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TDMS Study 88035-05 Pathology Tables

NTP Experiment-Test: 88035-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                             PRIMACLONE                                        Date: 12/27/96
Route: DOSED FEED                                                                                                 Time: 09:32:01




       Facility:  Battelle Columbus Laboratory

       Chemical CAS #:  0000125-33-7

       Lock Date:  11/17/94

       Cage Range:  All

       Reasons For Removal:    All

       Removal Date Range:     All

       Treatment Groups:       Merge     001   001                      0 PPM
                               Merge     002   002                      0 PPM
                               Merge     003   003                      600 PPM
                               Merge     004   004                      600 PPM
                               Merge     005   005                      1300 PPM
                               Merge     006   006                      1300 PPM
                               Merge     007   007                      2500 PPM
                               Merge     008   008                      2500 PPM





























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

                                                              Page   1


NTP Experiment-Test: 88035-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                             PRIMACLONE                                        Date: 12/27/96  
Route: DOSED FEED                                                                                                 Time: 09:32:01  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 PPM        600 PPM      1300 PPM     2500 PPM                                  
                                                                                                                                    
____________________________________________________________________________________________________________________________________

DISPOSITION SUMMARY                                                                                                                 

  Animals Initially In Study                          50           50           50           50                                     
  Early Deaths                                                                                                                      
    Moribund Sacrifice                                21           18           14           19                                     
    Natural Death                                      5            5            5            3                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                24           27           31           27                                     
    Natural Death                                                                             1                                     

  Animals Examined Microscopically                    50           50           50           50                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Esophagus                                          (49)         (50)         (50)         (50)                                   
      Cyst                                                                       1 (2%)                                             
   Intestine Large, Colon                             (50)         (50)         (50)         (50)                                   
      Parasite Metazoan                                1 (2%)                                                                       
   Intestine Large, Rectum                            (49)         (50)         (50)         (50)                                   
      Parasite Metazoan                                             2 (4%)       2 (4%)       3 (6%)                                
   Intestine Small, Ileum                             (50)         (50)         (50)         (49)                                   
      Inflammation, Chronic Active                                                            1 (2%)                                
   Liver                                              (50)         (50)         (50)         (50)                                   
      Angiectasis                                      2 (4%)                    1 (2%)       3 (6%)                                
      Basophilic Focus                                39 (78%)     35 (70%)     38 (76%)     10 (20%)                               
      Clear Cell Focus                                 6 (12%)      5 (10%)                                                         
      Eosinophilic Focus                               2 (4%)                    1 (2%)      18 (36%)                               
      Hematopoietic Cell Proliferation                              1 (2%)                                                          
      Hepatodiaphragmatic Nodule                       5 (10%)     13 (26%)     11 (22%)      5 (10%)                               
      Inflammation, Chronic                           38 (76%)     38 (76%)     44 (88%)     34 (68%)                               
      Mixed Cell Focus                                 5 (10%)                   1 (2%)       6 (12%)                               
      Pigmentation, Hemosiderin                       25 (50%)     14 (28%)     12 (24%)     19 (38%)                               
      Bile Duct, Hyperplasia                          30 (60%)     23 (46%)     35 (70%)     33 (66%)                               
      Hepatocyte, Degeneration                         1 (2%)                                                                       
      Hepatocyte, Degeneration, Cystic                              1 (2%)                    1 (2%)                                
      Hepatocyte, Necrosis                             4 (8%)       1 (2%)       3 (6%)       4 (8%)                                
      Hepatocyte, Vacuolization Cytoplasmic           25 (50%)     44 (88%)     46 (92%)     44 (88%)                               
      Hepatocyte, Centrilobular, Degeneration                       1 (2%)                    1 (2%)                                
      Hepatocyte, Centrilobular, Hypertrophy           1 (2%)      36 (72%)     38 (76%)     35 (70%)                               
      Portal Vein, Thrombosis                                                                 1 (2%)                                
   Mesentery                                          (9)          (10)         (7)          (7)                                    
      Accessory Spleen                                 1 (11%)                                                                      
      Fat, Inflammation, Chronic Active                             1 (10%)                                                         
      Fat, Necrosis                                    7 (78%)      5 (50%)      5 (71%)      6 (86%)                               
   Pancreas                                           (49)         (50)         (50)         (50)                                   
      Cyst                                             1 (2%)                                                                       
      Inflammation, Chronic Active                                  1 (2%)       1 (2%)                                             

