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TDMS Study 05108-01 Pathology Tables



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


NTP Experiment-Test: 05108-01                                                                                     Report: PEIRPT03
Study Type: CHRONIC                                                                                               Date: 09/13/94
Route: GAVAGE                                                                                                     Time: 21:31:40




       Facility:  TSI Mason Research

       Chemical CAS #:  58-33-3

       Lock Date:  10/28/91

       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: 05108-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/13/94  
Route: GAVAGE                                                                                                     Time: 21:31:40  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   VEHICLE      8.3          16.6         33.3                                      
                                                   FEMALE       MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially In Study                          60           60           60           60                                     
  Scheduled Sacrifice                                 10           10           10            7                                     
  Early Deaths                                                                                                                      
    Moribund                                          12           12           10           11                                     
    Accident                                           1                                      2                                     
    Dead                                               5            4            9           16                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                29           33           31           24                                     
    Moribund                                           2            1                                                               
    Dead                                               1                                                                            
  Animals Examined Microscopically                    60           60           60           60                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Esophagus                                          (60)         (59)         (60)         (58)                                   
      Erosion                                                       1 (2%)                                                          
      Hyperkeratosis                                                1 (2%)       1 (2%)                                             
      Inflammation, Acute                                           1 (2%)                                                          
   Intestine Small, Duodenum                          (59)         (57)         (54)         (47)                                   
      Necrosis                                                                   1 (2%)                                             
   Intestine Small, Ileum                             (58)         (57)         (53)         (44)                                   
      Necrosis                                                                   1 (2%)                                             
   Liver                                              (60)         (59)         (60)         (59)                                   
      Basophilic Focus                                28 (47%)     32 (54%)     23 (38%)     20 (34%)                               
      Clear Cell Focus                                 2 (3%)                                 1 (2%)                                
      Fatty Change, Diffuse                            2 (3%)                                                                       
      Fatty Change, Focal                              5 (8%)                                 1 (2%)                                
      Fibrosis                                                                   2 (3%)                                             
      Hemorrhage                                       1 (2%)                                                                       
      Hepatodiaphragmatic Nodule                       1 (2%)       6 (10%)      5 (8%)      10 (17%)                               
      Inflammation, Granulomatous                      6 (10%)      1 (2%)       2 (3%)       1 (2%)                                
      Mixed Cell Focus                                 3 (5%)       1 (2%)       2 (3%)       7 (12%)                               
      Necrosis                                         1 (2%)                    1 (2%)                                             
      Pigmentation                                     2 (3%)                                 1 (2%)                                
      Bile Duct, Hyperplasia                                        1 (2%)                                                          
   Mesentery                                          (1)          (3)                       (1)                                    
      Fat, Mineralization                              1 (100%)                                                                     
      Fat, Necrosis                                    1 (100%)     2 (67%)                                                         
   Pancreas                                           (60)         (59)         (60)         (56)                                   
      Acinus, Atrophy                                  1 (2%)                                 1 (2%)                                
      Acinus, Hyperplasia                                           1 (2%)                                                          
   Salivary Glands                                    (60)         (59)         (59)         (59)                                   
      Atrophy                                                       1 (2%)                                                          
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    2                                                              
NTP Experiment-Test: 05108-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/13/94  
Route: GAVAGE                                                                                                     Time: 21:31:40  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   VEHICLE      8.3          16.6         33.3                                      
                                                   FEMALE       MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Duct, Metaplasia, Squamous                       1 (2%)                    2 (3%)       2 (3%)                                
   Stomach, Forestomach                               (59)         (59)         (60)         (57)                                   
      Hyperkeratosis                                                2 (3%)                    1 (2%)                                
      Hyperplasia, Basal Cell                                       3 (5%)       1 (2%)       2 (4%)                                
