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TDMS Study 05166-01 Pathology Tables


                                     INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
                                               3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE


NTP Experiment-Test: 05166-01                                                                                     Report: PEIRPT03
Study Type: CHRONIC                                                                                               Date: 09/18/94
Route: DOSED WATER                                                                                                Time: 00:50:59




       Facility:  Hazleton Laboratories America, Inc.

       Chemical CAS #:  612-82-8

       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: 05166-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE                           Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 00:50:59  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   CONTROL      0.003        0.007        0.015                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially In Study                          70           45           75           70                                     
  Scheduled Sacrifice                                 10                                     10                                     
  Early Deaths                                                                                                                      
    Moribund                                           1            5           37           45                                     
    Dead                                                            1            6            5                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                59           39           32           10                                     
  Animals Examined Microscopically                    60           45           75           60                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large, Cecum                             (60)         (45)         (75)         (60)                                   
      Edema                                                                                   1 (2%)                                
      Parasite Metazoan                                                          1 (1%)                                             
   Intestine Large, Colon                             (60)         (45)         (75)         (60)                                   
      Mineralization                                                             2 (3%)                                             
      Parasite Metazoan                                4 (7%)       2 (4%)       9 (12%)      6 (10%)                               
   Intestine Large, Rectum                            (60)         (45)         (74)         (60)                                   
      Parasite Metazoan                                6 (10%)      7 (16%)      5 (7%)       5 (8%)                                
   Intestine Small, Jejunum                           (60)         (45)         (74)         (59)                                   
      Muscularis, Mineralization                                                 1 (1%)                                             
   Liver                                              (60)         (45)         (74)         (60)                                   
      Angiectasis                                                                6 (8%)       2 (3%)                                
      Basophilic Focus                                             13 (29%)     11 (15%)      3 (5%)                                
      Congestion                                                                              1 (2%)                                
      Cyst                                                                                    2 (3%)                                
      Degeneration, Chronic                                                      1 (1%)                                             
      Degeneration, Cystic                                          3 (7%)      12 (16%)     11 (18%)                               
      Eosinophilic Focus                                            7 (16%)     57 (77%)     38 (63%)                               
      Fatty Change, Multifocal                                                   4 (5%)       2 (3%)                                
      Hematocyst                                                                              1 (2%)                                
      Hematopoietic Cell Proliferation                              7 (16%)     19 (26%)      8 (13%)                               
      Hemorrhage                                                                              1 (2%)                                
      Hepatodiaphragmatic Nodule                       7 (12%)      7 (16%)      7 (9%)       3 (5%)                                
      Hyperplasia, Re Cell                                                                    1 (2%)                                
      Inflammation, Acute, Multifocal                                            2 (3%)                                             
      Inflammation, Granulomatous, Multifocal         11 (18%)     19 (42%)     10 (14%)     10 (17%)                               
      Inflammation, Multifocal, Suppurative                                                   1 (2%)                                
      Mixed Cell Focus                                             34 (76%)     49 (66%)     32 (53%)                               
      Necrosis, Coagulative, Focal                                  1 (2%)                    1 (2%)                                
      Necrosis, Coagulative, Multifocal                                          2 (3%)                                             
      Necrosis, Focal                                               2 (4%)       5 (7%)       1 (2%)                                
      Bile Duct, Cyst                                                            2 (3%)       1 (2%)                                
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    2                                                              
NTP Experiment-Test: 05166-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE                           Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 00:50:59  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   CONTROL      0.003        0.007        0.015                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Bile Duct, Hyperplasia                          20 (33%)      2 (4%)       1 (1%)                                             
      Centrilobular, Necrosis                                       1 (2%)                                                          
   Mesentery                                          (3)          (3)          (1)                                                 
      Hemorrhage                                                    1 (33%)                                                         
      Artery, Mineralization                                                     1 (100%)                                           
      Fat, Necrosis, Focal                             3 (100%)     2 (67%)                                                         
   Pancreas                                           (60)         (45)         (74)         (60)                                   
      Inflammation, Chronic                            1 (2%)                                                                       
      Acinus, Atrophy                                  5 (8%)       2 (4%)       1 (1%)       2 (3%)                                
      Acinus, Hyperplasia, Focal                                                 1 (1%)                                             
      Artery, Mineralization                                                     1 (1%)                                             
   Pharynx                                                         (1)          (8)          (7)                                    
      Hyperplasia, Focal                                                         1 (13%)                                            
   Salivary Glands                                    (60)         (43)         (72)         (60)                                   
      Inflammation, Chronic                                         1 (2%)       3 (4%)       1 (2%)                                
   Stomach, Forestomach                               (60)         (45)         (74)         (60)                                   