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

                                                             Page    2                                                              
NTP Experiment-Test: 88035-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                             PRIMACLONE                                        Date: 12/27/96  
Route: DOSED FEED                                                                                                 Time: 09:32:01  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 PPM        600 PPM      1300 PPM     2500 PPM                                  
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Acinus, Atrophy                                  8 (16%)      7 (14%)     11 (22%)     11 (22%)                               
   Salivary Glands                                    (49)         (50)         (50)         (50)                                   
      Parotid Gland, Atrophy                                        1 (2%)                                                          
      Parotid Gland, Inflammation, Chronic Active                   1 (2%)                                                          
   Stomach, Forestomach                               (49)         (50)         (50)         (50)                                   
      Hyperplasia, Basal Cell                                                    1 (2%)                                             
      Epithelium, Hyperplasia                          4 (8%)       4 (8%)       3 (6%)       4 (8%)                                
      Epithelium, Inflammation, Chronic Active         2 (4%)       2 (4%)       2 (4%)       2 (4%)                                
      Epithelium, Ulcer                                2 (4%)       2 (4%)       2 (4%)       2 (4%)                                
   Stomach, Glandular                                 (49)         (50)         (50)         (50)                                   
      Epithelium, Erosion                                           2 (4%)                    1 (2%)                                
      Epithelium, Inflammation, Chronic Active                      1 (2%)                                                          
      Epithelium, Ulcer                                             1 (2%)                    1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Blood Vessel                                       (49)         (50)         (50)         (50)                                   
      Inflammation, Chronic Active                                                            1 (2%)                                
   Heart                                              (49)         (50)         (50)         (50)                                   
      Cardiomyopathy, Chronic                         21 (43%)     29 (58%)     27 (54%)     21 (42%)                               
      Atrium, Thrombosis                               1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (50)         (50)         (50)         (50)                                   
      Accessory Adrenal Cortical Nodule                                          1 (2%)                                             
      Angiectasis                                                                1 (2%)                                             
      Atrophy                                                                    1 (2%)                                             
      Degeneration, Fatty                             13 (26%)     11 (22%)      8 (16%)      6 (12%)                               
      Hyperplasia                                     10 (20%)      8 (16%)     10 (20%)      8 (16%)                               
      Hypertrophy                                      1 (2%)       1 (2%)       2 (4%)       3 (6%)                                
      Inflammation, Chronic Active                                               1 (2%)                                             
      Inflammation, Granulomatous                                   1 (2%)                                                          
      Necrosis                                         1 (2%)                                                                       
   Adrenal Medulla                                    (50)         (50)         (49)         (50)                                   
      Hyperplasia                                      6 (12%)      5 (10%)      9 (18%)      7 (14%)                               
   Pituitary Gland                                    (49)         (50)         (49)         (50)                                   
      Angiectasis                                      1 (2%)                                                                       
      Pars Distalis, Cyst                             24 (49%)     24 (48%)     36 (73%)     28 (56%)                               
      Pars Distalis, Hyperplasia                      26 (53%)     25 (50%)     26 (53%)     21 (42%)                               
      Pars Intermedia, Cyst                                         1 (2%)       1 (2%)       1 (2%)                                
   Thyroid Gland                                      (49)         (50)         (50)         (50)                                   
      C-Cell, Hyperplasia                             14 (29%)     15 (30%)     11 (22%)      5 (10%)                               
      Follicular Cell, Hyperplasia                                               1 (2%)                                             
____________________________________________________________________________________________________________________________________

