National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/1903

TDMS Study 05108-01 Pathology Tables

NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97
Route: GAVAGE                                                                                                     Time: 08:43:56




       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






































                                                              Page   1

NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 5| 4| 0| 7| 7| 4| 4| 4| 7| 4| 4| 4| 4| 7| 7| 7| 7| 4| 7| 7| 7| 7| 6|             
                             DAY ON TEST   | 3| 1| 1| 1| 2| 3| 3| 7| 5| 5| 3| 6| 5| 5| 5| 3| 3| 3| 3| 5| 3| 3| 3| 3| 2|             
                                           | 6| 7| 3| 2| 3| 6| 6| 3| 0| 0| 4| 2| 1| 0| 0| 7| 7| 7| 7| 1| 6| 6| 6| 5| 9|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5|             
    VEHICLE                                | 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8|             
    FEMALE                                 | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ALIMENTARY SYSTEM                         |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Rectum                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Cecum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Jejunum                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Basophilic Focus                     | X                 X     X  X  X  X  X  X     X  X  X  X     X  X  X     X|             
      Clear Cell Focus                     |                         X                                                |             
      Fatty Change, Diffuse                |    3                 2                                                   |             
      Fatty Change, Focal                  |                                        1                             2   |             
      Hemorrhage                           |             2                                                            |             
      Hepatodiaphragmatic Nodule           |                                                                          |             
      Inflammation, Granulomatous          |                2                             2                           |             
      Mixed Cell Focus                     |                                                                          |             
      Necrosis                             |                                                                          |             
      Pigmentation                         | 3                             2                                          |             
                                            __________________________________________________________________________|             
   Mesentery                               |                                                 +                        |             
      Fat, Mineralization                  |                                                 1                        |             
      Fat, Necrosis                        |                                                 3                        |             
                                            __________________________________________________________________________|             
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Acinus, Atrophy                      |                                                                          |             
                                            __________________________________________________________________________|             
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Duct, Metaplasia, Squamous           |                                                                          |             
                                            __________________________________________________________________________|             
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Necrosis                             |                               3                                          |             
                                            __________________________________________________________________________|             
   Tongue                                  |                                                             +            |             
 _____________________________________________________________________________________________________________________|             
 CARDIOVASCULAR SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cardiomyopathy                       | 2  2                       2                 2  2  2  2     2     2  2  2|             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM                          |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                      2   |             
                                            __________________________________________________________________________|             
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                          |             
                                            __________________________________________________________________________|             
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Parathyroid Gland                       | +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  M  +  +  +  +|             
                                            __________________________________________________________________________|             
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  M  +  +|             
      Pars Distalis, Angiectasis           | 2  2              3  2        2        2     2  2                       2|             
      Pars Distalis, Cyst                  |          X                                                               |             
 _____________________________________________________________________________________________________________________|             
                                                             Page   2                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 5| 4| 0| 7| 7| 4| 4| 4| 7| 4| 4| 4| 4| 7| 7| 7| 7| 4| 7| 7| 7| 7| 6|             
                             DAY ON TEST   | 3| 1| 1| 1| 2| 3| 3| 7| 5| 5| 3| 6| 5| 5| 5| 3| 3| 3| 3| 5| 3| 3| 3| 3| 2|             
                                           | 6| 7| 3| 2| 3| 6| 6| 3| 0| 0| 4| 2| 1| 0| 0| 7| 7| 7| 7| 1| 6| 6| 6| 5| 9|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5|             
    VEHICLE                                | 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8|             
    FEMALE                                 | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM - cont                   |                                                                          |             
                                           |                                                                          |             
      Pars Distalis, Hyperplasia           |    2  2           1        2     1     2              2        2     2   |             
      Pars Nervosa, Angiectasis            |                                                                          |             
      Pars Nervosa, Cyst                   |                                                                          |             
                                            __________________________________________________________________________|             
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      C-Cell, Hyperplasia                  |                                                    2  2           1      |             
      Follicle, Cyst                       |                                                    X                     |             
 _____________________________________________________________________________________________________________________|             
 GENERAL BODY SYSTEM                       |                                                                          |             
                                           |                                                                          |             
    None                                   |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENITAL SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Clitoral Gland                          | M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                          |             
      Inflammation, Acute                  |                                                                          |             
                                            __________________________________________________________________________|             
   Ovary                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |                                                 X                       X|             
                                            __________________________________________________________________________|             
   Uterus                                  | +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                                                                          |             
      Inflammation, Acute                  |                                                          2               |             
      Metaplasia, Osseous                  |                                                                          |             
      Cervix, Fibrosis                     |                                                                          |             
      Cervix, Inflammation, Acute          |                                                                          |             
      Cervix, Pigmentation                 |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Blood                                   |                                                       +                  |             
                                            __________________________________________________________________________|             
   Bone Marrow                             | +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Lymph Node                              |       +  +           +                                +              +  +|             
      Pancreatic, Angiectasis              |                                                                          |             
      Pancreatic, Infiltration Cellular,   |                                                                          |             
           Histiocyte                      |       2                                                                  |             
                                            __________________________________________________________________________|             
   Lymph Node, Mandibular                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Angiectasis                          |                                                                          |             
      Infiltration Cellular, Histiocyte    |                                              1                           |             
                                            __________________________________________________________________________|             
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fibrosis                             |                                                       3                  |             
      Hematopoietic Cell Proliferation     |       3                       2                                          |             
      Infarct                              |                                                                         3|             
      Infiltration Cellular, Histiocyte    |                                              3                           |             
                                            __________________________________________________________________________|             
   Thymus                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  M  +  M  +  +  +  +  +  +  +|             
      Hemorrhage                           |             2                                                            |             
 _____________________________________________________________________________________________________________________|             
 INTEGUMENTARY SYSTEM                      |                                                                          |             
                                           |                                                                          |             
 _____________________________________________________________________________________________________________________|             
                                                             Page   3                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 5| 4| 0| 7| 7| 4| 4| 4| 7| 4| 4| 4| 4| 7| 7| 7| 7| 4| 7| 7| 7| 7| 6|             
                             DAY ON TEST   | 3| 1| 1| 1| 2| 3| 3| 7| 5| 5| 3| 6| 5| 5| 5| 3| 3| 3| 3| 5| 3| 3| 3| 3| 2|             
                                           | 6| 7| 3| 2| 3| 6| 6| 3| 0| 0| 4| 2| 1| 0| 0| 7| 7| 7| 7| 1| 6| 6| 6| 5| 9|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5|             
    VEHICLE                                | 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8|             
    FEMALE                                 | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 INTEGUMENTARY SYSTEM - cont               |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Mammary Gland                           | +  +  +  +  +  +  +  +  M  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +|             
      Galactocele                          |    X              X                          X        X              X  X|             
                                            __________________________________________________________________________|             
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst Epithelial Inclusion            |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 MUSCULOSKELETAL SYSTEM                    |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Bone                                    | +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 NERVOUS SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 RESPIRATORY SYSTEM                        |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |             3                                                            |             
      Alveolar Epithelium, Hyperplasia     |          1                          1                                    |             
                                            __________________________________________________________________________|             
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  M  +  +|             
      Fungus                               |                                                                          |             
      Inflammation, Acute                  |                               4                                          |             
                                            __________________________________________________________________________|             
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Eye                                     |                                                          +               |             
      Lens, Cataract                       |                                                          2               |             
 _____________________________________________________________________________________________________________________|             
 URINARY SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Nephropathy                          | 2  1           1  1     1  1  1  1  1  1  1  1  2  2  2  1  2  1     1  1|             
      Pigmentation                         |                                                                      3   |             
      Artery, Inflammation, Chronic Active |                                              2                           |             
      Cortex, Mineralization               |                         1  1        1     1              1               |             
                                            __________________________________________________________________________|             
   Urinary Bladder                         | +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
                                                             Page   4                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 6| 5| 4| 4| 7| 7| 7| 7| 7| 7| 7| 7| 6| 4| 7| 7| 6| 6| 5| 7| 7| 7| 7| 7|             
                             DAY ON TEST   | 3| 7| 4| 7| 5| 3| 3| 3| 3| 2| 3| 3| 3| 7| 1| 3| 3| 4| 3| 4| 3| 3| 3| 3| 3|             
                                           | 7| 4| 7| 7| 0| 7| 7| 7| 5| 2| 7| 7| 7| 3| 3| 7| 7| 5| 6| 6| 7| 7| 7| 7| 5|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6|             
    VEHICLE                                | 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3|             
    FEMALE                                 | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ALIMENTARY SYSTEM                         |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Rectum                 | +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Cecum                  | +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Jejunum                | +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Basophilic Focus                     |    X           X  X  X  X        X     X     X  X                       X|             
      Clear Cell Focus                     |                                                                      X   |             
      Fatty Change, Diffuse                |                                                                          |             
      Fatty Change, Focal                  |                            1              1                              |             
      Hemorrhage                           |                                                                          |             
      Hepatodiaphragmatic Nodule           |                                                                          |             
      Inflammation, Granulomatous          | 1                 1                                         2        1   |             
      Mixed Cell Focus                     |                                  X     X                                 |             
      Necrosis                             |                                                                          |             
      Pigmentation                         |                                                                          |             
                                            __________________________________________________________________________|             
   Mesentery                               |                                                                          |             
      Fat, Mineralization                  |                                                                          |             
      Fat, Necrosis                        |                                                                          |             
                                            __________________________________________________________________________|             
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Acinus, Atrophy                      |                            3                                             |             
                                            __________________________________________________________________________|             
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Duct, Metaplasia, Squamous           |                                                                          |             
                                            __________________________________________________________________________|             
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Necrosis                             |                                                                          |             
                                            __________________________________________________________________________|             
   Tongue                                  |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 CARDIOVASCULAR SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cardiomyopathy                       | 2                             2  1     2     1     2  2     2  2     2  2|             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM                          |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                          |             
                                            __________________________________________________________________________|             
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                   2                                                      |             
                                            __________________________________________________________________________|             
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Parathyroid Gland                       | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Pars Distalis, Angiectasis           |    2  2        2                    2  2     2  2  2  2              2  2|             
      Pars Distalis, Cyst                  | X     X                                                           X      |             
 _____________________________________________________________________________________________________________________|             
                                                             Page   5                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 6| 5| 4| 4| 7| 7| 7| 7| 7| 7| 7| 7| 6| 4| 7| 7| 6| 6| 5| 7| 7| 7| 7| 7|             
                             DAY ON TEST   | 3| 7| 4| 7| 5| 3| 3| 3| 3| 2| 3| 3| 3| 7| 1| 3| 3| 4| 3| 4| 3| 3| 3| 3| 3|             
                                           | 7| 4| 7| 7| 0| 7| 7| 7| 5| 2| 7| 7| 7| 3| 3| 7| 7| 5| 6| 6| 7| 7| 7| 7| 5|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6|             
    VEHICLE                                | 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3|             
    FEMALE                                 | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM - cont                   |                                                                          |             
                                           |                                                                          |             
      Pars Distalis, Hyperplasia           | 3              3     1     3        2     2        2        1     2      |             
      Pars Nervosa, Angiectasis            |                            2                 2                           |             
      Pars Nervosa, Cyst                   |                                                       X                  |             
                                            __________________________________________________________________________|             
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      C-Cell, Hyperplasia                  | 2                                2                       1  2            |             
      Follicle, Cyst                       |                X                                                         |             
 _____________________________________________________________________________________________________________________|             
 GENERAL BODY SYSTEM                       |                                                                          |             
                                           |                                                                          |             
    None                                   |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENITAL SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Clitoral Gland                          | M  +  +  +  +  +  +  +  +  +  +     +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                       2                  |             
      Inflammation, Acute                  |                                                       2                  |             
                                            __________________________________________________________________________|             
   Ovary                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |             X                                                            |             
                                            __________________________________________________________________________|             
