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TDMS Study 05099-08 Pathology Tables

NTP Experiment-Test: 05099-08         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                      SALICYLAZOSULFAPYRIDINE                                  Date: 04/03/96
Route: GAVAGE                                                                                                     Time: 20:16:26




       Facility:  Southern Research Institute

       Chemical CAS #:  599-79-1

       Lock Date:  04/19/94

       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: 05099-08         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                      SALICYLAZOSULFAPYRIDINE                                  Date: 04/03/96  
Route: GAVAGE                                                                                                     Time: 20:16:26  
____________________________________________________________________________________________________________________________________

         B6C3F1 MICE FEMALE                        0 MG/KG      675          1350         2700                                      
                                                                MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________

DISPOSITION SUMMARY                                                                                                                 

  Animals Initially In Study                          60           60           60           60                                     

  Scheduled Sacrifice                                 10           10           10           10                                     
  Early Deaths                                                                                                                      
    Accidently Killed                                  1                         1                                                  
    Moribund Sacrifice                                 5            6            8            6                                     
    Natural Death                                      2            3            4            4                                     
    Dosing Accident                                    1                                      2                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                41           41           36           38                                     
    Accidently Killed                                                            1                                                  

  Animals Examined Microscopically                    60           60           60           60                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Esophagus                                          (60)         (60)         (60)         (60)                                   
      Inflammation, Chronic                            1 (2%)                                 1 (2%)                                
      Perforation                                      1 (2%)                                                                       
   Intestine Large, Cecum                             (59)         (59)         (58)         (56)                                   
      Edema                                            1 (2%)                                                                       
      Inflammation, Subacute                           1 (2%)                                                                       
   Intestine Small, Duodenum                          (60)         (59)         (58)         (56)                                   
      Hyperplasia                                                                             1 (2%)                                
      Necrosis                                                                                1 (2%)                                
   Intestine Small, Jejunum                           (59)         (59)         (58)         (56)                                   
      Dilatation                                                                              1 (2%)                                
      Peyer's Patch, Hyperplasia, Lymphoid                          2 (3%)                                                          
   Intestine Small, Ileum                             (59)         (59)         (58)         (55)                                   
      Dilatation                                                                              1 (2%)                                
      Inflammation, Subacute                                        1 (2%)                                                          
   Liver                                              (60)         (60)         (60)         (59)                                   
      Angiectasis                                      2 (3%)                    1 (2%)                                             
      Basophilic Focus                                 1 (2%)                    1 (2%)       1 (2%)                                
      Clear Cell Focus                                              1 (2%)       1 (2%)       1 (2%)                                
      Congestion                                       1 (2%)                                 1 (2%)                                
      Cytologic Alterations                                         3 (5%)       6 (10%)      8 (14%)                               
      Depletion Glycogen                                                         1 (2%)                                             
      Eosinophilic Focus                               6 (10%)     14 (23%)     13 (22%)     16 (27%)                               
      Eosinophilic Focus, Multiple                                  4 (7%)       2 (3%)       4 (7%)                                
      Fibrosis                                                                   1 (2%)                                             
      Hematopoietic Cell Proliferation                              1 (2%)       1 (2%)       1 (2%)                                
      Hemorrhage                                                                 1 (2%)                                             
      Hyperplasia, Lymphoid                            1 (2%)                                                                       
      Inflammation, Chronic                                         1 (2%)                                                          

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

                                                             Page    2                                                              
NTP Experiment-Test: 05099-08         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                      SALICYLAZOSULFAPYRIDINE                                  Date: 04/03/96  
Route: GAVAGE                                                                                                     Time: 20:16:26  
____________________________________________________________________________________________________________________________________