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

                                                             Page    3                                                              
NTP Experiment-Test: 88035-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                             PRIMACLONE                                        Date: 12/27/96  
Route: DOSED FEED                                                                                                 Time: 09:32:01  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 PPM        600 PPM      1300 PPM     2500 PPM                                  
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (49)         (49)         (50)         (50)                                   
      Cyst                                                          2 (4%)       1 (2%)       2 (4%)                                
      Hyperplasia                                     12 (24%)      5 (10%)      8 (16%)     10 (20%)                               
      Inflammation, Chronic Active                     4 (8%)      10 (20%)      2 (4%)       3 (6%)                                
   Ovary                                              (50)         (50)         (50)         (49)                                   
      Atrophy                                                       1 (2%)                    1 (2%)                                
      Cyst                                             3 (6%)       4 (8%)       2 (4%)       1 (2%)                                
      Inflammation, Chronic Active                                                            1 (2%)                                
   Uterus                                             (50)         (50)         (50)         (49)                                   
      Angiectasis                                                   1 (2%)                                                          
      Edema                                                         1 (2%)                                                          
      Hemorrhage                                       1 (2%)       1 (2%)                                                          
      Hydrometra                                       2 (4%)                                                                       
      Hyperplasia, Cystic                              2 (4%)                    4 (8%)       3 (6%)                                
      Inflammation, Chronic Active                     1 (2%)                                                                       
   Vagina                                             (1)                       (1)          (2)                                    
      Cyst                                                                       1 (100%)                                           
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (50)         (50)         (50)                                   
      Atrophy                                                       1 (2%)                                                          
      Hyperplasia                                      5 (10%)     10 (20%)      7 (14%)      7 (14%)                               
      Hyperplasia, Histiocytic                                      3 (6%)                                                          
      Hyperplasia, Mast Cell                           1 (2%)                                                                       
      Myelofibrosis                                    4 (8%)       1 (2%)       1 (2%)       1 (2%)                                
   Lymph Node                                         (11)         (7)          (8)          (12)                                   
      Mediastinal, Hyperplasia, Histiocytic            1 (9%)                                                                       
      Mediastinal, Necrosis                            1 (9%)                                                                       
   Lymph Node, Mandibular                             (49)         (50)         (50)         (50)                                   
      Ectasia                                                                    1 (2%)                                             
      Inflammation, Chronic Active                                               1 (2%)                                             
   Lymph Node, Mesenteric                             (50)         (50)         (50)         (49)                                   
      Ectasia                                                                    1 (2%)       3 (6%)                                
   Spleen                                             (49)         (50)         (50)         (50)                                   
      Accessory Spleen                                 2 (4%)                                                                       
      Fibrosis                                         1 (2%)       1 (2%)       1 (2%)                                             
      Hematopoietic Cell Proliferation                 2 (4%)       3 (6%)       1 (2%)       2 (4%)                                
      Hemorrhage                                                                 1 (2%)                                             

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

                                                             Page    4                                                              
NTP Experiment-Test: 88035-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                             PRIMACLONE                                        Date: 12/27/96  
Route: DOSED FEED                                                                                                 Time: 09:32:01  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 PPM        600 PPM      1300 PPM     2500 PPM                                  
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Necrosis                                         2 (4%)       1 (2%)       1 (2%)                                             
   Thymus                                             (49)         (45)         (47)         (46)                                   
      Cyst                                                          1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (50)         (50)         (50)         (50)                                   
      Cyst                                             1 (2%)                                 1 (2%)                                
      Hyperplasia, Cystic                             37 (74%)     44 (88%)     43 (86%)     37 (74%)                               
      Inflammation, Chronic Active                     1 (2%)                                                                       
   Skin                                               (50)         (50)         (50)         (50)                                   
      Hyperkeratosis                                   1 (2%)                    1 (2%)                                             
      Inflammation, Chronic Active                                               2 (4%)                                             
      Ulcer                                                                      1 (2%)                                             
      Epidermis, Hyperplasia                           1 (2%)                    2 (4%)                                             
      Subcutaneous Tissue, Hemorrhage, Acute                                                  1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (50)         (50)         (50)         (50)                                   
      Osteopetrosis                                    2 (4%)       5 (10%)                   1 (2%)                                
   Skeletal Muscle                                                 (1)                       (2)                                    
      Hemorrhage, Acute                                                                       1 (50%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (50)         (50)         (50)                                   
      Hemorrhage                                       1 (2%)       3 (6%)       3 (6%)       1 (2%)                                
      Hydrocephalus                                    1 (2%)                    1 (2%)                                             
   Spinal Cord                                                     (1)                       (2)                                    
      Hemorrhage                                                                              1 (50%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (49)         (50)         (50)         (50)                                   
      Inflammation, Chronic Active                     1 (2%)       4 (8%)       1 (2%)       3 (6%)                                
      Necrosis                                         1 (2%)                                                                       
      Alveolar Epithelium, Hyperplasia                 5 (10%)      5 (10%)      6 (12%)      2 (4%)                                
      Alveolus, Infiltration Cellular, Histiocyte     36 (73%)     44 (88%)     45 (90%)     46 (92%)                               
      Artery, Vein, Mineralization                    38 (78%)     39 (78%)     38 (76%)     44 (88%)                               
      Interstitium, Inflammation, Chronic Active                                              1 (2%)                                
      Perivascular, Infiltration Cellular,                                                                                          
          Lymphocyte                                   4 (8%)       1 (2%)       3 (6%)       5 (10%)                               