   Uterus                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                                                                          |             
      Inflammation, Acute                  |                                                                          |             
      Metaplasia, Osseous                  |                                           2                              |             
      Cervix, Fibrosis                     |                                                    2                     |             
      Cervix, Inflammation, Acute          |                                              2                           |             
      Cervix, Pigmentation                 |                                                    2                     |             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Blood                                   |                            +                             +               |             
                                            __________________________________________________________________________|             
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Lymph Node                              |    +     +                 +                       +                 +   |             
      Pancreatic, Angiectasis              |                                                    2                     |             
      Pancreatic, Infiltration Cellular,   |                                                                          |             
           Histiocyte                      |                                                                      2   |             
                                            __________________________________________________________________________|             
   Lymph Node, Mandibular                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Angiectasis                          |                                                                      2   |             
      Infiltration Cellular, Histiocyte    |                                                                      2   |             
                                            __________________________________________________________________________|             
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fibrosis                             |                                                    2                     |             
      Hematopoietic Cell Proliferation     |                                           2                              |             
      Infarct                              |                                                                          |             
      Infiltration Cellular, Histiocyte    |                                                                      3   |             
                                            __________________________________________________________________________|             
   Thymus                                  | +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 INTEGUMENTARY SYSTEM                      |                                                                          |             
                                           |                                                                          |             
 _____________________________________________________________________________________________________________________|             
                                                             Page   6                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 6| 5| 4| 4| 7| 7| 7| 7| 7| 7| 7| 7| 6| 4| 7| 7| 6| 6| 5| 7| 7| 7| 7| 7|             
                             DAY ON TEST   | 3| 7| 4| 7| 5| 3| 3| 3| 3| 2| 3| 3| 3| 7| 1| 3| 3| 4| 3| 4| 3| 3| 3| 3| 3|             
                                           | 7| 4| 7| 7| 0| 7| 7| 7| 5| 2| 7| 7| 7| 3| 3| 7| 7| 5| 6| 6| 7| 7| 7| 7| 5|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6|             
    VEHICLE                                | 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3|             
    FEMALE                                 | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 INTEGUMENTARY SYSTEM - cont               |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Mammary Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Galactocele                          |    X              X                    X                    X            |             
                                            __________________________________________________________________________|             
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst Epithelial Inclusion            |       X                                                                  |             
 _____________________________________________________________________________________________________________________|             
 MUSCULOSKELETAL SYSTEM                    |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 NERVOUS SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 RESPIRATORY SYSTEM                        |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                                                                          |             
      Alveolar Epithelium, Hyperplasia     |                                                 3                        |             
                                            __________________________________________________________________________|             
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fungus                               |                      3                                                   |             
      Inflammation, Acute                  |                      3                                                   |             
                                            __________________________________________________________________________|             
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Eye                                     |                                                                          |             
      Lens, Cataract                       |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 URINARY SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Nephropathy                          | 2  1     1  1  1  2  1  1  2  2  1  2  2     2  2  2  1  1  1  1  1  1  2|             
      Pigmentation                         |                                                                          |             
      Artery, Inflammation, Chronic Active |                                                                          |             
      Cortex, Mineralization               |             1                                                            |             
                                            __________________________________________________________________________|             
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
                                                             Page   7                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 7| 5| 7| 6| 4| 4| 4|                                            |            |
                             DAY ON TEST   | 3| 3| 3| 2| 7| 3| 8| 5| 5| 5|                                            |            |
                                           | 7| 7| 7| 9| 4| 7| 4| 1| 0| 0|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      T     |
                               ANIMAL ID   | 6| 6| 6| 6| 6| 6| 6| 6| 6| 6|                                            |      A     |
    VEHICLE                                | 4| 4| 4| 4| 4| 5| 5| 5| 5| 5|                                            |      L     |
    FEMALE                                 | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 ALIMENTARY SYSTEM                         |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Esophagus                               | +  +  +  +  +  +  +  +  +  +                                             |  60        |
                                            __________________________________________________________________________|____________|
   Intestine Large, Colon                  | +  +  +  +  +  +  A  +  +  +                                             |  59        |
                                            __________________________________________________________________________|____________|
   Intestine Large, Rectum                 | +  +  +  +  +  +  A  +  +  +                                             |  58        |
                                            __________________________________________________________________________|____________|
   Intestine Large, Cecum                  | +  +  +  +  A  +  A  +  +  +                                             |  57        |
                                            __________________________________________________________________________|____________|
   Intestine Small, Duodenum               | +  +  +  +  +  +  A  +  +  +                                             |  59        |
                                            __________________________________________________________________________|____________|
   Intestine Small, Jejunum                | +  +  +  +  +  +  A  +  +  +                                             |  58        |
                                            __________________________________________________________________________|____________|
   Intestine Small, Ileum                  | +  +  +  +  +  +  A  +  +  +                                             |  58        |
                                            __________________________________________________________________________|____________|
   Liver                                   | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Basophilic Focus                     | X                 X                                                      |     28     |
      Clear Cell Focus                     |                                                                          |      2     |
      Fatty Change, Diffuse                |                                                                          |      2  2.5|
      Fatty Change, Focal                  |          2                                                               |      5  1.4|
      Hemorrhage                           |                                                                          |      1  2.0|
      Hepatodiaphragmatic Nodule           |                      X                                                   |      1     |
      Inflammation, Granulomatous          |                                                                          |      6  1.5|
      Mixed Cell Focus                     |                X                                                         |      3     |
      Necrosis                             |                   2                                                      |      1  2.0|
      Pigmentation                         |                                                                          |      2  2.5|
                                            __________________________________________________________________________|____________|
   Mesentery                               |                                                                          |   1        |
      Fat, Mineralization                  |                                                                          |      1  1.0|
      Fat, Necrosis                        |                                                                          |      1  3.0|
                                            __________________________________________________________________________|____________|
   Pancreas                                | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Acinus, Atrophy                      |                                                                          |      1  3.0|
                                            __________________________________________________________________________|____________|
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Duct, Metaplasia, Squamous           |                         1                                                |      1  1.0|
                                            __________________________________________________________________________|____________|
   Stomach, Forestomach                    | +  +  +  M  +  +  +  +  +  +                                             |  59        |
                                            __________________________________________________________________________|____________|
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Necrosis                             |                   2                                                      |      2  2.5|
                                            __________________________________________________________________________|____________|
   Tongue                                  |                                                                          |   1        |
 _____________________________________________________________________________________________________________________|            |
 CARDIOVASCULAR SYSTEM                     |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Heart                                   | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Cardiomyopathy                       | 2  2  2  2  2  2  2                                                      |     29  1.9|
 _____________________________________________________________________________________________________________________|            |
 ENDOCRINE SYSTEM                          |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Hyperplasia                          |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Hyperplasia                          |          1                                                               |      2  1.5|
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page   8                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 7| 5| 7| 6| 4| 4| 4|                                            |            |
                             DAY ON TEST   | 3| 3| 3| 2| 7| 3| 8| 5| 5| 5|                                            |            |
                                           | 7| 7| 7| 9| 4| 7| 4| 1| 0| 0|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      T     |
                               ANIMAL ID   | 6| 6| 6| 6| 6| 6| 6| 6| 6| 6|                                            |      A     |
    VEHICLE                                | 4| 4| 4| 4| 4| 5| 5| 5| 5| 5|                                            |      L     |
    FEMALE                                 | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 ENDOCRINE SYSTEM - cont                   |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +                                             |  60        |
                                            __________________________________________________________________________|____________|
   Parathyroid Gland                       | +  +  +  +  +  +  +  +  +  +                                             |  58        |
                                            __________________________________________________________________________|____________|
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Pars Distalis, Angiectasis           | 2  2  2     2  2        2  1                                             |     27  2.0|
      Pars Distalis, Cyst                  |    X           X           X                                             |      7     |
      Pars Distalis, Hyperplasia           | 2                       2  2                                             |     21  2.0|
      Pars Nervosa, Angiectasis            |       2                                                                  |      3  2.0|
      Pars Nervosa, Cyst                   |                                                                          |      1     |
                                            __________________________________________________________________________|____________|
   Thyroid Gland                           | +  +  +  +  +  +  A  +  +  +                                             |  59        |
      C-Cell, Hyperplasia                  |    1     2                 1                                             |     10  1.6|
      Follicle, Cyst                       |                                                                          |      2     |
 _____________________________________________________________________________________________________________________|            |
 GENERAL BODY SYSTEM                       |                                                                          |            |
                                           |                                                                          |            |
    None                                   |                                                                          |            |
 _____________________________________________________________________________________________________________________|            |
 GENITAL SYSTEM                            |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Clitoral Gland                          | +  +  +  +  +  M  +  +  +  +                                             |  56        |
      Hyperplasia                          |                                                                          |      1  2.0|
      Inflammation, Acute                  |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Ovary                                   | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Cyst                                 |                                                                          |      3     |
                                            __________________________________________________________________________|____________|
   Uterus                                  | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Hemorrhage                           |                   4                                                      |      1  4.0|
      Inflammation, Acute                  |                                                                          |      1  2.0|
      Metaplasia, Osseous                  |                                                                          |      1  2.0|
      Cervix, Fibrosis                     |                                                                          |      1  2.0|
      Cervix, Inflammation, Acute          |                                                                          |      1  2.0|
      Cervix, Pigmentation                 |                                                                          |      1  2.0|
 _____________________________________________________________________________________________________________________|            |
 HEMATOPOIETIC SYSTEM                      |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Blood                                   | +        +                                                               |   5        |
                                            __________________________________________________________________________|____________|
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +                                             |  59        |
                                            __________________________________________________________________________|____________|
   Lymph Node                              |          +                                                               |  12        |
      Pancreatic, Angiectasis              |                                                                          |      1  2.0|
      Pancreatic, Infiltration Cellular,   |                                                                          |            |
           Histiocyte                      |                                                                          |      2  2.0|
                                            __________________________________________________________________________|____________|
   Lymph Node, Mandibular                  | +  +  +  +  +  +  +  +  +  +                                             |  60        |
                                            __________________________________________________________________________|____________|
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Angiectasis                          |                                                                          |      1  2.0|
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page   9                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 7| 5| 7| 6| 4| 4| 4|                                            |            |
                             DAY ON TEST   | 3| 3| 3| 2| 7| 3| 8| 5| 5| 5|                                            |            |
                                           | 7| 7| 7| 9| 4| 7| 4| 1| 0| 0|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      T     |
                               ANIMAL ID   | 6| 6| 6| 6| 6| 6| 6| 6| 6| 6|                                            |      A     |
    VEHICLE                                | 4| 4| 4| 4| 4| 5| 5| 5| 5| 5|                                            |      L     |
    FEMALE                                 | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 HEMATOPOIETIC SYSTEM - cont               |                                                                          |            |
                                           |                                                                          |            |
      Infiltration Cellular, Histiocyte    |                                                                          |      2  1.5|
                                            __________________________________________________________________________|____________|
   Spleen                                  | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Fibrosis                             |                                                                          |      2  2.5|
      Hematopoietic Cell Proliferation     |                                                                          |      3  2.3|
      Infarct                              |                                                                          |      1  3.0|
      Infiltration Cellular, Histiocyte    |                                                                          |      2  3.0|
                                            __________________________________________________________________________|____________|
   Thymus                                  | +  M  +  +  +  +  +  +  +  +                                             |  55        |
      Hemorrhage                           |                                                                          |      1  2.0|
 _____________________________________________________________________________________________________________________|            |
 INTEGUMENTARY SYSTEM                      |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Mammary Gland                           | +  +  +  +  +  +  +  +  +  +                                             |  58        |
      Galactocele                          |    X  X  X     X                                                         |     14     |
                                            __________________________________________________________________________|____________|
   Skin                                    | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Cyst Epithelial Inclusion            |                X                                                         |      2     |
 _____________________________________________________________________________________________________________________|            |
 MUSCULOSKELETAL SYSTEM                    |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Bone                                    | +  +  +  +  +  +  +  +  +  +                                             |  59        |
 _____________________________________________________________________________________________________________________|            |
 NERVOUS SYSTEM                            |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Brain                                   | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Hemorrhage                           |          3                                                               |      1  3.0|
 _____________________________________________________________________________________________________________________|            |
 RESPIRATORY SYSTEM                        |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Lung                                    | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Hemorrhage                           |                                                                          |      1  3.0|
