National Toxicology Program

National Toxicology Program
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TDMS Study 05099-99 Pathology Tables


                                     INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
                                                      SALICYLAZOSULFAPYRIDINE


NTP Experiment-Test: 05099-99                                                                                     Report: PEIRPT03
Study Type: CHRONIC                                                                                               Date: 05/04/95
Route: GAVAGE                                                                                                     Time: 14:45:44


                                               05099/08 -VS- 05099/10 COMPARISON


       Facility:  SOUTHERN RESEARCH INSTITUTE

       Chemical CAS #:  599-79-1

       Lock Date:  04/19/94

       Cage Range:  All

       Reasons For Removal:    25018 Dosing Accident                   25019 Moribund Sacrifice
                               25020 Natural Death                     25017 Scheduled Sacrifice
                               25021 Terminal Sacrifice

       Removal Date Range:     All

       Treatment Groups:       Include 001    0 MG/KG
                               Include 004    RTD     0 MG/KG




























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

                                                             Page   1

NTP Experiment-Test: 05099-99         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                      SALICYLAZOSULFAPYRIDINE                                  Date: 05/04/95  
Route: GAVAGE                                                                                                     Time: 14:45:44  
____________________________________________________________________________________________________________________________________

         B6C3F1 MICE MALE                          0 MG/KG      RTD                                                                 
                                                                0 MG/KG                                                             
____________________________________________________________________________________________________________________________________

DISPOSITION SUMMARY                                                                                                                 

  Animals Initially In Study                          60          110                                                               

  Scheduled Sacrifice                                              42                                                               
  Early Deaths                                                                                                                      
    Moribund Sacrifice                                 5            6                                                               
    Natural Death                                      3            4                                                               
    Dosing Accident                                    2                                                                            
  Survivors                                                                                                                         
    Terminal Sacrifice                                40                                                                            

  Animals Examined Microscopically                    50           52                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Esophagus                                          (50)         (52)                                                             
      Hemorrhage                                       1 (2%)                                                                       
   Intestine Large, Cecum                             (47)         (51)                                                             
      Parasite Metazoan                                1 (2%)                                                                       
   Liver                                              (50)         (52)                                                             
      Angiectasis                                                   1 (2%)                                                          
      Basophilic Focus                                 1 (2%)       2 (4%)                                                          
      Clear Cell Focus                                 2 (4%)       1 (2%)                                                          
      Eosinophilic Focus                               5 (10%)      5 (10%)                                                         
      Eosinophilic Focus, Multiple                     1 (2%)                                                                       
      Fatty Change, Focal                              1 (2%)                                                                       
      Hematopoietic Cell Proliferation                              1 (2%)                                                          
      Hemorrhage                                       1 (2%)       1 (2%)                                                          
      Inflammation, Subacute                           3 (6%)                                                                       
      Mineralization                                   2 (4%)                                                                       
      Mixed Cell Focus                                 2 (4%)                                                                       
      Necrosis                                         3 (6%)       2 (4%)                                                          
      Pigmentation, Bile                               1 (2%)       1 (2%)                                                          
      Vacuolization Cytoplasmic                        3 (6%)       3 (6%)                                                          
      Bile Duct, Cyst                                  2 (4%)       1 (2%)                                                          
   Mesentery                                          (4)          (6)                                                              
      Fat, Mineralization                                           1 (17%)                                                         
      Fat, Necrosis                                    3 (75%)      4 (67%)                                                         
   Pancreas                                           (50)         (52)                                                             
      Inflammation, Subacute                                        1 (2%)                                                          
      Acinus, Depletion Secretory                      1 (2%)                                                                       
      Duct, Cyst                                                    1 (2%)                                                          
   Stomach, Forestomach                               (50)         (52)                                                             
      Edema                                            1 (2%)                                                                       
      Foreign Body                                                  1 (2%)                                                          
      Hyperplasia                                     18 (36%)     27 (52%)                                                         

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

                                                             Page    2                                                              
NTP Experiment-Test: 05099-99         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                      SALICYLAZOSULFAPYRIDINE                                  Date: 05/04/95  
Route: GAVAGE                                                                                                     Time: 14:45:44  
____________________________________________________________________________________________________________________________________