         B6C3F1 MICE FEMALE                        0 MG/KG      675          1350         2700                                      
                                                                MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Inflammation, Subacute                           2 (3%)       2 (3%)       3 (5%)       4 (7%)                                
      Mineralization                                                             1 (2%)                                             
      Mixed Cell Focus                                 2 (3%)                    2 (3%)       1 (2%)                                
      Necrosis                                                      3 (5%)       5 (8%)       2 (3%)                                
      Pigmentation, Bile                               1 (2%)       1 (2%)                                                          
      Thrombosis                                                    1 (2%)                                                          
      Vacuolization Cytoplasmic                        3 (5%)                    1 (2%)       1 (2%)                                
      Bile Duct, Cyst                                  2 (3%)                    1 (2%)                                             
   Mesentery                                          (7)          (11)         (3)          (5)                                    
      Cyst                                             1 (14%)                                                                      
      Inflammation, Subacute                           1 (14%)                                                                      
      Polyarteritis                                    2 (29%)                                                                      
      Fat, Inflammation, Subacute                                                             1 (20%)                               
      Fat, Necrosis                                    4 (57%)     11 (100%)     1 (33%)      4 (80%)                               
   Pancreas                                           (60)         (59)         (60)         (59)                                   
      Edema                                            1 (2%)       1 (2%)                                                          
      Fibrosis                                                                                1 (2%)                                
      Hemorrhage                                                                 1 (2%)                                             
      Inflammation, Chronic                                                      1 (2%)                                             
      Inflammation, Subacute                                                                  1 (2%)                                
      Polyarteritis                                    1 (2%)                                                                       
      Acinus, Atrophy                                               1 (2%)       4 (7%)       1 (2%)                                
      Acinus, Depletion Secretory                      1 (2%)                    1 (2%)                                             
      Acinus, Necrosis                                              1 (2%)                    1 (2%)                                
      Duct, Cyst                                       1 (2%)       1 (2%)                    1 (2%)                                
   Salivary Glands                                    (59)         (60)         (60)         (60)                                   
      Acinus, Atrophy                                  1 (2%)                                                                       
   Stomach, Forestomach                               (60)         (59)         (60)         (59)                                   
      Diverticulum                                     1 (2%)       1 (2%)                                                          
      Edema                                                                                   1 (2%)                                
      Hyperplasia                                     13 (22%)      7 (12%)      6 (10%)      4 (7%)                                
      Inflammation, Subacute                           2 (3%)       2 (3%)                    1 (2%)                                
      Mineralization                                   1 (2%)                    1 (2%)                                             
      Polyarteritis                                    1 (2%)                                                                       
      Ulcer                                            2 (3%)                                 1 (2%)                                
   Stomach, Glandular                                 (60)         (59)         (60)         (59)                                   
      Cyst                                             3 (5%)                    1 (2%)       1 (2%)                                
      Edema                                                                      2 (3%)                                             
      Erosion                                                                                 1 (2%)                                
      Hyperplasia                                                   1 (2%)                    1 (2%)                                
      Inflammation, Subacute                                        2 (3%)                                                          
      Mineralization                                   3 (5%)       8 (14%)      4 (7%)       5 (8%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    

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

                                                             Page    3                                                              
NTP Experiment-Test: 05099-08         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                      SALICYLAZOSULFAPYRIDINE                                  Date: 04/03/96  
Route: GAVAGE                                                                                                     Time: 20:16:26  
____________________________________________________________________________________________________________________________________

         B6C3F1 MICE FEMALE                        0 MG/KG      675          1350         2700                                      
                                                                MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (60)         (60)         (60)         (60)                                   
      Cardiomyopathy                                                1 (2%)                                                          
      Congestion                                                                 1 (2%)                                             
      Degeneration                                     1 (2%)                                                                       
      Fibrosis                                         1 (2%)       1 (2%)       1 (2%)                                             
      Foreign Body                                     1 (2%)                                                                       
      Hemorrhage                                                    1 (2%)                                                          
      Mineralization                                   1 (2%)                    1 (2%)                                             
      Pericardium, Inflammation, Chronic               1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (60)         (60)         (60)         (60)                                   
      Accessory Adrenal Cortical Nodule                1 (2%)       1 (2%)                                                          
      Cyst                                             2 (3%)                    1 (2%)       1 (2%)                                
      Hematopoietic Cell Proliferation                 1 (2%)                                                                       
      Hyperplasia                                                   2 (3%)       3 (5%)       4 (7%)                                
      Hypertrophy                                                   1 (2%)       1 (2%)       1 (2%)                                
      Vacuolization Cytoplasmic, Focal                                           1 (2%)                                             
      Capsule, Hyperplasia                             1 (2%)                                                                       
      Spindle Cell, Hyperplasia                        1 (2%)                                 1 (2%)                                
      X-Zone, Vacuolization Cytoplasmic                             1 (2%)       3 (5%)       2 (3%)                                
   Adrenal Medulla                                    (60)         (60)         (60)         (60)                                   
      Hyperplasia                                      2 (3%)                    1 (2%)                                             
   Islets, Pancreatic                                 (60)         (60)         (60)         (60)                                   
      Hyperplasia                                                   1 (2%)                                                          
   Pituitary Gland                                    (59)         (55)         (60)         (56)                                   
      Pars Distalis, Cyst                              1 (2%)                                                                       
      Pars Distalis, Hyperplasia                      13 (22%)     12 (22%)      7 (12%)      8 (14%)                               
      Pars Intermedia, Hyperplasia                                               1 (2%)                                             
   Thyroid Gland                                      (60)         (60)         (60)         (60)                                   
      Polyarteritis                                    1 (2%)                                                                       
      Follicle, Cyst                                   6 (10%)      4 (7%)       3 (5%)                                             
      Follicle, Degeneration                           3 (5%)       9 (15%)      9 (15%)     14 (23%)                               
      Follicular Cell, Hyperplasia                    20 (33%)      5 (8%)       2 (3%)       1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    

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

                                                             Page    4                                                              
NTP Experiment-Test: 05099-08         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                      SALICYLAZOSULFAPYRIDINE                                  Date: 04/03/96  
Route: GAVAGE                                                                                                     Time: 20:16:26  
____________________________________________________________________________________________________________________________________