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

                                                             Page    5                                                              
NTP Experiment-Test: 88035-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                             PRIMACLONE                                        Date: 12/27/96  
Route: DOSED FEED                                                                                                 Time: 09:32:01  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS FEMALE                   0 PPM        600 PPM      1300 PPM     2500 PPM                                  
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
RESPIRATORY SYSTEM - CONT                                                                                                           
   Nose                                               (50)         (49)         (50)         (50)                                   
      Inflammation, Chronic Active                     2 (4%)                    4 (8%)       5 (10%)                               
      Inflammation, Suppurative                        1 (2%)       1 (2%)                    1 (2%)                                
      Nasolacrimal Duct, Inflammation, Suppurative     2 (4%)       3 (6%)       3 (6%)       4 (8%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (1)          (1)          (2)          (2)                                    
      Inflammation, Chronic Active                                               1 (50%)                                            
      Anterior Chamber, Inflammation, Suppurative                                             1 (50%)                               
      Lens, Cataract                                   1 (100%)     1 (100%)     1 (50%)      1 (50%)                               
      Retina, Degeneration                             1 (100%)     1 (100%)     2 (100%)     1 (50%)                               
   Harderian Gland                                                              (1)                                                 
      Inflammation, Chronic Active                                               1 (100%)                                           
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (50)         (50)         (50)                                   
      Cyst                                                          1 (2%)                    1 (2%)                                
      Hydronephrosis                                                                          1 (2%)                                
      Mineralization                                  12 (24%)     10 (20%)      5 (10%)      8 (16%)                               
      Nephropathy, Chronic                            43 (86%)     43 (86%)     44 (88%)     43 (86%)                               
   Urinary Bladder                                    (50)         (50)         (50)         (49)                                   
      Inflammation, Chronic Active                                  1 (2%)                                                          
                                                                                                                                    

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

                                                             Page    6                                                              
NTP Experiment-Test: 88035-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                             PRIMACLONE                                        Date: 12/27/96  
Route: DOSED FEED                                                                                                 Time: 09:32:01  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 PPM        600 PPM      1300 PPM     2500 PPM                                  
                                                                                                                                    
____________________________________________________________________________________________________________________________________

DISPOSITION SUMMARY                                                                                                                 

  Animals Initially In Study                          50           50           50           50                                     
  Early Deaths                                                                                                                      
    Moribund Sacrifice                                33           33           39           36                                     
    Natural Death                                      4           10            7           14                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                13            7            4                                                  

