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TDMS Study 05035-03 Pathology Tables


                                     INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
                                                        4-HYDROXYACETANILIDE


NTP Experiment-Test: 05035-03                                                                                     Report: PEIRPT03
Study Type: CHRONIC                                                                                               Date: 09/05/94
Route: DOSED FEED                                                                                                 Time: 00:14:46




       Facility:  TSI Mason Research

       Chemical CAS #:  103-90-2

       Lock Date:  None

       Cage Range:  All

       Reasons For Removal:    All

       Removal Date Range:     All

       Treatment Groups:       Include All
































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

                                                             Page   1

NTP Experiment-Test: 05035-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        4-HYDROXYACETANILIDE                                   Date: 09/05/94  
Route: DOSED FEED                                                                                                 Time: 00:14:46  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   CONTROL      0.06% LF     0.3% MF      0.6% HF                                   
                                                   UF                                                                               
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially In Study                          60           60           60           60                                     
  Scheduled Sacrifice                                 10           10           10           10                                     
  Early Deaths                                                                                                                      
    Dead                                               6            4            3                                                  
    Moribund                                          14           12           13           22                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                28           34           34           27                                     
    Dead                                               1                                                                            
    Moribund                                           1                                      1                                     
  Animals Examined Microscopically                    50           50           50           50                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large, Cecum                             (47)         (48)         (50)         (50)                                   
      Parasite Metazoan                                2 (4%)       7 (15%)      4 (8%)       5 (10%)                               
   Intestine Large, Colon                             (48)         (49)         (49)         (49)                                   
      Parasite Metazoan                               10 (21%)      7 (14%)      3 (6%)       7 (14%)                               
   Intestine Large, Rectum                            (49)         (49)         (50)         (50)                                   
      Parasite Metazoan                                2 (4%)       9 (18%)      9 (18%)     10 (20%)                               
      Artery, Inflammation, Chronic                                              1 (2%)                                             
   Intestine Small, Duodenum                          (48)         (50)         (50)         (50)                                   
      Artery, Inflammation, Chronic                                              1 (2%)                                             
   Intestine Small, Jejunum                           (48)         (48)         (50)         (50)                                   
      Parasite Metazoan                                1 (2%)                                                                       
   Liver                                              (50)         (50)         (50)         (50)                                   
      Basophilic Focus                                38 (76%)     39 (78%)     32 (64%)     20 (40%)                               
      Clear Cell Focus                                 1 (2%)                                 2 (4%)                                
      Cyst                                                                       1 (2%)                                             
      Fatty Change                                    15 (30%)      5 (10%)     11 (22%)     17 (34%)                               
      Granuloma                                       26 (52%)     15 (30%)      7 (14%)      8 (16%)                               
      Hepatodiaphragmatic Nodule                      10 (20%)      8 (16%)      8 (16%)      6 (12%)                               
      Hyperplasia, Focal                               4 (8%)       2 (4%)       2 (4%)       8 (16%)                               
      Hyperplasia, Multifocal                                                    1 (2%)                                             
      Inflammation, Chronic, Focal                     1 (2%)                                                                       
      Necrosis, Focal                                  2 (4%)       5 (10%)      5 (10%)      2 (4%)                                
      Bile Duct, Cyst                                                            1 (2%)       1 (2%)                                
      Bile Duct, Hyperplasia                          15 (30%)     15 (30%)     13 (26%)     19 (38%)                               
      Hepatocyte, Hyperplasia                                       1 (2%)                                                          
      Perivascular, Inflammation, Chronic                                        1 (2%)                                             
   Mesentery                                          (6)          (3)          (6)          (8)                                    
      Fat, Necrosis                                    5 (83%)      2 (67%)      6 (100%)     8 (100%)                              
   Pancreas                                           (47)         (49)         (49)         (48)                                   
      Angiectasis                                                                1 (2%)       1 (2%)                                
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    2                                                              
NTP Experiment-Test: 05035-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        4-HYDROXYACETANILIDE                                   Date: 09/05/94  
Route: DOSED FEED                                                                                                 Time: 00:14:46  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   CONTROL      0.06% LF     0.3% MF      0.6% HF                                   
                                                   UF                                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Edema                                                                      1 (2%)                                             
      Acinus, Atrophy, Focal                          15 (32%)     12 (24%)      9 (18%)      9 (19%)                               
      Artery, Inflammation, Chronic                                              1 (2%)                                             
      Duct, Ectasia                                                                           1 (2%)                                
   Stomach, Forestomach                               (50)         (50)         (50)         (49)                                   
      Acanthosis                                       1 (2%)                    2 (4%)       1 (2%)                                
      Diverticulum                                     1 (2%)                                                                       
      Hyperkeratosis                                   2 (4%)                    1 (2%)       4 (8%)                                
      Hyperplasia, Basal Cell                          4 (8%)       5 (10%)                                                         
      Ulcer                                            3 (6%)       3 (6%)       2 (4%)       2 (4%)                                