      Necrosis                                                                   2 (3%)                                             
      Ulcer                                                                                   1 (2%)                                
   Stomach, Glandular                                 (60)         (58)         (54)         (51)                                   
      Hyperplasia                                                   1 (2%)                    1 (2%)                                
      Mineralization                                                                          1 (2%)                                
      Necrosis                                         2 (3%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (60)         (60)         (60)         (59)                                   
      Cardiomyopathy                                  29 (48%)     29 (48%)     28 (47%)     27 (46%)                               
      Inflammation, Chronic Active                                                            1 (2%)                                
      Mineralization                                                1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (60)         (59)         (59)         (58)                                   
      Accessory Adrenal Cortical Nodule                             2 (3%)       1 (2%)                                             
      Hemorrhage                                                    1 (2%)                                                          
      Hyperplasia                                      1 (2%)       1 (2%)       1 (2%)       2 (3%)                                
   Adrenal Medulla                                    (60)         (59)         (60)         (58)                                   
      Hyperplasia                                      2 (3%)       4 (7%)       3 (5%)       1 (2%)                                
   Islets, Pancreatic                                 (60)         (59)         (60)         (55)                                   
      Hyperplasia                                                   2 (3%)                                                          
   Pituitary Gland                                    (59)         (58)         (58)         (58)                                   
      Craniopharyngeal Duct, Cyst                                                             1 (2%)                                
      Pars Distalis, Angiectasis                      27 (46%)     24 (41%)     20 (34%)     16 (28%)                               
      Pars Distalis, Cyst                              7 (12%)      7 (12%)      3 (5%)                                             
      Pars Distalis, Hyperplasia                      21 (36%)     20 (34%)     18 (31%)     17 (29%)                               
      Pars Intermedia, Hyperplasia                                  1 (2%)                    1 (2%)                                
      Pars Nervosa, Angiectasis                        3 (5%)                                                                       
      Pars Nervosa, Cyst                               1 (2%)                                                                       
   Thyroid Gland                                      (59)         (59)         (55)         (54)                                   
      C-Cell, Hyperplasia                             10 (17%)      6 (10%)      8 (15%)      7 (13%)                               
      Follicle, Cyst                                   2 (3%)                    1 (2%)       1 (2%)                                
      Follicular Cell, Hyperplasia                                                            1 (2%)                                
____________________________________________________________________________________________________________________________________
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    3                                                              
NTP Experiment-Test: 05108-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/13/94  
Route: GAVAGE                                                                                                     Time: 21:31:40  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   VEHICLE      8.3          16.6         33.3                                      
                                                   FEMALE       MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (56)         (55)         (58)         (57)                                   
      Dilatation                                                                              1 (2%)                                
      Hyperplasia                                      1 (2%)                                                                       
      Inflammation, Acute                              1 (2%)                                 1 (2%)                                
      Necrosis                                                      2 (4%)                                                          
   Ovary                                              (60)         (59)         (60)         (58)                                   
      Cyst                                             3 (5%)       1 (2%)       2 (3%)                                             
   Uterus                                             (59)         (60)         (60)         (57)                                   
      Cyst                                                                                    1 (2%)                                
      Decidual Reaction                                                          1 (2%)                                             
      Hemorrhage                                       1 (2%)                                 1 (2%)                                
      Inflammation, Acute                              1 (2%)                                                                       
      Metaplasia, Osseous                              1 (2%)                                                                       
      Cervix, Fibrosis                                 1 (2%)                                                                       
      Cervix, Inflammation, Acute                      1 (2%)                                                                       
      Cervix, Pigmentation                             1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Lymph Node                                         (12)         (5)          (5)          (5)                                    
      Mediastinal, Angiectasis                                                                1 (20%)                               
      Mediastinal, Pigmentation                                                               1 (20%)                               
      Pancreatic, Angiectasis                          1 (8%)                                                                       
      Pancreatic, Hemorrhage                                                     1 (20%)                                            
      Pancreatic, Infiltration Cellular, Histiocyte    2 (17%)                                                                      
