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https://ntp.niehs.nih.gov/go/1883

TDMS Study 05108-02 Pathology Tables



                                     INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
                                                     PROMETHAZINE HYDROCHLORIDE


NTP Experiment-Test: 05108-02                                                                                     Report: PEIRPT03
Study Type: CHRONIC                                                                                               Date: 09/14/94
Route: GAVAGE                                                                                                     Time: 00:14:25




       Facility:  TSI Mason Research

       Chemical CAS #:  58-33-3

       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: 05108-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/14/94  
Route: GAVAGE                                                                                                     Time: 00:14:25  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE FEMALE                        VEHICLE      3.75         7.5          15.0                                      
                                                   FEMALE       MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially In Study                          60           60           60           60                                     
  Scheduled Sacrifice                                 10           10            9            9                                     
  Early Deaths                                                                                                                      
    Moribund                                          10            7            9            6                                     
    Dead                                               1            1            1            3                                     
    Accident                                                                     2            1                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                37           42           39           41                                     
    Dead                                               2                                                                            
  Animals Examined Microscopically                    60           60           60           60                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large, Colon                             (60)         (59)         (60)         (60)                                   
      Artery, Inflammation, Acute                                                             1 (2%)                                
   Intestine Large, Cecum                             (59)         (59)         (59)         (58)                                   
      Hyperplasia                                                   1 (2%)                    1 (2%)                                
      Epithelium, Hyperplasia                                                    3 (5%)       2 (3%)                                
   Intestine Small, Jejunum                           (56)         (59)         (58)         (57)                                   
      Diverticulum                                                  1 (2%)                                                          
      Erosion                                          1 (2%)                                                                       
      Inflammation, Chronic Active                     1 (2%)                                                                       
   Intestine Small, Ileum                             (58)         (59)         (60)         (58)                                   
      Lymphoid Tissue, Hyperplasia                                               1 (2%)                                             
   Liver                                              (60)         (60)         (60)         (60)                                   
      Basophilic Focus                                 1 (2%)       2 (3%)       2 (3%)       3 (5%)                                
      Clear Cell Focus                                              1 (2%)       1 (2%)                                             
      Eosinophilic Focus                               6 (10%)      3 (5%)       5 (8%)       3 (5%)                                
      Fatty Change, Focal                              1 (2%)                                                                       
      Hematopoietic Cell Proliferation                                                        1 (2%)                                
      Hematopoietic Cell Proliferation Granulocytic                 1 (2%)                                                          
      Infiltration Cellular, Lymphocyte                             2 (3%)       1 (2%)                                             
      Inflammation, Focal, Necrotizing                                           1 (2%)                                             
      Inflammation, Granulomatous                      1 (2%)                                                                       
      Mixed Cell Focus                                 4 (7%)                    4 (7%)       3 (5%)                                
      Necrosis                                         2 (3%)       3 (5%)       5 (8%)       1 (2%)                                
      Necrosis, Focal                                                                         1 (2%)                                
      Vacuolization Cytoplasmic, Focal                 1 (2%)                                 1 (2%)                                
      Centrilobular, Hypertrophy                                                 1 (2%)                                             
      Sinusoid, Centrilobular, Ectasia                                                        1 (2%)                                
   Mesentery                                          (4)          (1)          (3)          (2)                                    
      Inflammation, Chronic Active                                               1 (33%)                                            
      Inflammation, Granulomatous                      1 (25%)                                                                      
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    2                                                              
NTP Experiment-Test: 05108-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/14/94  
Route: GAVAGE                                                                                                     Time: 00:14:25  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE FEMALE                        VEHICLE      3.75         7.5          15.0                                      
                                                   FEMALE       MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Fat, Necrosis                                    2 (50%)                   1 (33%)      1 (50%)                               
   Pancreas                                           (60)         (59)         (60)         (59)                                   
      Acinus, Atrophy                                               1 (2%)                                                          
      Artery, Inflammation, Chronic Active             1 (2%)                                                                       
      Duct, Cyst                                                    1 (2%)       1 (2%)                                             
      Duct, Ectasia                                                 1 (2%)                                                          
   Salivary Glands                                    (59)         (60)         (60)         (59)                                   
      Artery, Inflammation, Chronic Active             1 (2%)                                                                       
   Stomach, Forestomach                               (60)         (60)         (60)         (60)                                   
      Acanthosis                                                    2 (3%)       3 (5%)       1 (2%)                                