      Hyperplasia, Multifocal                                                    1 (1%)                                             
      Inflammation, Chronic                            1 (2%)                                 1 (2%)                                
   Stomach, Glandular                                 (60)         (45)         (74)         (60)                                   
      Degeneration, Cystic                             1 (2%)       3 (7%)       6 (8%)      11 (18%)                               
      Erosion                                                                    2 (3%)                                             
      Erosion, Multifocal                                                        1 (1%)       1 (2%)                                
      Mineralization                                                             5 (7%)                                             
      Ulcer                                                                      1 (1%)                                             
   Tongue                                                          (2)          (3)          (10)                                   
      Hyperkeratosis, Focal                                                      1 (33%)      1 (10%)                               
      Artery, Mineralization                                                     1 (33%)                                            
   Tooth                                                                        (2)          (1)                                    
      Peridontal Tissue, Inflammation, Chronic                                                                                      
          Active                                                                 2 (100%)     1 (100%)                              
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (60)         (45)         (74)         (60)                                   
      Cardiomyopathy                                                             3 (4%)       3 (5%)                                
      Mineralization                                                             4 (5%)                                             
      Coronary Artery, Inflammation, Chronic                        1 (2%)                                                          
      Mitral Valve, Inflammation, Suppurative                                                 1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Gland, Cortex                              (60)         (45)         (74)         (60)                                   
      Angiectasis                                                                8 (11%)      8 (13%)                               
      Cyst                                                          1 (2%)                                                          
      Hematopoietic Cell Proliferation                                           1 (1%)                                             
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    3                                                              
NTP Experiment-Test: 05166-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE                           Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 00:50:59  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   CONTROL      0.003        0.007        0.015                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
      Hyperplasia, Focal                                            2 (4%)       3 (4%)       1 (2%)                                
      Vacuolization Cytoplasmic, Focal                 2 (3%)                   10 (14%)      5 (8%)                                
      Vacuolization Cytoplasmic, Multifocal                                                   1 (2%)                                
      Bilateral, Angiectasis                                                     1 (1%)                                             
      Bilateral, Hyperplasia, Multifocal                                         1 (1%)                                             
   Adrenal Gland, Medulla                             (60)         (45)         (74)         (60)                                   
      Hyperplasia, Focal                                                         2 (3%)                                             
   Parathyroid Gland                                  (53)         (44)         (70)         (58)                                   
      Hyperplasia                                                                5 (7%)       3 (5%)                                
   Pituitary Gland                                    (58)         (45)         (75)         (60)                                   
      Angiectasis                                      1 (2%)       6 (13%)      3 (4%)       1 (2%)                                
      Cyst                                            17 (29%)      7 (16%)     11 (15%)      8 (13%)                               
      Hemorrhage                                                    2 (4%)                                                          
      Pars Distalis, Hyperplasia                                                              1 (2%)                                
      Pars Distalis, Hyperplasia, Focal                2 (3%)       1 (2%)       2 (3%)       1 (2%)                                
   Thyroid Gland                                      (60)         (45)         (74)         (60)                                   
      Ultimobranchial Cyst                             2 (3%)       1 (2%)       7 (9%)       5 (8%)                                
      C-Cell, Hyperplasia                                           1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   Tissue NOS                                                                   (6)          (3)                                    
      Mineralization                                                             4 (67%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (60)         (45)         (75)         (59)                                   
      Hyperplasia                                                   1 (2%)       3 (4%)                                             
      Hyperplasia, Focal, Squamous                                               1 (1%)                                             
      Inflammation, Chronic Active                                  1 (2%)                    1 (2%)                                
      Inflammation, Suppurative                                                  1 (1%)       1 (2%)                                
      Bilateral, Duct, Ectasia                                      1 (2%)                                                          
      Duct, Ectasia                                    6 (10%)      2 (4%)      12 (16%)      5 (8%)                                
   Ovary                                              (60)         (44)         (75)         (60)                                   
      Cyst                                                          2 (5%)                                                          
      Bilateral, Periovarian Tissue, Cyst                                        1 (1%)                                             
      Periovarian Tissue, Cyst                         3 (5%)       4 (9%)       3 (4%)       2 (3%)                                
   Uterus                                             (60)         (44)         (75)         (60)                                   
      Fibrosis                                                                   1 (1%)                                             
      Hydrometra                                       5 (8%)       3 (7%)       1 (1%)                                             
      Pigmentation, Focal, Hemosiderin                              1 (2%)                                                          
      Thrombosis                                                                              1 (2%)                                
      Cervix, Dilatation                                                         1 (1%)                                             
      Endometrium, Cyst                                                          3 (4%)                                             
      Endometrium, Hyperplasia, Papillary                                                     1 (2%)                                
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    4                                                              
NTP Experiment-Test: 05166-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE                           Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 00:50:59  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   CONTROL      0.003        0.007        0.015                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Blood                                                                        (1)                                                 