   Lymph Node, Mandibular                             (60)         (59)         (59)         (59)                                   
      Angiectasis                                                                1 (2%)                                             
      Hemorrhage                                                    1 (2%)                                                          
   Lymph Node, Mesenteric                             (60)         (59)         (60)         (58)                                   
      Angiectasis                                      1 (2%)                    1 (2%)                                             
      Hemorrhage                                                                 1 (2%)                                             
      Hyperplasia                                                                1 (2%)                                             
      Infiltration Cellular, Histiocyte                2 (3%)                                                                       
   Spleen                                             (60)         (59)         (60)         (56)                                   
      Fibrosis                                         2 (3%)       2 (3%)       1 (2%)                                             
      Hematopoietic Cell Proliferation                 3 (5%)                    2 (3%)       1 (2%)                                
      Hemorrhage                                                    1 (2%)                                                          
      Infarct                                          1 (2%)                                 1 (2%)                                
      Infiltration Cellular, Histiocyte                2 (3%)                                                                       
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    4                                                              
NTP Experiment-Test: 05108-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/13/94  
Route: GAVAGE                                                                                                     Time: 21:31:40  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   VEHICLE      8.3          16.6         33.3                                      
                                                   FEMALE       MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
   Thymus                                             (55)         (58)         (57)         (55)                                   
      Fibrosis                                                                   1 (2%)                                             
      Hemorrhage                                       1 (2%)                                                                       
      Epithelial Cell, Ectopic Parathyroid Gland                                              1 (2%)                                
      Epithelial Cell, Hyperplasia                                               1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (58)         (54)         (59)         (52)                                   
      Galactocele                                     14 (24%)      5 (9%)       5 (8%)       5 (10%)                               
   Skin                                               (60)         (58)         (60)         (58)                                   
      Cyst Epithelial Inclusion                        2 (3%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (59)         (59)         (60)         (59)                                   
      Fibrous Osteodystrophy                                                     1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (60)         (60)         (60)         (59)                                   
      Degeneration                                                                            1 (2%)                                
      Hemorrhage                                       1 (2%)                                                                       
      Hydrocephalus                                                              1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (60)         (59)         (60)         (59)                                   
      Edema                                                         1 (2%)       2 (3%)                                             
      Hemorrhage                                       1 (2%)                                 1 (2%)                                
      Infiltration Cellular, Histiocyte                             2 (3%)       1 (2%)       1 (2%)                                
      Inflammation, Acute                                                        2 (3%)                                             
      Alveolar Epithelium, Hyperplasia                 4 (7%)       2 (3%)       1 (2%)                                             
   Nose                                               (59)         (59)         (59)         (59)                                   
      Fungus                                           1 (2%)       1 (2%)                                                          
      Inflammation, Acute                              2 (3%)       3 (5%)       6 (10%)      7 (12%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    5                                                              
NTP Experiment-Test: 05108-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/13/94  
Route: GAVAGE                                                                                                     Time: 21:31:40  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                   VEHICLE      8.3          16.6         33.3                                      
                                                   FEMALE       MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (1)          (1)          (3)          (3)                                    
      Lens, Cataract                                   1 (100%)     1 (100%)     1 (33%)      1 (33%)                               
      Retina, Atrophy                                                            1 (33%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (60)         (60)         (59)         (57)                                   
      Inflammation, Acute                                                        1 (2%)                                             
      Mineralization                                                2 (3%)       1 (2%)                                             
      Nephropathy                                     52 (87%)     52 (87%)     50 (85%)     41 (72%)                               
      Pigmentation                                     1 (2%)                                                                       
      Artery, Inflammation, Chronic Active             1 (2%)                                                                       
      Bilateral, Papilla, Necrosis                                               1 (2%)                                             
      Cortex, Mineralization                           8 (13%)      6 (10%)      8 (14%)      4 (7%)                                
      Pelvis, Inflammation, Chronic Active                          1 (2%)                                                          