      Alveolar Epithelium, Hyperplasia     |          2                                                               |      4  1.8|
                                            __________________________________________________________________________|____________|
   Nose                                    | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Fungus                               |                                                                          |      1  3.0|
      Inflammation, Acute                  |                                                                          |      2  3.5|
                                            __________________________________________________________________________|____________|
   Trachea                                 | +  +  +  +  +  +  +  +  +  +                                             |  60        |
 _____________________________________________________________________________________________________________________|            |
 SPECIAL SENSES SYSTEM                     |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Eye                                     |                                                                          |   1        |
      Lens, Cataract                       |                                                                          |      1  2.0|
 _____________________________________________________________________________________________________________________|            |
 URINARY SYSTEM                            |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Kidney                                  | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Nephropathy                          | 1  1  2  1  1  2  1  1  1                                                |     52  1.3|
      Pigmentation                         |                                                                          |      1  3.0|
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page  10                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 7| 5| 7| 6| 4| 4| 4|                                            |            |
                             DAY ON TEST   | 3| 3| 3| 2| 7| 3| 8| 5| 5| 5|                                            |            |
                                           | 7| 7| 7| 9| 4| 7| 4| 1| 0| 0|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      T     |
                               ANIMAL ID   | 6| 6| 6| 6| 6| 6| 6| 6| 6| 6|                                            |      A     |
    VEHICLE                                | 4| 4| 4| 4| 4| 5| 5| 5| 5| 5|                                            |      L     |
    FEMALE                                 | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 URINARY SYSTEM - cont                     |                                                                          |            |
                                           |                                                                          |            |
      Artery, Inflammation, Chronic Active |                                                                          |      1  2.0|
      Cortex, Mineralization               |                      1  1                                                |      8  1.0|
                                            __________________________________________________________________________|____________|
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +                                             |  59        |
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page  11                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 6| 5| 4| 4| 7| 7| 7| 7| 4| 7| 7| 7| 7| 6| 7| 7| 7| 7| 6| 7| 7| 6| 4| 4|             
                             DAY ON TEST   | 3| 3| 9| 5| 5| 3| 3| 3| 3| 5| 3| 3| 3| 3| 1| 3| 3| 3| 3| 7| 3| 3| 2| 5| 5|             
                                           | 6| 9| 7| 1| 0| 6| 6| 6| 6| 1| 6| 6| 6| 6| 6| 6| 6| 6| 5| 6| 6| 6| 4| 0| 0|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7|             
    8.3                                    | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ALIMENTARY SYSTEM                         |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Erosion                              |                                                                   3      |             
      Hyperkeratosis                       |                                                                          |             
      Inflammation, Acute                  |                                                                   2      |             
                                            __________________________________________________________________________|             
   Intestine Large, Colon                  | +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Rectum                 | +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Cecum                  | +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Duodenum               | +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Jejunum                | +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Ileum                  | +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Basophilic Focus                     | X              X        X     X  X     X     X  X  X  X        X     X  X|             
      Hepatodiaphragmatic Nodule           |          X                                                           X   |             
      Inflammation, Granulomatous          |                                                                          |             
      Mixed Cell Focus                     |                                                                          |             
      Bile Duct, Hyperplasia               |                                                                          |             
                                            __________________________________________________________________________|             
   Mesentery                               | +                 +        +                                             |             
      Fat, Necrosis                        | 3                 3                                                      |             
                                            __________________________________________________________________________|             
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Acinus, Hyperplasia                  |                                                                          |             
                                            __________________________________________________________________________|             
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Atrophy                              |                                                                          |             
                                            __________________________________________________________________________|             
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperkeratosis                       |                                                                   2      |             
      Hyperplasia, Basal Cell              |                            1                                      1      |             
                                            __________________________________________________________________________|             
   Stomach, Glandular                      | +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                          |             
                                            __________________________________________________________________________|             
   Tongue                                  |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 CARDIOVASCULAR SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cardiomyopathy                       | 2              2  2           2  2  2     1  2  2  2        2  2         |             
      Mineralization                       |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM                          |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Accessory Adrenal Cortical Nodule    |                                                                          |             
      Hemorrhage                           |                                                                          |             
      Hyperplasia                          |                                  2                                       |             
                                            __________________________________________________________________________|             
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |       1                                         1                        |             
                                            __________________________________________________________________________|             
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                        1                                 |             
                                            __________________________________________________________________________|             
   Parathyroid Gland                       | M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
                                                             Page  12                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 6| 5| 4| 4| 7| 7| 7| 7| 4| 7| 7| 7| 7| 6| 7| 7| 7| 7| 6| 7| 7| 6| 4| 4|             
                             DAY ON TEST   | 3| 3| 9| 5| 5| 3| 3| 3| 3| 5| 3| 3| 3| 3| 1| 3| 3| 3| 3| 7| 3| 3| 2| 5| 5|             
                                           | 6| 9| 7| 1| 0| 6| 6| 6| 6| 1| 6| 6| 6| 6| 6| 6| 6| 6| 5| 6| 6| 6| 4| 0| 0|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7|             
    8.3                                    | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM - cont                   |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Pituitary Gland                         | +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Pars Distalis, Angiectasis           | 3              2  2           2  2  3  2  2  2  2        2  1     2      |             
      Pars Distalis, Cyst                  |          X                    X        X              X                  |             
      Pars Distalis, Hyperplasia           |                2  2  2  3        2           3  2     2                 2|             
      Pars Intermedia, Hyperplasia         |                                                                          |             
                                            __________________________________________________________________________|             
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      C-Cell, Hyperplasia                  |             1                                                     1      |             
 _____________________________________________________________________________________________________________________|             
 GENERAL BODY SYSTEM                       |                                                                          |             
                                           |                                                                          |             
    None                                   |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENITAL SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Clitoral Gland                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Necrosis                             |                                                       3           2      |             
                                            __________________________________________________________________________|             
   Ovary                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |          X                                                               |             
                                            __________________________________________________________________________|             
   Uterus                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Vagina                                  |                                                    +                     |             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Blood                                   |       +                                                                  |             
                                            __________________________________________________________________________|             
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Lymph Node                              |                                                          +           +   |             
                                            __________________________________________________________________________|             
   Lymph Node, Mandibular                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                                                                          |             
                                            __________________________________________________________________________|             
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fibrosis                             |                                                                   2      |             
      Hemorrhage                           |                                                          2               |             
                                            __________________________________________________________________________|             
   Thymus                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 INTEGUMENTARY SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Mammary Gland                           | +  M  +  M  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  M  +  +  +  +  +|             
      Galactocele                          |                                                 X                        |             
                                            __________________________________________________________________________|             
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 MUSCULOSKELETAL SYSTEM                    |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 NERVOUS SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 RESPIRATORY SYSTEM                        |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
                                                             Page  13                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 6| 5| 4| 4| 7| 7| 7| 7| 4| 7| 7| 7| 7| 6| 7| 7| 7| 7| 6| 7| 7| 6| 4| 4|             
                             DAY ON TEST   | 3| 3| 9| 5| 5| 3| 3| 3| 3| 5| 3| 3| 3| 3| 1| 3| 3| 3| 3| 7| 3| 3| 2| 5| 5|             
                                           | 6| 9| 7| 1| 0| 6| 6| 6| 6| 1| 6| 6| 6| 6| 6| 6| 6| 6| 5| 6| 6| 6| 4| 0| 0|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7|             
    8.3                                    | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 RESPIRATORY SYSTEM - cont                 |                                                                          |             
                                           |                                                                          |             
      Edema                                |                                                                          |             
      Infiltration Cellular, Histiocyte    |                                                                          |             
      Alveolar Epithelium, Hyperplasia     |          2              2                                                |             
                                            __________________________________________________________________________|             
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fungus                               |                                                                          |             
      Inflammation, Acute                  |                                                 2                        |             
                                            __________________________________________________________________________|             
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Eye                                     |       +                                                                  |             
      Lens, Cataract                       |       2                                                                  |             
 _____________________________________________________________________________________________________________________|             
 URINARY SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Mineralization                       |                                                                          |             
      Nephropathy                          | 1        1  1  2  2  1  2  1  1  2  3  2  3  1  1  2     2  2     4  1  1|             
      Cortex, Mineralization               |          1                                                              1|             
      Pelvis, Inflammation, Chronic Active |                                                                          |             
                                            __________________________________________________________________________|             
   Urinary Bladder                         | +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
                                                             Page  14                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 4| 4| 7| 7| 5| 5| 5| 7| 7| 6| 5| 4| 7| 7| 6| 7| 7| 7| 7| 7| 6| 4|             
                             DAY ON TEST   | 3| 3| 3| 7| 5| 3| 3| 9| 9| 9| 3| 3| 3| 6| 5| 1| 3| 3| 3| 3| 3| 3| 3| 5| 5|             
                                           | 6| 6| 6| 9| 0| 5| 5| 7| 7| 1| 6| 6| 2| 6| 1| 7| 5| 2| 6| 6| 6| 6| 4| 7| 1|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7|             
    8.3                                    | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ALIMENTARY SYSTEM                         |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Esophagus                               | +  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Erosion                              |                                                                          |             
      Hyperkeratosis                       |                                                                   3      |             
      Inflammation, Acute                  |                                                                          |             
                                            __________________________________________________________________________|             
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  A  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Rectum                 | +  +  +  +  +  +  +  +  +  A  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Cecum                  | +  +  +  +  +  +  +  +  +  A  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  A  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Jejunum                | +  +  +  +  +  +  +  +  +  A  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  +  A  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
      Basophilic Focus                     |       X     X     X  X  X     X  X        X     X  X  X  X     X  X     X|             
      Hepatodiaphragmatic Nodule           |                X                 X                          X            |             
      Inflammation, Granulomatous          |                      1                                                   |             
      Mixed Cell Focus                     |                      X                                                   |             
      Bile Duct, Hyperplasia               |             1                                                            |             
                                            __________________________________________________________________________|             
   Mesentery                               |                                                                          |             
      Fat, Necrosis                        |                                                                          |             
                                            __________________________________________________________________________|             
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
      Acinus, Hyperplasia                  |                                                                          |             
                                            __________________________________________________________________________|             
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
      Atrophy                              |                                                                   2      |             
                                            __________________________________________________________________________|             
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperkeratosis                       |                                                                   3      |             
      Hyperplasia, Basal Cell              |                                                                   2      |             
                                            __________________________________________________________________________|             
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                    2                     |             
                                            __________________________________________________________________________|             
   Tongue                                  |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 CARDIOVASCULAR SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cardiomyopathy                       | 2  2           2     2  2  1  2              2  2     2           2  1  2|             
      Mineralization                       |                            1                                             |             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM                          |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
      Accessory Adrenal Cortical Nodule    |                                                                X         |             
      Hemorrhage                           |                            3                                             |             
      Hyperplasia                          |                                                                          |             
                                            __________________________________________________________________________|             
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                      2   |             
                                            __________________________________________________________________________|             
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                          |             
                                            __________________________________________________________________________|             
   Parathyroid Gland                       | +  +  M  +  +  +  +  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
                                                             Page  15                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 4| 4| 7| 7| 5| 5| 5| 7| 7| 6| 5| 4| 7| 7| 6| 7| 7| 7| 7| 7| 6| 4|             
                             DAY ON TEST   | 3| 3| 3| 7| 5| 3| 3| 9| 9| 9| 3| 3| 3| 6| 5| 1| 3| 3| 3| 3| 3| 3| 3| 5| 5|             
                                           | 6| 6| 6| 9| 0| 5| 5| 7| 7| 1| 6| 6| 2| 6| 1| 7| 5| 2| 6| 6| 6| 6| 4| 7| 1|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7|             
    8.3                                    | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM - cont                   |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
      Pars Distalis, Angiectasis           |       1           2  2     3  2  2                    1     2            |             
      Pars Distalis, Cyst                  |       X                             X                                    |             
      Pars Distalis, Hyperplasia           |       3        2                 2              2     2  2           2   |             
      Pars Intermedia, Hyperplasia         |                                                                   2      |             
                                            __________________________________________________________________________|             
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