      Epithelium, Inflammation, Acute                  1 (2%)                                                                       
      Perivascular, Inflammation, Chronic                           1 (2%)                                                          
      Submucosa, Edema                                              1 (2%)                                                          
   Stomach, Glandular                                 (49)         (50)         (50)         (50)                                   
      Inflammation, Chronic                            2 (4%)                    2 (4%)       4 (8%)                                
      Mineralization                                   1 (2%)                                 1 (2%)                                
      Ulcer                                            1 (2%)                                                                       
      Artery, Inflammation, Chronic                                              1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Blood Vessel                                                    (1)                                                              
      Inflammation, Subacute                                        1 (100%)                                                        
   Heart                                              (49)         (50)         (50)         (50)                                   
      Cardiomyopathy                                  27 (55%)     29 (58%)     28 (56%)     30 (60%)                               
      Artery, Inflammation, Chronic                                              1 (2%)       1 (2%)                                
      Coronary Artery, Inflammation, Chronic                        1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Gland, Cortex                              (50)         (50)         (50)         (49)                                   
      Atrophy                                          1 (2%)       1 (2%)       1 (2%)       1 (2%)                                
      Congestion                                       2 (4%)       1 (2%)                    1 (2%)                                
      Cytoplasmic Alteration, Focal                   12 (24%)      7 (14%)      6 (12%)     13 (27%)                               
      Hyperplasia                                      2 (4%)                                                                       
      Hypertrophy                                                   2 (4%)                                                          
      Necrosis, Focal                                  1 (2%)                    1 (2%)                                             
      Vacuolization Cytoplasmic                                                  1 (2%)                                             
   Adrenal Gland, Medulla                             (39)         (47)         (44)         (47)                                   
      Hyperplasia                                      1 (3%)                                                                       
      Hyperplasia, Focal                               4 (10%)                   5 (11%)      5 (11%)                               
   Parathyroid Gland                                  (42)         (46)         (37)         (42)                                   
      Hyperplasia                                                   2 (4%)                                                          
   Pituitary Gland                                    (47)         (50)         (50)         (49)                                   
      Pars Distalis, Angiectasis                       5 (11%)      1 (2%)       4 (8%)       4 (8%)                                
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    3                                                              
NTP Experiment-Test: 05035-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        4-HYDROXYACETANILIDE                                   Date: 09/05/94  
Route: DOSED FEED                                                                                                 Time: 00:14:46  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   CONTROL      0.06% LF     0.3% MF      0.6% HF                                   
                                                   UF                                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
      Pars Distalis, Cyst                             22 (47%)     20 (40%)     17 (34%)     22 (45%)                               
      Pars Distalis, Hemorrhage                        2 (4%)       2 (4%)       1 (2%)                                             
      Pars Distalis, Hyperplasia, Focal                7 (15%)      6 (12%)     10 (20%)      9 (18%)                               
      Pars Intermedia, Cyst                                         1 (2%)       1 (2%)                                             
      Pars Intermedia, Hyperplasia                                               1 (2%)                                             
   Thyroid Gland                                      (49)         (50)         (50)         (50)                                   
      C-Cell, Hyperplasia                             25 (51%)     26 (52%)     21 (42%)     15 (30%)                               
      Follicle, Cyst                                                             1 (2%)                                             
      Follicular Cell, Hyperplasia                                                            3 (6%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (43)         (47)         (43)         (40)                                   
      Abscess                                          5 (12%)      3 (6%)       2 (5%)       3 (8%)                                
      Cyst                                             1 (2%)       5 (11%)      4 (9%)       1 (3%)                                
      Ectasia                                          1 (2%)                    1 (2%)                                             
      Fibrosis                                                                   1 (2%)                                             
      Inflammation, Acute                              2 (5%)       2 (4%)                                                          
      Inflammation, Chronic                            3 (7%)       1 (2%)       2 (5%)                                             
   Ovary                                              (49)         (50)         (50)         (49)                                   
      Angiectasis                                                                1 (2%)                                             
      Atrophy                                                       2 (4%)       1 (2%)                                             
      Congestion                                                                              2 (4%)                                
      Cyst                                             4 (8%)       3 (6%)       6 (12%)      3 (6%)                                
   Uterus                                             (49)         (50)         (50)         (50)                                   
      Angiectasis                                      1 (2%)                                                                       
      Atrophy                                          1 (2%)       2 (4%)       2 (4%)                                             
      Dilatation                                                    2 (4%)                    1 (2%)                                
      Inflammation, Chronic Active                     1 (2%)                                                                       
      Mineralization, Focal                            1 (2%)                                                                       
      Prolapse                                         1 (2%)       1 (2%)                                                          
      Thrombosis                                       2 (4%)       2 (4%)       1 (2%)                                             
      Endometrium, Cyst                                             2 (4%)       3 (6%)                                             
      Endometrium, Hyperplasia, Cystic                 2 (4%)       2 (4%)                                                          
      Serosa, Inflammation, Acute                                   1 (2%)                                                          
   Vagina                                                          (1)                       (2)                                    