      Hyperkeratosis                                                2 (3%)       3 (5%)       3 (5%)                                
      Hyperplasia, Basal Cell                          1 (2%)       2 (3%)       1 (2%)       1 (2%)                                
      Hyperplasia, Squamous                                                      1 (2%)       1 (2%)                                
      Inflammation, Chronic Active                                  1 (2%)       1 (2%)                                             
   Stomach, Glandular                                 (59)         (59)         (60)         (59)                                   
      Hyperplasia                                                   1 (2%)       2 (3%)       1 (2%)                                
      Inflammation, Chronic Active                     2 (3%)                                                                       
      Necrosis                                                                                1 (2%)                                
      Ulcer                                            2 (3%)                                                                       
      Artery, Inflammation, Acute                                                             1 (2%)                                
   Tongue                                                          (1)                                                              
      Congestion                                                    1 (100%)                                                        
      Hemorrhage                                                    1 (100%)                                                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (60)         (60)         (59)         (60)                                   
      Mineralization                                   1 (2%)       1 (2%)                    3 (5%)                                
      Artery, Inflammation, Acute                                                             1 (2%)                                
      Artery, Mineralization                           1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (60)         (60)         (60)         (60)                                   
      Accessory Adrenal Cortical Nodule                1 (2%)       1 (2%)                                                          
      Hyperplasia                                      1 (2%)                                                                       
      Hypertrophy                                                   1 (2%)       2 (3%)                                             
      Capsule, Hyperplasia                             1 (2%)                                                                       
   Islets, Pancreatic                                 (59)         (59)         (60)         (59)                                   
      Hyperplasia                                      2 (3%)       1 (2%)                    1 (2%)                                
   Parathyroid Gland                                  (47)         (47)         (50)         (44)                                   
      Infiltration Cellular, Lymphocyte                                          1 (2%)                                             
   Pituitary Gland                                    (56)         (59)         (59)         (58)                                   
      Pars Distalis, Angiectasis                       3 (5%)       1 (2%)       1 (2%)       6 (10%)                               
      Pars Distalis, Cyst                                                                     1 (2%)                                
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    3                                                              
NTP Experiment-Test: 05108-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/14/94  
Route: GAVAGE                                                                                                     Time: 00:14:25  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE FEMALE                        VEHICLE      3.75         7.5          15.0                                      
                                                   FEMALE       MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
      Pars Distalis, Hyperplasia                       9 (16%)     14 (24%)      9 (15%)     11 (19%)                               
   Thyroid Gland                                      (60)         (60)         (57)         (60)                                   
      Follicle, Cyst                                   3 (5%)       1 (2%)                    1 (2%)                                
      Follicular Cell, Hyperplasia                     3 (5%)       5 (8%)       1 (2%)       4 (7%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (2)                                    (3)                                    
      Dilatation                                       2 (100%)                               3 (100%)                              
   Ovary                                              (59)         (59)         (58)         (58)                                   
      Amyloid Deposition                                                                      1 (2%)                                
      Angiectasis                                      2 (3%)                    1 (2%)       1 (2%)                                
      Atrophy                                                                    1 (2%)                                             
      Cyst                                            10 (17%)     13 (22%)      6 (10%)     12 (21%)                               
      Hemorrhage                                       1 (2%)                                                                       
      Hyperplasia                                      1 (2%)                                                                       
      Mineralization                                   1 (2%)                                                                       
      Pigmentation                                     1 (2%)                                                                       
      Thrombosis                                       2 (3%)                                                                       
   Uterus                                             (60)         (60)         (60)         (60)                                   
      Angiectasis                                                                1 (2%)       1 (2%)                                
      Hemorrhage                                       1 (2%)                                                                       
      Hyperplasia                                                                             1 (2%)                                
      Inflammation, Acute                                                        1 (2%)                                             
      Mineralization                                                                          1 (2%)                                
      Pigmentation                                                                            1 (2%)                                
      Thrombosis                                                                              1 (2%)                                
      Endometrium, Hyperplasia                         2 (3%)       3 (5%)       9 (15%)      7 (12%)                               
      Endometrium, Hyperplasia, Cystic                                           2 (3%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (60)         (59)         (60)         (59)                                   
      Angiectasis                                                                             1 (2%)                                
      Myelofibrosis                                                              1 (2%)                                             
   Lymph Node                                         (4)          (7)          (3)          (2)                                    
      Mediastinal, Hematopoietic Cell Proliferation                 1 (14%)                                                         
   Lymph Node, Mandibular                             (58)         (58)         (58)         (57)                                   