   Urinary Bladder                                    (59)         (57)         (56)         (53)                                   
      Hemorrhage                                                                 1 (2%)                                             
      Necrosis                                                                   1 (2%)                                             
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    6                                                              
NTP Experiment-Test: 05108-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/13/94  
Route: GAVAGE                                                                                                     Time: 21:31:40  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     VEHICLE      8.3          16.6         33.3                                      
                                                   MALE         MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially In Study                          60           60           60           60                                     
  Scheduled Sacrifice                                 10           10           10            9                                     
  Early Deaths                                                                                                                      
    Moribund                                          24           27           27           21                                     
    Dead                                               3            5           12           20                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                23           14            9           10                                     
    Moribund                                                        1                                                               
    Dead                                                            3            2                                                  
  Animals Examined Microscopically                    60           60           60           60                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Esophagus                                          (60)         (60)         (59)         (59)                                   
      Hemorrhage                                                    1 (2%)       1 (2%)                                             
      Hyperkeratosis                                                             1 (2%)       3 (5%)                                
      Inflammation, Acute                              1 (2%)       1 (2%)                    1 (2%)                                
      Necrosis                                                                                1 (2%)                                
   Intestine Large, Colon                             (59)         (57)         (54)         (49)                                   
      Artery, Inflammation, Chronic Active                          2 (4%)                                                          
   Intestine Large, Cecum                             (57)         (56)         (52)         (45)                                   
      Hyperplasia                                                                1 (2%)                                             
   Intestine Small, Ileum                             (56)         (57)         (53)         (45)                                   
      Necrosis                                                      1 (2%)                                                          
   Liver                                              (60)         (60)         (60)         (60)                                   
      Angiectasis                                      2 (3%)       7 (12%)      2 (3%)                                             
      Basophilic Focus                                20 (33%)     32 (53%)     25 (42%)     23 (38%)                               
      Clear Cell Focus                                 8 (13%)      7 (12%)      8 (13%)     13 (22%)                               
      Degeneration, Cystic                             5 (8%)       4 (7%)       7 (12%)      4 (7%)                                
      Eosinophilic Focus                               2 (3%)       5 (8%)       5 (8%)       4 (7%)                                
      Fatty Change, Diffuse                           13 (22%)     15 (25%)     25 (42%)     37 (62%)                               
      Fatty Change, Focal                                                                     1 (2%)                                
      Fibrosis                                                      1 (2%)                                                          
      Hematopoietic Cell Proliferation                                           1 (2%)                                             
      Hepatodiaphragmatic Nodule                      11 (18%)      1 (2%)       1 (2%)       1 (2%)                                
      Hyperplasia                                      1 (2%)                                 1 (2%)                                
      Infarct                                                       2 (3%)                                                          
      Leukocytosis                                     1 (2%)                                                                       
      Mixed Cell Focus                                 4 (7%)       3 (5%)       8 (13%)     11 (18%)                               
      Necrosis                                                                   5 (8%)       1 (2%)                                
      Necrosis, Focal                                  1 (2%)       1 (2%)                    1 (2%)                                
      Thrombosis                                                    2 (3%)                    1 (2%)                                
      Artery, Necrosis                                              1 (2%)                                                          
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    7                                                              
NTP Experiment-Test: 05108-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/13/94  
Route: GAVAGE                                                                                                     Time: 21:31:40  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     VEHICLE      8.3          16.6         33.3                                      
                                                   MALE         MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Bile Duct, Cyst                                                            1 (2%)                                             
      Bile Duct, Hyperplasia                          46 (77%)     39 (65%)     22 (37%)     12 (20%)                               
      Centrilobular, Hypertrophy                                                 1 (2%)       8 (13%)                               
   Mesentery                                          (2)          (7)          (3)          (3)                                    
      Artery, Inflammation, Chronic Active                          1 (14%)                                                         