      C-Cell, Hyperplasia                  |                               1                                          |             
 _____________________________________________________________________________________________________________________|             
 GENERAL BODY SYSTEM                       |                                                                          |             
                                           |                                                                          |             
    None                                   |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENITAL SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Clitoral Gland                          | +  +  +  +  +  M  +  +  +  +  M  +  +  A  +  +  +  +  +  +  +  +  M  +  +|             
      Necrosis                             |                                                                          |             
                                            __________________________________________________________________________|             
   Ovary                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |                                                                          |             
                                            __________________________________________________________________________|             
   Uterus                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Vagina                                  |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Blood                                   |                                     +                 +              +   |             
                                            __________________________________________________________________________|             
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +     +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Lymph Node                              |          +                                                           +   |             
                                            __________________________________________________________________________|             
   Lymph Node, Mandibular                  | +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                            2                                             |             
                                            __________________________________________________________________________|             
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
      Fibrosis                             |                                                       3                  |             
      Hemorrhage                           |                                                                          |             
                                            __________________________________________________________________________|             
   Thymus                                  | +  +  +  +  +  M  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 INTEGUMENTARY SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Mammary Gland                           | M  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
      Galactocele                          |                                              X                           |             
                                            __________________________________________________________________________|             
   Skin                                    | +  +  +  +  +  +  M  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 MUSCULOSKELETAL SYSTEM                    |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +     +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 NERVOUS SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 RESPIRATORY SYSTEM                        |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
                                                             Page  16                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 4| 4| 7| 7| 5| 5| 5| 7| 7| 6| 5| 4| 7| 7| 6| 7| 7| 7| 7| 7| 6| 4|             
                             DAY ON TEST   | 3| 3| 3| 7| 5| 3| 3| 9| 9| 9| 3| 3| 3| 6| 5| 1| 3| 3| 3| 3| 3| 3| 3| 5| 5|             
                                           | 6| 6| 6| 9| 0| 5| 5| 7| 7| 1| 6| 6| 2| 6| 1| 7| 5| 2| 6| 6| 6| 6| 4| 7| 1|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7|             
    8.3                                    | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 RESPIRATORY SYSTEM - cont                 |                                                                          |             
                                           |                                                                          |             
      Edema                                |                            2                                             |             
      Infiltration Cellular, Histiocyte    |                            2        1                                    |             
      Alveolar Epithelium, Hyperplasia     |                                                                          |             
                                            __________________________________________________________________________|             
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +     +  +  +  +  +  +  +  +  +  +|             
      Fungus                               |                                     2                                    |             
      Inflammation, Acute                  |                            4        2                                    |             
                                            __________________________________________________________________________|             
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Eye                                     |                                                                          |             
      Lens, Cataract                       |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 URINARY SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Mineralization                       |                            2           1                                 |             
      Nephropathy                          | 1  1  1  1  1  1  2  3  2  3  2  1  2        1  1  1  1  2  2  1  4  1   |             
      Cortex, Mineralization               |                                           1                             1|             
      Pelvis, Inflammation, Chronic Active |                                                                          |             
                                            __________________________________________________________________________|             
   Urinary Bladder                         | +  +  +  +  +  +  +  M  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
                                                             Page  17                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 6| 4| 7| 7| 7| 7| 4|                                            |            |
                             DAY ON TEST   | 3| 3| 0| 9| 5| 3| 3| 3| 3| 5|                                            |            |
                                           | 5| 6| 4| 2| 1| 6| 6| 5| 5| 0|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      T     |
                               ANIMAL ID   | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7|                                            |      A     |
    8.3                                    | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7|                                            |      L     |
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 ALIMENTARY SYSTEM                         |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Esophagus                               | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Erosion                              |                                                                          |      1  3.0|
      Hyperkeratosis                       |                                                                          |      1  3.0|
      Inflammation, Acute                  |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +                                             |  57        |
                                            __________________________________________________________________________|____________|
   Intestine Large, Rectum                 | +  +  +  +  +  +  +  +  +  +                                             |  57        |
                                            __________________________________________________________________________|____________|
   Intestine Large, Cecum                  | +  +  +  +  +  +  +  +  +  +                                             |  57        |
                                            __________________________________________________________________________|____________|
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +                                             |  57        |
                                            __________________________________________________________________________|____________|
   Intestine Small, Jejunum                | +  +  +  +  +  +  +  +  +  +                                             |  57        |
                                            __________________________________________________________________________|____________|
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  +  +                                             |  57        |
                                            __________________________________________________________________________|____________|
   Liver                                   | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Basophilic Focus                     |    X     X  X        X                                                   |     32     |
      Hepatodiaphragmatic Nodule           |       X                                                                  |      6     |
      Inflammation, Granulomatous          |                                                                          |      1  1.0|
      Mixed Cell Focus                     |                                                                          |      1     |
      Bile Duct, Hyperplasia               |                                                                          |      1  1.0|
                                            __________________________________________________________________________|____________|
   Mesentery                               |                                                                          |   3        |
      Fat, Necrosis                        |                                                                          |      2  3.0|
                                            __________________________________________________________________________|____________|
   Pancreas                                | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Acinus, Hyperplasia                  |                   2                                                      |      1  2.0|
                                            __________________________________________________________________________|____________|
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Atrophy                              |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Hyperkeratosis                       |                                                                          |      2  2.5|
      Hyperplasia, Basal Cell              |                                                                          |      3  1.3|
                                            __________________________________________________________________________|____________|
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +                                             |  58        |
      Hyperplasia                          |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Tongue                                  | +                                                                        |   1        |
 _____________________________________________________________________________________________________________________|            |
 CARDIOVASCULAR SYSTEM                     |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Heart                                   | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Cardiomyopathy                       | 2  2                 2  2                                                |     29  1.9|
      Mineralization                       |                                                                          |      1  1.0|
 _____________________________________________________________________________________________________________________|            |
 ENDOCRINE SYSTEM                          |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Accessory Adrenal Cortical Nodule    |                   X                                                      |      2     |
      Hemorrhage                           |                                                                          |      1  3.0|
      Hyperplasia                          |                                                                          |      1  2.0|
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page  18                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 6| 4| 7| 7| 7| 7| 4|                                            |            |
                             DAY ON TEST   | 3| 3| 0| 9| 5| 3| 3| 3| 3| 5|                                            |            |
                                           | 5| 6| 4| 2| 1| 6| 6| 5| 5| 0|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      T     |
                               ANIMAL ID   | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7|                                            |      A     |
    8.3                                    | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7|                                            |      L     |
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 ENDOCRINE SYSTEM - cont                   |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Hyperplasia                          |                      1                                                   |      4  1.3|
                                            __________________________________________________________________________|____________|
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Hyperplasia                          | 2                                                                        |      2  1.5|
                                            __________________________________________________________________________|____________|
   Parathyroid Gland                       | +  +  +  +  +  +  +  +  +  +                                             |  56        |
                                            __________________________________________________________________________|____________|
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +                                             |  58        |
      Pars Distalis, Angiectasis           |    3  3              2                                                   |     24  2.1|
      Pars Distalis, Cyst                  |                X                                                         |      7     |
      Pars Distalis, Hyperplasia           | 2              2     2     2                                             |     20  2.2|
      Pars Intermedia, Hyperplasia         |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      C-Cell, Hyperplasia                  | 1  1              1                                                      |      6  1.0|
 _____________________________________________________________________________________________________________________|            |
 GENERAL BODY SYSTEM                       |                                                                          |            |
                                           |                                                                          |            |
    None                                   |                                                                          |            |
 _____________________________________________________________________________________________________________________|            |
 GENITAL SYSTEM                            |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Clitoral Gland                          | +  +  +  +  +  +  M  +  +  +                                             |  55        |
      Necrosis                             |                                                                          |      2  2.5|
                                            __________________________________________________________________________|____________|
   Ovary                                   | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Cyst                                 |                                                                          |      1     |
                                            __________________________________________________________________________|____________|
   Uterus                                  | +  +  +  +  +  +  +  +  +  +                                             |  60        |
                                            __________________________________________________________________________|____________|
   Vagina                                  |                                                                          |   1        |
 _____________________________________________________________________________________________________________________|            |
 HEMATOPOIETIC SYSTEM                      |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Blood                                   |          +                                                               |   5        |
                                            __________________________________________________________________________|____________|
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +                                             |  59        |
                                            __________________________________________________________________________|____________|
   Lymph Node                              |          +                                                               |   5        |
                                            __________________________________________________________________________|____________|
   Lymph Node, Mandibular                  | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Hemorrhage                           |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +                                             |  59        |
                                            __________________________________________________________________________|____________|
   Spleen                                  | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Fibrosis                             |                                                                          |      2  2.5|
      Hemorrhage                           |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Thymus                                  | +  +  +  +  +  +  +  +  +  +                                             |  58        |
 _____________________________________________________________________________________________________________________|            |
 INTEGUMENTARY SYSTEM                      |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Mammary Gland                           | +  +  +  +  +  +  +  +  +  +                                             |  54        |
      Galactocele                          |    X  X  X                                                               |      5     |
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page  19                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 6| 4| 7| 7| 7| 7| 4|                                            |            |
                             DAY ON TEST   | 3| 3| 0| 9| 5| 3| 3| 3| 3| 5|                                            |            |
                                           | 5| 6| 4| 2| 1| 6| 6| 5| 5| 0|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      T     |
                               ANIMAL ID   | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7|                                            |      A     |
    8.3                                    | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7|                                            |      L     |
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 INTEGUMENTARY SYSTEM - cont               |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Skin                                    | +  +  +  +  +  +  +  +  +  +                                             |  58        |
 _____________________________________________________________________________________________________________________|            |
 MUSCULOSKELETAL SYSTEM                    |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Bone                                    | +  +  +  +  +  +  +  +  +  +                                             |  59        |
 _____________________________________________________________________________________________________________________|            |
 NERVOUS SYSTEM                            |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Brain                                   | +  +  +  +  +  +  +  +  +  +                                             |  60        |
 _____________________________________________________________________________________________________________________|            |
 RESPIRATORY SYSTEM                        |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Lung                                    | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Edema                                |                                                                          |      1  2.0|
      Infiltration Cellular, Histiocyte    |                                                                          |      2  1.5|
      Alveolar Epithelium, Hyperplasia     |                                                                          |      2  2.0|
                                            __________________________________________________________________________|____________|
   Nose                                    | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Fungus                               |                                                                          |      1  2.0|
      Inflammation, Acute                  |                                                                          |      3  2.7|
                                            __________________________________________________________________________|____________|
   Trachea                                 | +  +  +  +  +  +  +  +  +  +                                             |  59        |
 _____________________________________________________________________________________________________________________|            |
 SPECIAL SENSES SYSTEM                     |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Eye                                     |                                                                          |   1        |
      Lens, Cataract                       |                                                                          |      1  2.0|
 _____________________________________________________________________________________________________________________|            |
 URINARY SYSTEM                            |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Kidney                                  | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Mineralization                       |                                                                          |      2  1.5|
      Nephropathy                          | 1  3  2  1     2  2  1  1  1                                             |     52  1.6|
      Cortex, Mineralization               |             1              1                                             |      6  1.0|
      Pelvis, Inflammation, Chronic Active |                            2                                             |      1  2.0|
                                            __________________________________________________________________________|____________|
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +                                             |  57        |
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page  20                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 6| 4| 7| 7| 7| 4| 4| 7| 7| 7| 6| 4| 7| 7| 7| 4| 4| 7| 7| 7| 6| 6|             
                             DAY ON TEST   | 3| 3| 3| 6| 7| 3| 3| 3| 5| 5| 3| 3| 3| 0| 5| 3| 3| 3| 5| 5| 3| 3| 3| 8| 4|             