  Animals Examined Microscopically                    50           50           50           50                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Esophagus                                          (50)         (50)         (50)         (49)                                   
      Inflammation, Chronic Active                                               1 (2%)                                             
      Ulcer                                                                      1 (2%)                                             
   Intestine Large, Colon                             (50)         (50)         (49)         (46)                                   
      Mineralization                                                1 (2%)                    2 (4%)                                
      Parasite Metazoan                                             2 (4%)       1 (2%)                                             
      Muscularis, Mineralization                                                              1 (2%)                                
   Intestine Large, Rectum                            (50)         (50)         (49)         (47)                                   
      Mineralization                                                1 (2%)                                                          
      Parasite Metazoan                                3 (6%)       3 (6%)       1 (2%)       2 (4%)                                
   Intestine Small, Duodenum                          (50)         (50)         (50)         (47)                                   
      Erosion                                                       2 (4%)                                                          
      Inflammation, Suppurative                                     2 (4%)                                                          
      Mineralization                                                1 (2%)                                                          
   Intestine Small, Jejunum                           (50)         (50)         (49)         (45)                                   
      Ulcer                                                                      1 (2%)                                             
   Liver                                              (50)         (50)         (50)         (50)                                   
      Basophilic Focus                                14 (28%)      9 (18%)      8 (16%)      6 (12%)                               
      Clear Cell Focus                                                           2 (4%)       1 (2%)                                
      Eosinophilic Focus                               1 (2%)       6 (12%)      5 (10%)      2 (4%)                                
      Hepatodiaphragmatic Nodule                       3 (6%)       2 (4%)       5 (10%)      3 (6%)                                
      Inflammation, Chronic                           18 (36%)     19 (38%)     22 (44%)     24 (48%)                               
      Mixed Cell Focus                                              2 (4%)                    1 (2%)                                
      Pigmentation, Hemosiderin                       19 (38%)     18 (36%)     15 (30%)     19 (38%)                               
      Bile Duct, Hyperplasia                          47 (94%)     50 (100%)    50 (100%)    44 (88%)                               
      Hepatocyte, Degeneration, Cystic                16 (32%)     27 (54%)     27 (54%)     18 (36%)                               
      Hepatocyte, Necrosis                            10 (20%)     12 (24%)      6 (12%)     10 (20%)                               
      Hepatocyte, Vacuolization Cytoplasmic           26 (52%)     28 (56%)     33 (66%)     43 (86%)                               
      Hepatocyte, Centrilobular, Degeneration                       1 (2%)                                                          
      Hepatocyte, Centrilobular, Hypertrophy                       14 (28%)     33 (66%)     40 (80%)                               
      Portal Vein, Thrombosis                          1 (2%)                                                                       
   Mesentery                                          (11)         (6)          (9)          (3)                                    
      Angiectasis                                                                             1 (33%)                               
      Hemorrhage                                                                 1 (11%)                                            

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

                                                             Page    7                                                              
NTP Experiment-Test: 88035-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                             PRIMACLONE                                        Date: 12/27/96  
Route: DOSED FEED                                                                                                 Time: 09:32:01  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 PPM        600 PPM      1300 PPM     2500 PPM                                  
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Inflammation, Chronic Active                                               1 (11%)      1 (33%)                               
      Artery, Inflammation, Chronic Active                                                    1 (33%)                               
      Artery, Mineralization                                                                  1 (33%)                               
      Artery, Necrosis, Fibrinoid                                                             1 (33%)                               
      Fat, Inflammation, Chronic Active                                          1 (11%)                                            
      Fat, Mineralization                                                        1 (11%)                                            
      Fat, Necrosis                                    6 (55%)      3 (50%)      4 (44%)                                            
      Fat, Pigmentation, Hematoidin                                              1 (11%)                                            
      Fat, Pigmentation, Hemosiderin                   1 (9%)                    1 (11%)                                            
   Pancreas                                           (50)         (50)         (50)         (49)                                   
      Inflammation, Chronic Active                                  1 (2%)                                                          
      Acinus, Atrophy                                 25 (50%)     14 (28%)     12 (24%)      8 (16%)                               
      Acinus, Hypertrophy                                                                     1 (2%)                                
      Artery, Inflammation, Chronic Active                          1 (2%)                                                          
   Stomach, Forestomach                               (50)         (50)         (50)         (49)                                   
      Hyperplasia                                                                1 (2%)                                             
      Inflammation, Chronic Active                                                            1 (2%)                                
      Mineralization                                                3 (6%)       3 (6%)      12 (24%)                               
      Perforation                                                   2 (4%)       1 (2%)                                             
      Epithelium, Hyperplasia                          4 (8%)      11 (22%)     19 (38%)     10 (20%)                               
      Epithelium, Inflammation, Chronic Active         2 (4%)      10 (20%)     14 (28%)      9 (18%)                               
      Epithelium, Ulcer                                2 (4%)       7 (14%)     13 (26%)      8 (16%)                               
   Stomach, Glandular                                 (50)         (50)         (50)         (49)                                   
      Mineralization                                                6 (12%)     15 (30%)     36 (73%)                               
      Epithelium, Erosion                              2 (4%)       1 (2%)                                                          
      Epithelium, Inflammation, Chronic Active         2 (4%)       1 (2%)       1 (2%)                                             
      Epithelium, Necrosis                                          1 (2%)       2 (4%)       1 (2%)                                
      Epithelium, Ulcer                                4 (8%)       1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Blood Vessel                                       (50)         (50)         (50)         (50)                                   
      Inflammation, Chronic Active                     1 (2%)                                 1 (2%)                                
      Necrosis, Fibrinoid                                                                     1 (2%)                                
      Aorta, Mineralization                                         5 (10%)      9 (18%)     31 (62%)                               
   Heart                                              (50)         (50)         (50)         (50)                                   
      Cardiomyopathy, Chronic                         42 (84%)     45 (90%)     43 (86%)     48 (96%)                               
      Mineralization                                                4 (8%)       8 (16%)     15 (30%)                               
      Pigmentation, Hemosiderin                        1 (2%)                                                                       
      Atrium, Thrombosis                               2 (4%)       3 (6%)                    2 (4%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    

