Share This:
https://ntp.niehs.nih.gov/go/1899

TDMS Study 05108-01 Pathology Tables



                              INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)
                                                     PROMETHAZINE HYDROCHLORIDE


NTP Experiment-Test: 05108-01                                                                                     Report: PEIRPT05
Study Type: CHRONIC                                                                                               Date: 09/13/94
Route: GAVAGE                                                                                                     Time: 21:31:41




       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 NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/13/94  
Route: GAVAGE                                                                                                     Time: 21:31:41  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         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                                                                                                                  
                                                                                                                                    
   Intestine Large, Colon                             (59)         (57)         (53)         (49)                                   
      Sarcoma                                                                                 1 (2%)                                
   Intestine Large, Rectum                            (58)         (57)         (54)         (46)                                   
      Sarcoma Stromal, Metastatic, Uterus              1 (2%)                                                                       
   Intestine Small, Ileum                             (58)         (57)         (53)         (44)                                   
   Liver                                              (60)         (59)         (60)         (59)                                   
      Hepatocellular Adenoma                                                     1 (2%)       1 (2%)                                
   Pancreas                                           (60)         (59)         (60)         (56)                                   
   Salivary Glands                                    (60)         (59)         (59)         (59)                                   
   Stomach, Forestomach                               (59)         (59)         (60)         (57)                                   
      Squamous Cell Papilloma                                       1 (2%)       1 (2%)       1 (2%)                                
   Stomach, Glandular                                 (60)         (58)         (54)         (51)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (60)         (60)         (60)         (59)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (60)         (59)         (59)         (58)                                   
      Adenoma                                                       1 (2%)                                                          
   Adrenal Medulla                                    (60)         (59)         (60)         (58)                                   
      Pheochromocytoma Benign                          4 (7%)       1 (2%)       2 (3%)       3 (5%)                                
   Islets, Pancreatic                                 (60)         (59)         (60)         (55)                                   
      Adenoma                                          1 (2%)       1 (2%)                                                          
      Adenoma, Multiple                                1 (2%)                                                                       
                                                             Page   2                                                               
NTP Experiment-Test: 05108-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/13/94  
Route: GAVAGE                                                                                                     Time: 21:31:41  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   VEHICLE      8.3          16.6         33.3                                      
                                                   FEMALE       MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - cont                                                                                                             
   Pituitary Gland                                    (59)         (58)         (58)         (58)                                   
      Pars Distalis, Adenoma                          24 (41%)     25 (43%)     19 (33%)     17 (29%)                               
      Pars Distalis, Adenoma, Multiple                 4 (7%)       1 (2%)       4 (7%)       1 (2%)                                
   Thyroid Gland                                      (59)         (59)         (55)         (54)                                   
      Bilateral, C-Cell, Adenoma                                    1 (2%)                    1 (2%)                                
      C-Cell, Adenoma                                  4 (7%)       3 (5%)      10 (18%)      1 (2%)                                
      C-Cell, Carcinoma                                                                       1 (2%)                                
      Follicular Cell, Adenoma                         2 (3%)       2 (3%)       2 (4%)                                             
      Follicular Cell, Carcinoma                                                 1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (56)         (55)         (58)         (57)                                   
      Adenoma                                          3 (5%)       9 (16%)      1 (2%)       2 (4%)                                
      Carcinoma                                                                               1 (2%)                                
   Ovary                                              (60)         (59)         (60)         (58)                                   
      Arrhenoblastoma Benign                           1 (2%)                                                                       
      Granulosa Cell Tumor Benign                                   1 (2%)                                                          
   Uterus                                             (59)         (60)         (60)         (57)                                   
      Polyp Stromal                                   12 (20%)      7 (12%)      5 (8%)       1 (2%)                                
      Sarcoma                                          1 (2%)                                 1 (2%)                                
      Sarcoma Stromal                                  1 (2%)                    1 (2%)                                             
   Vagina                                                          (1)                                                              