         B6C3F1 MICE MALE                          0 MG/KG      RTD                                                                 
                                                                0 MG/KG                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Inflammation, Subacute                           4 (8%)      12 (23%)                                                         
      Ulcer                                            3 (6%)       2 (4%)                                                          
   Stomach, Glandular                                 (50)         (52)                                                             
      Erosion                                                       1 (2%)                                                          
      Hyperplasia                                      1 (2%)                                                                       
      Mineralization                                   1 (2%)                                                                       
      Pigmentation                                     1 (2%)                                                                       
      Ulcer                                            1 (2%)                                                                       
   Tooth                                                           (1)                                                              
      Developmental Malformation                                    1 (100%)                                                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Blood Vessel                                       (50)         (52)                                                             
      Polyarteritis                                                 1 (2%)                                                          
   Heart                                              (50)         (52)                                                             
      Embolus                                          1 (2%)                                                                       
      Mineralization                                   1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (50)         (52)                                                             
      Accessory Adrenal Cortical Nodule                             1 (2%)                                                          
      Embolus                                          1 (2%)                                                                       
      Hyperplasia                                      8 (16%)                                                                      
      Hypertrophy                                     11 (22%)      8 (15%)                                                         
      Vacuolization Cytoplasmic                        1 (2%)                                                                       
      Capsule, Hyperplasia                             1 (2%)                                                                       
      Spindle Cell, Hyperplasia                                     1 (2%)                                                          
   Adrenal Medulla                                    (50)         (52)                                                             
      Embolus                                          1 (2%)                                                                       
   Islets, Pancreatic                                 (50)         (52)                                                             
      Embolus                                          1 (2%)                                                                       
      Hyperplasia                                      2 (4%)       3 (6%)                                                          
   Parathyroid Gland                                  (48)         (48)                                                             
      Cyst                                                          2 (4%)                                                          
   Pituitary Gland                                    (44)         (48)                                                             
      Pars Distalis, Cyst                                           1 (2%)                                                          
      Pars Distalis, Hyperplasia                                    2 (4%)                                                          
   Thyroid Gland                                      (50)         (52)                                                             
      Follicle, Cyst                                   6 (12%)      2 (4%)                                                          
      Follicle, Degeneration                           3 (6%)       5 (10%)                                                         
      Follicular Cell, Hyperplasia                     9 (18%)                                                                      
____________________________________________________________________________________________________________________________________

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

                                                             Page    3                                                              
NTP Experiment-Test: 05099-99         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                      SALICYLAZOSULFAPYRIDINE                                  Date: 05/04/95  
Route: GAVAGE                                                                                                     Time: 14:45:44  
____________________________________________________________________________________________________________________________________

         B6C3F1 MICE MALE                          0 MG/KG      RTD                                                                 
                                                                0 MG/KG                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Coagulating Gland                                  (5)                                                                           
      Dilatation                                       5 (100%)                                                                     
   Epididymis                                         (50)         (52)                                                             
      Congestion                                       1 (2%)                                                                       
      Granuloma Sperm                                  1 (2%)                                                                       
      Inflammation, Chronic                            1 (2%)                                                                       
      Mineralization                                                1 (2%)                                                          
   Preputial Gland                                    (49)         (51)                                                             
      Congestion                                       1 (2%)                                                                       
      Inflammation, Subacute                           2 (4%)       1 (2%)                                                          
      Duct, Cyst                                      45 (92%)     44 (86%)                                                         
   Prostate                                           (50)         (52)                                                             
      Cyst                                             1 (2%)                                                                       
      Hyperplasia                                      1 (2%)                                                                       
      Inflammation, Suppurative                        1 (2%)                                                                       
   Seminal Vesicle                                    (50)         (52)                                                             
      Atrophy                                          2 (4%)                                                                       
      Dilatation                                      14 (28%)      1 (2%)                                                          
      Infiltration Cellular, Mast Cell                              1 (2%)                                                          
      Inflammation, Chronic                            1 (2%)                                                                       
   Testes                                             (50)         (52)                                                             
      Mineralization                                   1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (52)                                                             
      Myeloid Cell, Hyperplasia                        2 (4%)                                                                       
   Lymph Node                                         (3)          (4)                                                              
      Bronchial, Hyperplasia, Lymphoid                              1 (25%)                                                         
      Inguinal, Hyperplasia, Lymphoid                  1 (33%)                                                                      
   Lymph Node, Mesenteric                             (50)         (52)                                                             
      Angiectasis                                     17 (34%)     20 (38%)                                                         
      Edema                                                         1 (2%)                                                          
      Hyperplasia, Lymphoid                            4 (8%)       5 (10%)                                                         
      Necrosis                                                      1 (2%)                                                          
   Spleen                                             (50)         (52)                                                             
      Angiectasis                                                   1 (2%)                                                          
      Atrophy                                          5 (10%)      2 (4%)                                                          
      Congestion                                       1 (2%)       1 (2%)                                                          