      Cyst                                                          1 (100%)                                                        
      Metestrus                                                                               2 (100%)                              
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    4                                                              
NTP Experiment-Test: 05035-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        4-HYDROXYACETANILIDE                                   Date: 09/05/94  
Route: DOSED FEED                                                                                                 Time: 00:14:46  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   CONTROL      0.06% LF     0.3% MF      0.6% HF                                   
                                                   UF                                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Blood                                              (31)         (6)          (4)          (29)                                   
      Lymphocytosis                                                                           1 (3%)                                
   Bone Marrow                                        (49)         (49)         (49)         (50)                                   
      Hyperplasia                                      6 (12%)     12 (24%)      7 (14%)     17 (34%)                               
      Myelofibrosis                                    5 (10%)      2 (4%)       5 (10%)      2 (4%)                                
   Lymph Node                                         (50)         (49)         (50)         (50)                                   
      Inguinal, Lymphatic, Angiectasis                                                        1 (2%)                                
      Mediastinal, Congestion                          2 (4%)       3 (6%)       1 (2%)                                             
      Mediastinal, Granuloma                                        1 (2%)                                                          
      Mediastinal, Infiltration Cellular, Plasma                                                                                    
          Cell                                                                                1 (2%)                                
      Mediastinal, Lymphatic, Angiectasis                                        1 (2%)                                             
      Pancreatic, Congestion                           2 (4%)                                                                       
      Renal, Angiectasis                                            1 (2%)                                                          
      Renal, Congestion                                                          1 (2%)                                             
      Renal, Granuloma                                              1 (2%)                                                          
      Renal, Pigmentation                                                        1 (2%)                                             
   Lymph Node, Mandibular                             (43)         (46)         (45)         (44)                                   
      Congestion                                       1 (2%)       1 (2%)       2 (4%)       1 (2%)                                
      Granuloma                                        2 (5%)                                                                       
      Hyperplasia, Lymphoid                            1 (2%)                                                                       
      Infiltration Cellular, Plasma Cell              32 (74%)     38 (83%)     35 (78%)     28 (64%)                               
      Lymphatic, Angiectasis                                        1 (2%)                    1 (2%)                                
   Lymph Node, Mesenteric                             (48)         (48)         (49)         (50)                                   
      Congestion                                       1 (2%)       2 (4%)       3 (6%)       4 (8%)                                
      Granuloma                                       36 (75%)     38 (79%)     34 (69%)     27 (54%)                               
      Hyperplasia, Lymphoid                            1 (2%)                                                                       
      Infiltration Cellular, Plasma Cell                                                      1 (2%)                                
      Artery, Inflammation, Acute                                                1 (2%)                                             
      Artery, Thrombosis                                                         1 (2%)                                             
      Lymphatic, Angiectasis                                        2 (4%)                                                          
   Spleen                                             (50)         (50)         (50)         (50)                                   
      Congestion                                                    1 (2%)                                                          
      Granuloma                                        3 (6%)                    1 (2%)       3 (6%)                                
      Hematopoietic Cell Proliferation                33 (66%)     29 (58%)     23 (46%)     19 (38%)                               
      Hemorrhage                                                                 1 (2%)                                             
      Infarct                                                                    1 (2%)       1 (2%)                                
      Pigmentation, Hemosiderin                       23 (46%)     22 (44%)     28 (56%)     19 (38%)                               
      Capsule, Hemorrhage                                                        1 (2%)                                             
   Thymus                                             (39)         (42)         (36)         (42)                                   
      Congestion                                       1 (3%)                    1 (3%)                                             
      Cyst                                                          2 (5%)       1 (3%)       1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    5                                                              
NTP Experiment-Test: 05035-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        4-HYDROXYACETANILIDE                                   Date: 09/05/94  
Route: DOSED FEED                                                                                                 Time: 00:14:46  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   CONTROL      0.06% LF     0.3% MF      0.6% HF                                   
                                                   UF                                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (46)         (47)         (48)         (43)                                   
      Abscess                                                       1 (2%)                                                          
      Ectasia                                          8 (17%)      2 (4%)       4 (8%)       3 (7%)                                
      Galactocele                                     13 (28%)      8 (17%)     10 (21%)      8 (19%)                               
      Hypertrophy                                                                             1 (2%)                                
      Inflammation, Acute                                                                     1 (2%)                                
   Skin                                               (50)         (46)         (48)         (48)                                   
      Abscess                                          1 (2%)       1 (2%)                                                          
      Cyst Epithelial Inclusion                                                               1 (2%)                                
      Hemorrhage, Focal                                                                       1 (2%)                                
      Hyperkeratosis                                   1 (2%)                                                                       
      Ulcer                                                         1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (49)         (50)         (50)         (50)                                   
      Hyperostosis                                     7 (14%)      3 (6%)       6 (12%)     10 (20%)                               