         B6C3F1 MICE FEMALE                        0 MG/KG      675          1350         2700                                      
                                                                MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (60)         (60)         (60)         (60)                                   
      Atrophy                                                                    1 (2%)                                             
      Hemorrhage                                                                              1 (2%)                                
      Necrosis                                                                                1 (2%)                                
      Duct, Cyst                                      16 (27%)     21 (35%)     24 (40%)     15 (25%)                               
   Ovary                                              (59)         (59)         (59)         (59)                                   
      Cyst                                             9 (15%)     13 (22%)     14 (24%)      5 (8%)                                
      Hemorrhage                                       1 (2%)                                                                       
      Mineralization                                                             1 (2%)                                             
      Thrombosis                                                                 1 (2%)                                             
   Uterus                                             (60)         (60)         (60)         (59)                                   
      Cyst                                                                       1 (2%)                                             
      Dilatation                                       4 (7%)      18 (30%)     14 (23%)     11 (19%)                               
      Hemorrhage                                                                 3 (5%)       1 (2%)                                
      Hydrometra                                                                 1 (2%)                                             
      Hyperplasia, Cystic                             51 (85%)     48 (80%)     51 (85%)     50 (85%)                               
      Inflammation, Suppurative                        1 (2%)                                                                       
      Mineralization                                                             1 (2%)                                             
      Thrombosis                                                                 2 (3%)       1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (60)         (60)         (60)         (60)                                   
      Atrophy                                          1 (2%)                                                                       
   Lymph Node                                         (8)          (7)          (11)         (4)                                    
      Hyperplasia, Lymphoid                                                                   1 (25%)                               
      Inguinal, Hyperplasia, Lymphoid                               1 (14%)                   1 (25%)                               
      Mediastinal, Hyperplasia, Lymphoid               2 (25%)      2 (29%)      3 (27%)                                            
      Renal, Hyperplasia, Lymphoid                                  1 (14%)                                                         
   Lymph Node, Mandibular                             (59)         (60)         (60)         (59)                                   
      Angiectasis                                      2 (3%)                                                                       
      Hyperplasia, Lymphoid                            4 (7%)       1 (2%)       2 (3%)       4 (7%)                                
      Pigmentation                                                  1 (2%)                                                          
   Lymph Node, Mesenteric                             (59)         (60)         (60)         (58)                                   
      Angiectasis                                      3 (5%)                    2 (3%)                                             
      Hyperplasia, Lymphoid                            1 (2%)       2 (3%)       2 (3%)       4 (7%)                                
      Necrosis                                         2 (3%)                                 2 (3%)                                
   Spleen                                             (60)         (60)         (60)         (59)                                   
      Atrophy                                          1 (2%)                    1 (2%)       2 (3%)                                
      Congestion                                                    1 (2%)       1 (2%)                                             
      Cyst                                             1 (2%)                                                                       
      Hematopoietic Cell Proliferation                 9 (15%)     28 (47%)     29 (48%)     33 (56%)                               
      Hyperplasia, Lymphoid                           18 (30%)     28 (47%)     17 (28%)     15 (25%)                               
      Pigmentation, Hemosiderin                       14 (23%)     47 (78%)     49 (82%)     56 (95%)                               
      Polyarteritis                                    1 (2%)                                                                       

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

                                                             Page    5                                                              
NTP Experiment-Test: 05099-08         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                      SALICYLAZOSULFAPYRIDINE                                  Date: 04/03/96  
Route: GAVAGE                                                                                                     Time: 20:16:26  
____________________________________________________________________________________________________________________________________

         B6C3F1 MICE FEMALE                        0 MG/KG      675          1350         2700                                      
                                                                MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
   Thymus                                             (60)         (59)         (59)         (59)                                   
      Atrophy                                          1 (2%)       1 (2%)       2 (3%)       4 (7%)                                
      Cyst                                                                       2 (3%)                                             
      Hyperplasia, Lymphoid                            1 (2%)       1 (2%)       1 (2%)       2 (3%)                                
      Inflammation, Granulomatous                                                1 (2%)                                             
      Thymocyte, Necrosis                              1 (2%)                                 1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (60)         (60)         (60)         (60)                                   
      Duct, Cyst                                                                 1 (2%)                                             
   Skin                                               (60)         (60)         (60)         (60)                                   
      Cyst Epithelial Inclusion                                     1 (2%)                                                          
      Hyperkeratosis                                                             1 (2%)                                             
      Inflammation, Chronic                            1 (2%)                                                                       
      Inflammation, Subacute                                        1 (2%)       1 (2%)                                             
      Subcutaneous Tissue, Abscess                                  1 (2%)                                                          
      Subcutaneous Tissue, Edema                                                 1 (2%)                                             
      Subcutaneous Tissue, Fibrosis                                 1 (2%)                                                          
      Subcutaneous Tissue, Foreign Body                             1 (2%)                                                          
      Subcutaneous Tissue, Hemorrhage                                            1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (60)         (60)         (60)         (60)                                   
      Cranium, Fibrous Osteodystrophy                  1 (2%)                                 2 (3%)                                
      Cranium, Hyperostosis                                                                   1 (2%)                                
      Femur, Fibrous Osteodystrophy                    3 (5%)                    2 (3%)                                             
   Skeletal Muscle                                    (1)                       (2)          (1)                                    
      Abscess                                          1 (100%)                                                                     
      Foreign Body                                     1 (100%)                                                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (60)         (60)         (60)         (60)                                   
      Compression                                      1 (2%)                    2 (3%)                                             
      Cyst Epithelial Inclusion                                     1 (2%)       1 (2%)                                             
      Hemorrhage                                                    1 (2%)                                                          
      Vacuolization Cytoplasmic                        1 (2%)       1 (2%)                                                          
   Spinal Cord                                        (2)          (1)                       (2)                                    
      Vacuolization Cytoplasmic                        1 (50%)                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    

