          
      Lymphatic, Foreign Body                                       3 (10%)      3 (6%)                                             
      Perivascular, Foreign Body                                                 1 (2%)                                             
      Subpleura, Hemorrhage                                                      1 (2%)                                             
   Nose                                               (50)         (23)         (49)                                                
      Lumen, Foreign Body                              1 (2%)                                                                       
      Lumen, Fungus                                    7 (14%)      2 (9%)       9 (18%)                                            
      Lumen, Inflammation, Suppurative                 8 (16%)      2 (9%)       8 (16%)                                            
      Nasolacrimal Duct, Inflammation, Suppurative     2 (4%)                    3 (6%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (7)          (5)          (3)                                                 
      Cataract                                         3 (43%)      3 (60%)      3 (100%)                                           
      Hemorrhage                                       1 (14%)                                                                      
      Inflammation, Suppurative                        1 (14%)                                                                      
      Retina, Degeneration                             4 (57%)                   3 (100%)                                           
   Harderian Gland                                    (1)                                                                           
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   13                                                              
NTP Experiment-Test: 05002-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        GAMMA-BUTYROLACTONE                                    Date: 09/02/94  
Route: GAVAGE                                                                                                     Time: 17:49:23  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     VEHICLE      112.         225.                                                   
                                                   CONTROL      MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
SPECIAL SENSES SYSTEM - CONT                                                                                                        
      Pigmentation                                     1 (100%)                                                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (23)         (50)                                                
      Bacterium                                        1 (2%)                                                                       
      Hydronephrosis                                                2 (9%)                                                          
      Hydronephrosis, Multiple                                      1 (4%)                                                          
      Infarct                                          1 (2%)                                                                       
      Inflammation, Suppurative                        1 (2%)                                                                       
      Nephropathy, Chronic                            41 (82%)     15 (65%)     46 (92%)                                            
      Medulla, Necrosis                                             1 (4%)                                                          
      Pelvis, Hemorrhage                                            1 (4%)                                                          
      Pelvis, Necrosis                                              1 (4%)                                                          
      Renal Tubule, Mineralization                     1 (2%)       1 (4%)       2 (4%)                                             
      Renal Tubule, Pigmentation                       1 (2%)       1 (4%)       4 (8%)                                             
   Urinary Bladder                                    (48)         (22)         (50)                                                
      Inflammation, Chronic                                         1 (5%)                                                          
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   14                                                              
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                             ----------              END OF REPORT             ----------                                           
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NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.