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TDMS Study 05099-98 Pathology Tables


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


NTP Experiment-Test: 05099-98                                                                                     Report: PEIRPT03
Study Type: CHRONIC                                                                                               Date: 05/10/95
Route: GAVAGE                                                                                                     Time: 11:43:27


                                               05099/07 -VS- 05099/09 COMPARISON


       Facility:  SOUTHERN RESEARCH INSTITUTE

       Chemical CAS #:  599-79-1

       Lock Date:  02/03/93

       Cage Range:  All

       Reasons For Removal:    25004 Dead                              25018 Dosing Accident
                               25014 Gavage Death                      25005 Interval Sacrifice
                               25003 Moribund                          25019 Moribund Sacrifice
                               25020 Natural Death                     25021 Terminal Sacrifice

       Removal Date Range:     All

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



























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

                                                             Page   1

NTP Experiment-Test: 05099-98         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                      SALICYLAZOSULFAPYRIDINE                                  Date: 05/10/95  
Route: GAVAGE                                                                                                     Time: 11:43:27  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      0 MG/KG                                                             
                                                   AD LIB       RTD                                                                 
____________________________________________________________________________________________________________________________________

DISPOSITION SUMMARY                                                                                                                 

  Animals Initially In Study                          70          110                                                               

  Scheduled Sacrifice                                              33                                                               
  Early Deaths                                                                                                                      
    Moribund Sacrifice                                13                                                                            
    Natural Death                                      1                                                                            
    Dosing Accident                                    1                                                                            
    Gavage Death                                                    2                                                               
    Moribund                                                       13                                                               
    Dead                                                            2                                                               
  Survivors                                                                                                                         
    Terminal Sacrifice                                35                                                                            

  Animals Examined Microscopically                    50           50                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Esophagus                                          (50)         (49)                                                             
      Inflammation, Suppurative                                     1 (2%)                                                          
   Intestine Large, Colon                             (49)         (50)                                                             
      Dilatation                                                    1 (2%)                                                          
      Parasite Metazoan                                7 (14%)      8 (16%)                                                         
   Intestine Large, Rectum                            (50)         (50)                                                             
      Parasite Metazoan                               10 (20%)      9 (18%)                                                         
   Intestine Large, Cecum                             (50)         (50)                                                             
      Dilatation                                                    1 (2%)                                                          
      Edema                                                         1 (2%)                                                          
      Hemorrhage                                                    1 (2%)                                                          
   Intestine Small, Ileum                             (49)         (49)                                                             
      Inflammation, Chronic Active                     1 (2%)                                                                       
   Liver                                              (50)         (50)                                                             
      Basophilic Focus                                33 (66%)     24 (48%)                                                         
      Clear Cell Focus                                32 (64%)     11 (22%)                                                         
      Congestion                                       1 (2%)       1 (2%)                                                          
      Degeneration, Cystic                             4 (8%)       2 (4%)                                                          
      Developmental Malformation                                    1 (2%)                                                          
      Eosinophilic Focus                               7 (14%)      9 (18%)                                                         
      Hepatodiaphragmatic Nodule                       5 (10%)      1 (2%)                                                          
      Inflammation, Subacute                                        1 (2%)                                                          
      Mixed Cell Focus                                 5 (10%)     16 (32%)                                                         
      Bile Duct, Hyperplasia                          45 (90%)     36 (72%)                                                         
      Centrilobular, Atrophy                           3 (6%)       3 (6%)                                                          
      Hepatocyte, Vacuolization Cytoplasmic            2 (4%)       2 (4%)                                                          
      Kupffer Cell, Hyperplasia                                     1 (2%)                                                          
      Kupffer Cell, Pigmentation                                    2 (4%)                                                          