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

                                                             Page    6                                                              
NTP Experiment-Test: 05099-08         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                      SALICYLAZOSULFAPYRIDINE                                  Date: 04/03/96  
Route: GAVAGE                                                                                                     Time: 20:16:26  
____________________________________________________________________________________________________________________________________

         B6C3F1 MICE FEMALE                        0 MG/KG      675          1350         2700                                      
                                                                MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (60)         (60)         (60)         (60)                                   
      Congestion                                                                              1 (2%)                                
      Foreign Body                                     1 (2%)       1 (2%)                    1 (2%)                                
      Hemorrhage                                                    2 (3%)                    2 (3%)                                
      Hyperplasia, Macrophage                                       1 (2%)                                                          
      Inflammation, Subacute                                        1 (2%)       1 (2%)                                             
      Pigmentation                                                  1 (2%)                                                          
      Alveolar Epithelium, Hyperplasia                 3 (5%)                    3 (5%)                                             
      Alveolus, Infiltration Cellular, Histiocyte      2 (3%)       3 (5%)                                                          
      Mediastinum, Inflammation, Chronic               1 (2%)                                 1 (2%)                                
   Nose                                               (60)         (60)         (60)         (60)                                   
      Glands, Cyst                                                  2 (3%)       4 (7%)                                             
      Glands, Mineralization                                        1 (2%)       2 (3%)                                             
      Lumen, Exudate                                   1 (2%)       2 (3%)       1 (2%)                                             
      Lumen, Foreign Body                                           1 (2%)                                                          
      Olfactory Epithelium, Degeneration               8 (13%)     11 (18%)     12 (20%)      6 (10%)                               
      Respiratory Epithelium, Mineralization                        2 (3%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (60)         (60)         (60)         (59)                                   
      Fibrosis                                                                                1 (2%)                                
      Glomerulosclerosis                                            2 (3%)                    1 (2%)                                
      Metaplasia, Osseous                                           5 (8%)       2 (3%)       1 (2%)                                
      Mineralization                                  14 (23%)     27 (45%)     24 (40%)     13 (22%)                               
      Polyarteritis                                    1 (2%)                                                                       
      Cortex, Cyst                                                                            1 (2%)                                
      Pelvis, Mineralization                                        1 (2%)                                                          
      Renal Tubule, Casts                             26 (43%)     26 (43%)     26 (43%)     34 (58%)                               
      Renal Tubule, Degeneration                                    3 (5%)       1 (2%)                                             
      Renal Tubule, Dilatation                                                   1 (2%)                                             
      Renal Tubule, Pigmentation, Hemosiderin                       1 (2%)                                                          
      Renal Tubule, Regeneration                      17 (28%)     17 (28%)     14 (23%)     17 (29%)                               
   Urinary Bladder                                    (60)         (60)         (60)         (60)                                   
      Dilatation                                       1 (2%)                    1 (2%)                                             

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

                                                             Page    7                                                              
NTP Experiment-Test: 05099-08         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                      SALICYLAZOSULFAPYRIDINE                                  Date: 04/03/96  
Route: GAVAGE                                                                                                     Time: 20:16:26  
____________________________________________________________________________________________________________________________________

         B6C3F1 MICE FEMALE                        0 MG/KG      675          1350         2700                                      
                                                                MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
URINARY SYSTEM - CONT                                                                                                               
      Polyarteritis                                    1 (2%)                                                                       
                                                                                                                                    

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

                                                             Page    8                                                              
NTP Experiment-Test: 05099-08         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                      SALICYLAZOSULFAPYRIDINE                                  Date: 04/03/96  
Route: GAVAGE                                                                                                     Time: 20:16:26  
____________________________________________________________________________________________________________________________________

         B6C3F1 MICE MALE                          0 MG/KG      0 MG/KG      675          1350         2700                         
                                                                FEED RTD     MG/KG        MG/KG        MG/KG                        
____________________________________________________________________________________________________________________________________

DISPOSITION SUMMARY                                                                                                                 

  Animals Initially In Study                          60           60           60           60           60                        

  Scheduled Sacrifice                                 10           10           10           10           10                        
  Early Deaths                                                                                                                      
    Moribund Sacrifice                                 5            3            4            3            4                        
    Natural Death                                      3            1            5            6                                     
    Dosing Accident                                    2            1                                                               
  Survivors                                                                                                                         
    Terminal Sacrifice                                40           45           41           41           46                        

