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TDMS Study 05108-02 Pathology Tables



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


NTP Experiment-Test: 05108-02                                                                                     Report: PEIRPT05
Study Type: CHRONIC                                                                                               Date: 09/14/94
Route: GAVAGE                                                                                                     Time: 00:14:27




       Facility:  TSI Mason Research

       Chemical CAS #:  58-33-3

       Lock Date:  None

       Cage Range:  All

       Reasons For Removal:    All

       Removal Date Range:     All

       Treatment Groups:       Include All
































a  Number of animals examined microscopically at site and number of animals with lesion

                                                             Page   1

NTP Experiment-Test: 05108-02  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/14/94  
Route: GAVAGE                                                                                                     Time: 00:14:27  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE FEMALE                        VEHICLE      3.75         7.5          15.0                                      
                                                   FEMALE       MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially in Study                          60           60           60           60                                     
  Scheduled Sacrifice                                 10           10            9            9                                     
  Early Deaths                                                                                                                      
    Moribund                                          10            7            9            6                                     
    Dead                                               1            1            1            3                                     
    Accident                                                                     2            1                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                37           42           39           41                                     
    Dead                                               2                                                                            
  Animals Examined Microscopically                    60           60           60           60                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Esophagus                                          (60)         (59)         (58)         (59)                                   
      Squamous Cell Papilloma                                                                 1 (2%)                                
   Gallbladder                                        (56)         (59)         (56)         (57)                                   
   Intestine Large, Colon                             (60)         (59)         (60)         (60)                                   
   Intestine Large, Cecum                             (59)         (59)         (59)         (58)                                   
   Intestine Small, Duodenum                          (58)         (59)         (60)         (59)                                   
   Intestine Small, Jejunum                           (56)         (59)         (58)         (57)                                   
   Intestine Small, Ileum                             (58)         (59)         (60)         (58)                                   
   Liver                                              (60)         (60)         (60)         (60)                                   
      Hemangiosarcoma                                                            1 (2%)                                             
      Hepatocellular Carcinoma                         1 (2%)       1 (2%)       1 (2%)       2 (3%)                                
      Hepatocellular Adenoma                           2 (3%)       4 (7%)       6 (10%)      9 (15%)                               
      Hepatocellular Adenoma, Multiple                 1 (2%)                                                                       
      Histiocytic Sarcoma                                           2 (3%)       1 (2%)       2 (3%)                                
   Mesentery                                          (4)          (1)          (3)          (2)                                    
      Fibroma                                          1 (25%)                                                                      
      Sarcoma                                                       1 (100%)                  1 (50%)                               
   Pancreas                                           (60)         (59)         (60)         (59)                                   
      Sarcoma, Metastatic, Skin                                     1 (2%)                                                          
   Salivary Glands                                    (59)         (60)         (60)         (59)                                   
   Stomach, Forestomach                               (60)         (60)         (60)         (60)                                   
      Mast Cell Tumor Benign                           1 (2%)                                                                       
      Squamous Cell Papilloma                          1 (2%)       1 (2%)       1 (2%)       2 (3%)                                
   Stomach, Glandular                                 (59)         (59)         (60)         (59)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                             Page   2                                                               
NTP Experiment-Test: 05108-02  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/14/94  
Route: GAVAGE                                                                                                     Time: 00:14:27  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE FEMALE                        VEHICLE      3.75         7.5          15.0                                      
                                                   FEMALE       MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (60)         (60)         (59)         (60)                                   
      Alveolar/Bronchiolar Carcinoma, Metastatic,                                                                                   
           Lung                                        1 (2%)                                                                       
      Carcinoma, Metastatic, Harderian Gland                                     1 (2%)                                             
      Histiocytic Sarcoma                                           1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (60)         (60)         (60)         (60)                                   
      Capsule, Adenoma                                 2 (3%)                    1 (2%)                                             
   Islets, Pancreatic                                 (59)         (59)         (60)         (59)                                   
      Adenoma                                          1 (2%)                                                                       
   Pituitary Gland                                    (56)         (59)         (59)         (58)                                   
      Carcinoma                                                                  1 (2%)                                             
      Pars Distalis, Adenoma                           5 (9%)       2 (3%)       4 (7%)       3 (5%)                                
      Pars Distalis, Adenoma, Multiple                              1 (2%)                                                          
      Pars Intermedia, Adenoma                                                   1 (2%)                                             
   Thyroid Gland                                      (60)         (60)         (57)         (60)                                   
      Carcinoma                                                                               1 (2%)                                
      Bilateral, Follicular Cell, Adenoma                                                     1 (2%)                                
      Follicular Cell, Adenoma                         4 (7%)       2 (3%)       1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Ovary                                              (59)         (59)         (58)         (58)                                   
      Adenoma, Tubular                                                                        1 (2%)                                
      Cystadenoma                                                   2 (3%)       2 (3%)       1 (2%)                                
      Hemangioma                                                                 1 (2%)                                             
      Histiocytic Sarcoma                                                                     1 (2%)                                
      Luteoma                                                       1 (2%)                                                          
   Uterus                                             (60)         (60)         (60)         (60)                                   
      Adenoma                                                                    1 (2%)                                             
