Skip to Main Navigation
Skip to Page Content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Share This:
https://ntp.niehs.nih.gov/go/1895

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                                                              
                             ------------------------------------------------------------                                           
                             ----------              END OF REPORT             ----------                                           
                             ------------------------------------------------------------