      Fat, Fibrosis                                                                           1 (33%)                               
      Fat, Hemorrhage                                               3 (43%)      1 (33%)                                            
      Fat, Inflammation, Chronic Active                                                       1 (33%)                               
      Fat, Mineralization                              1 (50%)                   1 (33%)                                            
      Fat, Necrosis                                                 2 (29%)      2 (67%)      1 (33%)                               
      Fat, Pigmentation                                             1 (14%)                                                         
   Pancreas                                           (59)         (60)         (59)         (60)                                   
      Acinus, Hyperplasia                              2 (3%)       1 (2%)                                                          
      Artery, Fibrosis                                              1 (2%)                                                          
      Artery, Inflammation, Chronic Active             1 (2%)       3 (5%)                                                          
   Pharynx                                                                                   (2)                                    
      Inflammation, Acute                                                                     1 (50%)                               
      Palate, Inflammation, Acute                                                             1 (50%)                               
   Salivary Glands                                    (60)         (60)         (60)         (59)                                   
      Duct, Metaplasia, Squamous                                    2 (3%)       1 (2%)       2 (3%)                                
   Stomach, Forestomach                               (59)         (60)         (60)         (60)                                   
      Cyst Epithelial Inclusion                                                               1 (2%)                                
      Hyperkeratosis                                   2 (3%)       5 (8%)       1 (2%)       4 (7%)                                
      Hyperplasia, Basal Cell                          5 (8%)       7 (12%)      2 (3%)       6 (10%)                               
      Hyperplasia, Squamous                                         1 (2%)                    1 (2%)                                
      Inflammation, Acute                                                        1 (2%)                                             
      Mineralization                                                1 (2%)                                                          
      Necrosis                                         3 (5%)       6 (10%)      2 (3%)       1 (2%)                                
      Ulcer                                            4 (7%)                    1 (2%)       4 (7%)                                
   Stomach, Glandular                                 (59)         (60)         (57)         (54)                                   
      Erosion                                                       1 (2%)                                                          
      Hyperplasia                                      1 (2%)                                                                       
      Inflammation, Chronic Active                     1 (2%)                                                                       
      Mineralization                                   1 (2%)      10 (17%)      8 (14%)                                            
      Necrosis                                                                                2 (4%)                                
   Tongue                                             (1)          (1)                       (1)                                    
      Hyperkeratosis                                                                          1 (100%)                              
      Inflammation, Acute                              1 (100%)                                                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (60)         (60)         (60)         (60)                                   
      Cardiomyopathy                                  53 (88%)     39 (65%)     46 (77%)     52 (87%)                               
      Congestion                                                                              1 (2%)                                
      Inflammation, Acute                                           1 (2%)       1 (2%)                                             
      Mineralization                                                6 (10%)      5 (8%)       2 (3%)                                
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    8                                                              
NTP Experiment-Test: 05108-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/13/94  
Route: GAVAGE                                                                                                     Time: 21:31:40  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     VEHICLE      8.3          16.6         33.3                                      
                                                   MALE         MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
CARDIOVASCULAR SYSTEM - CONT                                                                                                        
      Thrombosis                                                    1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (60)         (60)         (59)         (60)                                   
      Accessory Adrenal Cortical Nodule                                          1 (2%)                                             
      Hyperplasia                                                   2 (3%)                                                          
      Hypertrophy                                      2 (3%)                                                                       
   Adrenal Medulla                                    (60)         (60)         (59)         (59)                                   
      Hyperplasia                                     13 (22%)     15 (25%)     14 (24%)      9 (15%)                               
      Bilateral, Hyperplasia                           2 (3%)                                                                       
   Islets, Pancreatic                                 (60)         (60)         (59)         (58)                                   
      Hyperplasia                                      1 (2%)                    2 (3%)       3 (5%)                                
   Parathyroid Gland                                  (56)         (57)         (57)         (56)                                   
      Hyperplasia                                      1 (2%)       8 (14%)      8 (14%)      3 (5%)                                
      Bilateral, Hyperplasia                           1 (2%)                                                                       