      Histiocytic Sarcoma                                                        1 (2%)       1 (2%)                                
      Leiomyosarcoma                                                             1 (2%)       1 (2%)                                
      Polyp Stromal                                    1 (2%)       3 (5%)       3 (5%)       2 (3%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                             Page   3                                                               
NTP Experiment-Test: 05108-02  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/14/94  
Route: GAVAGE                                                                                                     Time: 00:14:27  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE FEMALE                        VEHICLE      3.75         7.5          15.0                                      
                                                   FEMALE       MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (60)         (59)         (60)         (59)                                   
   Lymph Node                                         (4)          (7)          (3)          (2)                                    
   Lymph Node, Mandibular                             (58)         (58)         (58)         (57)                                   
   Lymph Node, Mesenteric                             (56)         (59)         (58)         (54)                                   
      Hemangioma                                                    1 (2%)                                                          
      Histiocytic Sarcoma                                           1 (2%)       1 (2%)       1 (2%)                                
      Sarcoma, Metastatic, Skin                                     1 (2%)                                                          
   Spleen                                             (59)         (59)         (59)         (60)                                   
      Hemangioma                                                                 1 (2%)                                             
      Hemangiosarcoma                                                                         1 (2%)                                
      Histiocytic Sarcoma                                           1 (2%)       1 (2%)       2 (3%)                                
   Thymus                                             (52)         (58)         (55)         (57)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (46)         (47)         (48)         (51)                                   
      Adenocarcinoma                                                1 (2%)                                                          
      Adenoma                                          1 (2%)                    1 (2%)                                             
   Skin                                               (60)         (59)         (60)         (59)                                   
      Basosquamous Tumor Benign                        1 (2%)                                                                       
      Subcutaneous Tissue, Fibrosarcoma                1 (2%)                                                                       
      Subcutaneous Tissue, Sarcoma                     1 (2%)       2 (3%)                    1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (60)         (60)         (60)         (60)                                   
      Osteosarcoma                                     1 (2%)                                                                       
   Skeletal Muscle                                                 (1)          (2)                                                 
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (60)         (59)         (60)         (60)                                   
      Carcinoma, Metastatic, Pituitary Gland                                     1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (60)         (60)         (59)         (60)                                   
      Alveolar/Bronchiolar Adenoma                     8 (13%)      2 (3%)                    2 (3%)                                
      Alveolar/Bronchiolar Carcinoma                   2 (3%)                                                                       
      Carcinoma, Metastatic, Harderian Gland           1 (2%)                    1 (2%)                                             
      Carcinoma, Metastatic, Thyroid Gland                                                    1 (2%)                                
      Hepatocellular Carcinoma, Metastatic, Liver      1 (2%)                    1 (2%)                                             
                                                             Page   4                                                               
NTP Experiment-Test: 05108-02  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/14/94  
Route: GAVAGE                                                                                                     Time: 00:14:27  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE FEMALE                        VEHICLE      3.75         7.5          15.0                                      
                                                   FEMALE       MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
RESPIRATORY SYSTEM - cont                                                                                                           
      Histiocytic Sarcoma                                           2 (3%)                    2 (3%)                                
      Osteosarcoma, Metastatic, Uncertain Primary                                                                                   
          Site                                         1 (2%)                                                                       
      Mediastinum, Carcinoma, Metastatic, Lung         1 (2%)                                                                       
   Nose                                               (57)         (58)         (58)         (56)                                   
      Carcinoma, Metastatic, Harderian Gland                                     1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Ear                                                                          (1)                                                 
      Sarcoma                                                                    1 (100%)                                           
   Harderian Gland                                    (3)          (5)          (1)          (1)                                    
      Adenoma                                          2 (67%)      4 (80%)                   1 (100%)                              
      Carcinoma                                                                  1 (100%)                                           
      Bilateral, Carcinoma                             1 (33%)                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (60)         (60)         (60)         (60)                                   
      Alveolar/Bronchiolar Carcinoma, Metastatic,                                                                                   
           Lung                                        1 (2%)                                                                       
      Histiocytic Sarcoma                                           1 (2%)                                                          
      Osteosarcoma, Metastatic, Uncertain Primary                                                                                   
          Site                                         1 (2%)                                                                       
   Urinary Bladder                                    (60)         (58)         (60)         (58)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SYSTEMIC LESIONS                                                                                                                   
   Multiple Organs                                   *(60)        *(60)        *(60)        *(60)                                   
      Histiocytic Sarcoma                                           2 (3%)       1 (2%)       2 (3%)                                
      Lymphoma Malignant Lymphocytic                   1 (2%)       3 (5%)       4 (7%)       3 (5%)                                
      Lymphoma Malignant Mixed                         7 (12%)     12 (20%)      9 (15%)      7 (12%)                               
      Lymphoma Malignant Undifferentiated Cell                      1 (2%)       1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
     *   Number of animals with any tissue examined microscopically                                                                 
                                                             Page   5                                                               
NTP Experiment-Test: 05108-02  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/14/94  
Route: GAVAGE                                                                                                     Time: 00:14:27  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE FEMALE                        VEHICLE      3.75         7.5          15.0                                      
                                                   FEMALE       MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
TUMOR SUMMARY                                                                                                                       
                                                                                                                                    