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

                                                             Page    8                                                              
NTP Experiment-Test: 88035-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                             PRIMACLONE                                        Date: 12/27/96  
Route: DOSED FEED                                                                                                 Time: 09:32:01  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 PPM        600 PPM      1300 PPM     2500 PPM                                  
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (50)         (50)         (50)         (50)                                   
      Accessory Adrenal Cortical Nodule                             2 (4%)       1 (2%)                                             
      Atrophy                                                                    1 (2%)                                             
      Degeneration, Fatty                             26 (52%)     18 (36%)     19 (38%)     12 (24%)                               
      Hyperplasia                                     17 (34%)      4 (8%)       9 (18%)      6 (12%)                               
      Hypertrophy                                      3 (6%)       2 (4%)                                                          
      Inflammation, Chronic Active                     1 (2%)                                                                       
      Mineralization                                                                          1 (2%)                                
      Necrosis                                                                                1 (2%)                                
      Thrombosis                                       1 (2%)                                                                       
   Adrenal Medulla                                    (50)         (50)         (50)         (49)                                   
      Hemorrhage                                                    1 (2%)                                                          
      Hyperplasia                                     19 (38%)     22 (44%)     30 (60%)     29 (59%)                               
      Necrosis                                         1 (2%)                                                                       
   Parathyroid Gland                                  (45)         (41)         (46)         (49)                                   
      Hyperplasia                                      2 (4%)      16 (39%)     26 (57%)     40 (82%)                               
   Pituitary Gland                                    (49)         (50)         (48)         (49)                                   
      Craniopharyngeal Duct, Cyst                                                             1 (2%)                                
      Pars Distalis, Cyst                              1 (2%)       7 (14%)      2 (4%)       4 (8%)                                
      Pars Distalis, Hyperplasia                      17 (35%)     18 (36%)     16 (33%)      7 (14%)                               
      Pars Intermedia, Cyst                            1 (2%)       2 (4%)       1 (2%)       1 (2%)                                
   Thyroid Gland                                      (50)         (50)         (49)         (49)                                   
      C-Cell, Hyperplasia                             11 (22%)     11 (22%)      5 (10%)      3 (6%)                                
      Follicle, Cyst                                   1 (2%)       3 (6%)       1 (2%)       6 (12%)                               
      Follicle, Hyperplasia, Cystic                                              1 (2%)                                             
      Follicular Cell, Hyperplasia                     1 (2%)                                 1 (2%)                                
      Follicular Cell, Hyperplasia, Cystic             1 (2%)       1 (2%)       1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Coagulating Gland                                  (2)          (1)                       (1)                                    
      Inflammation, Chronic Active                     1 (50%)      1 (100%)                  1 (100%)                              
   Epididymis                                         (50)         (50)         (50)         (48)                                   
      Granuloma Sperm                                               3 (6%)       3 (6%)       1 (2%)                                
      Mineralization                                                                          4 (8%)                                
      Necrosis                                                                                1 (2%)                                
   Preputial Gland                                    (50)         (50)         (50)         (49)                                   
      Cyst                                             2 (4%)       1 (2%)       3 (6%)                                             
      Hyperplasia                                      5 (10%)      7 (14%)      3 (6%)       4 (8%)                                
      Inflammation, Chronic Active                    47 (94%)     47 (94%)     40 (80%)     45 (92%)                               