      Hematopoietic Cell Proliferation                              1 (2%)                                                          
      Inflammation, Granulomatous                      1 (2%)                                                                       
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    4                                                              
NTP Experiment-Test: 05108-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/14/94  
Route: GAVAGE                                                                                                     Time: 00:14:25  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE FEMALE                        VEHICLE      3.75         7.5          15.0                                      
                                                   FEMALE       MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
   Lymph Node, Mesenteric                             (56)         (59)         (58)         (54)                                   
      Hemorrhage                                       1 (2%)                                                                       
      Inflammation, Granulomatous                      1 (2%)                                                                       
      Artery, Inflammation, Acute                                                             1 (2%)                                
   Spleen                                             (59)         (59)         (59)         (60)                                   
      Amyloid Deposition                               1 (2%)                                                                       
      Angiectasis                                                                1 (2%)                                             
      Hematopoietic Cell Proliferation                 5 (8%)       7 (12%)      5 (8%)       6 (10%)                               
      Infarct                                                                    1 (2%)                                             
   Thymus                                             (52)         (58)         (55)         (57)                                   
      Hyperplasia                                                                             1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (60)         (59)         (60)         (59)                                   
      Erosion                                                                    1 (2%)                                             
      Necrosis                                                                   1 (2%)       1 (2%)                                
      Subcutaneous Tissue, Inflammation, Chronic                                                                                    
          Active                                                                 1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (60)         (60)         (60)         (60)                                   
      Fracture                                                                                1 (2%)                                
   Skeletal Muscle                                                 (1)          (2)                                                 
      Inflammation, Chronic Active                                               1 (50%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (60)         (59)         (60)         (60)                                   
      Mineralization                                                             1 (2%)                                             
   Spinal Cord                                        (1)                                    (1)                                    
      Hemorrhage                                                                              1 (100%)                              
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (60)         (60)         (59)         (60)                                   
      Hemorrhage                                       1 (2%)       4 (7%)       4 (7%)       1 (2%)                                
      Infiltration Cellular, Histiocyte                1 (2%)                                                                       
      Alveolar Epithelium, Hyperplasia                 1 (2%)       3 (5%)       1 (2%)       1 (2%)                                
      Mediastinum, Inflammation, Granulomatous         1 (2%)                                                                       
   Nose                                               (57)         (58)         (58)         (56)                                   
      Glands, Cytoplasmic Alteration                                             2 (3%)                                             
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    5                                                              
NTP Experiment-Test: 05108-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/14/94  
Route: GAVAGE                                                                                                     Time: 00:14:25  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE FEMALE                        VEHICLE      3.75         7.5          15.0                                      
                                                   FEMALE       MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
RESPIRATORY SYSTEM - CONT                                                                                                           
      Mucosa, Cytoplasmic Alteration                                             2 (3%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                             (1)                                                              
      Cornea, Inflammation, Acute                                   1 (100%)                                                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (60)         (60)         (60)         (60)                                   
      Glomerulosclerosis                                                                      1 (2%)                                
      Inflammation, Granulomatous                      1 (2%)                                                                       
      Metaplasia, Osseous                                           1 (2%)                                                          
      Nephropathy                                      2 (3%)                    4 (7%)       2 (3%)                                
      Artery, Inflammation, Chronic Active             1 (2%)                                                                       
      Papilla, Mineralization                                                    1 (2%)                                             
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    6                                                              
NTP Experiment-Test: 05108-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/14/94  
Route: GAVAGE                                                                                                     Time: 00:14:25  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE MALE                          VEHICLE      11.25        22.5         45.0                                      
                                                   MALE         MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially In Study                          60           60           60           60                                     
  Scheduled Sacrifice                                 10           10           10           10                                     
  Early Deaths                                                                                                                      
    Moribund                                           8            4            6            6                                     
    Dead                                               3            2            4                                                  
  Survivors                                                                                                                         
    Terminal Sacrifice                                39           44           40           44                                     