   Skeletal Muscle                                    (1)                                                                           
      Myopathy Degenerative                            1 (100%)                                                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (49)         (50)         (50)         (50)                                   
      Hemorrhage                                       3 (6%)                    2 (4%)       1 (2%)                                
      Hydrocephalus                                    7 (14%)      5 (10%)      5 (10%)      6 (12%)                               
      Choroid Plexus, Perivascular, Inflammation,                                                                                   
           Chronic                                                  1 (2%)                                                          
   Peripheral Nerve                                                                          (1)                                    
      Degeneration                                                                            1 (100%)                              
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (50)         (50)         (50)                                   
      Congestion                                       3 (6%)       5 (10%)      2 (4%)       1 (2%)                                
      Fungus                                                                     1 (2%)                                             
      Hemorrhage, Focal                                3 (6%)                    1 (2%)                                             
      Infiltration Cellular, Histiocyte                2 (4%)                                                                       
      Alveolar Epithelium, Metaplasia                  1 (2%)                                 1 (2%)                                
      Peribronchial, Inflammation, Chronic            20 (40%)     18 (36%)     22 (44%)     22 (44%)                               
   Nose                                               (47)         (50)         (50)         (50)                                   
      Abscess                                                       1 (2%)                                                          
      Fungus                                           3 (6%)       2 (4%)                    2 (4%)                                
      Hemorrhage                                       2 (4%)                                                                       
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    6                                                              
NTP Experiment-Test: 05035-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        4-HYDROXYACETANILIDE                                   Date: 09/05/94  
Route: DOSED FEED                                                                                                 Time: 00:14:46  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   CONTROL      0.06% LF     0.3% MF      0.6% HF                                   
                                                   UF                                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
RESPIRATORY SYSTEM - CONT                                                                                                           
      Inflammation, Acute                              4 (9%)       7 (14%)                   4 (8%)                                
      Inflammation, Chronic                           17 (36%)     21 (42%)     16 (32%)     14 (28%)                               
      Metaplasia, Squamous                            10 (21%)     14 (28%)     18 (36%)     14 (28%)                               
      Respiratory Epithelium, Degeneration, Hyaline    6 (13%)      1 (2%)       1 (2%)       4 (8%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Ear                                                (3)          (1)          (1)          (2)                                    
      Inflammation, Chronic                                         1 (100%)                                                        
      Ulcer, Multifocal                                                          1 (100%)                                           
   Eye                                                (9)          (11)         (7)          (9)                                    
      Cornea, Inflammation, Acute, Focal                            1 (9%)                                                          
      Lens, Degeneration                                                                      2 (22%)                               
      Retina, Degeneration                                          2 (18%)      1 (14%)      3 (33%)                               
   Harderian Gland                                    (8)          (8)          (5)          (5)                                    
      Inflammation, Chronic                            2 (25%)      1 (13%)      1 (20%)                                            
      Pigmentation                                     7 (88%)      7 (88%)      4 (80%)      5 (100%)                              
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (50)         (50)         (50)                                   
      Abscess, Multiple                                1 (2%)                                                                       
      Calculus Gross Observation                                                              1 (2%)                                
      Cyst                                             1 (2%)                                 1 (2%)                                
      Inflammation, Chronic                                                                   1 (2%)                                
      Nephropathy                                     48 (96%)     49 (98%)     47 (94%)     43 (86%)                               
      Artery, Inflammation, Chronic                                              1 (2%)                                             
      Artery, Inflammation, Subacute                                1 (2%)                                                          
      Pelvis, Transitional Epithelium, Hyperplasia                                            2 (4%)                                
      Renal Tubule, Cyst                                            1 (2%)                                                          
      Renal Tubule, Degeneration                                                 1 (2%)                                             
      Renal Tubule, Hyperplasia                                                               1 (2%)                                
      Renal Tubule, Pigmentation                       1 (2%)       1 (2%)       2 (4%)       3 (6%)                                
   Urinary Bladder                                    (44)         (45)         (49)         (50)                                   
      Calculus Gross Observation                                                              1 (2%)                                
      Inflammation, Chronic                                         6 (13%)      2 (4%)       1 (2%)                                
      Artery, Inflammation, Chronic                                              1 (2%)                                             
      Transitional Epithelium, Hyperplasia, Diffuse                                           1 (2%)                                
      Transitional Epithelium, Hyperplasia, Focal                                3 (6%)                                             
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    7                                                              
NTP Experiment-Test: 05035-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        4-HYDROXYACETANILIDE                                   Date: 09/05/94  
Route: DOSED FEED                                                                                                 Time: 00:14:46  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     CONTROL      0.06% LM     0.3% MM      0.6% HM                                   
                                                   UM                                                                               
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially In Study                          60           60           60           60                                     
  Scheduled Sacrifice                                 10           10           10           10                                     