      Anemia                                                                     1 (100%)                                           
   Bone Marrow                                        (60)         (45)         (73)         (59)                                   
      Atrophy                                                                    1 (1%)       4 (7%)                                
      Hemorrhage                                                                 2 (3%)       4 (7%)                                
      Hyperplasia                                                                             7 (12%)                               
      Hyperplasia, Multifocal, Re Cell                 1 (2%)                                                                       
   Lymph Node                                         (60)         (45)         (75)         (60)                                   
      Hemorrhage                                                                              1 (2%)                                
      Deep Cervical, Hyperplasia, Plasma Cell                                    1 (1%)                                             
      Iliac, Hyperplasia, Plasma Cell                                                         1 (2%)                                
      Inguinal, Hyperplasia, Plasma Cell                                         1 (1%)                                             
      Mediastinal, Hemorrhage                         21 (35%)      7 (16%)      4 (5%)       3 (5%)                                
      Mediastinal, Hyperplasia, Plasma Cell                                                   2 (3%)                                
      Mediastinal, Pigmentation, Hemosiderin                        1 (2%)       2 (3%)                                             
      Mediastinal, Sinus, Infiltration Cellular,                                                                                    
           Histiocyte                                                            1 (1%)                                             
      Renal, Hemorrhage                                                          2 (3%)                                             
   Lymph Node, Mandibular                             (60)         (43)         (72)         (60)                                   
      Hemorrhage                                       3 (5%)       2 (5%)       3 (4%)       2 (3%)                                
      Hyperplasia, Lymphoid                            1 (2%)       2 (5%)       2 (3%)       2 (3%)                                
      Hyperplasia, Plasma Cell                         1 (2%)       5 (12%)     20 (28%)     18 (30%)                               
      Sinus, Ectasia                                   3 (5%)       3 (7%)       2 (3%)       1 (2%)                                
   Lymph Node, Mesenteric                             (60)         (45)         (73)         (60)                                   
      Atrophy                                                                    2 (3%)       1 (2%)                                
      Hemorrhage                                                                 1 (1%)                                             
   Spleen                                             (60)         (45)         (74)         (60)                                   
      Depletion Lymphoid                                                         1 (1%)                                             
      Fibrosis                                                                   2 (3%)                                             
      Fibrosis, Focal                                                            1 (1%)                                             
      Hematopoietic Cell Proliferation                              6 (13%)     20 (27%)     14 (23%)                               
      Hemorrhage, Multifocal                           1 (2%)                                                                       
      Pigmentation, Hemosiderin                                                  1 (1%)                                             
      Red Pulp, Atrophy                                                                       2 (3%)                                
   Thymus                                             (54)         (32)         (67)         (45)                                   
      Cyst                                                          2 (6%)                    1 (2%)                                
      Depletion Lymphoid                                                                      1 (2%)                                
      Hemorrhage                                                                              1 (2%)                                
      Epithelial Cell, Hyperplasia                     7 (13%)     15 (47%)     17 (25%)      3 (7%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    5                                                              
NTP Experiment-Test: 05166-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE                           Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 00:50:59  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   CONTROL      0.003        0.007        0.015                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (56)         (42)         (73)         (54)                                   
      Fibrosis, Focal                                  1 (2%)                                                                       
      Duct, Ectasia                                    2 (4%)       1 (2%)                                                          
   Skin                                               (60)         (45)         (75)         (59)                                   
      Acanthosis                                                    3 (7%)                    1 (2%)                                
      Cyst Epithelial Inclusion                                                  1 (1%)       3 (5%)                                
      Inflammation, Chronic Active                     2 (3%)                                 1 (2%)                                
      Ulcer                                                         1 (2%)                                                          
      Epidermis, Hyperplasia, Basal Cell, Focal                                  1 (1%)                                             
      Hair Follicle, Hyperplasia, Basal Cell, Focal                              1 (1%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                                            (2)          (2)          (1)                                    
      Cranium, Fibrous Osteodystrophy                                            2 (100%)     1 (100%)                              
      Cranium, Osteopetrosis                                        1 (50%)                                                         
      Sternum, Fibrous Osteodystrophy                                            1 (50%)                                            
      Sternum, Osteopetrosis                                        1 (50%)                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (60)         (45)         (75)         (60)                                   
      Brain Stem, Compression                          1 (2%)                    1 (1%)                                             
      Brain Stem, Hemorrhage                                                     1 (1%)                                             
      Cerebellum, Hemorrhage                                                                  1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (60)         (45)         (74)         (60)                                   
      Congestion                                                                 1 (1%)       2 (3%)                                
      Edema                                                                                   1 (2%)                                
      Foreign Body                                                                            1 (2%)                                
      Hemorrhage                                                                 2 (3%)       2 (3%)                                
      Infiltration Cellular, Histiocyte               12 (20%)     23 (51%)     36 (49%)     29 (48%)                               
      Metaplasia, Focal, Osseous                                                 1 (1%)                                             