      Squamous Cell Papilloma                                       1 (100%)                                                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Blood                                              (5)          (5)          (3)          (5)                                    
   Bone Marrow                                        (59)         (59)         (58)         (59)                                   
   Lymph Node                                         (12)         (5)          (5)          (5)                                    
   Lymph Node, Mandibular                             (60)         (59)         (59)         (59)                                   
   Lymph Node, Mesenteric                             (60)         (59)         (60)         (58)                                   
   Spleen                                             (60)         (59)         (60)         (56)                                   
      Hemangioma                                                    1 (2%)                                                          
   Thymus                                             (55)         (58)         (57)         (55)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                             Page   3                                                               
NTP Experiment-Test: 05108-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/13/94  
Route: GAVAGE                                                                                                     Time: 21:31:41  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   VEHICLE      8.3          16.6         33.3                                      
                                                   FEMALE       MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (58)         (54)         (59)         (52)                                   
      Adenoma                                          3 (5%)       3 (6%)                                                          
      Fibroadenoma                                    11 (19%)      9 (17%)     10 (17%)      6 (12%)                               
      Fibroadenoma, Multiple                           3 (5%)       4 (7%)                                                          
   Skin                                               (60)         (58)         (60)         (58)                                   
      Basal Cell Adenoma                                            1 (2%)                                                          
      Squamous Cell Papilloma                                       1 (2%)                                                          
      Subcutaneous Tissue, Fibroma                     1 (2%)                                                                       
      Subcutaneous Tissue, Hemangiopericytoma                                                 1 (2%)                                
      Subcutaneous Tissue, Hemangiosarcoma             1 (2%)                                                                       
      Subcutaneous Tissue, Sarcoma                                                            1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Skeletal Muscle                                                              (2)                                                 
      Sarcoma                                                                    1 (50%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (60)         (60)         (60)         (59)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (60)         (59)         (60)         (59)                                   
      Alveolar/Bronchiolar Adenoma                     2 (3%)       1 (2%)                                                          
      Alveolar/Bronchiolar Carcinoma                                             1 (2%)                                             
      Schwannoma Malignant, Metastatic, Ear                                      1 (2%)                                             
      Squamous Cell Carcinoma, Metastatic,                                                                                          
          Uncertain Primary Site                                                              1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Ear                                                                          (3)                                                 
      Schwannoma Malignant                                                       1 (33%)                                            
      Squamous Cell Papilloma                                                    1 (33%)                                            
   Zymbal's Gland                                                                            (1)                                    
      Carcinoma                                                                               1 (100%)                              
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                             Page   4                                                               
NTP Experiment-Test: 05108-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/13/94  
Route: GAVAGE                                                                                                     Time: 21:31:41  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   VEHICLE      8.3          16.6         33.3                                      
                                                   FEMALE       MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (60)         (60)         (59)         (57)                                   
   Urinary Bladder                                    (59)         (57)         (56)         (53)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SYSTEMIC LESIONS                                                                                                                   
   Multiple Organs                                   *(60)        *(60)        *(60)        *(60)                                   
      Leukemia Mononuclear                            17 (28%)     18 (30%)     13 (22%)      9 (15%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
     *   Number of animals with any tissue examined microscopically                                                                 
                                                             Page   5                                                               
NTP Experiment-Test: 05108-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/13/94  
Route: GAVAGE                                                                                                     Time: 21:31:41  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   VEHICLE      8.3          16.6         33.3                                      
                                                   FEMALE       MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
TUMOR SUMMARY                                                                                                                       
                                                                                                                                    