                                           | 5| 5| 5| 6| 5| 5| 5| 5| 1| 1| 5| 5| 5| 4| 1| 4| 4| 4| 7| 0| 4| 4| 4| 6| 3|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8|             
    16.6                                   | 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ALIMENTARY SYSTEM                         |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperkeratosis                       |                                                                          |             
                                            __________________________________________________________________________|             
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Rectum                 | +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Cecum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
      Necrosis                             |                                                                          |             
                                            __________________________________________________________________________|             
   Intestine Small, Jejunum                | +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
      Necrosis                             |                                                                          |             
                                            __________________________________________________________________________|             
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Basophilic Focus                     |          X     X     X  X     X                          X     X  X      |             
      Fibrosis                             |                                                    2                     |             
      Hepatodiaphragmatic Nodule           |                                                       X  X        X      |             
      Inflammation, Granulomatous          |                                                                          |             
      Mixed Cell Focus                     |          X                                                               |             
      Necrosis                             |                                                    2                     |             
                                            __________________________________________________________________________|             
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Duct, Metaplasia, Squamous           |                                                                          |             
                                            __________________________________________________________________________|             
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia, Basal Cell              |    1                                                                     |             
      Necrosis                             |                                                                          |             
                                            __________________________________________________________________________|             
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 CARDIOVASCULAR SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cardiomyopathy                       |       2  2        2  2        2     2  2        2  2     2  2     2     2|             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM                          |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Accessory Adrenal Cortical Nodule    |                                                                          |             
      Hyperplasia                          |                                                                          |             
                                            __________________________________________________________________________|             
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                   1      |             
                                            __________________________________________________________________________|             
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Parathyroid Gland                       | M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Pars Distalis, Angiectasis           |    2     2  2  2                          2                    2  2  2  2|             
      Pars Distalis, Cyst                  |                                                    X                     |             
      Pars Distalis, Hyperplasia           | 1  3                 3           3        2  2  2                        |             
                                            __________________________________________________________________________|             
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
      C-Cell, Hyperplasia                  |                               1                                2     1   |             
      Follicle, Cyst                       |                                                                   X      |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  21                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 6| 4| 7| 7| 7| 4| 4| 7| 7| 7| 6| 4| 7| 7| 7| 4| 4| 7| 7| 7| 6| 6|             
                             DAY ON TEST   | 3| 3| 3| 6| 7| 3| 3| 3| 5| 5| 3| 3| 3| 0| 5| 3| 3| 3| 5| 5| 3| 3| 3| 8| 4|             
                                           | 5| 5| 5| 6| 5| 5| 5| 5| 1| 1| 5| 5| 5| 4| 1| 4| 4| 4| 7| 0| 4| 4| 4| 6| 3|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8|             
    16.6                                   | 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 GENERAL BODY SYSTEM                       |                                                                          |             
                                           |                                                                          |             
    None                                   |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENITAL SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Clitoral Gland                          | M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  M  +  +  +|             
                                            __________________________________________________________________________|             
   Ovary                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |                                                                          |             
                                            __________________________________________________________________________|             
   Oviduct                                 |                                                                          |             
                                            __________________________________________________________________________|             
   Uterus                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Decidual Reaction                    |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Blood                                   |                               +                                         +|             
                                            __________________________________________________________________________|             
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  M  +  +  M  +|             
                                            __________________________________________________________________________|             
   Lymph Node                              |                                     +  +                                +|             
      Pancreatic, Hemorrhage               |                                        2                                 |             
                                            __________________________________________________________________________|             
   Lymph Node, Mandibular                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Angiectasis                          |                                                                          |             
                                            __________________________________________________________________________|             
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Angiectasis                          | 2                                                                        |             
      Hemorrhage                           |                                        2                                 |             
      Hyperplasia                          |                                                                          |             
                                            __________________________________________________________________________|             
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fibrosis                             |                               2                                          |             
      Hematopoietic Cell Proliferation     |                                                                          |             
                                            __________________________________________________________________________|             
   Thymus                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fibrosis                             |                                                                          |             
      Epithelial Cell, Hyperplasia         |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 INTEGUMENTARY SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Mammary Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Galactocele                          |                                                                          |             
                                            __________________________________________________________________________|             
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 MUSCULOSKELETAL SYSTEM                    |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fibrous Osteodystrophy               |                                                                      3   |             
                                            __________________________________________________________________________|             
   Skeletal Muscle                         |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 NERVOUS SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hydrocephalus                        |          2                                                               |             
 _____________________________________________________________________________________________________________________|             
 RESPIRATORY SYSTEM                        |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
                                                             Page  22                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 6| 4| 7| 7| 7| 4| 4| 7| 7| 7| 6| 4| 7| 7| 7| 4| 4| 7| 7| 7| 6| 6|             
                             DAY ON TEST   | 3| 3| 3| 6| 7| 3| 3| 3| 5| 5| 3| 3| 3| 0| 5| 3| 3| 3| 5| 5| 3| 3| 3| 8| 4|             
                                           | 5| 5| 5| 6| 5| 5| 5| 5| 1| 1| 5| 5| 5| 4| 1| 4| 4| 4| 7| 0| 4| 4| 4| 6| 3|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8|             
    16.6                                   | 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 RESPIRATORY SYSTEM - cont                 |                                                                          |             
                                           |                                                                          |             
      Edema                                |                                                                          |             
      Infiltration Cellular, Histiocyte    |                                                                          |             
      Inflammation, Acute                  |                   1                                                      |             
      Alveolar Epithelium, Hyperplasia     |                                                                          |             
                                            __________________________________________________________________________|             
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  M  +|             
      Inflammation, Acute                  |                                                       2                  |             
                                            __________________________________________________________________________|             
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Ear                                     | +                                                                       +|             
                                            __________________________________________________________________________|             
   Eye                                     |                                                                   +      |             
      Lens, Cataract                       |                                                                          |             
      Retina, Atrophy                      |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 URINARY SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Acute                  |                                                                          |             
      Mineralization                       |                                                                          |             
      Nephropathy                          | 2  1  1  3  1  1  2  2     1  2  1  2  1     1  2  3  1  1  2  1  1  2  2|             
      Bilateral, Papilla, Necrosis         |                                                                          |             
      Cortex, Mineralization               |                         1  1              1                              |             
                                            __________________________________________________________________________|             
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                                                                          |             
      Necrosis                             |                                                                          |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  23                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 5| 4| 3| 7| 7| 7| 7| 4| 7| 6| 6| 5| 4| 7| 7| 7| 6| 5| 7| 7| 6| 4| 4|             
                             DAY ON TEST   | 3| 3| 4| 5| 6| 3| 3| 3| 3| 5| 3| 8| 4| 5| 5| 3| 3| 3| 7| 7| 3| 3| 1| 7| 5|             
                                           | 4| 4| 7| 0| 0| 4| 4| 4| 4| 1| 5| 9| 4| 0| 1| 5| 5| 5| 5| 6| 4| 4| 4| 9| 1|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8|             
    16.6                                   | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ALIMENTARY SYSTEM                         |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperkeratosis                       |                                                                          |             
                                            __________________________________________________________________________|             
   Intestine Large, Colon                  | +  +  A  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  A  A  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Rectum                 | +  +  A  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  A  A  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Cecum                  | +  +  A  +  A  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  A  A  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Duodenum               | +  +  A  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  A  A  +|             
      Necrosis                             |                                                          3               |             
                                            __________________________________________________________________________|             
   Intestine Small, Jejunum                | +  +  A  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  A  A  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Ileum                  | +  +  A  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  A  A  +|             
      Necrosis                             |                                                 3                        |             
                                            __________________________________________________________________________|             
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Basophilic Focus                     |                X        X     X     X     X  X  X  X  X  X              X|             
      Fibrosis                             |                                        2                                 |             
      Hepatodiaphragmatic Nodule           |                                                                         X|             
      Inflammation, Granulomatous          |                                                    1                     |             
      Mixed Cell Focus                     |                                                                X         |             
      Necrosis                             |                                                                          |             
                                            __________________________________________________________________________|             
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
      Duct, Metaplasia, Squamous           |                                     1        1                           |             
                                            __________________________________________________________________________|             
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia, Basal Cell              |                                                                          |             
      Necrosis                             |                                                          2               |             
                                            __________________________________________________________________________|             
   Stomach, Glandular                      | +  +  A  +  A  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  A  +|             
 _____________________________________________________________________________________________________________________|             
 CARDIOVASCULAR SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cardiomyopathy                       | 2  2        1     2     2        2  2                       2  2        2|             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM                          |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Adrenal Cortex                          | +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Accessory Adrenal Cortical Nodule    |                                           X                              |             
      Hyperplasia                          |                                                                          |             
                                            __________________________________________________________________________|             
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                     1                       1            |             
                                            __________________________________________________________________________|             
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Parathyroid Gland                       | +  +  +  +  +  +  M  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  A  +|             
      Pars Distalis, Angiectasis           |    2     2        2  2  2           2           2        3               |             
      Pars Distalis, Cyst                  |                                              X                           |             
      Pars Distalis, Hyperplasia           |                      3     2  2  2        2  2  2              2         |             
                                            __________________________________________________________________________|             
   Thyroid Gland                           | +  +  A  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  A  +|             
      C-Cell, Hyperplasia                  |                      2           1              1        1  3            |             
      Follicle, Cyst                       |                                                                          |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  24                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 5| 4| 3| 7| 7| 7| 7| 4| 7| 6| 6| 5| 4| 7| 7| 7| 6| 5| 7| 7| 6| 4| 4|             
                             DAY ON TEST   | 3| 3| 4| 5| 6| 3| 3| 3| 3| 5| 3| 8| 4| 5| 5| 3| 3| 3| 7| 7| 3| 3| 1| 7| 5|             
                                           | 4| 4| 7| 0| 0| 4| 4| 4| 4| 1| 5| 9| 4| 0| 1| 5| 5| 5| 5| 6| 4| 4| 4| 9| 1|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8|             
    16.6                                   | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 GENERAL BODY SYSTEM                       |                                                                          |             
                                           |                                                                          |             
    None                                   |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENITAL SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Clitoral Gland                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Ovary                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |                                        X                                X|             
                                            __________________________________________________________________________|             
   Oviduct                                 |                                                                          |             
                                            __________________________________________________________________________|             
   Uterus                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Decidual Reaction                    |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Blood                                   |                                                                          |             
                                            __________________________________________________________________________|             
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Lymph Node                              |                                     +                                    |             
      Pancreatic, Hemorrhage               |                                                                          |             
                                            __________________________________________________________________________|             
   Lymph Node, Mandibular                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Angiectasis                          |                                                       2                  |             
                                            __________________________________________________________________________|             
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Angiectasis                          |                                                                          |             
      Hemorrhage                           |                                                                          |             
      Hyperplasia                          |                                              1                           |             
                                            __________________________________________________________________________|             
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fibrosis                             |                                                                          |             
      Hematopoietic Cell Proliferation     |                                  3                                       |             
                                            __________________________________________________________________________|             
   Thymus                                  | +  +  +  +  +  +  +  M  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  M|             
      Fibrosis                             | 2                                                                        |             