      Metaplasia, Squamous                                                       1 (1%)                                             
      Mineralization                                                             2 (3%)                                             
      Pigmentation                                                                            1 (2%)                                
      Alveolar Epithelium, Hyperplasia, Focal          1 (2%)       7 (16%)     20 (27%)      7 (12%)                               
      Alveolar Epithelium, Hyperplasia, Multifocal                  4 (9%)      10 (14%)      6 (10%)                               
      Artery, Mineralization                                                     1 (1%)                                             
      Bronchiole, Inflammation, Suppurative                                                   1 (2%)                                
      Interstitium, Inflammation                                                 4 (5%)       2 (3%)                                
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    6                                                              
NTP Experiment-Test: 05166-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE                           Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 00:50:59  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   CONTROL      0.003        0.007        0.015                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
RESPIRATORY SYSTEM - CONT                                                                                                           
      Peribronchiolar, Alveolus, Inflammation,                                                                                      
           Suppurative                                                                        1 (2%)                                
   Nose                                               (60)         (44)         (75)         (60)                                   
      Foreign Body                                                                            1 (2%)                                
      Fungus                                                                     1 (1%)                                             
      Hemorrhage                                       5 (8%)                    2 (3%)       4 (7%)                                
      Inflammation, Suppurative                                                  6 (8%)       5 (8%)                                
      Olfactory Epithelium, Hyperplasia, Focal                                   1 (1%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Ear                                                                                       (1)                                    
      Pinna, Ulcer                                                                            1 (100%)                              
   Eye                                                             (1)          (4)          (4)                                    
      Anterior Chamber, Hemorrhage                                               2 (50%)                                            
      Cornea, Inflammation, Suppurative                                          3 (75%)      3 (75%)                               
   Harderian Gland                                                              (1)          (1)                                    
      Pigmentation, Porphyrin                                                    1 (100%)     1 (100%)                              
   Zymbal's Gland                                     (57)         (44)         (73)         (60)                                   
      Cyst                                                          1 (2%)                    1 (2%)                                
      Ectasia                                                                    4 (5%)                                             
      Hyperplasia, Focal, Glandular                                 3 (7%)       3 (4%)                                             
      Hyperplasia, Focal, Squamous                                  1 (2%)       4 (5%)       2 (3%)                                
      Hypertrophy                                                                3 (4%)       3 (5%)                                
      Inflammation, Chronic Active                                               1 (1%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (60)         (45)         (74)         (60)                                   
      Hemorrhage                                                                              1 (2%)                                
      Karyomegaly                                                  28 (62%)     61 (82%)     56 (93%)                               
      Nephropathy                                     47 (78%)     44 (98%)     72 (97%)     59 (98%)                               
      Medulla, Inflammation, Suppurative                                                      1 (2%)                                
   Urinary Bladder                                    (60)         (45)         (75)         (60)                                   
      Dilatation                                                                 2 (3%)                                             
      Hemorrhage                                                                 1 (1%)                                             
      Hyperplasia, Papillary                                                                  1 (2%)                                
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    7                                                              
NTP Experiment-Test: 05166-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE                           Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 00:50:59  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     CONTROL      0.003        0.007        0.015                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially In Study                          70           45           75           70                                     
  Scheduled Sacrifice                                 10                                     10                                     
  Early Deaths                                                                                                                      
    Moribund                                                        2           19           45                                     
    Dead                                                            2            5           15                                     
    Accident                                                                     1                                                  
  Survivors                                                                                                                         
    Terminal Sacrifice                                60           41           49                                                  
    Dead                                                                         1                                                  
  Animals Examined Microscopically                    60           45           75           60                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large, Cecum                             (60)         (45)         (75)         (58)                                   
      Hemorrhage                                                                 1 (1%)                                             
      Inflammation, Suppurative                                                               1 (2%)                                
      Parasite Metazoan                                2 (3%)       2 (4%)       2 (3%)                                             
   Intestine Large, Colon                             (60)         (45)         (75)         (58)                                   
      Parasite Metazoan                                8 (13%)      6 (13%)      8 (11%)      9 (16%)                               
      Artery, Inflammation, Necrotizing                                                       1 (2%)                                
   Intestine Large, Rectum                            (60)         (44)         (75)         (60)                                   
      Parasite Metazoan                                8 (13%)      8 (18%)      5 (7%)       5 (8%)                                
   Intestine Small, Ileum                             (60)         (44)         (75)         (54)                                   