   Total Animals with Primary Neoplasms (b)            50          44          41          33                                       
     Total Primary Neoplasms                           96          92          74          50                                       
                                                                                                                                    
   Total Animals with Benign Neoplasms                 43          37          40          24                                       
     Total Benign Neoplasms                            76          74          56          35                                       
                                                                                                                                    
   Total Animals with Malignant Neoplasms              19          18          16          15                                       
     Total Malignant Neoplasms                         20          18          18          15                                       
                                                                                                                                    
   Total Animals with Metastatic Neoplasms              1                       1           1                                       
     Total Metastatic Neoplasm                          1                       1           1                                       
                                                                                                                                    
   Total Animals with Malignant Neoplasms                                                   1                                       
   Uncertain Primary Site                                                                                                           
                                                                                                                                    
   Total Animals with Neoplasms Uncertain-                                                                                          
   Benign or Malignant                                                                                                              
     Total Uncertain Neoplasms                                                                                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Primary tumors: all tumors except metastatic tumors                                                                              
                                                             Page   6                                                               
NTP Experiment-Test: 05108-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/13/94  
Route: GAVAGE                                                                                                     Time: 21:31:41  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         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)                                   
      Squamous Cell Carcinoma, Metastatic,                                                                                          
          Uncertain Primary Site                                                 1 (2%)                                             
   Intestine Large, Cecum                             (57)         (56)         (52)         (45)                                   
      Adenocarcinoma                                                                          1 (2%)                                
      Polyp Adenomatous                                                                       1 (2%)                                
   Intestine Small, Duodenum                          (59)         (58)         (56)         (53)                                   
   Intestine Small, Ileum                             (56)         (57)         (53)         (45)                                   
   Liver                                              (60)         (60)         (60)         (60)                                   
      Hepatocellular Carcinoma                                                   1 (2%)                                             
      Hepatocellular Adenoma                           4 (7%)       2 (3%)       2 (3%)       1 (2%)                                
      Histiocytic Sarcoma                                                        2 (3%)                                             
   Mesentery                                          (2)          (7)          (3)          (3)                                    
      Hemangiosarcoma                                                            1 (33%)                                            
   Pancreas                                           (59)         (60)         (59)         (60)                                   
      Acinus, Adenoma                                  2 (3%)       2 (3%)       1 (2%)                                             
   Salivary Glands                                    (60)         (60)         (60)         (59)                                   
   Stomach, Forestomach                               (59)         (60)         (60)         (60)                                   
      Squamous Cell Papilloma                                                                 1 (2%)                                
   Stomach, Glandular                                 (59)         (60)         (57)         (54)                                   
   Tongue                                             (1)          (1)                       (1)                                    
      Squamous Cell Papilloma                          1 (100%)                                                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                             Page   7                                                               
NTP Experiment-Test: 05108-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/13/94  
Route: GAVAGE                                                                                                     Time: 21:31:41  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     VEHICLE      8.3          16.6         33.3                                      
                                                   MALE         MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (60)         (60)         (60)         (60)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (60)         (60)         (59)         (60)                                   
   Adrenal Medulla                                    (60)         (60)         (59)         (59)                                   
      Pheochromocytoma Malignant                       3 (5%)       1 (2%)       1 (2%)       1 (2%)                                
      Pheochromocytoma Complex                                                                1 (2%)                                
      Pheochromocytoma Benign                         10 (17%)      6 (10%)      8 (14%)      1 (2%)                                
      Bilateral, Pheochromocytoma Benign               4 (7%)       5 (8%)       1 (2%)       1 (2%)                                
   Islets, Pancreatic                                 (60)         (60)         (59)         (58)                                   
      Adenoma                                          5 (8%)       2 (3%)       2 (3%)       1 (2%)                                
   Parathyroid Gland                                  (56)         (57)         (57)         (56)                                   
   Pituitary Gland                                    (60)         (60)         (58)         (59)                                   
      Pars Distalis, Adenoma                          20 (33%)     17 (28%)     16 (28%)      8 (14%)                               
      Pars Distalis, Adenoma, Multiple                 1 (2%)       1 (2%)       1 (2%)                                             
   Thyroid Gland                                      (59)         (59)         (54)         (50)                                   
      Bilateral, C-Cell, Adenoma                                    1 (2%)                                                          
      C-Cell, Adenoma                                  4 (7%)       4 (7%)       3 (6%)       2 (4%)                                
      Follicular Cell, Adenoma                         1 (2%)       1 (2%)       1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   Tissue NOS                                                                   (1)                                                 
      Squamous Cell Carcinoma, Metastatic,                                                                                          
          Uncertain Primary Site                                                 1 (100%)                                           
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (60)         (60)         (60)         (60)                                   
   Preputial Gland                                    (58)         (60)         (58)         (58)                                   
      Adenoma                                          2 (3%)       5 (8%)       2 (3%)       2 (3%)                                
      Bilateral, Adenoma                                                                      1 (2%)                                
   Prostate                                           (58)         (60)         (60)         (57)                                   
   Seminal Vesicle                                    (59)         (60)         (59)         (60)                                   
   Testes                                             (60)         (60)         (60)         (60)                                   
      Bilateral, Interstitial Cell, Adenoma           34 (57%)     30 (50%)     33 (55%)     37 (62%)                               
      Interstitial Cell, Adenoma                      18 (30%)     18 (30%)     17 (28%)     13 (22%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                             Page   8                                                               
NTP Experiment-Test: 05108-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/13/94  
Route: GAVAGE                                                                                                     Time: 21:31:41  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     VEHICLE      8.3          16.6         33.3                                      
                                                   MALE         MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Blood                                              (11)         (12)         (13)         (7)                                    
   Bone Marrow                                        (60)         (60)         (58)         (59)                                   
      Histiocytic Sarcoma                                                        1 (2%)                                             