   Total Animals with Primary Neoplasms (b)            33          33          30          29                                       
     Total Primary Neoplasms                           46          46          44          42                                       
                                                                                                                                    
   Total Animals with Benign Neoplasms                 26          20          17          18                                       
     Total Benign Neoplasms                            31          23          23          23                                       
                                                                                                                                    
   Total Animals with Malignant Neoplasms              15          21          19          17                                       
     Total Malignant Neoplasms                         15          23          21          19                                       
                                                                                                                                    
   Total Animals with Metastatic Neoplasms              5           1           3           1                                       
     Total Metastatic Neoplasm                          7           2           5           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: 05108-02  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/14/94  
Route: GAVAGE                                                                                                     Time: 00:14:27  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE MALE                          VEHICLE      11.25        22.5         45.0                                      
                                                   MALE         MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially in Study                          60           60           60           60                                     
  Scheduled Sacrifice                                 10           10           10           10                                     
  Early Deaths                                                                                                                      
    Moribund                                           8            4            6            6                                     
    Dead                                               3            2            4                                                  
  Survivors                                                                                                                         
    Terminal Sacrifice                                39           44           40           44                                     
  Animals Examined Microscopically                    60           60           60           60                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Gallbladder                                        (57)         (58)         (55)         (55)                                   
   Intestine Large, Colon                             (59)         (59)         (59)         (60)                                   
   Intestine Small, Duodenum                          (55)         (59)         (56)         (60)                                   
      Adenocarcinoma                                                                          1 (2%)                                
   Intestine Small, Jejunum                           (58)         (60)         (57)         (60)                                   
      Adenocarcinoma                                                             2 (4%)                                             
   Intestine Small, Ileum                             (59)         (59)         (59)         (60)                                   
      Adenocarcinoma                                                1 (2%)                                                          
   Liver                                              (60)         (60)         (59)         (60)                                   
      Hemangioma                                                                 1 (2%)                                             
      Hemangiosarcoma                                                                         1 (2%)                                
      Hemangiosarcoma, Multiple                                     2 (3%)                                                          
      Hepatoblastoma                                                                          1 (2%)                                
      Hepatocellular Carcinoma                         8 (13%)      9 (15%)      5 (8%)       8 (13%)                               
      Hepatocellular Carcinoma, Multiple                                                      1 (2%)                                
      Hepatocellular Adenoma                          14 (23%)     12 (20%)     12 (20%)     11 (18%)                               
      Hepatocellular Adenoma, Multiple                 3 (5%)       3 (5%)       3 (5%)      10 (17%)                               
      Hepatocholangiocarcinoma                                      1 (2%)                                                          
      Histiocytic Sarcoma                              1 (2%)                    1 (2%)                                             
      Mast Cell Tumor Malignant                                                  1 (2%)                                             
   Pancreas                                           (60)         (60)         (59)         (60)                                   
   Salivary Glands                                    (58)         (60)         (60)         (60)                                   
   Stomach, Forestomach                               (60)         (60)         (59)         (60)                                   
      Squamous Cell Papilloma                          1 (2%)                                                                       
   Stomach, Glandular                                 (60)         (60)         (59)         (60)                                   
      Hemangiosarcoma, Metastatic, Liver                            1 (2%)                                                          
   Tongue                                             (1)          (2)                       (2)                                    
      Squamous Cell Papilloma                                       1 (50%)                   1 (50%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                             Page   7                                                               
NTP Experiment-Test: 05108-02  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/14/94  
Route: GAVAGE                                                                                                     Time: 00:14:27  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE MALE                          VEHICLE      11.25        22.5         45.0                                      