      Hemorrhage                                                                              1 (2%)                                
      Hyperplasia, Lymphoid                                                                   1 (2%)                                
   Liver                                              (60)         (45)         (75)         (60)                                   
      Angiectasis                                                                             3 (5%)                                
      Basophilic Focus                                 1 (2%)      31 (69%)     54 (72%)     27 (45%)                               
      Congestion                                                                 1 (1%)                                             
      Degeneration, Cystic                                         24 (53%)     67 (89%)     51 (85%)                               
      Eosinophilic Focus                                                        57 (76%)     53 (88%)                               
      Fatty Change, Diffuse                                                      1 (1%)                                             
      Fatty Change, Focal                              1 (2%)       1 (2%)                    1 (2%)                                
      Fatty Change, Multifocal                                      1 (2%)                    6 (10%)                               
      Hematocyst                                                                              1 (2%)                                
      Hematopoietic Cell Proliferation                              2 (4%)      27 (36%)     15 (25%)                               
      Hemorrhage, Focal                                1 (2%)                                                                       
      Hepatodiaphragmatic Nodule                       3 (5%)       1 (2%)       3 (4%)       6 (10%)                               
      Infarct                                          1 (2%)                    3 (4%)                                             
      Inflammation, Acute, Focal                       3 (5%)                                                                       
      Inflammation, Acute, Multifocal                  1 (2%)                                 1 (2%)                                
      Inflammation, Granulomatous, Multifocal          1 (2%)       5 (11%)      3 (4%)       2 (3%)                                
      Mixed Cell Focus                                             37 (82%)     54 (72%)     30 (50%)                               
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    8                                                              
NTP Experiment-Test: 05166-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE                           Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 00:50:59  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     CONTROL      0.003        0.007        0.015                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Necrosis, Coagulative, Focal                                                            1 (2%)                                
      Necrosis, Coagulative, Multifocal                1 (2%)                                 2 (3%)                                
      Necrosis, Focal                                  2 (3%)       4 (9%)       9 (12%)      1 (2%)                                
      Necrosis, Multifocal                                                       1 (1%)       1 (2%)                                
      Bile Duct, Hyperplasia                          39 (65%)      3 (7%)       2 (3%)       1 (2%)                                
      Bile Duct, Hyperplasia, Focal, Adenomatous                                              1 (2%)                                
      Biliary Tract, Inflammation, Subacute                                      1 (1%)                                             
      Caudate Lobe, Infarct                            1 (2%)                    1 (1%)                                             
      Caudate Lobe, Regeneration                                                              1 (2%)                                
      Caudate Lobe, Periportal, Fibrosis                                                      1 (2%)                                
      Centrilobular, Necrosis, Coagulative                          1 (2%)       1 (1%)       5 (8%)                                
      Serosa, Cyst                                     1 (2%)                                                                       
      Serosa, Fibrosis, Focal                          1 (2%)                                                                       
      Serosa, Pigmentation, Focal, Hemosiderin         1 (2%)                                                                       
   Mesentery                                          (2)          (6)          (6)          (7)                                    
      Hemorrhage                                       1 (50%)                                                                      
      Inflammation, Granulomatous                                                             1 (14%)                               
      Artery, Inflammation, Chronic                                 1 (17%)                                                         
      Artery, Mineralization                                                                  5 (71%)                               
      Fat, Necrosis, Focal                             2 (100%)     5 (83%)      6 (100%)     1 (14%)                               
   Pancreas                                           (60)         (44)         (75)         (57)                                   
      Inflammation, Chronic                            1 (2%)                    1 (1%)                                             
      Acinus, Atrophy                                  9 (15%)      4 (9%)       7 (9%)                                             
      Artery, Mineralization                                                                  1 (2%)                                
   Salivary Glands                                    (60)         (45)         (74)         (60)                                   
      Inflammation, Chronic Active                                               1 (1%)                                             
      Necrosis                                                                                1 (2%)                                
      Acinus, Atrophy                                                            1 (1%)       2 (3%)                                
   Stomach, Forestomach                               (60)         (45)         (75)         (59)                                   
      Erosion, Focal                                                             1 (1%)                                             
      Hyperplasia                                                                1 (1%)                                             
      Ulcer                                                                      2 (3%)       1 (2%)                                
   Stomach, Glandular                                 (60)         (45)         (75)         (59)                                   
      Degeneration, Cystic                            22 (37%)                   4 (5%)      15 (25%)                               
      Ectopic Tissue                                                             1 (1%)                                             
      Erosion                                                                                 1 (2%)                                
      Mineralization                                                                          8 (14%)                               
      Ulcer                                                                                   1 (2%)                                
      Ulcer, Multifocal                                             1 (2%)                                                          
   Tongue                                                                       (1)          (3)                                    
      Hyperplasia, Focal                                                                      1 (33%)                               
   Tooth                                                           (1)                                                              
      Dysplasia                                                     1 (100%)                                                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    9                                                              