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

                                                             Page    2                                                              
NTP Experiment-Test: 05099-98         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                      SALICYLAZOSULFAPYRIDINE                                  Date: 05/10/95  
Route: GAVAGE                                                                                                     Time: 11:43:27  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      0 MG/KG                                                             
                                                   AD LIB       RTD                                                                 
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Lobules, Necrosis                                             1 (2%)                                                          
   Mesentery                                          (17)         (20)                                                             
      Fat, Necrosis                                   14 (82%)     18 (90%)                                                         
   Pancreas                                           (50)         (50)                                                             
      Atrophy                                         18 (36%)     18 (36%)                                                         
      Necrosis                                                      1 (2%)                                                          
      Acinar Cell, Basophilic Focus                    1 (2%)                                                                       
      Acinar Cell, Cytoplasmic Alteration              1 (2%)       3 (6%)                                                          
      Acinar Cell, Hyperplasia, Focal                 16 (32%)      8 (16%)                                                         
   Salivary Glands                                    (50)         (50)                                                             
      Inflammation, Chronic                                         1 (2%)                                                          
   Stomach, Forestomach                               (50)         (50)                                                             
      Developmental Malformation                                    1 (2%)                                                          
      Edema                                            1 (2%)                                                                       
      Inflammation, Chronic                                         1 (2%)                                                          
      Mineralization                                                2 (4%)                                                          
      Ulcer                                            1 (2%)                                                                       
   Stomach, Glandular                                 (49)         (50)                                                             
      Edema                                                         1 (2%)                                                          
      Erosion                                          1 (2%)                                                                       
      Mineralization                                                1 (2%)                                                          
      Ulcer                                            1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Blood Vessel                                       (50)         (50)                                                             
      Embolus                                          1 (2%)                                                                       
      Hypertrophy                                                   1 (2%)                                                          
      Inflammation, Chronic Active                                  1 (2%)                                                          
   Heart                                              (50)         (50)                                                             
      Cardiomyopathy                                  23 (46%)     32 (64%)                                                         
      Inflammation, Subacute                                        1 (2%)                                                          
      Pericardium, Fibrosis                            1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (50)         (50)                                                             
      Accessory Adrenal Cortical Nodule               19 (38%)     15 (30%)                                                         
      Angiectasis                                                   1 (2%)                                                          
      Congestion                                       1 (2%)                                                                       
      Cyst                                             1 (2%)       1 (2%)                                                          
      Degeneration, Fatty                              8 (16%)      6 (12%)                                                         
      Hemorrhage                                       2 (4%)       1 (2%)                                                          
      Hyperplasia, Focal                               4 (8%)       1 (2%)                                                          
      Hypertrophy, Focal                               5 (10%)      1 (2%)                                                          

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

                                                             Page    3                                                              
NTP Experiment-Test: 05099-98         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                      SALICYLAZOSULFAPYRIDINE                                  Date: 05/10/95  
Route: GAVAGE                                                                                                     Time: 11:43:27  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      0 MG/KG                                                             
                                                   AD LIB       RTD                                                                 
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
      Mineralization, Focal                                         1 (2%)                                                          
   Adrenal Medulla                                    (50)         (50)                                                             
      Hyperplasia                                     15 (30%)      5 (10%)                                                         
   Pituitary Gland                                    (50)         (50)                                                             
      Congestion                                       1 (2%)                                                                       
      Pars Distalis, Angiectasis                       4 (8%)       4 (8%)                                                          
      Pars Distalis, Cyst                              5 (10%)      7 (14%)                                                         
      Pars Distalis, Hyperplasia, Focal               15 (30%)      8 (16%)                                                         
      Pars Intermedia, Angiectasis                                  1 (2%)                                                          
      Pars Intermedia, Cyst                            2 (4%)       1 (2%)                                                          
   Thyroid Gland                                      (50)         (49)                                                             
      Ultimobranchial Cyst                             1 (2%)                                                                       
      C-Cell, Hyperplasia                             14 (28%)      9 (18%)                                                         
      Follicle, Cyst                                   1 (2%)       2 (4%)                                                          
      Follicle, Mineralization                                      7 (14%)                                                         
      Follicular Cell, Hyperplasia                     1 (2%)       3 (6%)                                                          
      Follicular Cell, Hypertrophy                     1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (50)         (50)                                                             
      Atypia Cellular                                 25 (50%)     37 (74%)                                                         
      Hypospermia                                     40 (80%)     34 (68%)                                                         
   Preputial Gland                                    (50)         (50)                                                             
      Ectasia                                         20 (40%)     10 (20%)                                                         
      Hyperplasia                                      1 (2%)       2 (4%)                                                          
      Inflammation, Chronic                           24 (48%)     29 (58%)                                                         
      Inflammation, Suppurative                       19 (38%)      8 (16%)                                                         
   Prostate                                           (50)         (50)                                                             
      Corpora Amylacea                                28 (56%)     27 (54%)                                                         
      Hyperplasia, Lymphoid                            1 (2%)                                                                       
      Inflammation, Suppurative                       17 (34%)     26 (52%)                                                         
      Epithelium, Hyperplasia                          8 (16%)     14 (28%)                                                         
   Seminal Vesicle                                    (50)         (50)                                                             
      Dilatation                                       1 (2%)                                                                       
   Testes                                             (50)         (50)                                                             
      Interstitial Cell, Hyperplasia                   1 (2%)       7 (14%)                                                         
      Seminiferous Tubule, Atrophy                                  1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    