                                                   MALE         MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (60)         (60)         (60)         (60)                                   
      Hemangiosarcoma                                               1 (2%)                                                          
      Hepatocholangiocarcinoma, Metastatic, Liver                   1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (58)         (60)         (58)         (58)                                   
      Adenoma                                          1 (2%)       1 (2%)       3 (5%)                                             
      Capsule, Adenoma                                 1 (2%)       1 (2%)       2 (3%)                                             
   Adrenal Medulla                                    (56)         (56)         (56)         (55)                                   
   Islets, Pancreatic                                 (60)         (60)         (59)         (60)                                   
      Adenoma                                          1 (2%)                                 3 (5%)                                
   Pituitary Gland                                    (58)         (60)         (55)         (56)                                   
      Sarcoma, Metastatic, Nose                        1 (2%)                                                                       
   Thyroid Gland                                      (58)         (60)         (58)         (60)                                   
      Follicular Cell, Adenoma                                      1 (2%)                                                          
      Follicular Cell, Carcinoma                                                 1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (60)         (60)         (60)         (60)                                   
   Preputial Gland                                    (17)         (24)         (20)         (21)                                   
      Adenoma                                                       1 (4%)                                                          
   Prostate                                           (55)         (55)         (57)         (55)                                   
   Seminal Vesicle                                    (60)         (60)         (60)         (60)                                   
   Testes                                             (60)         (59)         (60)         (60)                                   
      Interstitial Cell, Adenoma                       1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (59)         (60)         (60)         (60)                                   
      Hemangiosarcoma                                                                         1 (2%)                                
      Histiocytic Sarcoma                              1 (2%)                                                                       
      Mast Cell Tumor Malignant                                                  1 (2%)                                             
   Lymph Node                                         (1)          (1)          (4)          (1)                                    
      Axillary, Mast Cell Tumor Malignant                                        1 (25%)                                            
      Mediastinal, Mast Cell Tumor Malignant                                     1 (25%)                                            
   Lymph Node, Mandibular                             (53)         (51)         (53)         (54)                                   
                                                             Page   8                                                               
NTP Experiment-Test: 05108-02  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/14/94  
Route: GAVAGE                                                                                                     Time: 00:14:27  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE MALE                          VEHICLE      11.25        22.5         45.0                                      
                                                   MALE         MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - cont                                                                                                         
      Mast Cell Tumor Malignant                                                  1 (2%)                                             
   Lymph Node, Mesenteric                             (53)         (55)         (53)         (56)                                   
   Spleen                                             (59)         (58)         (60)         (60)                                   
      Hemangioma                                                    1 (2%)                                                          
      Hemangiosarcoma                                               1 (2%)                    2 (3%)                                
      Histiocytic Sarcoma                              1 (2%)                                                                       
      Mast Cell Tumor Malignant                                                  1 (2%)                                             
   Thymus                                             (47)         (48)         (52)         (51)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (60)         (60)         (60)         (60)                                   
      Squamous Cell Carcinoma                                                                 1 (2%)                                
      Subcutaneous Tissue, Hemangioma                                                         1 (2%)                                
      Subcutaneous Tissue, Hemangiosarcoma                                                    1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Skeletal Muscle                                    (1)          (3)          (1)          (1)                                    
      Hepatocholangiocarcinoma, Metastatic, Liver                   1 (33%)                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (60)         (60)         (60)         (60)                                   
      Meningioma Benign                                                          1 (2%)                                             
      Sarcoma, Metastatic, Nose                        1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (60)         (60)         (60)         (60)                                   
      Alveolar/Bronchiolar Adenoma                     8 (13%)      6 (10%)      6 (10%)      7 (12%)                               
      Alveolar/Bronchiolar Adenoma, Multiple           1 (2%)                                                                       
      Alveolar/Bronchiolar Carcinoma                   2 (3%)       6 (10%)      1 (2%)       1 (2%)                                