  Animals Examined Microscopically                    60           60           60           60           60                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Esophagus                                          (60)         (60)         (60)         (60)         (60)                      
      Hemorrhage                                       1 (2%)       1 (2%)                                                          
   Gallbladder                                        (59)         (59)         (58)         (59)         (58)                      
      Fibrosis                                                                   1 (2%)                                             
      Inflammation, Suppurative                                                               1 (2%)                                
      Epithelium, Hyperplasia                                                                 1 (2%)                                
   Intestine Large, Cecum                             (57)         (60)         (56)         (56)         (60)                      
      Parasite Metazoan                                1 (2%)                                                                       
   Intestine Small, Duodenum                          (57)         (60)         (57)         (57)         (60)                      
      Dilatation                                                                                           1 (2%)                   
      Inflammation, Subacute                                                                  1 (2%)                                
      Necrosis                                                                                1 (2%)                                
      Ulcer                                                                                   1 (2%)                                
   Intestine Small, Jejunum                           (57)         (60)         (56)         (57)         (60)                      
      Hyperplasia, Glandular                                        1 (2%)                                                          
      Peyer's Patch, Hyperplasia, Lymphoid                                                    2 (4%)                                
   Intestine Small, Ileum                             (57)         (60)         (56)         (56)         (60)                      
      Inflammation, Chronic                                                                                1 (2%)                   
      Peyer's Patch, Hyperplasia, Lymphoid                          1 (2%)                                                          
   Liver                                              (60)         (60)         (60)         (60)         (60)                      
      Angiectasis                                                   1 (2%)       1 (2%)       1 (2%)                                
      Basophilic Focus                                 1 (2%)                    4 (7%)                                             
      Clear Cell Focus                                 3 (5%)       2 (3%)      15 (25%)      4 (7%)       8 (13%)                  
      Clear Cell Focus, Multiple                                                              1 (2%)       3 (5%)                   
      Cytologic Alterations                                                      2 (3%)       8 (13%)     10 (17%)                  
      Developmental Malformation                                                 1 (2%)                                             
      Eosinophilic Focus                               5 (8%)       1 (2%)      17 (28%)     19 (32%)     14 (23%)                  
      Eosinophilic Focus, Multiple                     1 (2%)                    2 (3%)       3 (5%)       9 (15%)                  
      Fatty Change, Focal                              1 (2%)                                                                       
      Hematopoietic Cell Proliferation                                                                     1 (2%)                   
      Hemorrhage                                       1 (2%)                    1 (2%)                                             

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

                                                             Page    9                                                              
NTP Experiment-Test: 05099-08         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                      SALICYLAZOSULFAPYRIDINE                                  Date: 04/03/96  
Route: GAVAGE                                                                                                     Time: 20:16:26  
____________________________________________________________________________________________________________________________________

         B6C3F1 MICE MALE                          0 MG/KG      0 MG/KG      675          1350         2700                         
                                                                FEED RTD     MG/KG        MG/KG        MG/KG                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Hepatodiaphragmatic Nodule                                                              1 (2%)                                
      Inflammation, Chronic                                                                                1 (2%)                   
      Inflammation, Subacute                           3 (5%)       1 (2%)       1 (2%)       1 (2%)                                
      Mineralization                                   2 (3%)       1 (2%)                    3 (5%)                                
      Mixed Cell Focus                                 2 (3%)                    4 (7%)       1 (2%)       2 (3%)                   
      Necrosis                                         3 (5%)       2 (3%)       6 (10%)      5 (8%)       3 (5%)                   
      Pigmentation, Bile                               1 (2%)                                                                       
      Pigmentation, Hemosiderin                                                               1 (2%)                                
      Vacuolization Cytoplasmic                       13 (22%)      7 (12%)     12 (20%)      8 (13%)                               
      Bile Duct, Cyst                                  2 (3%)                                                                       
      Bile Duct, Hyperplasia                                                                  1 (2%)                                
   Mesentery                                          (4)          (2)          (4)          (1)          (1)                       
      Hemorrhage                                                                 1 (25%)                                            
      Inflammation, Subacute                                                     1 (25%)                                            
      Fat, Inflammation, Subacute                                   1 (50%)                                                         
      Fat, Necrosis                                    3 (75%)      1 (50%)      2 (50%)      1 (100%)     1 (100%)                 
   Pancreas                                           (60)         (60)         (60)         (60)         (60)                      
      Inflammation, Subacute                                                     1 (2%)       1 (2%)                                
      Necrosis                                                                                             1 (2%)                   
      Polyarteritis                                                              1 (2%)                                             
      Acinus, Atrophy                                               1 (2%)       2 (3%)                                             
      Acinus, Depletion Secretory                      1 (2%)                                                                       
      Duct, Cyst                                                                 1 (2%)                                             
   Salivary Glands                                    (60)         (60)         (60)         (60)         (60)                      
      Vacuolization Cytoplasmic                                                                            1 (2%)                   
      Submandibular Gland, Depletion Secretory                                   2 (3%)                    1 (2%)                   
   Stomach, Forestomach                               (60)         (60)         (60)         (59)         (60)                      
      Cyst                                                                       1 (2%)                                             
      Diverticulum                                                  1 (2%)                                                          
      Edema                                            1 (2%)                                 1 (2%)                                
      Hyperplasia                                     18 (30%)     25 (42%)     13 (22%)     12 (20%)     10 (17%)                  
      Inflammation, Subacute                           4 (7%)      13 (22%)      5 (8%)       3 (5%)       2 (3%)                   
      Mineralization                                                             1 (2%)                                             
      Ulcer                                            3 (5%)       2 (3%)       3 (5%)       2 (3%)                                
   Stomach, Glandular                                 (60)         (60)         (60)         (58)         (60)                      
      Atypia Cellular                                                                         2 (3%)                                
      Cyst                                                                                    3 (5%)                                
      Erosion                                          1 (2%)       1 (2%)                                                          
      Hyperplasia                                      1 (2%)                    1 (2%)                    1 (2%)                   
      Inflammation, Subacute                                        1 (2%)       2 (3%)                                             
      Mineralization                                   1 (2%)                   14 (23%)      9 (16%)      7 (12%)                  
      Necrosis                                                                                1 (2%)                                
      Pigmentation                                     1 (2%)                                                                       
      Polyarteritis                                                              1 (2%)                                             
      Ulcer                                            1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    