NTP Experiment-Test: 05166-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE                           Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 00:50:59  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     CONTROL      0.003        0.007        0.015                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (60)         (45)         (75)         (59)                                   
      Cardiomyopathy                                  17 (28%)     19 (42%)     35 (47%)     31 (53%)                               
      Dilatation                                                                              1 (2%)                                
      Inflammation, Acute                                                                     1 (2%)                                
      Mineralization                                                                          6 (10%)                               
      Atrium, Dilatation                                                         1 (1%)                                             
      Atrium, Thrombosis                                                         2 (3%)                                             
      Mitral Valve, Inflammation, Chronic                                                     1 (2%)                                
      Mitral Valve, Thrombosis                                                                2 (3%)                                
      Myocardium, Inflammation, Acute                                                         1 (2%)                                
      Myocardium, Inflammation, Chronic Active                                                1 (2%)                                
      Myocardium, Necrosis, Focal                      1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Gland, Cortex                              (60)         (44)         (75)         (59)                                   
      Angiectasis                                                                             1 (2%)                                
      Hematopoietic Cell Proliferation                                           1 (1%)                                             
      Hyperplasia, Focal                                                         1 (1%)                                             
      Vacuolization Cytoplasmic, Focal                                           5 (7%)       5 (8%)                                
   Adrenal Gland, Medulla                             (60)         (45)         (75)         (59)                                   
      Hyperplasia, Focal                                                         1 (1%)                                             
      Bilateral, Hyperplasia, Focal                                                           1 (2%)                                
   Parathyroid Gland                                  (55)         (45)         (71)         (58)                                   
      Hyperplasia                                                                            11 (19%)                               
   Pituitary Gland                                    (60)         (45)         (75)         (60)                                   
      Angiectasis                                                                1 (1%)                                             
      Cyst                                             2 (3%)       2 (4%)       1 (1%)       1 (2%)                                
      Pars Distalis, Hyperplasia, Focal                2 (3%)                    3 (4%)       1 (2%)                                
   Thyroid Gland                                      (60)         (44)         (75)         (60)                                   
      Ultimobranchial Cyst                             3 (5%)                    1 (1%)       7 (12%)                               
      C-Cell, Hyperplasia                              1 (2%)                    1 (1%)                                             
      Follicle, Cyst                                                             1 (1%)                                             
      Follicular Cell, Hyperplasia, Focal                                        1 (1%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   Tissue NOS                                                                   (1)          (4)                                    
      Inflammation, Chronic                                                      1 (100%)                                           
      Mineralization                                                                          3 (75%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   10                                                              
NTP Experiment-Test: 05166-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE                           Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 00:50:59  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     CONTROL      0.003        0.007        0.015                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (60)         (45)         (75)         (60)                                   
      Inflammation, Chronic                                                      1 (1%)                                             
      Inflammation, Suppurative                                                               1 (2%)                                
      Arteriole, Inflammation, Chronic                                           1 (1%)                                             
   Preputial Gland                                    (60)         (45)         (75)         (60)                                   
      Atrophy                                                                    1 (1%)       1 (2%)                                
      Hyperplasia, Focal                                                         1 (1%)       3 (5%)                                
      Hyperplasia, Focal, Squamous                                                            2 (3%)                                
      Inflammation, Chronic Active                     7 (12%)      2 (4%)       9 (12%)      8 (13%)                               
      Duct, Ectasia                                    2 (3%)       2 (4%)       7 (9%)      13 (22%)                               
   Prostate                                           (60)         (45)         (75)         (60)                                   
      Hyperplasia, Focal                               1 (2%)       2 (4%)                    3 (5%)                                
      Hyperplasia, Multifocal                                                    1 (1%)                                             
      Inflammation, Acute                                                        1 (1%)                                             
      Inflammation, Chronic Active                    35 (58%)     28 (62%)     32 (43%)     15 (25%)                               
      Inflammation, Subacute                                                     1 (1%)                                             
      Inflammation, Suppurative                                     1 (2%)                    2 (3%)                                
      Vacuolization Cytoplasmic, Focal                              1 (2%)                                                          
   Seminal Vesicle                                    (60)         (44)         (75)         (58)                                   
      Atrophy                                                       1 (2%)       8 (11%)      5 (9%)                                
      Hyperplasia, Focal                                                                      2 (3%)                                
   Testes                                             (60)         (45)         (75)         (60)                                   
      Hemorrhage                                                                 1 (1%)       1 (2%)                                
      Hypospermia                                      9 (15%)      3 (7%)       5 (7%)       6 (10%)                               
      Mineralization                                   3 (5%)                                 1 (2%)                                
      Interstitial Cell, Hyperplasia                  44 (73%)     35 (78%)     28 (37%)      4 (7%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (60)         (44)         (75)         (60)                                   
      Atrophy                                                                                 8 (13%)                               
      Hemorrhage                                                                              8 (13%)                               
      Hyperplasia                                                                1 (1%)       3 (5%)                                