  Early Deaths                                                                                                                      
    Moribund                                          22           20           25           22                                     
    Dead                                               1            2            2            4                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                27           28           23           24                                     
  Animals Examined Microscopically                    50           50           50           50                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large, Cecum                             (48)         (49)         (49)         (48)                                   
      Parasite Metazoan                                6 (13%)      5 (10%)      7 (14%)      4 (8%)                                
      Ulcer                                            1 (2%)       1 (2%)                                                          
   Intestine Large, Colon                             (48)         (49)         (50)         (50)                                   
      Parasite Metazoan                                9 (19%)      8 (16%)      5 (10%)      5 (10%)                               
   Intestine Large, Rectum                            (50)         (47)         (47)         (49)                                   
      Parasite Metazoan                               12 (24%)     10 (21%)      7 (15%)      8 (16%)                               
   Intestine Small, Duodenum                          (50)         (50)         (50)         (50)                                   
      Artery, Inflammation, Chronic                    1 (2%)                                                                       
      Muscularis, Hypertrophy                                       1 (2%)       1 (2%)                                             
   Intestine Small, Jejunum                           (50)         (48)         (49)         (49)                                   
      Ulcer                                                                                   1 (2%)                                
   Liver                                              (50)         (50)         (50)         (50)                                   
      Angiectasis                                                   2 (4%)       1 (2%)                                             
      Basophilic Focus                                 6 (12%)      2 (4%)       1 (2%)       2 (4%)                                
      Clear Cell Focus                                 1 (2%)                                 2 (4%)                                
      Congestion                                                    1 (2%)       2 (4%)       1 (2%)                                
      Cytoplasmic Alteration, Focal                    1 (2%)                                                                       
      Eosinophilic Focus                                                                      1 (2%)                                
      Fatty Change                                     9 (18%)      7 (14%)      9 (18%)      3 (6%)                                
      Granuloma                                        2 (4%)       1 (2%)                                                          
      Hemorrhage, Focal                                1 (2%)                                                                       
      Hepatodiaphragmatic Nodule                       3 (6%)       5 (10%)      5 (10%)      4 (8%)                                
      Hyperplasia, Focal                               3 (6%)       1 (2%)       1 (2%)       4 (8%)                                
      Hyperplasia, Multifocal                          1 (2%)                                                                       
      Necrosis, Focal                                  3 (6%)       5 (10%)      6 (12%)      1 (2%)                                
      Bile Duct, Hyperplasia                          42 (84%)     44 (88%)     43 (86%)     43 (86%)                               
      Centrilobular, Necrosis                                                                 1 (2%)                                
      Subserosa, Thrombosis                            1 (2%)                                                                       
   Mesentery                                          (3)          (9)          (3)          (2)                                    
      Accessory Spleen                                 1 (33%)                                                                      
      Edema                                                                                   1 (50%)                               
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    8                                                              
NTP Experiment-Test: 05035-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        4-HYDROXYACETANILIDE                                   Date: 09/05/94  
Route: DOSED FEED                                                                                                 Time: 00:14:46  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     CONTROL      0.06% LM     0.3% MM      0.6% HM                                   
                                                   UM                                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Fibrosis                                                      1 (11%)                                                         
      Inflammation, Acute                                           1 (11%)                                                         
      Fat, Necrosis                                    1 (33%)      3 (33%)      2 (67%)      1 (50%)                               
   Pancreas                                           (49)         (49)         (47)         (47)                                   
      Congestion                                                                 1 (2%)                                             
      Ectopic Tissue                                                                          1 (2%)                                
      Edema                                                         1 (2%)       1 (2%)                                             
      Hemorrhage, Focal                                                          1 (2%)                                             
      Pigmentation, Focal, Hemosiderin                              1 (2%)                                                          
      Acinus, Atrophy, Focal                          26 (53%)     17 (35%)     16 (34%)     20 (43%)                               
      Artery, Hypertrophy                                                        1 (2%)                                             
      Artery, Inflammation, Chronic                    2 (4%)                                                                       
   Salivary Glands                                    (50)         (50)         (50)         (50)                                   
      Karyomegaly                                     45 (90%)     44 (88%)     46 (92%)     48 (96%)                               
   Stomach, Forestomach                               (49)         (50)         (46)         (50)                                   
      Acanthosis                                       2 (4%)       1 (2%)       1 (2%)       2 (4%)                                
      Bulla                                                                                   1 (2%)                                
      Hyperkeratosis                                                1 (2%)       1 (2%)       1 (2%)                                
      Hyperplasia, Basal Cell                          3 (6%)                    4 (9%)       1 (2%)                                
      Inflammation, Acute                                                        1 (2%)                                             
      Inflammation, Chronic                            1 (2%)                                 1 (2%)                                
      Perforation                                                   1 (2%)       1 (2%)                                             
      Ulcer                                            4 (8%)       2 (4%)       3 (7%)       1 (2%)                                
      Serosa, Inflammation, Chronic                    1 (2%)                                                                       
   Stomach, Glandular                                 (50)         (50)         (50)         (50)                                   