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

                                                             Page   10                                                              
NTP Experiment-Test: 05099-08         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                      SALICYLAZOSULFAPYRIDINE                                  Date: 04/03/96  
Route: GAVAGE                                                                                                     Time: 20:16:26  
____________________________________________________________________________________________________________________________________

         B6C3F1 MICE MALE                          0 MG/KG      0 MG/KG      675          1350         2700                         
                                                                FEED RTD     MG/KG        MG/KG        MG/KG                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (60)         (60)         (60)         (60)         (60)                      
      Cardiomyopathy                                                                          1 (2%)                                
      Embolus                                          1 (2%)                                                                       
      Fibrosis                                                                                1 (2%)                                
      Mineralization                                   1 (2%)                                 1 (2%)                                
      Polyarteritis                                                              1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (60)         (60)         (59)         (59)         (60)                      
      Accessory Adrenal Cortical Nodule                                          1 (2%)       2 (3%)                                
      Cyst                                                          1 (2%)                                                          
      Embolus                                          1 (2%)                                                                       
      Hemorrhage                                                                 1 (2%)       1 (2%)                                
      Hyperplasia                                      8 (13%)                  12 (20%)      9 (15%)      6 (10%)                  
      Hypertrophy                                     12 (20%)      9 (15%)     12 (20%)     14 (24%)     13 (22%)                  
      Necrosis                                                                   1 (2%)                                             
      Vacuolization Cytoplasmic                        1 (2%)                                                                       
      Capsule, Hyperplasia                             1 (2%)                    7 (12%)                   5 (8%)                   
   Adrenal Medulla                                    (60)         (60)         (59)         (59)         (60)                      
      Embolus                                          1 (2%)                                                                       
      Hemorrhage                                                                 1 (2%)                                             
      Hyperplasia                                                                2 (3%)                                             
   Islets, Pancreatic                                 (60)         (60)         (60)         (60)         (60)                      
      Embolus                                          1 (2%)                                                                       
      Hyperplasia                                      2 (3%)                    4 (7%)       1 (2%)       3 (5%)                   
   Parathyroid Gland                                  (58)         (58)         (57)         (57)         (59)                      
      Cyst                                                                                                 2 (3%)                   
   Pituitary Gland                                    (54)         (56)         (56)         (57)         (57)                      
      Pars Distalis, Cyst                                           4 (7%)       2 (4%)                                             
      Pars Distalis, Hyperplasia                                                              1 (2%)                                
   Thyroid Gland                                      (60)         (60)         (60)         (60)         (60)                      
      Polyarteritis                                                              1 (2%)                                             
      Follicle, Cyst                                   6 (10%)      4 (7%)       7 (12%)     12 (20%)      9 (15%)                  
      Follicle, Degeneration                           4 (7%)       3 (5%)       4 (7%)       1 (2%)       4 (7%)                   
      Follicular Cell, Hyperplasia                     9 (15%)      1 (2%)       4 (7%)       3 (5%)       2 (3%)                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    

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

                                                             Page   11                                                              
NTP Experiment-Test: 05099-08         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                      SALICYLAZOSULFAPYRIDINE                                  Date: 04/03/96  
Route: GAVAGE                                                                                                     Time: 20:16:26  
____________________________________________________________________________________________________________________________________