   Lymph Node                                         (15)         (16)         (15)         (5)                                    
   Lymph Node, Mandibular                             (60)         (60)         (59)         (59)                                   
   Lymph Node, Mesenteric                             (59)         (60)         (60)         (59)                                   
   Spleen                                             (60)         (60)         (59)         (60)                                   
      Fibroma                                                                    1 (2%)                                             
   Thymus                                             (51)         (53)         (56)         (55)                                   
      Histiocytic Sarcoma                                                                     1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (58)         (52)         (47)         (46)                                   
      Adenoma                                                       1 (2%)                    1 (2%)                                
      Adenoma, Multiple                                1 (2%)                                                                       
      Fibroadenoma                                     4 (7%)       2 (4%)                                                          
   Skin                                               (60)         (60)         (60)         (60)                                   
      Basosquamous Tumor Benign                                                  1 (2%)                                             
      Keratoacanthoma                                                            2 (3%)                                             
      Squamous Cell Carcinoma                          1 (2%)                                                                       
      Squamous Cell Papilloma                          2 (3%)       1 (2%)                                                          
      Trichoepithelioma                                1 (2%)                                                                       
      Subcutaneous Tissue, Fibroma                     3 (5%)       3 (5%)       3 (5%)       2 (3%)                                
      Subcutaneous Tissue, Fibroma, Multiple                                     1 (2%)                                             
      Subcutaneous Tissue, Osteosarcoma                1 (2%)                                                                       
      Subcutaneous Tissue, Sarcoma                                               1 (2%)                                             
      Subcutaneous Tissue, Schwannoma Malignant        1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Skeletal Muscle                                    (1)          (6)                       (1)                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (60)         (60)         (60)         (60)                                   
      Astrocytoma Malignant                            1 (2%)       1 (2%)                                                          
      Glioma Malignant                                                           1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                             Page   9                                                               
NTP Experiment-Test: 05108-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/13/94  
Route: GAVAGE                                                                                                     Time: 21:31:41  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     VEHICLE      8.3          16.6         33.3                                      
                                                   MALE         MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (60)         (60)         (59)         (60)                                   
      Alveolar/Bronchiolar Adenoma                     1 (2%)                                 1 (2%)                                
      Alveolar/Bronchiolar Carcinoma                                             1 (2%)                                             
      Osteosarcoma, Metastatic, Skin                   1 (2%)                                                                       
      Squamous Cell Carcinoma, Multiple                                          1 (2%)                                             
   Nose                                               (60)         (60)         (60)         (60)                                   
      Fibroma                                          1 (2%)                                                                       
      Squamous Cell Papilloma                          1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Zymbal's Gland                                                                            (1)                                    
      Carcinoma                                                                               1 (100%)                              
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (60)         (60)         (60)         (60)                                   
      Histiocytic Sarcoma                                                                     1 (2%)                                
      Lipoma                                                                                  1 (2%)                                
      Liposarcoma                                                                1 (2%)                                             
      Squamous Cell Carcinoma, Metastatic,                                                                                          
          Uncertain Primary Site                                                 1 (2%)                                             
      Renal Tubule, Adenoma                                         1 (2%)       1 (2%)                                             
      Renal Tubule, Carcinoma                          2 (3%)                                                                       
   Urinary Bladder                                    (59)         (58)         (59)         (57)                                   
      Transitional Epithelium, Papilloma                            1 (2%)                                                          
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SYSTEMIC LESIONS                                                                                                                   
   Multiple Organs                                   *(60)        *(60)        *(60)        *(60)                                   
      Histiocytic Sarcoma                                                        2 (3%)       1 (2%)                                
      Leukemia Mononuclear                            22 (37%)     31 (52%)     24 (40%)     19 (32%)                               
      Mesothelioma Malignant                                                     1 (2%)       1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
     *   Number of animals with any tissue examined microscopically                                                                 
                                                             Page  10                                                               
NTP Experiment-Test: 05108-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/13/94  
Route: GAVAGE                                                                                                     Time: 21:31:41  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     VEHICLE      8.3          16.6         33.3                                      
                                                   MALE         MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
TUMOR SUMMARY                                                                                                                       
                                                                                                                                    
   Total Animals with Primary Neoplasms (b)            57          52          57          54                                       
     Total Primary Neoplasms                          151         136         131          99                                       
                                                                                                                                    
   Total Animals with Benign Neoplasms                 57          52          54          52                                       
     Total Benign Neoplasms                           120         103          96          74                                       
                                                                                                                                    
   Total Animals with Malignant Neoplasms              28          32          29          23                                       
     Total Malignant Neoplasms                         31          33          35          25                                       
                                                                                                                                    
   Total Animals with Metastatic Neoplasms              1                       1                                                   
     Total Metastatic Neoplasm                          1                       3                                                   
                                                                                                                                    
   Total Animals with Malignant Neoplasms                                       1                                                   
   Uncertain Primary Site                                                                                                           
                                                                                                                                    
   Total Animals with Neoplasms Uncertain-                                                                                          
   Benign or Malignant                                                                                                              
     Total Uncertain Neoplasms                                                                                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Primary tumors: all tumors except metastatic tumors                                                                              
                                                             Page  11                                                               
                             ------------------------------------------------------------                                           
                             ----------              END OF REPORT             ----------                                           
                             ------------------------------------------------------------