  Animals Examined Microscopically                    60           60           60           60                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Esophagus                                          (60)         (60)         (58)         (60)                                   
      Hyperkeratosis                                   1 (2%)                                                                       
   Intestine Large, Cecum                             (59)         (60)         (59)         (60)                                   
      Hyperplasia                                                   1 (2%)                                                          
   Liver                                              (60)         (60)         (59)         (60)                                   
      Basophilic Focus                                 1 (2%)       6 (10%)      2 (3%)       2 (3%)                                
      Clear Cell Focus                                 1 (2%)       2 (3%)       2 (3%)       1 (2%)                                
      Eosinophilic Focus                               3 (5%)       9 (15%)     10 (17%)     12 (20%)                               
      Eosinophilic Focus, Multiple                                                            1 (2%)                                
      Fatty Change                                                                            1 (2%)                                
      Fatty Change, Diffuse                                         1 (2%)       1 (2%)       1 (2%)                                
      Fatty Change, Focal                              4 (7%)       2 (3%)       2 (3%)       6 (10%)                               
      Fibrosis                                                                                1 (2%)                                
      Hematopoietic Cell Proliferation                                           1 (2%)                                             
      Inflammation, Chronic Active                                               1 (2%)                                             
      Inflammation, Focal, Necrotizing                 1 (2%)       1 (2%)                    1 (2%)                                
      Inflammation, Granulomatous                      1 (2%)                                                                       
      Mixed Cell Focus                                 3 (5%)       5 (8%)       1 (2%)       7 (12%)                               
      Necrosis                                         2 (3%)                                                                       
      Necrosis, Focal                                                                         2 (3%)                                
      Centrilobular, Hypertrophy                                                 6 (10%)      6 (10%)                               
   Mesentery                                          (1)                                    (2)                                    
      Inflammation, Chronic Active                                                            1 (50%)                               
      Fat, Necrosis                                    1 (100%)                                                                     
   Pancreas                                           (60)         (60)         (59)         (60)                                   
      Duct, Cyst                                                                              1 (2%)                                
   Stomach, Forestomach                               (60)         (60)         (59)         (60)                                   
      Acanthosis                                                                 1 (2%)                                             
      Hyperkeratosis                                   2 (3%)       1 (2%)       1 (2%)                                             
      Hyperplasia, Basal Cell                          3 (5%)       1 (2%)                                                          
      Inflammation, Chronic Active                     2 (3%)       1 (2%)                                                          
      Necrosis                                         1 (2%)                                                                       
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    7                                                              
NTP Experiment-Test: 05108-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/14/94  
Route: GAVAGE                                                                                                     Time: 00:14:25  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE MALE                          VEHICLE      11.25        22.5         45.0                                      
                                                   MALE         MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
   Stomach, Glandular                                 (60)         (60)         (59)         (60)                                   
      Hyperplasia                                                   1 (2%)       1 (2%)                                             
      Inflammation, Chronic Active                                               1 (2%)                                             
      Mineralization                                   1 (2%)                                                                       
      Necrosis                                                      1 (2%)                                                          
   Tongue                                             (1)          (2)                       (2)                                    
      Mineralization                                   1 (100%)                               1 (50%)                               
   Tooth                                              (1)                                                                           
      Developmental Malformation                       1 (100%)                                                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (60)         (60)         (60)         (60)                                   
      Cardiomyopathy                                   1 (2%)                    2 (3%)       1 (2%)                                
      Mineralization                                                             1 (2%)                                             
      Artery, Inflammation, Chronic Active             1 (2%)                    1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (58)         (60)         (58)         (58)                                   
      Accessory Adrenal Cortical Nodule                2 (3%)                    1 (2%)                                             
      Hyperplasia                                                                             3 (5%)                                
      Hypertrophy                                      3 (5%)       6 (10%)      8 (14%)      2 (3%)                                
   Islets, Pancreatic                                 (60)         (60)         (59)         (60)                                   
      Hyperplasia                                      4 (7%)       1 (2%)       3 (5%)                                             
   Pituitary Gland                                    (58)         (60)         (55)         (56)                                   
      Pars Distalis, Cyst                                           1 (2%)       1 (2%)                                             
      Pars Distalis, Hyperplasia                       1 (2%)                    1 (2%)       2 (4%)                                
   Thyroid Gland                                      (58)         (60)         (58)         (60)                                   
      Artery, Inflammation, Chronic Active                                       1 (2%)                                             
      Follicular Cell, Hyperplasia                                               3 (5%)       3 (5%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (60)         (60)         (60)         (60)                                   
      Granuloma Sperm                                  1 (2%)                                                                       