      Carcinoma, Metastatic, Harderian Gland           1 (2%)                                                                       
      Carcinoma, Metastatic, Thyroid Gland                                       1 (2%)                                             
      Hepatocellular Carcinoma, Metastatic, Liver      1 (2%)       3 (5%)       3 (5%)       2 (3%)                                
      Hepatocholangiocarcinoma, Metastatic, Liver                   1 (2%)                                                          
      Histiocytic Sarcoma                              1 (2%)                                                                       
      Mediastinum, Hemangioma                                                                 1 (2%)                                
   Nose                                               (59)         (57)         (60)         (55)                                   
      Sarcoma                                          1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                             Page   9                                                               
NTP Experiment-Test: 05108-02  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/14/94  
Route: GAVAGE                                                                                                     Time: 00:14:27  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE MALE                          VEHICLE      11.25        22.5         45.0                                      
                                                   MALE         MG/KG        MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Harderian Gland                                    (1)          (4)          (2)          (3)                                    
      Adenoma                                                       2 (50%)      2 (100%)     2 (67%)                               
      Carcinoma                                        1 (100%)                                                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (60)         (60)         (60)         (60)                                   
      Renal Tubule, Adenoma                            1 (2%)                                 1 (2%)                                
   Urinary Bladder                                    (59)         (60)         (58)         (59)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SYSTEMIC LESIONS                                                                                                                   
   Multiple Organs                                   *(60)        *(60)        *(60)        *(60)                                   
      Histiocytic Sarcoma                              1 (2%)                    1 (2%)                                             
      Lymphoma Malignant Histiocytic                                             2 (3%)                                             
      Lymphoma Malignant Lymphocytic                                2 (3%)       2 (3%)       3 (5%)                                
      Lymphoma Malignant Mixed                         3 (5%)       6 (10%)      2 (3%)       1 (2%)                                
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     *   Number of animals with any tissue examined microscopically                                                                 
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NTP Experiment-Test: 05108-02  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 09/14/94  
Route: GAVAGE                                                                                                     Time: 00:14:27  
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         B6C3F1 MICE MALE                          VEHICLE      11.25        22.5         45.0                                      
                                                   MALE         MG/KG        MG/KG        MG/KG                                     
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TUMOR SUMMARY                                                                                                                       
                                                                                                                                    
   Total Animals with Primary Neoplasms (b)            32          40          30          38                                       
     Total Primary Neoplasms                           48          58          52          59                                       
                                                                                                                                    
   Total Animals with Benign Neoplasms                 26          25          24          30                                       
     Total Benign Neoplasms                            32          29          30          37                                       
                                                                                                                                    
   Total Animals with Malignant Neoplasms              15          23          14          19                                       
     Total Malignant Neoplasms                         16          29          22          22                                       
                                                                                                                                    
   Total Animals with Metastatic Neoplasms              3           5           4           2                                       
     Total Metastatic Neoplasm                          4           7           4           2                                       
                                                                                                                                    
   Total Animals with Malignant Neoplasms                                                                                           
   Uncertain Primary Site                                                                                                           
                                                                                                                                    
   Total Animals with Neoplasms Uncertain-                                                                                          
   Benign or Malignant                                                                                                              
     Total Uncertain Neoplasms                                                                                                      
                                                                                                                                    
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a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Primary tumors: all tumors except metastatic tumors                                                                              
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