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

                                                             Page    9                                                              
NTP Experiment-Test: 88035-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                             PRIMACLONE                                        Date: 12/27/96  
Route: DOSED FEED                                                                                                 Time: 09:32:01  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 PPM        600 PPM      1300 PPM     2500 PPM                                  
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
GENITAL SYSTEM - CONT                                                                                                               
   Prostate                                           (50)         (50)         (50)         (48)                                   
      Cyst                                                                       1 (2%)                                             
      Inflammation, Chronic Active                    37 (74%)     34 (68%)     34 (68%)     30 (63%)                               
      Mineralization                                                                          2 (4%)                                
   Seminal Vesicle                                    (50)         (50)         (50)         (48)                                   
      Atrophy                                                                                 2 (4%)                                
      Mineralization                                                1 (2%)       2 (4%)       8 (17%)                               
   Testes                                             (50)         (50)         (50)         (48)                                   
      Necrosis                                                                   1 (2%)                                             
      Germinal Epithelium, Degeneration                2 (4%)       2 (4%)       2 (4%)       3 (6%)                                
      Interstitial Cell, Hyperplasia                  11 (22%)     11 (22%)      8 (16%)     11 (23%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (50)         (50)         (50)                                   
      Atrophy                                          1 (2%)       1 (2%)                    1 (2%)                                
      Hyperplasia                                     38 (76%)     35 (70%)     28 (56%)     12 (24%)                               
      Inflammation, Suppurative                                     1 (2%)                                                          
      Myelofibrosis                                    2 (4%)       1 (2%)                    1 (2%)                                
   Lymph Node                                         (24)         (23)         (16)         (10)                                   
      Lumbar, Hyperplasia, Lymphoid                                              1 (6%)                                             
      Mediastinal, Hyperplasia, Plasma Cell                                      1 (6%)                                             
      Renal, Ectasia                                                             1 (6%)       3 (30%)                               
      Renal, Erythrophagocytosis                                                              1 (10%)                               
      Renal, Pigmentation, Hemosiderin                                                        2 (20%)                               
   Lymph Node, Mandibular                             (50)         (50)         (48)         (49)                                   
      Ectasia                                                       3 (6%)                                                          
   Lymph Node, Mesenteric                             (50)         (50)         (50)         (48)                                   
      Ectasia                                          2 (4%)       2 (4%)       4 (8%)       2 (4%)                                
      Fibrosis                                                                                1 (2%)                                
   Spleen                                             (50)         (50)         (50)         (49)                                   
      Accessory Spleen                                                           1 (2%)                                             
      Congestion                                       1 (2%)                    1 (2%)                                             
      Fibrosis                                         9 (18%)     19 (38%)      9 (18%)     12 (24%)                               
      Hematopoietic Cell Proliferation                              2 (4%)       6 (12%)      1 (2%)                                
      Hyperplasia, Lymphoid                            1 (2%)                                                                       
      Metaplasia, Lipocyte                                          1 (2%)                                                          
      Necrosis                                                                   1 (2%)       1 (2%)                                
   Thymus                                             (49)         (47)         (44)         (46)                                   
      Cyst                                                          2 (4%)       1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    