      Hyperplasia, Lymphoid                            1 (2%)       1 (2%)                                                          
      Inflammation, Chronic                            1 (2%)                                 1 (2%)                                
      Mineralization                                                1 (2%)       1 (2%)       2 (4%)                                
      Ulcer                                                                      1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (50)         (50)         (50)         (50)                                   
      Cardiomyopathy                                  40 (80%)     40 (80%)     42 (84%)     35 (70%)                               
      Dilatation                                                                 1 (2%)                                             
      Atrium, Inflammation, Chronic                    1 (2%)       1 (2%)                                                          
      Atrium, Thrombosis                               4 (8%)       1 (2%)       1 (2%)       1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Gland, Cortex                              (50)         (50)         (50)         (50)                                   
      Atrophy                                                                                 1 (2%)                                
      Congestion                                                                 1 (2%)                                             
      Cytoplasmic Alteration, Focal                    4 (8%)       6 (12%)      9 (18%)      3 (6%)                                
      Hemorrhage, Focal                                                                       1 (2%)                                
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    9                                                              
NTP Experiment-Test: 05035-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        4-HYDROXYACETANILIDE                                   Date: 09/05/94  
Route: DOSED FEED                                                                                                 Time: 00:14:46  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     CONTROL      0.06% LM     0.3% MM      0.6% HM                                   
                                                   UM                                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
      Hyperplasia, Focal                                            1 (2%)                                                          
      Necrosis, Focal                                  2 (4%)                                                                       
      Vacuolization Cytoplasmic                        1 (2%)                    1 (2%)       1 (2%)                                
   Adrenal Gland, Medulla                             (44)         (49)         (49)         (46)                                   
      Hyperplasia                                                                             2 (4%)                                
      Hyperplasia, Focal                               8 (18%)      9 (18%)      8 (16%)      5 (11%)                               
      Necrosis, Focal                                               1 (2%)                                                          
   Islets, Pancreatic                                 (49)         (49)         (46)         (48)                                   
      Hyperplasia                                      1 (2%)       1 (2%)                    2 (4%)                                
   Parathyroid Gland                                  (42)         (45)         (46)         (45)                                   
      Hyperplasia                                                   4 (9%)       6 (13%)      8 (18%)                               
   Pituitary Gland                                    (48)         (49)         (49)         (48)                                   
      Pars Distalis, Angiectasis                       1 (2%)                    2 (4%)                                             
      Pars Distalis, Cyst                              2 (4%)       4 (8%)       1 (2%)       2 (4%)                                
      Pars Distalis, Hyperplasia, Focal               18 (38%)     15 (31%)     15 (31%)     10 (21%)                               
      Pars Distalis, Pigmentation, Hemosiderin         2 (4%)                    1 (2%)                                             
      Pars Intermedia, Pigmentation, Hemosiderin                                 1 (2%)                                             
   Thyroid Gland                                      (50)         (50)         (50)         (50)                                   
      C-Cell, Hyperplasia                             15 (30%)     12 (24%)     17 (34%)     13 (26%)                               
      Follicle, Cyst                                   1 (2%)                                 1 (2%)                                
      Follicular Cell, Hyperplasia                     1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (50)         (50)         (50)         (50)                                   
      Degeneration, Focal                                                                     1 (2%)                                
   Penis                                                                        (1)          (1)                                    
      Concretion                                                                 1 (100%)     1 (100%)                              
   Preputial Gland                                    (48)         (50)         (49)         (47)                                   
      Abscess                                          3 (6%)       1 (2%)       5 (10%)      3 (6%)                                
      Cyst                                             2 (4%)       1 (2%)                                                          
      Ectasia                                          1 (2%)                                 1 (2%)                                
      Hyperplasia                                                                2 (4%)                                             
      Inflammation, Acute                              2 (4%)       1 (2%)       1 (2%)       1 (2%)                                
      Inflammation, Chronic                           17 (35%)     15 (30%)     13 (27%)     15 (32%)                               
      Inflammation, Subacute                                                     1 (2%)                                             
   Prostate                                           (47)         (49)         (50)         (49)                                   
      Abscess                                                                                 1 (2%)                                
      Atrophy                                         13 (28%)     16 (33%)     17 (34%)     13 (27%)                               
      Hyperplasia, Focal                               1 (2%)                                 3 (6%)                                
      Inflammation, Acute                              6 (13%)      6 (12%)      5 (10%)      5 (10%)                               
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   10                                                              
NTP Experiment-Test: 05035-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        4-HYDROXYACETANILIDE                                   Date: 09/05/94  
Route: DOSED FEED                                                                                                 Time: 00:14:46  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     CONTROL      0.06% LM     0.3% MM      0.6% HM                                   
                                                   UM                                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
GENITAL SYSTEM - CONT                                                                                                               
      Inflammation, Chronic                            7 (15%)      6 (12%)      5 (10%)      7 (14%)                               
      Inflammation, Subacute                                                     1 (2%)                                             
      Metaplasia, Squamous                             1 (2%)                                                                       
   Seminal Vesicle                                    (48)         (49)         (50)         (50)                                   
      Atrophy                                         30 (63%)     35 (71%)     32 (64%)     29 (58%)                               