      Mineralization                                   1 (2%)                                                                       
   Preputial Gland                                    (17)         (24)         (20)         (21)                                   
      Abscess                                                       2 (8%)                                                          
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    8                                                              
NTP Experiment-Test: 05108-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/14/94  
Route: GAVAGE                                                                                                     Time: 00:14:25  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE MALE                          VEHICLE      11.25        22.5         45.0                                      
                                                   MALE         MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
GENITAL SYSTEM - CONT                                                                                                               
      Dilatation                                       8 (47%)     19 (79%)     16 (80%)     18 (86%)                               
   Prostate                                           (55)         (55)         (57)         (55)                                   
      Hyperplasia                                                   1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Lymph Node                                         (1)          (1)          (4)          (1)                                    
      Mediastinal, Angiectasis                                                   1 (25%)                                            
   Lymph Node, Mandibular                             (53)         (51)         (53)         (54)                                   
      Hematopoietic Cell Proliferation                              1 (2%)                                                          
   Lymph Node, Mesenteric                             (53)         (55)         (53)         (56)                                   
      Hyperplasia, Lymphoid                            1 (2%)                                                                       
      Infiltration Cellular, Histiocyte                                          1 (2%)                                             
      Thrombosis                                                    1 (2%)                                                          
      Artery, Inflammation, Chronic Active                                       1 (2%)                                             
   Spleen                                             (59)         (58)         (60)         (60)                                   
      Angiectasis                                                   4 (7%)       1 (2%)                                             
      Hematopoietic Cell Proliferation                 2 (3%)       9 (16%)      6 (10%)      3 (5%)                                
      Hyperplasia                                                   4 (7%)                                                          
      Necrosis                                                                   1 (2%)                                             
   Thymus                                             (47)         (48)         (52)         (51)                                   
      Depletion Lymphoid                               1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (60)         (60)         (60)         (60)                                   
      Necrosis                                                                                2 (3%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Skeletal Muscle                                    (1)          (3)          (1)          (1)                                    
      Artery, Inflammation, Chronic Active             1 (100%)                                                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (60)         (60)         (60)         (60)                                   
      Inflammation, Chronic Active                                               1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    9                                                              
NTP Experiment-Test: 05108-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/14/94  
Route: GAVAGE                                                                                                     Time: 00:14:25  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE MALE                          VEHICLE      11.25        22.5         45.0                                      
                                                   MALE         MG/KG        MG/KG        MG/KG                                     
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 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (60)         (60)         (60)         (60)                                   
      Edema                                            1 (2%)                                                                       
      Hemorrhage                                       1 (2%)       3 (5%)       3 (5%)       1 (2%)                                
      Infiltration Cellular, Histiocyte                6 (10%)      3 (5%)                    1 (2%)                                
      Alveolar Epithelium, Hyperplasia                 1 (2%)       2 (3%)       2 (3%)       1 (2%)                                
   Nose                                               (59)         (57)         (60)         (55)                                   
      Inflammation, Acute                              1 (2%)                    2 (3%)       2 (4%)                                
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 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (2)          (3)                                                              
      Cornea, Inflammation, Acute                                   1 (33%)                                                         
      Lens, Cataract                                   1 (50%)                                                                      
   Harderian Gland                                    (1)          (4)          (2)          (3)                                    
      Hyperplasia                                                                             1 (33%)                               
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 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (60)         (60)         (60)         (60)                                   
      Cyst                                             1 (2%)       4 (7%)                    2 (3%)                                
      Infarct                                                                    1 (2%)                                             
      Infiltration Cellular, Plasma Cell                            1 (2%)                                                          
      Nephropathy                                      7 (12%)      8 (13%)      9 (15%)      6 (10%)                               
      Artery, Inflammation, Chronic Active                                       1 (2%)                                             
      Cortex, Mineralization                                                     2 (3%)                                             
      Papilla, Mineralization                                                    1 (2%)                                             
      Renal Tubule, Regeneration                       6 (10%)      2 (3%)       6 (10%)      3 (5%)                                
   Urinary Bladder                                    (59)         (60)         (58)         (59)                                   
      Calculus Gross Observation                                                              1 (2%)                                
      Calculus Micro Observation Only                                                         2 (3%)                                
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
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