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

                                                             Page   10                                                              
NTP Experiment-Test: 88035-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                             PRIMACLONE                                        Date: 12/27/96  
Route: DOSED FEED                                                                                                 Time: 09:32:01  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 PPM        600 PPM      1300 PPM     2500 PPM                                  
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (48)         (49)         (50)         (47)                                   
      Cyst                                             1 (2%)       1 (2%)       2 (4%)                                             
      Hyperplasia, Cystic                             28 (58%)     25 (51%)     16 (32%)      6 (13%)                               
      Mineralization                                                1 (2%)                                                          
   Skin                                               (50)         (50)         (50)         (50)                                   
      Hyperkeratosis                                                1 (2%)                                                          
      Hyperplasia, Basal Cell                                                                 1 (2%)                                
      Inflammation, Chronic Active                     2 (4%)       1 (2%)       1 (2%)                                             
      Inflammation, Suppurative                                                               1 (2%)                                
      Epidermis, Hyperplasia                           1 (2%)       1 (2%)                                                          
      Pinna, Ulcer                                                                            1 (2%)                                
      Sebaceous Gland, Hyperplasia                     1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (50)         (50)         (50)         (50)                                   
      Fibrous Osteodystrophy                                       10 (20%)     26 (52%)     37 (74%)                               
      Necrosis                                                                   1 (2%)                                             
      Osteopetrosis                                                 2 (4%)                    1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (50)         (49)         (49)                                   
      Hemorrhage                                       4 (8%)       2 (4%)       4 (8%)       1 (2%)                                
      Inflammation, Chronic Active                                               1 (2%)                                             
   Spinal Cord                                        (1)          (1)                                                              
      Demyelination                                    1 (100%)                                                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (50)         (50)         (50)                                   
      Inflammation, Chronic Active                     2 (4%)                    3 (6%)       3 (6%)                                
      Metaplasia, Osseous                              1 (2%)       1 (2%)                    2 (4%)                                
      Alveolar Epithelium, Hyperplasia                 6 (12%)      1 (2%)       2 (4%)       4 (8%)                                
      Alveolus, Hemorrhage                                                       1 (2%)                                             
      Alveolus, Infiltration Cellular, Histiocyte     18 (36%)     18 (36%)     19 (38%)     15 (30%)                               
      Alveolus, Inflammation, Suppurative                                        1 (2%)       4 (8%)                                
      Artery, Thrombosis                                            1 (2%)                                                          
      Artery, Vein, Mineralization                    46 (92%)     42 (84%)     43 (86%)     45 (90%)                               
      Interstitium, Inflammation, Chronic Active                                              2 (4%)                                
      Interstitium, Mineralization                                  3 (6%)       7 (14%)     25 (50%)                               
      Interstitium, Alveolus, Inflammation,                                                                                         
          Suppurative                                                                         5 (10%)                               

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

                                                             Page   11                                                              
NTP Experiment-Test: 88035-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                             PRIMACLONE                                        Date: 12/27/96  
Route: DOSED FEED                                                                                                 Time: 09:32:01  
____________________________________________________________________________________________________________________________________

         FISCHER 344 RATS MALE                     0 PPM        600 PPM      1300 PPM     2500 PPM                                  
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
RESPIRATORY SYSTEM - CONT                                                                                                           
      Perivascular, Infiltration Cellular,                                                                                          
          Lymphocyte                                   1 (2%)       1 (2%)       1 (2%)       1 (2%)                                
   Nose                                               (50)         (50)         (50)         (50)                                   
      Inflammation, Chronic Active                     8 (16%)     12 (24%)     10 (20%)      9 (18%)                               
      Inflammation, Suppurative                        6 (12%)      7 (14%)      3 (6%)       9 (18%)                               
      Arteriole, Venule, Thrombosis                    1 (2%)       2 (4%)                    1 (2%)                                
      Nasolacrimal Duct, Inflammation, Suppurative                               2 (4%)       2 (4%)                                
      Respiratory Epithelium, Metaplasia, Squamous                                            1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                             (1)          (2)                                                 
      Anterior Chamber, Inflammation, Suppurative                                1 (50%)                                            
      Lens, Cataract                                                             1 (50%)                                            
      Retina, Degeneration                                                       2 (100%)                                           
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (50)         (50)         (50)                                   
      Cyst                                             2 (4%)       2 (4%)      12 (24%)      9 (18%)                               
      Infarct                                          1 (2%)                                                                       
      Inflammation, Suppurative                                     1 (2%)                                                          
      Nephropathy, Chronic                            49 (98%)     48 (96%)     50 (100%)    50 (100%)                              
      Papilla, Hyperplasia, Atypical                   1 (2%)                                                                       
      Renal Tubule, Hyperplasia                        1 (2%)       2 (4%)       4 (8%)      10 (20%)                               
   Urinary Bladder                                    (50)         (50)         (50)         (48)                                   
      Hemorrhage                                       1 (2%)                                 1 (2%)                                
      Inflammation, Suppurative                                     1 (2%)                                                          
                                                                                                                                    

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

                                                             Page   12                                                              
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