      Epithelial Cell, Hyperplasia         |                                                       1                  |             
 _____________________________________________________________________________________________________________________|             
 INTEGUMENTARY SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Mammary Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Galactocele                          |                X                                         X     X         |             
                                            __________________________________________________________________________|             
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 MUSCULOSKELETAL SYSTEM                    |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fibrous Osteodystrophy               |                                                                          |             
                                            __________________________________________________________________________|             
   Skeletal Muscle                         |                                  +                                       |             
 _____________________________________________________________________________________________________________________|             
 NERVOUS SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hydrocephalus                        |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 RESPIRATORY SYSTEM                        |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
                                                             Page  25                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 5| 4| 3| 7| 7| 7| 7| 4| 7| 6| 6| 5| 4| 7| 7| 7| 6| 5| 7| 7| 6| 4| 4|             
                             DAY ON TEST   | 3| 3| 4| 5| 6| 3| 3| 3| 3| 5| 3| 8| 4| 5| 5| 3| 3| 3| 7| 7| 3| 3| 1| 7| 5|             
                                           | 4| 4| 7| 0| 0| 4| 4| 4| 4| 1| 5| 9| 4| 0| 1| 5| 5| 5| 5| 6| 4| 4| 4| 9| 1|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8|             
    16.6                                   | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 RESPIRATORY SYSTEM - cont                 |                                                                          |             
                                           |                                                                          |             
      Edema                                |                                                                          |             
      Infiltration Cellular, Histiocyte    |                                                                          |             
      Inflammation, Acute                  |             2                                                            |             
      Alveolar Epithelium, Hyperplasia     |                                                                          |             
                                            __________________________________________________________________________|             
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Acute                  |    2           1                                                        2|             
                                            __________________________________________________________________________|             
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Ear                                     |                                                 +                        |             
                                            __________________________________________________________________________|             
   Eye                                     |                                                                          |             
      Lens, Cataract                       |                                                                          |             
      Retina, Atrophy                      |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 URINARY SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  +|             
      Inflammation, Acute                  |                                                                          |             
      Mineralization                       |                                        1                                 |             
      Nephropathy                          | 2  3     1     2  3  1  2  2  2  1  2  1     2  1  1  1  3  2  2  2      |             
      Bilateral, Papilla, Necrosis         |                                                                          |             
      Cortex, Mineralization               |          1                 1                                            1|             
                                            __________________________________________________________________________|             
   Urinary Bladder                         | +  +  A  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  A  +|             
      Hemorrhage                           |                                                                          |             
      Necrosis                             |                                                                          |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  26                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 6| 5| 4| 7| 7| 6| 4| 3|                                            |            |
                             DAY ON TEST   | 3| 3| 5| 5| 5| 3| 3| 8| 5| 0|                                            |            |
                                           | 4| 4| 2| 0| 0| 4| 4| 5| 0| 6|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      T     |
                               ANIMAL ID   | 8| 8| 8| 8| 8| 8| 8| 8| 8| 8|                                            |      A     |
    16.6                                   | 8| 8| 8| 8| 8| 9| 9| 9| 9| 9|                                            |      L     |
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 ALIMENTARY SYSTEM                         |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Esophagus                               | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Hyperkeratosis                       |                            2                                             |      1  2.0|
                                            __________________________________________________________________________|____________|
   Intestine Large, Colon                  | +  +  +  A  +  +  +  +  +  A                                             |  53        |
                                            __________________________________________________________________________|____________|
   Intestine Large, Rectum                 | +  +  +  A  +  +  +  +  +  +                                             |  54        |
                                            __________________________________________________________________________|____________|
   Intestine Large, Cecum                  | +  +  +  A  +  +  +  +  +  A                                             |  52        |
                                            __________________________________________________________________________|____________|
   Intestine Small, Duodenum               | +  +  +  A  +  +  +  +  +  +                                             |  54        |
      Necrosis                             |                                                                          |      1  3.0|
                                            __________________________________________________________________________|____________|
   Intestine Small, Jejunum                | +  +  +  A  +  +  +  +  +  A                                             |  53        |
                                            __________________________________________________________________________|____________|
   Intestine Small, Ileum                  | +  +  +  A  +  +  +  +  +  A                                             |  53        |
      Necrosis                             |                                                                          |      1  3.0|
                                            __________________________________________________________________________|____________|
   Liver                                   | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Basophilic Focus                     |          X  X     X     X                                                |     23     |
      Fibrosis                             |                                                                          |      2  2.0|
      Hepatodiaphragmatic Nodule           |    X                                                                     |      5     |
      Inflammation, Granulomatous          |                2                                                         |      2  1.5|
      Mixed Cell Focus                     |                                                                          |      2     |
      Necrosis                             |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Pancreas                                | +  +  +  +  +  +  +  +  +  +                                             |  60        |
                                            __________________________________________________________________________|____________|
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Duct, Metaplasia, Squamous           |                                                                          |      2  1.0|
                                            __________________________________________________________________________|____________|
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Hyperplasia, Basal Cell              |                                                                          |      1  1.0|
      Necrosis                             |                3                                                         |      2  2.5|
                                            __________________________________________________________________________|____________|
   Stomach, Glandular                      | +  +  +  A  +  +  +  +  +  +                                             |  54        |
 _____________________________________________________________________________________________________________________|            |
 CARDIOVASCULAR SYSTEM                     |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Heart                                   | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Cardiomyopathy                       | 2  2              2  2     1                                             |     28  1.9|
 _____________________________________________________________________________________________________________________|            |
 ENDOCRINE SYSTEM                          |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Accessory Adrenal Cortical Nodule    |                                                                          |      1     |
      Hyperplasia                          | 2                                                                        |      1  2.0|
                                            __________________________________________________________________________|____________|
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Hyperplasia                          |                                                                          |      3  1.0|
                                            __________________________________________________________________________|____________|
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +                                             |  60        |
                                            __________________________________________________________________________|____________|
   Parathyroid Gland                       | M  +  +  M  +  +  +  +  +  +                                             |  55        |
                                            __________________________________________________________________________|____________|
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +                                             |  58        |
      Pars Distalis, Angiectasis           | 2              2     2                                                   |     20  2.1|
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page  27                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 6| 5| 4| 7| 7| 6| 4| 3|                                            |            |
                             DAY ON TEST   | 3| 3| 5| 5| 5| 3| 3| 8| 5| 0|                                            |            |
                                           | 4| 4| 2| 0| 0| 4| 4| 5| 0| 6|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      T     |
                               ANIMAL ID   | 8| 8| 8| 8| 8| 8| 8| 8| 8| 8|                                            |      A     |
    16.6                                   | 8| 8| 8| 8| 8| 9| 9| 9| 9| 9|                                            |      L     |
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 ENDOCRINE SYSTEM - cont                   |                                                                          |            |
                                           |                                                                          |            |
      Pars Distalis, Cyst                  |    X                                                                     |      3     |
      Pars Distalis, Hyperplasia           |    2  3     2                                                            |     18  2.2|
                                            __________________________________________________________________________|____________|
   Thyroid Gland                           | +  +  +  A  +  +  +  +  +  +                                             |  55        |
      C-Cell, Hyperplasia                  |                                                                          |      8  1.5|
      Follicle, Cyst                       |                                                                          |      1     |
 _____________________________________________________________________________________________________________________|            |
 GENERAL BODY SYSTEM                       |                                                                          |            |
                                           |                                                                          |            |
    None                                   |                                                                          |            |
 _____________________________________________________________________________________________________________________|            |
 GENITAL SYSTEM                            |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Clitoral Gland                          | +  +  +  +  +  +  +  +  +  +                                             |  58        |
                                            __________________________________________________________________________|____________|
   Ovary                                   | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Cyst                                 |                                                                          |      2     |
                                            __________________________________________________________________________|____________|
   Oviduct                                 |                            +                                             |   1        |
                                            __________________________________________________________________________|____________|
   Uterus                                  | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Decidual Reaction                    |    4                                                                     |      1  4.0|
 _____________________________________________________________________________________________________________________|            |
 HEMATOPOIETIC SYSTEM                      |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Blood                                   |       +                                                                  |   3        |
                                            __________________________________________________________________________|____________|
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +                                             |  58        |
                                            __________________________________________________________________________|____________|
   Lymph Node                              |       +                                                                  |   5        |
      Pancreatic, Hemorrhage               |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Lymph Node, Mandibular                  | +  +  +  +  +  +  +  +  M  +                                             |  59        |
      Angiectasis                          |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Angiectasis                          |                                                                          |      1  2.0|
      Hemorrhage                           |                                                                          |      1  2.0|
      Hyperplasia                          |                                                                          |      1  1.0|
                                            __________________________________________________________________________|____________|
   Spleen                                  | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Fibrosis                             |                                                                          |      1  2.0|
      Hematopoietic Cell Proliferation     |    3                                                                     |      2  3.0|
                                            __________________________________________________________________________|____________|
   Thymus                                  | +  +  +  +  +  +  +  +  +  +                                             |  57        |
      Fibrosis                             |                                                                          |      1  2.0|
      Epithelial Cell, Hyperplasia         |                                                                          |      1  1.0|
 _____________________________________________________________________________________________________________________|            |
 INTEGUMENTARY SYSTEM                      |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Mammary Gland                           | +  +  +  +  +  +  +  +  M  +                                             |  59        |
      Galactocele                          |       X              X                                                   |      5     |
                                            __________________________________________________________________________|____________|
   Skin                                    | +  +  +  +  +  +  +  +  +  +                                             |  60        |
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page  28                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 6| 5| 4| 7| 7| 6| 4| 3|                                            |            |
                             DAY ON TEST   | 3| 3| 5| 5| 5| 3| 3| 8| 5| 0|                                            |            |
                                           | 4| 4| 2| 0| 0| 4| 4| 5| 0| 6|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      T     |
                               ANIMAL ID   | 8| 8| 8| 8| 8| 8| 8| 8| 8| 8|                                            |      A     |
    16.6                                   | 8| 8| 8| 8| 8| 9| 9| 9| 9| 9|                                            |      L     |
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 INTEGUMENTARY SYSTEM - cont               |                                                                          |            |
                                           |                                                                          |            |
 _____________________________________________________________________________________________________________________|            |
 MUSCULOSKELETAL SYSTEM                    |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Bone                                    | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Fibrous Osteodystrophy               |                                                                          |      1  3.0|
                                            __________________________________________________________________________|____________|
   Skeletal Muscle                         |       +                                                                  |   2        |
 _____________________________________________________________________________________________________________________|            |
 NERVOUS SYSTEM                            |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Brain                                   | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Hydrocephalus                        |                                                                          |      1  2.0|
 _____________________________________________________________________________________________________________________|            |
 RESPIRATORY SYSTEM                        |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Lung                                    | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Edema                                |       2                    1                                             |      2  1.5|
      Infiltration Cellular, Histiocyte    |       2                                                                  |      1  2.0|
      Inflammation, Acute                  |                                                                          |      2  1.5|
      Alveolar Epithelium, Hyperplasia     |          2                                                               |      1  2.0|
                                            __________________________________________________________________________|____________|
   Nose                                    | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Inflammation, Acute                  |                   1     1                                                |      6  1.5|
                                            __________________________________________________________________________|____________|
   Trachea                                 | +  +  +  +  +  +  +  +  +  +                                             |  60        |
 _____________________________________________________________________________________________________________________|            |
 SPECIAL SENSES SYSTEM                     |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Ear                                     |                                                                          |   3        |
                                            __________________________________________________________________________|____________|
   Eye                                     |                   +        +                                             |   3        |
      Lens, Cataract                       |                   3                                                      |      1  3.0|
      Retina, Atrophy                      |                   2                                                      |      1  2.0|
 _____________________________________________________________________________________________________________________|            |
 URINARY SYSTEM                            |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Kidney                                  | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Inflammation, Acute                  |                            2                                             |      1  2.0|
      Mineralization                       |                                                                          |      1  1.0|
      Nephropathy                          | 2  1  1     1  2  2  2                                                   |     50  1.7|
      Bilateral, Papilla, Necrosis         |                            3                                             |      1  3.0|
      Cortex, Mineralization               |             1           1                                                |      8  1.0|
                                            __________________________________________________________________________|____________|
   Urinary Bladder                         | +  +  +  A  +  +  +  +  +  +                                             |  56        |