      Proliferation Connective Tissue                                                         1 (2%)                                
   Lymph Node                                         (60)         (45)         (75)         (60)                                   
      Bronchial, Hemorrhage                            1 (2%)                                                                       
      Deep Cervical, Hyperplasia, Plasma Cell                                    1 (1%)                                             
      Mediastinal, Hemorrhage                          5 (8%)       6 (13%)      9 (12%)      7 (12%)                               
      Mediastinal, Hyperplasia, Lymphoid               2 (3%)       1 (2%)                                                          
      Mediastinal, Hyperplasia, Plasma Cell                         1 (2%)       1 (1%)                                             
      Mediastinal, Hyperplasia, Re Cell                                          1 (1%)                                             
      Mediastinal, Infiltration Cellular,                                                                                           
          Polymorphonuclear                                                                   1 (2%)                                
      Mediastinal, Pigmentation, Hemosiderin           2 (3%)                                 1 (2%)                                
      Mediastinal, Sinus, Infiltration Cellular,                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   11                                                              
NTP Experiment-Test: 05166-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE                           Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 00:50:59  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     CONTROL      0.003        0.007        0.015                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
           Histiocyte                                                            1 (1%)                                             
      Pancreatic, Hemorrhage                           1 (2%)                                                                       
   Lymph Node, Mandibular                             (60)         (45)         (74)         (60)                                   
      Hemorrhage                                                                 2 (3%)       1 (2%)                                
      Hyperplasia, Lymphoid                                                                   3 (5%)                                
      Hyperplasia, Plasma Cell                         2 (3%)       5 (11%)     18 (24%)     16 (27%)                               
      Sinus, Ectasia                                                2 (4%)       3 (4%)       1 (2%)                                
   Lymph Node, Mesenteric                             (60)         (44)         (75)         (56)                                   
      Atrophy                                                                                 1 (2%)                                
      Hemorrhage                                       1 (2%)                    2 (3%)       1 (2%)                                
      Hyperplasia, Re Cell                             1 (2%)                                                                       
      Infiltration Cellular, Polymorphonuclear                                                1 (2%)                                
      Sinus, Ectasia                                                             1 (1%)       1 (2%)                                
   Spleen                                             (60)         (45)         (75)         (55)                                   
      Congestion                                                                 1 (1%)       3 (5%)                                
      Depletion Lymphoid                                            1 (2%)                    3 (5%)                                
      Fibrosis                                         1 (2%)                    1 (1%)       1 (2%)                                
      Hematopoietic Cell Proliferation                              1 (2%)      22 (29%)     11 (20%)                               
      Hyperplasia, Focal, Re Cell                                                             1 (2%)                                
      Necrosis                                                                                2 (4%)                                
      Necrosis, Multifocal                                                                    1 (2%)                                
      Thrombosis                                                                 1 (1%)                                             
      Capsule, Fibrosis, Focal                         1 (2%)                                                                       
      Capsule, Hematopoietic Cell Proliferation                                               1 (2%)                                
      Red Pulp, Necrosis                                                                      1 (2%)                                
   Thymus                                             (47)         (40)         (50)         (48)                                   
      Congestion                                                                              1 (2%)                                
      Cyst                                                                                    1 (2%)                                
      Depletion Lymphoid                                                                      3 (6%)                                
      Ectopic Parathyroid Gland                                                               1 (2%)                                
      Hemorrhage                                                                 1 (2%)       2 (4%)                                
      Hyperplasia, Lymphoid                            1 (2%)                                                                       
      Epithelial Cell, Hyperplasia                     9 (19%)      9 (23%)      4 (8%)       1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (60)         (44)         (75)         (60)                                   
      Acanthosis                                                                 1 (1%)       1 (2%)                                
      Cyst Epithelial Inclusion                                                  1 (1%)                                             
      Erosion, Focal                                                                          1 (2%)                                
      Fibrosis, Focal                                                                         2 (3%)                                
      Fibrosis, Multifocal                                                                    1 (2%)                                
      Inflammation, Chronic Active                                  1 (2%)       1 (1%)                                             
      Ulcer                                                                                   1 (2%)                                
      Hair Follicle, Hyperplasia, Basal Cell, Focal                              4 (5%)       1 (2%)                                
      Hair Follicle, Hyperplasia, Basal Cell,                                                                                       
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   12                                                              
NTP Experiment-Test: 05166-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE                           Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 00:50:59  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     CONTROL      0.003        0.007        0.015                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
INTEGUMENTARY SYSTEM - CONT                                                                                                         
          Multifocal                                                             1 (1%)       1 (2%)                                
      Sebaceous Gland, Hyperplasia, Focal                                        6 (8%)       1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                                                                      (5)                                    
      Cranium, Fibrous Osteodystrophy                                                         5 (100%)                              
      Sternum, Fibrous Osteodystrophy                                                         3 (60%)                               