      Dilatation                                                                 1 (2%)       2 (4%)                                
      Inflammation, Acute                                           1 (2%)                                                          
   Testes                                             (50)         (50)         (50)         (50)                                   
      Cyst                                                          1 (2%)                                                          
      Hemorrhage                                                                 1 (2%)                                             
      Hypospermia                                                                             1 (2%)                                
      Artery, Inflammation                                          1 (2%)                                                          
      Interstitial Cell, Hyperplasia                   1 (2%)       2 (4%)       5 (10%)      3 (6%)                                
      Seminiferous Tubule, Atrophy                    37 (74%)     36 (72%)     33 (66%)     25 (50%)                               
      Seminiferous Tubule, Hypospermia                 1 (2%)       3 (6%)       2 (4%)       4 (8%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (50)         (50)         (49)                                   
      Hyperplasia                                     19 (38%)     20 (40%)     20 (40%)     20 (41%)                               
      Myelofibrosis                                                 3 (6%)       2 (4%)       3 (6%)                                
   Lymph Node                                         (50)         (50)         (50)         (49)                                   
      Inguinal, Infiltration Cellular, Plasma Cell                                            1 (2%)                                
      Lumbar, Infiltration Cellular, Plasma Cell                                              1 (2%)                                
      Mediastinal, Congestion                          1 (2%)       1 (2%)       1 (2%)                                             
      Mediastinal, Infiltration Cellular, Plasma                                                                                    
          Cell                                         1 (2%)       1 (2%)                    1 (2%)                                
      Mediastinal, Lymphatic, Angiectasis              1 (2%)                                 1 (2%)                                
      Pancreatic, Congestion                           1 (2%)                    1 (2%)                                             
      Pancreatic, Infiltration Cellular, Plasma                                                                                     
          Cell                                                      1 (2%)                                                          
      Pancreatic, Lymphatic, Angiectasis               1 (2%)                                                                       
      Renal, Congestion                                             1 (2%)                                                          
      Renal, Infiltration Cellular, Plasma Cell                                               2 (4%)                                
      Renal, Lymphatic, Angiectasis                                                           1 (2%)                                
   Lymph Node, Mandibular                             (47)         (45)         (49)         (45)                                   
      Angiectasis                                                                1 (2%)                                             
      Congestion                                                    1 (2%)       4 (8%)                                             
      Granuloma                                                                               1 (2%)                                
      Hyperplasia, Lymphoid                                                                   1 (2%)                                
      Infiltration Cellular, Plasma Cell              34 (72%)     38 (84%)     38 (78%)     27 (60%)                               
      Lymphatic, Angiectasis                           3 (6%)       5 (11%)                   5 (11%)                               
   Lymph Node, Mesenteric                             (49)         (50)         (50)         (48)                                   
      Congestion                                       3 (6%)       1 (2%)       4 (8%)       3 (6%)                                
      Granuloma                                       23 (47%)     30 (60%)     25 (50%)     22 (46%)                               
      Infiltration Cellular, Plasma Cell                                                      1 (2%)                                
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   11                                                              
NTP Experiment-Test: 05035-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        4-HYDROXYACETANILIDE                                   Date: 09/05/94  
Route: DOSED FEED                                                                                                 Time: 00:14:46  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     CONTROL      0.06% LM     0.3% MM      0.6% HM                                   
                                                   UM                                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Lymphatic, Angiectasis                           7 (14%)      2 (4%)       5 (10%)      4 (8%)                                
   Spleen                                             (50)         (50)         (50)         (50)                                   
      Congestion                                       2 (4%)                    1 (2%)       1 (2%)                                
      Fibrosis, Focal                                  2 (4%)       3 (6%)                    6 (12%)                               
      Granuloma                                        1 (2%)                                                                       
      Hematopoietic Cell Proliferation                11 (22%)     13 (26%)     15 (30%)     20 (40%)                               
      Necrosis, Focal                                                                         1 (2%)                                
      Pigmentation, Hemosiderin                        4 (8%)       9 (18%)      8 (16%)      5 (10%)                               
      Thrombosis                                                                 1 (2%)                                             
      Capsule, Fibrosis, Focal                                                   1 (2%)                                             
   Thymus                                             (40)         (37)         (40)         (42)                                   
      Atrophy                                          1 (3%)                                                                       
      Congestion                                                                              1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (36)         (34)         (35)         (36)                                   
      Abscess                                                       1 (3%)                                                          
      Ectasia                                          5 (14%)      5 (15%)      3 (9%)       5 (14%)                               
      Galactocele                                      3 (8%)       1 (3%)                                                          
      Hypertrophy                                                                             1 (3%)                                
   Skin                                               (50)         (50)         (48)         (49)                                   
      Acanthosis                                       1 (2%)                                                                       
      Hyperkeratosis                                   1 (2%)                                 2 (4%)                                
      Hyperplasia, Basal Cell                          1 (2%)       1 (2%)                                                          
      Dermis, Fibrosis                                              1 (2%)                                                          
      Subcutaneous Tissue, Lymphatic, Dilatation                                 1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (49)         (50)         (50)         (49)                                   