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

                                                             Page    4                                                              
NTP Experiment-Test: 05099-98         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                      SALICYLAZOSULFAPYRIDINE                                  Date: 05/10/95  
Route: GAVAGE                                                                                                     Time: 11:43:27  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      0 MG/KG                                                             
                                                   AD LIB       RTD                                                                 
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (50)                                                             
      Hypercellularity                                 3 (6%)       2 (4%)                                                          
   Lymph Node                                         (9)          (11)                                                             
      Inguinal, Hemorrhage                                          1 (9%)                                                          
      Mediastinal, Hemorrhage                          6 (67%)      2 (18%)                                                         
      Mediastinal, Hyperplasia, Lymphoid                            1 (9%)                                                          
      Mediastinal, Infiltration Cellular, Mast Cell                 1 (9%)                                                          
      Mediastinal, Pigmentation                        5 (56%)      4 (36%)                                                         
      Pancreatic, Pigmentation                                      2 (18%)                                                         
   Lymph Node, Mandibular                             (50)         (50)                                                             
      Ectasia                                          5 (10%)      3 (6%)                                                          
      Hemorrhage                                       4 (8%)       3 (6%)                                                          
      Hyperplasia, Lymphoid                            5 (10%)      1 (2%)                                                          
      Hyperplasia, Plasma Cell                         1 (2%)                                                                       
      Pigmentation                                                  7 (14%)                                                         
   Lymph Node, Mesenteric                             (50)         (50)                                                             
      Ectasia                                                       1 (2%)                                                          
      Hemorrhage                                       3 (6%)       4 (8%)                                                          
      Hyperplasia, Lymphoid                            1 (2%)       2 (4%)                                                          
      Pigmentation                                                  4 (8%)                                                          
   Spleen                                             (50)         (50)                                                             
      Fibrosis                                         8 (16%)      3 (6%)                                                          
      Hematopoietic Cell Proliferation                14 (28%)      6 (12%)                                                         
      Pigmentation, Hemosiderin                       14 (28%)     12 (24%)                                                         
   Thymus                                             (47)         (46)                                                             
      Hemorrhage                                                    1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (48)         (49)                                                             
      Hyperplasia, Cystic                             11 (23%)     12 (24%)                                                         
      Hyperplasia, Lobular                             2 (4%)                                                                       
   Skin                                               (50)         (50)                                                             
      Acanthosis                                                    1 (2%)                                                          
      Cyst Epithelial Inclusion                        2 (4%)       1 (2%)                                                          
      Hemorrhage                                       1 (2%)                                                                       
      Hyperkeratosis                                                1 (2%)                                                          
      Inflammation, Chronic                            1 (2%)       1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    

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

                                                             Page    5                                                              
NTP Experiment-Test: 05099-98         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                      SALICYLAZOSULFAPYRIDINE                                  Date: 05/10/95  
Route: GAVAGE                                                                                                     Time: 11:43:27  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      0 MG/KG                                                             
                                                   AD LIB       RTD                                                                 
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Skeletal Muscle                                    (1)          (2)                                                              
      Hemorrhage                                                    1 (50%)                                                         
      Inflammation, Suppurative                                     1 (50%)                                                         
      Necrosis                                                      1 (50%)                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (50)                                                             
      Compression                                      4 (8%)       5 (10%)                                                         
      Hemorrhage                                                    1 (2%)                                                          
      Hydrocephalus                                    1 (2%)       1 (2%)                                                          
      Mineralization                                   1 (2%)                                                                       
      Necrosis                                         1 (2%)       2 (4%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (50)                                                             
      Congestion                                       1 (2%)       3 (6%)                                                          
      Edema                                                         2 (4%)                                                          
      Foreign Body                                                  4 (8%)                                                          
      Hemorrhage                                                    2 (4%)                                                          
      Infiltration Cellular, Histiocyte                8 (16%)     10 (20%)                                                         
      Inflammation, Subacute                           3 (6%)       1 (2%)                                                          
      Alveolar Epithelium, Hyperplasia                10 (20%)      5 (10%)                                                         
      Fat, Mediastinum, Necrosis                       1 (2%)                                                                       
   Nose                                               (50)         (50)                                                             
      Exudate                                         15 (30%)     14 (28%)                                                         
      Foreign Body                                     4 (8%)       6 (12%)                                                         
      Fungus                                           6 (12%)      3 (6%)                                                          
      Mucosa, Hyperplasia                              6 (12%)      3 (6%)                                                          
      Mucosa, Metaplasia, Squamous                     1 (2%)       2 (4%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                             (1)                                                              
      Cataract                                                      1 (100%)                                                        
      Retina, Atrophy                                               1 (100%)                                                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    

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

                                                             Page    6                                                              
NTP Experiment-Test: 05099-98         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                      SALICYLAZOSULFAPYRIDINE                                  Date: 05/10/95  
Route: GAVAGE                                                                                                     Time: 11:43:27  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 MG/KG      0 MG/KG                                                             
                                                   AD LIB       RTD                                                                 
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (50)                                                             
      Cyst                                             1 (2%)                                                                       
      Fibrosis                                                      1 (2%)                                                          
      Inflammation, Suppurative                        6 (12%)                                                                      
      Mineralization                                   3 (6%)       2 (4%)                                                          
      Nephropathy                                     48 (96%)     43 (86%)                                                         
      Renal Tubule, Necrosis                                        1 (2%)                                                          
      Renal Tubule, Pigmentation                       2 (4%)       2 (4%)                                                          
      Transitional Epithelium, Hyperplasia            10 (20%)      3 (6%)                                                          
                                                                                                                                    

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

                                                             Page    7                                                              
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