         B6C3F1 MICE MALE                          0 MG/KG      0 MG/KG      675          1350         2700                         
                                                                FEED RTD     MG/KG        MG/KG        MG/KG                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Coagulating Gland                                  (5)                       (1)                       (1)                       
      Dilatation                                       5 (100%)                  1 (100%)                                           
      Inflammation, Chronic                                                                                1 (100%)                 
   Epididymis                                         (60)         (60)         (60)         (60)         (60)                      
      Congestion                                       1 (2%)                                                                       
      Granuloma Sperm                                  1 (2%)                                                                       
      Infiltration Cellular, Lymphocyte                                                       1 (2%)                                
      Inflammation, Chronic                            1 (2%)                                                                       
   Preputial Gland                                    (59)         (60)         (59)         (59)         (60)                      
      Congestion                                       1 (2%)                                                                       
      Inflammation, Subacute                           2 (3%)                    1 (2%)       1 (2%)                                
      Duct, Cyst                                      49 (83%)     50 (83%)     48 (81%)     41 (69%)     45 (75%)                  
   Prostate                                           (60)         (60)         (60)         (60)         (60)                      
      Cyst                                             1 (2%)                                                                       
      Hyperplasia                                      1 (2%)                                                                       
      Inflammation, Subacute                                                                  1 (2%)                                
      Inflammation, Suppurative                        1 (2%)                                 1 (2%)                                
      Polyarteritis                                                              1 (2%)                                             
   Seminal Vesicle                                    (60)         (60)         (60)         (60)         (60)                      
      Atrophy                                          2 (3%)                                 2 (3%)       2 (3%)                   
      Dilatation                                      14 (23%)      1 (2%)       2 (3%)       4 (7%)                                
      Inflammation, Chronic                            1 (2%)                                              1 (2%)                   
      Epithelium, Hyperplasia                                                                 1 (2%)                                
   Testes                                             (60)         (60)         (60)         (60)         (60)                      
      Atrophy                                                                    1 (2%)                    1 (2%)                   
      Mineralization                                   1 (2%)                                                                       
      Thrombosis                                                                 1 (2%)                                             
      Interstitial Cell, Hyperplasia                                                                       1 (2%)                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (60)         (60)         (60)         (60)         (60)                      
      Atrophy                                                       2 (3%)                                                          
      Myeloid Cell, Hyperplasia                        2 (3%)                                                                       
   Lymph Node                                         (3)          (1)          (3)          (3)          (4)                       
      Inguinal, Angiectasis                                                      1 (33%)                                            
      Inguinal, Hyperplasia, Lymphoid                  1 (33%)                   1 (33%)                                            
      Inguinal, Infiltration Cellular, Mast Cell                                                           1 (25%)                  
      Inguinal, Pigmentation                                                     1 (33%)                                            
      Mediastinal, Angiectasis                                                                1 (33%)                               
      Mediastinal, Hematopoietic Cell Proliferation                              1 (33%)                                            
      Mediastinal, Hyperplasia, Lymphoid                                         1 (33%)      1 (33%)      1 (25%)                  
      Pancreatic, Angiectasis                                                                 1 (33%)                               
      Renal, Hyperplasia, Lymphoid                                                                         1 (25%)                  
   Lymph Node, Mandibular                             (60)         (59)         (59)         (59)         (59)                      

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

                                                             Page   12                                                              
NTP Experiment-Test: 05099-08         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                      SALICYLAZOSULFAPYRIDINE                                  Date: 04/03/96  
Route: GAVAGE                                                                                                     Time: 20:16:26  
____________________________________________________________________________________________________________________________________

         B6C3F1 MICE MALE                          0 MG/KG      0 MG/KG      675          1350         2700                         
                                                                FEED RTD     MG/KG        MG/KG        MG/KG                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Hyperplasia, Lymphoid                                         1 (2%)       1 (2%)                    1 (2%)                   
   Lymph Node, Mesenteric                             (60)         (58)         (60)         (60)         (60)                      
      Angiectasis                                     17 (28%)     23 (40%)     18 (30%)     18 (30%)     13 (22%)                  
      Hyperplasia, Lymphoid                            4 (7%)       3 (5%)       3 (5%)       3 (5%)       3 (5%)                   
      Infiltration Cellular, Histiocyte                                          1 (2%)                                             
      Necrosis                                                                   1 (2%)                                             
   Spleen                                             (60)         (60)         (60)         (59)         (60)                      
      Atrophy                                          5 (8%)                    1 (2%)       2 (3%)                                
      Congestion                                       1 (2%)                    1 (2%)                    1 (2%)                   
      Hematopoietic Cell Proliferation                13 (22%)      3 (5%)      24 (40%)     30 (51%)     23 (38%)                  
      Hyperplasia, Lymphoid                            5 (8%)       8 (13%)     12 (20%)     10 (17%)      7 (12%)                  
      Pigmentation, Hemosiderin                        2 (3%)       1 (2%)      29 (48%)     42 (71%)     57 (95%)                  
      Capsule, Inflammation, Subacute                                            1 (2%)                                             
   Thymus                                             (54)         (56)         (53)         (56)         (56)                      
      Atrophy                                          3 (6%)                    2 (4%)       1 (2%)       1 (2%)                   
      Cyst                                             2 (4%)       1 (2%)       4 (8%)       7 (13%)      2 (4%)                   
      Mineralization                                                1 (2%)                                                          
      Polyarteritis                                                              1 (2%)                                             
      Thymocyte, Necrosis                              1 (2%)                                              1 (2%)                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (60)         (60)         (60)         (60)         (60)                      
      Hyperkeratosis                                                1 (2%)                                                          
      Subcutaneous Tissue, Edema                                    1 (2%)       1 (2%)                                             
      Subcutaneous Tissue, Hemorrhage                                            1 (2%)                                             
      Subcutaneous Tissue, Inflammation, Chronic       1 (2%)                                                                       
      Subcutaneous Tissue, Inflammation, Subacute                                1 (2%)                                             
      Subcutaneous Tissue, Metaplasia, Osseous                                                             1 (2%)                   
      Subcutaneous Tissue, Mineralization              1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (60)         (60)         (60)         (60)         (60)                      
      Cranium, Hyperostosis                            2 (3%)       1 (2%)                    1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (60)         (60)         (60)         (60)         (60)                      
      Compression                                      1 (2%)                                                                       
      Embolus                                          1 (2%)                                                                       
      Hydrocephalus                                                                                        1 (2%)                   
      Pigmentation, Hemosiderin                                     1 (2%)                                                          
      Vacuolization Cytoplasmic                                     1 (2%)                                                          