      Hydrocephalus                                    6 (12%)      4 (8%)       4 (8%)       4 (8%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (50)         (50)         (50)                                   
      Congestion                                       1 (2%)       1 (2%)       3 (6%)       3 (6%)                                
      Fungus                                                        1 (2%)                                                          
      Granuloma                                                     2 (4%)                                                          
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   12                                                              
NTP Experiment-Test: 05035-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        4-HYDROXYACETANILIDE                                   Date: 09/05/94  
Route: DOSED FEED                                                                                                 Time: 00:14:46  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     CONTROL      0.06% LM     0.3% MM      0.6% HM                                   
                                                   UM                                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
RESPIRATORY SYSTEM - CONT                                                                                                           
      Hemorrhage, Focal                                                          1 (2%)                                             
      Inflammation, Focal, Subacute                                 1 (2%)                                                          
      Alveolar Epithelium, Metaplasia                  1 (2%)       3 (6%)       4 (8%)       3 (6%)                                
      Alveolus, Inflammation, Acute, Focal                                                    1 (2%)                                
      Interstitium, Inflammation, Chronic                                                     1 (2%)                                
      Peribronchial, Inflammation, Chronic            25 (50%)     20 (40%)     15 (30%)     18 (36%)                               
      Pleura, Fibrosis                                 1 (2%)                                                                       
      Pleura, Inflammation, Chronic, Focal                                                    1 (2%)                                
   Nose                                               (49)         (50)         (50)         (49)                                   
      Cyst                                                          1 (2%)                                                          
      Fibrosis                                                                   1 (2%)                                             
      Fungus                                           6 (12%)      4 (8%)       3 (6%)       3 (6%)                                
      Hemorrhage                                       2 (4%)                                 1 (2%)                                
      Inflammation, Acute                              4 (8%)       5 (10%)      6 (12%)      4 (8%)                                
      Inflammation, Chronic                           20 (41%)     22 (44%)     17 (34%)     10 (20%)                               
      Metaplasia, Squamous                            35 (71%)     30 (60%)     30 (60%)     22 (45%)                               
      Parasite Metazoan                                                                       2 (4%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (3)          (5)          (11)         (8)                                    
      Anterior Chamber, Fibrosis                                                 1 (9%)                                             
      Anterior Chamber, Inflammation, Acute                                                   1 (13%)                               
      Lens, Degeneration                               1 (33%)                                2 (25%)                               
      Retina, Degeneration                                                                    2 (25%)                               
      Retrobulbar, Hemorrhage                                                                 1 (13%)                               
   Harderian Gland                                    (4)          (5)          (9)          (6)                                    
      Inflammation, Chronic                                                      2 (22%)                                            
      Pigmentation                                     4 (100%)     4 (80%)      9 (100%)     6 (100%)                              
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (50)         (50)         (50)                                   
      Atrophy, Focal                                   1 (2%)                                                                       
      Congestion                                                                              1 (2%)                                
      Cyst                                                                       1 (2%)                                             
      Fibrosis, Focal                                                            1 (2%)       1 (2%)                                
      Mineralization, Focal                                         1 (2%)                    1 (2%)                                
      Nephropathy                                     50 (100%)    50 (100%)    50 (100%)    49 (98%)                               
      Cortex, Necrosis, Focal                                                    1 (2%)       1 (2%)                                
      Interstitial Tissue, Hyperplasia                                                        1 (2%)                                
      Pelvis, Transitional Epithelium, Hyperplasia                               1 (2%)                                             
      Renal Tubule, Cyst                               2 (4%)       2 (4%)       1 (2%)       4 (8%)                                
      Renal Tubule, Hyperplasia                        1 (2%)       5 (10%)      3 (6%)       5 (10%)                               
      Renal Tubule, Necrosis, Focal                                 1 (2%)                                                          
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   13                                                              
NTP Experiment-Test: 05035-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                        4-HYDROXYACETANILIDE                                   Date: 09/05/94  
Route: DOSED FEED                                                                                                 Time: 00:14:46  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     CONTROL      0.06% LM     0.3% MM      0.6% HM                                   
                                                   UM                                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
URINARY SYSTEM - CONT                                                                                                               
      Renal Tubule, Pigmentation                       3 (6%)       5 (10%)      2 (4%)       1 (2%)                                
      Transitional Epithelium, Hyperplasia             1 (2%)                                 1 (2%)                                
      Transitional Epithelium, Hyperplasia, Focal      2 (4%)                                 1 (2%)                                
   Urinary Bladder                                    (49)         (48)         (47)         (46)                                   
      Concretion                                                    2 (4%)       1 (2%)                                             
      Inflammation, Chronic                                         2 (4%)       1 (2%)                                             
      Artery, Inflammation, Chronic                    1 (2%)                                                                       
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   14                                                              
                             ------------------------------------------------------------                                           
                             ----------              END OF REPORT             ----------                                           
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