   Pituitary Gland                                    (60)         (60)         (58)         (59)                                   
      Pars Distalis, Angiectasis                      12 (20%)      7 (12%)      6 (10%)      3 (5%)                                
      Pars Distalis, Cyst                              4 (7%)       3 (5%)       4 (7%)                                             
      Pars Distalis, Fibrosis                                                    1 (2%)                                             
      Pars Distalis, Hyperplasia                      22 (37%)     14 (23%)     16 (28%)      9 (15%)                               
      Pars Distalis, Infarct                                                                  1 (2%)                                
      Pars Nervosa, Cyst                                                         1 (2%)                                             
   Thyroid Gland                                      (59)         (59)         (54)         (50)                                   
      C-Cell, Hyperplasia                              9 (15%)      2 (3%)       1 (2%)       1 (2%)                                
      Follicle, Cyst                                                1 (2%)       1 (2%)       1 (2%)                                
      Follicular Cell, Hyperplasia                     3 (5%)                    1 (2%)       1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Preputial Gland                                    (58)         (60)         (58)         (58)                                   
      Hyperplasia                                                   2 (3%)       1 (2%)       1 (2%)                                
      Necrosis                                         1 (2%)       1 (2%)       2 (3%)                                             
   Prostate                                           (58)         (60)         (60)         (57)                                   
      Hyperplasia                                                                3 (5%)                                             
      Inflammation, Chronic Active                     2 (3%)       1 (2%)       1 (2%)       2 (4%)                                
      Mineralization                                                             1 (2%)                                             
   Seminal Vesicle                                    (59)         (60)         (59)         (60)                                   
      Inflammation, Acute                              1 (2%)       1 (2%)                                                          
   Testes                                             (60)         (60)         (60)         (60)                                   
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page    9                                                              
NTP Experiment-Test: 05108-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/13/94  
Route: GAVAGE                                                                                                     Time: 21:31:40  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     VEHICLE      8.3          16.6         33.3                                      
                                                   MALE         MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
GENITAL SYSTEM - CONT                                                                                                               
      Atrophy                                          1 (2%)                                                                       
      Interstitial Cell, Hyperplasia                  14 (23%)     20 (33%)     19 (32%)     14 (23%)                               
      Seminiferous Tubule, Atrophy                    13 (22%)      5 (8%)       3 (5%)       8 (13%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Lymph Node                                         (15)         (16)         (15)         (5)                                    
      Mediastinal, Angiectasis                         1 (7%)                    1 (7%)                                             
      Pancreatic, Pigmentation                         1 (7%)                                                                       
      Renal, Angiectasis                                            1 (6%)                                                          
   Lymph Node, Mesenteric                             (59)         (60)         (60)         (59)                                   
      Degeneration                                     1 (2%)                                                                       
      Infiltration Cellular, Histiocyte                             1 (2%)                                                          
   Spleen                                             (60)         (60)         (59)         (60)                                   
      Cyst                                                                                    1 (2%)                                
      Fibrosis                                         3 (5%)       6 (10%)      4 (7%)       4 (7%)                                
      Hematopoietic Cell Proliferation                 2 (3%)       1 (2%)       2 (3%)                                             
      Infarct                                          1 (2%)       1 (2%)       2 (3%)                                             
   Thymus                                             (51)         (53)         (56)         (55)                                   
      Cyst                                             1 (2%)                                                                       
      Ectopic Parathyroid Gland                                                  1 (2%)                                             
      Epithelial Cell, Hyperplasia                     3 (6%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (58)         (52)         (47)         (46)                                   
      Galactocele                                                                             2 (4%)                                
      Acinus, Hyperplasia                                                                     1 (2%)                                
   Skin                                               (60)         (60)         (60)         (60)                                   
      Abscess                                          1 (2%)                                                                       
      Acanthosis                                                                              1 (2%)                                
      Cyst Epithelial Inclusion                        1 (2%)       1 (2%)                                                          
      Hyperkeratosis                                   2 (3%)                                 1 (2%)                                
      Necrosis                                                      1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Skeletal Muscle                                    (1)          (6)                       (1)                                    
      Edema                                                                                   1 (100%)                              