      Hemorrhage                           |                            3                                             |      1  3.0|
      Necrosis                             |                            4                                             |      1  4.0|
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page  29                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 6| 6| 5| 3| 7| 6| 5| 4| 4| 7| 7| 4| 2| 0| 7| 7| 6| 5| 4| 7| 7| 5| 4| 4|             
                             DAY ON TEST   | 3| 6| 2| 5| 9| 3| 5| 7| 5| 2| 3| 3| 5| 5| 3| 3| 3| 8| 9| 7| 3| 3| 9| 5| 5|             
                                           | 4| 6| 9| 0| 3| 1| 1| 5| 1| 1| 1| 1| 0| 9| 0| 1| 1| 9| 1| 0| 1| 1| 0| 1| 0|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9|             
    33.3                                   | 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ALIMENTARY SYSTEM                         |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Colon                  | +  +  +  A  +  +  +  +  +  +  +  +  +  A  A  +  +  +  A  +  +  +  A  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Rectum                 | +  +  +  A  A  +  +  +  +  +  +  +  +  A  A  +  +  +  A  +  +  +  A  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Cecum                  | +  +  +  A  A  +  A  +  +  +  +  +  +  A  A  +  +  +  A  A  +  +  A  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Duodenum               | +  +  +  A  A  +  A  +  +  +  +  +  +  +  A  +  +  +  A  +  +  +  A  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Jejunum                | +  +  +  A  A  +  A  +  +  +  +  +  +  A  A  +  +  +  A  A  +  +  A  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Ileum                  | +  +  +  A  A  +  A  +  +  +  +  +  +  A  A  +  +  +  A  A  +  +  A  +  +|             
                                            __________________________________________________________________________|             
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Basophilic Focus                     | X                       X  X        X        X  X        X  X  X     X   |             
      Clear Cell Focus                     |                                                                          |             
      Fatty Change, Focal                  |                                              2                           |             
      Hepatodiaphragmatic Nodule           |          X  X  X              X           X     X                        |             
      Inflammation, Granulomatous          |                                                                          |             
      Mixed Cell Focus                     |                   X                          X                           |             
      Pigmentation                         |                                                                          |             
                                            __________________________________________________________________________|             
   Mesentery                               |                         +                                                |             
                                            __________________________________________________________________________|             
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +|             
      Acinus, Atrophy                      |                      2                                                   |             
                                            __________________________________________________________________________|             
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Duct, Metaplasia, Squamous           |                                                                          |             
                                            __________________________________________________________________________|             
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperkeratosis                       |                                                                          |             
      Hyperplasia, Basal Cell              |                            2                                             |             
      Ulcer                                |                            2                                             |             
                                            __________________________________________________________________________|             
   Stomach, Glandular                      | +  +  +  A  +  +  +  +  +  +  +  +  +  +  A  +  +  +  A  +  +  +  A  +  +|             
      Hyperplasia                          |                                                                      1   |             
      Mineralization                       |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 CARDIOVASCULAR SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cardiomyopathy                       | 2  1           2              2  2     1     2  2           2  2  2      |             
      Inflammation, Chronic Active         |                            2                                             |             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM                          |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                          |             
                                            __________________________________________________________________________|             
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                          |             
                                            __________________________________________________________________________|             
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Parathyroid Gland                       | +  +  +  +  +  +  +  +  +  +  +  +  +  M  +  +  +  +  +  M  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +|             
      Craniopharyngeal Duct, Cyst          |                                                                          |             
      Pars Distalis, Angiectasis           |    2              2           2  3                       2  1     2      |             
      Pars Distalis, Hyperplasia           | 1     2  2                          2              2           3        1|             
 _____________________________________________________________________________________________________________________|             
                                                             Page  30                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 6| 6| 5| 3| 7| 6| 5| 4| 4| 7| 7| 4| 2| 0| 7| 7| 6| 5| 4| 7| 7| 5| 4| 4|             
                             DAY ON TEST   | 3| 6| 2| 5| 9| 3| 5| 7| 5| 2| 3| 3| 5| 5| 3| 3| 3| 8| 9| 7| 3| 3| 9| 5| 5|             
                                           | 4| 6| 9| 0| 3| 1| 1| 5| 1| 1| 1| 1| 0| 9| 0| 1| 1| 9| 1| 0| 1| 1| 0| 1| 0|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9|             
    33.3                                   | 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM - cont                   |                                                                          |             
                                           |                                                                          |             
      Pars Intermedia, Hyperplasia         |                                                                         3|             
                                            __________________________________________________________________________|             
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  A  +  +  +  +  +  +|             
      C-Cell, Hyperplasia                  |                                                 1           1            |             
      Follicle, Cyst                       |                                                                   X      |             
      Follicular Cell, Hyperplasia         |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENERAL BODY SYSTEM                       |                                                                          |             
                                           |                                                                          |             
    None                                   |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENITAL SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Clitoral Gland                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +|             
      Dilatation                           |                                                                          |             
      Inflammation, Acute                  |                                                                          |             
                                            __________________________________________________________________________|             
   Ovary                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Uterus                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |                                                                          |             
      Hemorrhage                           |                                                    4                     |             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Blood                                   |    +                                               +                     |             
                                            __________________________________________________________________________|             
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Lymph Node                              |    +  +                                                                  |             
      Mediastinal, Angiectasis             |       3                                                                  |             
      Mediastinal, Pigmentation            |                                                                          |             
                                            __________________________________________________________________________|             
   Lymph Node, Mandibular                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hematopoietic Cell Proliferation     |                                                                          |             
      Infarct                              |                                                                          |             
                                            __________________________________________________________________________|             
   Thymus                                  | +  +  +  +  +  +  +  +  +  +  M  +  +  +  A  +  +  +  +  +  +  +  +  +  +|             
      Epithelial Cell, Ectopic Parathyroid |                                                                          |             
          Gland                            |                                                    3                     |             
 _____________________________________________________________________________________________________________________|             
 INTEGUMENTARY SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Mammary Gland                           | +  +  +  +  M  +  +  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  M  +|             
      Galactocele                          |    X                             X                          X            |             
                                            __________________________________________________________________________|             
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 MUSCULOSKELETAL SYSTEM                    |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 NERVOUS SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Degeneration                         |                                                                          |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  31                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 6| 6| 5| 3| 7| 6| 5| 4| 4| 7| 7| 4| 2| 0| 7| 7| 6| 5| 4| 7| 7| 5| 4| 4|             
                             DAY ON TEST   | 3| 6| 2| 5| 9| 3| 5| 7| 5| 2| 3| 3| 5| 5| 3| 3| 3| 8| 9| 7| 3| 3| 9| 5| 5|             
                                           | 4| 6| 9| 0| 3| 1| 1| 5| 1| 1| 1| 1| 0| 9| 0| 1| 1| 9| 1| 0| 1| 1| 0| 1| 0|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9|             
    33.3                                   | 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 NERVOUS SYSTEM - cont                     |                                                                          |             
                                           |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 RESPIRATORY SYSTEM                        |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                                                                          |             
      Infiltration Cellular, Histiocyte    | 3                                                                        |             
                                            __________________________________________________________________________|             
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Acute                  |                                  1                                   1   |             
                                            __________________________________________________________________________|             
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Eye                                     |                                                 +                        |             
      Lens, Cataract                       |                                                                          |             
                                            __________________________________________________________________________|             
   Zymbal's Gland                          |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 URINARY SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Nephropathy                          | 2  2     1     1  1  1  1     2  2  1        2  2  1  1  1  2  1  2     1|             
      Cortex, Mineralization               |                                     1                                1   |             
                                            __________________________________________________________________________|             
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
                                                             Page  32                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 7| 3| 7| 7| 5| 5| 0| 7| 7| 4| 4| 3| 7| 7| 7| 5| 3| 7| 7| 4| 4| 3|             
                             DAY ON TEST   | 3| 3| 3| 3| 1| 3| 2| 6| 5| 8| 3| 0| 5| 4| 1| 3| 3| 3| 5| 9| 3| 3| 5| 4| 7|             
                                           | 1| 1| 1| 1| 1| 1| 9| 2| 0| 3| 1| 2| 0| 1| 1| 4| 4| 5| 2| 3| 4| 4| 1| 2| 1|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9|             
    33.3                                   | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ALIMENTARY SYSTEM                         |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Esophagus                               | +  +  +  +  +  +  +  +  +  A  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  A  A  +  A  +  A  A  +  +  +  +  A  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Rectum                 | +  +  +  +  +  +  +  +  A  A  +  A  +  A  M  +  +  +  +  A  +  +  +  A  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Cecum                  | +  +  +  +  +  +  +  +  A  A  +  A  +  A  M  +  +  +  +  A  +  +  +  A  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  A  A  +  A  +  M  M  +  +  +  +  A  +  +  +  A  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Jejunum                | +  +  +  +  +  +  +  +  A  A  +  A  +  A  M  +  +  +  +  A  +  +  +  A  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  A  A  +  A  +  A  M  +  M  +  +  A  +  +  +  A  +|             
                                            __________________________________________________________________________|             
   Liver                                   | +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Basophilic Focus                     |    X     X                                   X     X     X     X        X|             
      Clear Cell Focus                     |                                                                          |             
      Fatty Change, Focal                  |                                                                          |             
      Hepatodiaphragmatic Nodule           |          X           X                             X           X         |             
      Inflammation, Granulomatous          |                                  1                                       |             
      Mixed Cell Focus                     |       X                          X              X                        |             
      Pigmentation                         |                                                                          |             
                                            __________________________________________________________________________|             
   Mesentery                               |                                                                          |             
                                            __________________________________________________________________________|             
   Pancreas                                | +  +  +  +  +  +  +  +  +  A  +  +  +  M  M  +  +  +  +  +  +  +  +  +  +|             
      Acinus, Atrophy                      |                                                                          |             
                                            __________________________________________________________________________|             
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Duct, Metaplasia, Squamous           |                                                                          |             
                                            __________________________________________________________________________|             
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  A  +  +  +  M  M  +  +  +  +  +  +  +  +  +  +|             
      Hyperkeratosis                       |                                                                          |             
      Hyperplasia, Basal Cell              |                                                                          |             
      Ulcer                                |                                                                          |             
                                            __________________________________________________________________________|             
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  A  A  +  +  +  M  M  +  +  +  +  A  +  +  +  +  +|             
      Hyperplasia                          |                                                                          |             
      Mineralization                       |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 CARDIOVASCULAR SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Heart                                   | +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cardiomyopathy                       | 2     2              2        2  2           2  2  2  2     2        1   |             
      Inflammation, Chronic Active         |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM                          |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  A  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                   3                          2                           |             
                                            __________________________________________________________________________|             
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  A  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |    2                                                                     |             
                                            __________________________________________________________________________|             
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  A  +  A  +  M  M  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Parathyroid Gland                       | +  +  +  +  +  +  +  +  +  A  +  +  +  +  M  +  +  +  M  +  +  +  M  +  M|             
                                            __________________________________________________________________________|             
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Craniopharyngeal Duct, Cyst          | X                                                                        |             
      Pars Distalis, Angiectasis           |          2     2                             2  2  1        2            |             
      Pars Distalis, Hyperplasia           | 3     1  2     2              3                             3     2     2|             
 _____________________________________________________________________________________________________________________|             
                                                             Page  33                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 7| 3| 7| 7| 5| 5| 0| 7| 7| 4| 4| 3| 7| 7| 7| 5| 3| 7| 7| 4| 4| 3|             
                             DAY ON TEST   | 3| 3| 3| 3| 1| 3| 2| 6| 5| 8| 3| 0| 5| 4| 1| 3| 3| 3| 5| 9| 3| 3| 5| 4| 7|             
                                           | 1| 1| 1| 1| 1| 1| 9| 2| 0| 3| 1| 2| 0| 1| 1| 4| 4| 5| 2| 3| 4| 4| 1| 2| 1|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9|             
    33.3                                   | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM - cont                   |                                                                          |             
                                           |                                                                          |             
      Pars Intermedia, Hyperplasia         |                                                                          |             
                                            __________________________________________________________________________|             
   Thyroid Gland                           | +  +  +  +  +  +  +  +  A  +  +  +  +  +  M  +  +  +  +  A  +  +  +  A  +|             
      C-Cell, Hyperplasia                  | 1     2                                      1                 1         |             
      Follicle, Cyst                       |                                                                          |             
      Follicular Cell, Hyperplasia         | 2                                                                        |             
 _____________________________________________________________________________________________________________________|             
 GENERAL BODY SYSTEM                       |                                                                          |             
                                           |                                                                          |             
    None                                   |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENITAL SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Clitoral Gland                          | +  +  +  +  +  +  +  +  +  A  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +|             
      Dilatation                           |                               3                                          |             
      Inflammation, Acute                  |                                                 3                        |             
                                            __________________________________________________________________________|             
   Ovary                                   | +  +  +  +  +  +  +  +  +  A  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Uterus                                  | +  +  +  +  +  +  +  +  +  A  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |                                                                          |             
      Hemorrhage                           |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Blood                                   |                   +           +                       +                  |             
                                            __________________________________________________________________________|             
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Lymph Node                              |          +                                            +                  |             
      Mediastinal, Angiectasis             |                                                                          |             
      Mediastinal, Pigmentation            |          2                                                               |             