      Sternum, Osteopetrosis                                                                  2 (40%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (60)         (45)         (75)         (60)                                   
      Brain Stem, Inflammation, Acute                                                         1 (2%)                                
      Cerebellum, Necrosis                                                                    1 (2%)                                
      Cerebrum, Hemorrhage                                                                    2 (3%)                                
      Cerebrum, Hemorrhage, Multifocal                                           1 (1%)                                             
      Cerebrum, Necrosis, Focal                                                  1 (1%)       1 (2%)                                
      Thalamus, Cyst                                                             1 (1%)                                             
      Thalamus, Hemorrhage                                                                    1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (60)         (45)         (75)         (60)                                   
      Congestion                                                                 2 (3%)       1 (2%)                                
      Embolus                                                                    1 (1%)                                             
      Foreign Body                                                               1 (1%)                                             
      Granuloma                                                                               1 (2%)                                
      Hemorrhage                                                                              1 (2%)                                
      Infiltration Cellular, Histiocyte                9 (15%)      3 (7%)      13 (17%)     13 (22%)                               
      Inflammation, Focal, Granulomatous               1 (2%)                                                                       
      Mineralization                                                                          4 (7%)                                
      Necrosis, Focal                                                                         1 (2%)                                
      Alveolar Epithelium, Hyperplasia, Focal          5 (8%)      11 (24%)     19 (25%)      8 (13%)                               
      Alveolar Epithelium, Hyperplasia, Multifocal                  3 (7%)      12 (16%)      9 (15%)                               
      Capillary, Thrombosis                                                                   1 (2%)                                
      Interstitium, Inflammation                                                 3 (4%)       4 (7%)                                
   Nose                                               (60)         (45)         (75)         (60)                                   
      Foreign Body                                     2 (3%)       2 (4%)       1 (1%)                                             
      Fungus                                                        1 (2%)       1 (1%)                                             
      Hemorrhage                                       5 (8%)       5 (11%)      1 (1%)                                             
      Inflammation, Acute                                           1 (2%)                                                          
      Inflammation, Suppurative                        2 (3%)       4 (9%)       3 (4%)       1 (2%)                                
   Trachea                                            (60)         (45)         (75)         (60)                                   
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   13                                                              
NTP Experiment-Test: 05166-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                               3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE                           Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 00:50:59  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     CONTROL      0.003        0.007        0.015                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
RESPIRATORY SYSTEM - CONT                                                                                                           
      Inflammation, Suppurative                                                  1 (1%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (1)                                    (4)                                    
      Cataract                                         1 (100%)                               1 (25%)                               
      Cornea, Inflammation, Chronic Active                                                    1 (25%)                               
      Cornea, Inflammation, Suppurative                                                       2 (50%)                               
      Retina, Degeneration                             1 (100%)                                                                     
   Zymbal's Gland                                     (59)         (45)         (75)         (59)                                   
      Cyst                                                                       1 (1%)                                             
      Ectasia                                                                    1 (1%)       5 (8%)                                
      Hyperplasia, Focal, Glandular                                              1 (1%)       1 (2%)                                
      Hyperplasia, Focal, Squamous                                                            7 (12%)                               
      Hypertrophy                                                                             1 (2%)                                
      Inflammation, Acute                                                        1 (1%)                                             
      Inflammation, Chronic Active                                                            2 (3%)                                
      Inflammation, Granulomatous                                                1 (1%)                                             
      Bilateral, Hyperplasia, Focal, Glandular                                   1 (1%)                                             
      Bilateral, Hyperplasia, Focal, Squamous                                                 3 (5%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (60)         (45)         (75)         (59)                                   
      Cyst                                                          1 (2%)       1 (1%)       1 (2%)                                
      Degeneration, Hyaline                                                      1 (1%)                                             
      Hydronephrosis                                   1 (2%)       1 (2%)       1 (1%)       1 (2%)                                
      Inflammation, Acute                                                                     2 (3%)                                
      Inflammation, Suppurative                                                               1 (2%)                                
      Nephropathy                                     60 (100%)    43 (96%)     74 (99%)     59 (100%)                              
      Renal Tubule, Hyperplasia, Focal                                                        1 (2%)                                
      Renal Tubule, Necrosis                                                                  1 (2%)                                
      Transitional Epithelium, Hyperplasia,                                                                                         
          Multifocal                                                                          1 (2%)                                
   Urinary Bladder                                    (60)         (45)         (75)         (59)                                   
      Dilatation                                                                              1 (2%)                                
      Infiltration Cellular, Lymphocyte                1 (2%)       1 (2%)                                                          
      Lumen, Hemorrhage                                1 (2%)                                                                       
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   14                                                              
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