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

                                                             Page   13                                                              
NTP Experiment-Test: 05099-08         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                      SALICYLAZOSULFAPYRIDINE                                  Date: 04/03/96  
Route: GAVAGE                                                                                                     Time: 20:16:26  
____________________________________________________________________________________________________________________________________

         B6C3F1 MICE MALE                          0 MG/KG      0 MG/KG      675          1350         2700                         
                                                                FEED RTD     MG/KG        MG/KG        MG/KG                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (60)         (60)         (60)         (60)         (60)                      
      Congestion                                                                                           1 (2%)                   
      Hyperplasia, Macrophage                                       1 (2%)       3 (5%)                    1 (2%)                   
      Alveolar Epithelium, Hyperplasia                 4 (7%)       3 (5%)       5 (8%)       5 (8%)       8 (13%)                  
      Alveolus, Foreign Body                           1 (2%)       1 (2%)                                                          
      Alveolus, Hemorrhage                             1 (2%)       1 (2%)                                                          
      Alveolus, Infiltration Cellular, Histiocyte      4 (7%)       1 (2%)                    3 (5%)       2 (3%)                   
      Mediastinum, Hemorrhage                          1 (2%)       1 (2%)                                                          
      Mediastinum, Inflammation, Chronic                                         1 (2%)                                             
   Nose                                               (60)         (60)         (60)         (60)         (60)                      
      Glands, Cyst                                     1 (2%)       1 (2%)                    4 (7%)                                
      Glands, Fibrosis                                                           1 (2%)                                             
      Lumen, Inflammation, Subacute                                              1 (2%)                                             
      Nasolacrimal Duct, Exudate                                                 1 (2%)                                             
      Olfactory Epithelium, Degeneration               1 (2%)                    2 (3%)       8 (13%)      2 (3%)                   
      Olfactory Epithelium, Hyperplasia                                                       1 (2%)                                
      Respiratory Epithelium, Hyperplasia                                        1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                                          (1)                                                 
      Cornea, Inflammation, Subacute                                             1 (100%)                                           
   Harderian Gland                                    (3)          (3)          (5)          (1)          (2)                       
      Inflammation, Chronic                                                      1 (20%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (60)         (60)         (60)         (60)         (60)                      
      Bacterium                                        1 (2%)                                 1 (2%)                                
      Fibrosis                                         1 (2%)                    1 (2%)       1 (2%)                                
      Glomerulosclerosis                               3 (5%)                    1 (2%)       2 (3%)                                
      Infarct                                                       1 (2%)       2 (3%)       2 (3%)       1 (2%)                   
      Infiltration Cellular, Lymphocyte                1 (2%)                                                                       
      Inflammation, Chronic, Suppurative                                                      1 (2%)                                
      Inflammation, Subacute                           2 (3%)                                                                       
      Metaplasia, Osseous                                                        1 (2%)                    2 (3%)                   
      Mineralization                                  45 (75%)     50 (83%)     46 (77%)     46 (77%)     35 (58%)                  
      Polyarteritis                                                              1 (2%)                                             
      Cortex, Cyst                                     5 (8%)       4 (7%)       1 (2%)       7 (12%)      1 (2%)                   
      Cortex, Medulla, Inflammation, Suppurative       1 (2%)                                                                       
      Pelvis, Inflammation, Subacute                                                          1 (2%)                                
      Pelvis, Necrosis                                 1 (2%)                                                                       
      Renal Tubule, Casts                             14 (23%)      9 (15%)     11 (18%)     12 (20%)      4 (7%)                   

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

                                                             Page   14                                                              
NTP Experiment-Test: 05099-08         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                      SALICYLAZOSULFAPYRIDINE                                  Date: 04/03/96  
Route: GAVAGE                                                                                                     Time: 20:16:26  
____________________________________________________________________________________________________________________________________

         B6C3F1 MICE MALE                          0 MG/KG      0 MG/KG      675          1350         2700                         
                                                                FEED RTD     MG/KG        MG/KG        MG/KG                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
URINARY SYSTEM - CONT                                                                                                               
      Renal Tubule, Degeneration                       3 (5%)                    1 (2%)       1 (2%)       1 (2%)                   
      Renal Tubule, Regeneration                      45 (75%)     46 (77%)     46 (77%)     48 (80%)     28 (47%)                  
      Transitional Epithelium, Hyperplasia             1 (2%)                                                                       
   Urethra                                                                                   (1)                                    
      Hemorrhage                                                                              1 (100%)                              
      Inflammation, Subacute                                                                  1 (100%)                              
   Urinary Bladder                                    (60)         (60)         (60)         (60)         (60)                      
      Dilatation                                       1 (2%)                    1 (2%)       1 (2%)       1 (2%)                   
      Inflammation, Chronic                                                      2 (3%)       1 (2%)                                
      Inflammation, Subacute                           1 (2%)                                                                       
      Transitional Epithelium, Hyperplasia             1 (2%)                    1 (2%)                                             
                                                                                                                                    

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

                                                             Page   15                                                              
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                             ----------              END OF REPORT             ----------                                           
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