      Hemorrhage                                                                              1 (100%)                              
      Necrosis                                                      1 (17%)                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   10                                                              
NTP Experiment-Test: 05108-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/13/94  
Route: GAVAGE                                                                                                     Time: 21:31:40  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     VEHICLE      8.3          16.6         33.3                                      
                                                   MALE         MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (60)         (60)         (60)         (60)                                   
      Hemorrhage                                       2 (3%)                                                                       
      Mineralization                                   1 (2%)                                                                       
      Thrombosis                                       1 (2%)                                                                       
   Peripheral Nerve                                   (1)                       (2)                                                 
      Degeneration                                     1 (100%)                                                                     
      Inflammation, Chronic Active                     1 (100%)                                                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (60)         (60)         (59)         (60)                                   
      Edema                                                         4 (7%)       3 (5%)       5 (8%)                                
      Fibrosis                                                      1 (2%)       1 (2%)                                             
      Hemorrhage                                       3 (5%)      11 (18%)      3 (5%)       1 (2%)                                
      Infiltration Cellular, Histiocyte                2 (3%)       4 (7%)                    1 (2%)                                
      Inflammation, Acute                              1 (2%)       2 (3%)       2 (3%)       4 (7%)                                
      Alveolar Epithelium, Hyperplasia                 3 (5%)       1 (2%)                                                          
      Artery, Inflammation, Chronic Active                          1 (2%)                                                          
      Bronchiole, Inflammation, Acute                  1 (2%)                                                                       
      Mediastinum, Inflammation, Chronic Active                                  1 (2%)       1 (2%)                                
   Nose                                               (60)         (60)         (60)         (60)                                   
      Fungus                                           7 (12%)      5 (8%)       1 (2%)       5 (8%)                                
      Hyperkeratosis                                   1 (2%)       1 (2%)                                                          
      Inflammation, Acute                             13 (22%)     11 (18%)      8 (13%)      9 (15%)                               
   Trachea                                            (60)         (60)         (60)         (60)                                   
      Erosion                                                                                 1 (2%)                                
      Inflammation, Acute                                                                     1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (2)          (2)          (2)          (2)                                    
      Atrophy                                          1 (50%)                                                                      
      Lens, Cataract                                                1 (50%)      2 (100%)                                           
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (60)         (60)         (60)         (60)                                   
      Cyst                                             3 (5%)       3 (5%)       2 (3%)       4 (7%)                                
      Developmental Malformation                       1 (2%)                                                                       
      Hemorrhage                                                    1 (2%)                    1 (2%)                                
      Hydronephrosis                                                             2 (3%)                                             
      Mineralization                                   2 (3%)       6 (10%)      5 (8%)       1 (2%)                                
      Nephropathy                                     59 (98%)     56 (93%)     58 (97%)     56 (93%)                               
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   11                                                              
NTP Experiment-Test: 05108-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/13/94  
Route: GAVAGE                                                                                                     Time: 21:31:40  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                     VEHICLE      8.3          16.6         33.3                                      
                                                   MALE         MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
URINARY SYSTEM - CONT                                                                                                               
      Pelvis, Transitional Epithelium, Hyperplasia     1 (2%)                                                                       
      Pelvis, Transitional Epithelium, Inflammation    1 (2%)                                                                       
      Renal Tubule, Hyperplasia                                     5 (8%)                    1 (2%)                                
   Urinary Bladder                                    (59)         (58)         (59)         (57)                                   
      Calculus Gross Observation                       1 (2%)                                 1 (2%)                                
      Calculus Micro Observation Only                  1 (2%)                                 1 (2%)                                
      Dilatation                                                                              1 (2%)                                
      Hemorrhage                                       1 (2%)                                                                       
      Hyperplasia                                                                1 (2%)                                             
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                             Page   12                                                              
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