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

                                                             Page    4                                                              
NTP Experiment-Test: 05099-99         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                      SALICYLAZOSULFAPYRIDINE                                  Date: 05/04/95  
Route: GAVAGE                                                                                                     Time: 14:45:44  
____________________________________________________________________________________________________________________________________

         B6C3F1 MICE MALE                          0 MG/KG      RTD                                                                 
                                                                0 MG/KG                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Depletion Cellular                                            1 (2%)                                                          
      Hematopoietic Cell Proliferation                11 (22%)      6 (12%)                                                         
      Hyperplasia, Lymphoid                            5 (10%)      9 (17%)                                                         
      Pigmentation, Hemosiderin                        2 (4%)                                                                       
   Thymus                                             (45)         (51)                                                             
      Atrophy                                          3 (7%)       2 (4%)                                                          
      Cyst                                             2 (4%)       1 (2%)                                                          
      Necrosis                                                      1 (2%)                                                          
      Thymocyte, Necrosis                              1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (50)         (52)                                                             
      Subcutaneous Tissue, Inflammation, Chronic       1 (2%)                                                                       
      Subcutaneous Tissue, Mineralization              1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (50)         (52)                                                             
      Cranium, Hyperostosis                            2 (4%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (52)                                                             
      Compression                                      1 (2%)                                                                       
      Embolus                                          1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (52)                                                             
      Alveolar Epithelium, Hyperplasia                 4 (8%)       3 (6%)                                                          
      Alveolus, Foreign Body                           1 (2%)                                                                       
      Alveolus, Hemorrhage                             1 (2%)                                                                       
      Alveolus, Infiltration Cellular, Histiocyte      3 (6%)                                                                       
      Mediastinum, Hemorrhage                          1 (2%)                                                                       
   Nose                                               (50)         (52)                                                             
      Glands, Cyst                                     1 (2%)                                                                       
      Glands, Mineralization                                        3 (6%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    

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

                                                             Page    5                                                              
NTP Experiment-Test: 05099-99         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                      SALICYLAZOSULFAPYRIDINE                                  Date: 05/04/95  
Route: GAVAGE                                                                                                     Time: 14:45:44  
____________________________________________________________________________________________________________________________________

         B6C3F1 MICE MALE                          0 MG/KG      RTD                                                                 
                                                                0 MG/KG                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Ear                                                (1)          (1)                                                              
      External Ear, Inflammation, Granulomatous                     1 (100%)                                                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (52)                                                             
      Bacterium                                        1 (2%)                                                                       
      Fibrosis                                         1 (2%)                                                                       
      Glomerulosclerosis                               3 (6%)                                                                       
      Infarct                                                       5 (10%)                                                         
      Infiltration Cellular, Lymphocyte                1 (2%)                                                                       
      Inflammation, Chronic                                         1 (2%)                                                          
      Inflammation, Subacute                           2 (4%)       1 (2%)                                                          
      Mineralization                                  37 (74%)     49 (94%)                                                         
      Cortex, Cyst                                     5 (10%)      1 (2%)                                                          
      Cortex, Medulla, Inflammation, Suppurative       1 (2%)                                                                       
      Pelvis, Necrosis                                 1 (2%)                                                                       
      Renal Tubule, Casts                             13 (26%)     13 (25%)                                                         
      Renal Tubule, Degeneration                       3 (6%)       1 (2%)                                                          
      Renal Tubule, Regeneration                      38 (76%)     36 (69%)                                                         
      Transitional Epithelium, Hyperplasia             1 (2%)                                                                       
   Urinary Bladder                                    (50)         (52)                                                             
      Dilatation                                       1 (2%)                                                                       
      Inflammation, Subacute                           1 (2%)                                                                       
      Transitional Epithelium, Hyperplasia             1 (2%)                                                                       
                                                                                                                                    

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

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