                                            __________________________________________________________________________|             
   Lymph Node, Mandibular                  | +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  M  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Spleen                                  | +  +  +  +  +  +  +  +  +  A  +  +  +  M  M  +  +  +  +  A  +  +  +  +  +|             
      Hematopoietic Cell Proliferation     |                                                                         3|             
      Infarct                              |                                                                          |             
                                            __________________________________________________________________________|             
   Thymus                                  | +  +  +  +  +  +  +  +  M  A  +  +  +  +  +  +  +  +  +  +  +  M  +  +  +|             
      Epithelial Cell, Ectopic Parathyroid |                                                                          |             
          Gland                            |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 INTEGUMENTARY SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Mammary Gland                           | +  M  +  +  +  +  +  +  +  A  +  +  +  A  M  +  +  +  +  +  +  +  +  +  +|             
      Galactocele                          |                                              X                           |             
                                            __________________________________________________________________________|             
   Skin                                    | +  +  +  +  +  +  +  +  +  A  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 MUSCULOSKELETAL SYSTEM                    |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Bone                                    | +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 NERVOUS SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Brain                                   | +  +  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Degeneration                         |             2                                                            |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  34                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 7| 3| 7| 7| 5| 5| 0| 7| 7| 4| 4| 3| 7| 7| 7| 5| 3| 7| 7| 4| 4| 3|             
                             DAY ON TEST   | 3| 3| 3| 3| 1| 3| 2| 6| 5| 8| 3| 0| 5| 4| 1| 3| 3| 3| 5| 9| 3| 3| 5| 4| 7|             
                                           | 1| 1| 1| 1| 1| 1| 9| 2| 0| 3| 1| 2| 0| 1| 1| 4| 4| 5| 2| 3| 4| 4| 1| 2| 1|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS FEMALE                 | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9|             
    33.3                                   | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 NERVOUS SYSTEM - cont                     |                                                                          |             
                                           |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 RESPIRATORY SYSTEM                        |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Lung                                    | +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                                                                          |             
      Infiltration Cellular, Histiocyte    |                                                                          |             
                                            __________________________________________________________________________|             
   Nose                                    | +  +  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Acute                  | 1           2                                1                 2         |             
                                            __________________________________________________________________________|             
   Trachea                                 | +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Eye                                     |                                                                         +|             
      Lens, Cataract                       |                                                                         2|             
                                            __________________________________________________________________________|             
   Zymbal's Gland                          |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 URINARY SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Kidney                                  | +  +  +  +  +  +  +  +  +  A  +  +  +  +  M  +  +  +  +  A  +  +  +  +  +|             
      Nephropathy                          | 1  2  2  2     2  1  1        2  1  1        1  2  3  1     2  2         |             
      Cortex, Mineralization               |                                     1                                    |             
                                            __________________________________________________________________________|             
   Urinary Bladder                         | +  +  +  +  +  +  +  +  A  A  +  A  +  A  M  +  +  +  +  A  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
                                                             Page  35                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 4| 2| 0| 7| 7| 6| 5| 4|                                            |            |
                             DAY ON TEST   | 3| 3| 9| 5| 2| 3| 3| 4| 8| 5|                                            |            |
                                           | 4| 4| 9| 9| 9| 2| 4| 0| 7| 0|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS FEMALE                 | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1|                                            |      T     |
                               ANIMAL ID   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      A     |
    33.3                                   | 0| 0| 0| 0| 0| 1| 1| 1| 1| 1|                                            |      L     |
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 ALIMENTARY SYSTEM                         |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Esophagus                               | +  +  +  +  +  +  +  +  +  +                                             |  58        |
                                            __________________________________________________________________________|____________|
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +                                             |  49        |
                                            __________________________________________________________________________|____________|
   Intestine Large, Rectum                 | +  +  +  A  +  +  +  +  +  +                                             |  46        |
                                            __________________________________________________________________________|____________|
   Intestine Large, Cecum                  | +  +  +  +  A  +  +  +  +  +                                             |  44        |
                                            __________________________________________________________________________|____________|
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +                                             |  47        |
                                            __________________________________________________________________________|____________|
   Intestine Small, Jejunum                | +  +  +  +  +  +  +  +  +  +                                             |  45        |
                                            __________________________________________________________________________|____________|
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  +  +                                             |  44        |
                                            __________________________________________________________________________|____________|
   Liver                                   | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Basophilic Focus                     |    X           X           X                                             |     20     |
      Clear Cell Focus                     |                      X                                                   |      1     |
      Fatty Change, Focal                  |                                                                          |      1  2.0|
      Hepatodiaphragmatic Nodule           |                                                                          |     10     |
      Inflammation, Granulomatous          |                                                                          |      1  1.0|
      Mixed Cell Focus                     | X                    X                                                   |      7     |
      Pigmentation                         |                   2                                                      |      1  2.0|
                                            __________________________________________________________________________|____________|
   Mesentery                               |                                                                          |   1        |
                                            __________________________________________________________________________|____________|
   Pancreas                                | +  +  +  +  +  +  +  +  +  +                                             |  56        |
      Acinus, Atrophy                      |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Duct, Metaplasia, Squamous           |                         1  1                                             |      2  1.0|
                                            __________________________________________________________________________|____________|
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +                                             |  57        |
      Hyperkeratosis                       |                      2                                                   |      1  2.0|
      Hyperplasia, Basal Cell              |                      2                                                   |      2  2.0|
      Ulcer                                |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +                                             |  51        |
      Hyperplasia                          |                                                                          |      1  1.0|
      Mineralization                       |       1                                                                  |      1  1.0|
 _____________________________________________________________________________________________________________________|            |
 CARDIOVASCULAR SYSTEM                     |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Heart                                   | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Cardiomyopathy                       | 2              2  1  2     2                                             |     27  1.9|
      Inflammation, Chronic Active         |                                                                          |      1  2.0|
 _____________________________________________________________________________________________________________________|            |
 ENDOCRINE SYSTEM                          |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +                                             |  58        |
      Hyperplasia                          |                                                                          |      2  2.5|
                                            __________________________________________________________________________|____________|
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +                                             |  58        |
      Hyperplasia                          |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +                                             |  55        |
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page  36                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 4| 2| 0| 7| 7| 6| 5| 4|                                            |            |
                             DAY ON TEST   | 3| 3| 9| 5| 2| 3| 3| 4| 8| 5|                                            |            |
                                           | 4| 4| 9| 9| 9| 2| 4| 0| 7| 0|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS FEMALE                 | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1|                                            |      T     |
                               ANIMAL ID   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      A     |
    33.3                                   | 0| 0| 0| 0| 0| 1| 1| 1| 1| 1|                                            |      L     |
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 ENDOCRINE SYSTEM - cont                   |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Parathyroid Gland                       | +  +  M  +  +  +  +  M  +  +                                             |  51        |
                                            __________________________________________________________________________|____________|
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +                                             |  58        |
      Craniopharyngeal Duct, Cyst          |                                                                          |      1     |
      Pars Distalis, Angiectasis           | 2                 2  3                                                   |     16  2.0|
      Pars Distalis, Hyperplasia           |    3              2                                                      |     17  2.1|
      Pars Intermedia, Hyperplasia         |                                                                          |      1  3.0|
                                            __________________________________________________________________________|____________|
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +                                             |  54        |
      C-Cell, Hyperplasia                  |                1                                                         |      7  1.1|
      Follicle, Cyst                       |                                                                          |      1     |
      Follicular Cell, Hyperplasia         |                                                                          |      1  2.0|
 _____________________________________________________________________________________________________________________|            |
 GENERAL BODY SYSTEM                       |                                                                          |            |
                                           |                                                                          |            |
    None                                   |                                                                          |            |
 _____________________________________________________________________________________________________________________|            |
 GENITAL SYSTEM                            |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Clitoral Gland                          | +  +  +  +  +  +  +  +  +  +                                             |  57        |
      Dilatation                           |                                                                          |      1  3.0|
      Inflammation, Acute                  |                                                                          |      1  3.0|
                                            __________________________________________________________________________|____________|
   Ovary                                   | +  +  +  +  +  +  +  +  +  +                                             |  58        |
                                            __________________________________________________________________________|____________|
   Uterus                                  | +  +  +  +  +  +  +  +  +  +                                             |  57        |
      Cyst                                 | X                                                                        |      1     |
      Hemorrhage                           |                                                                          |      1  4.0|
 _____________________________________________________________________________________________________________________|            |
 HEMATOPOIETIC SYSTEM                      |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Blood                                   |                                                                          |   5        |
                                            __________________________________________________________________________|____________|
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +                                             |  59        |
                                            __________________________________________________________________________|____________|
   Lymph Node                              |       +                                                                  |   5        |
      Mediastinal, Angiectasis             |                                                                          |      1  3.0|
      Mediastinal, Pigmentation            |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Lymph Node, Mandibular                  | +  +  +  +  +  +  +  +  +  +                                             |  59        |
                                            __________________________________________________________________________|____________|
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +                                             |  58        |
                                            __________________________________________________________________________|____________|
   Spleen                                  | +  +  +  +  +  +  +  +  +  +                                             |  56        |
      Hematopoietic Cell Proliferation     |                                                                          |      1  3.0|
      Infarct                              |       4                                                                  |      1  4.0|
                                            __________________________________________________________________________|____________|
   Thymus                                  | +  +  +  +  +  +  +  +  +  +                                             |  55        |
      Epithelial Cell, Ectopic Parathyroid |                                                                          |            |
          Gland                            |                                                                          |      1  3.0|
 _____________________________________________________________________________________________________________________|            |
 INTEGUMENTARY SYSTEM                      |                                                                          |            |
                                           |                                                                          |            |
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page  37                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 4| 2| 0| 7| 7| 6| 5| 4|                                            |            |
                             DAY ON TEST   | 3| 3| 9| 5| 2| 3| 3| 4| 8| 5|                                            |            |
                                           | 4| 4| 9| 9| 9| 2| 4| 0| 7| 0|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS FEMALE                 | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1|                                            |      T     |
                               ANIMAL ID   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      A     |
    33.3                                   | 0| 0| 0| 0| 0| 1| 1| 1| 1| 1|                                            |      L     |
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 INTEGUMENTARY SYSTEM - cont               |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Mammary Gland                           | +  +  +  +  +  +  +  +  M  +                                             |  52        |
      Galactocele                          |                      X                                                   |      5     |
                                            __________________________________________________________________________|____________|
   Skin                                    | +  +  +  +  +  +  +  +  +  +                                             |  58        |
 _____________________________________________________________________________________________________________________|            |
 MUSCULOSKELETAL SYSTEM                    |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Bone                                    | +  +  +  +  +  +  +  +  +  +                                             |  59        |
 _____________________________________________________________________________________________________________________|            |
 NERVOUS SYSTEM                            |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Brain                                   | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Degeneration                         |                                                                          |      1  2.0|
 _____________________________________________________________________________________________________________________|            |
 RESPIRATORY SYSTEM                        |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Lung                                    | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Hemorrhage                           |                   1                                                      |      1  1.0|
      Infiltration Cellular, Histiocyte    |                                                                          |      1  3.0|
                                            __________________________________________________________________________|____________|
   Nose                                    | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Inflammation, Acute                  |             1                                                            |      7  1.3|
                                            __________________________________________________________________________|____________|
   Trachea                                 | +  +  +  +  +  +  +  +  +  +                                             |  59        |
 _____________________________________________________________________________________________________________________|            |
 SPECIAL SENSES SYSTEM                     |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Eye                                     |             +                                                            |   3        |
      Lens, Cataract                       |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Zymbal's Gland                          |                         +                                                |   1        |
 _____________________________________________________________________________________________________________________|            |
 URINARY SYSTEM                            |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Kidney                                  | +  +  +  +  +  +  +  +  +  +                                             |  57        |
      Nephropathy                          | 1  2  1        1  2  3                                                   |     41  1.5|
      Cortex, Mineralization               |                            1                                             |      4  1.0|
                                            __________________________________________________________________________|____________|
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +                                             |  53        |
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page  38                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 6| 6| 4| 4| 7| 6| 6| 4| 4| 7| 7| 7| 6| 5| 7| 7| 7| 6| 1| 7| 7| 6| 5| 4|             
                             DAY ON TEST   | 3| 7| 0| 6| 6| 3| 8| 4| 6| 6| 3| 3| 3| 8| 8| 3| 3| 3| 8| 7| 3| 0| 9| 7| 6|             
                                           | 0| 1| 2| 3| 2| 0| 7| 1| 3| 2| 0| 0| 0| 4| 4| 0| 0| 0| 6| 0| 0| 3| 7| 0| 2|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
    VEHICLE                                | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5|             
    MALE                                   | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ALIMENTARY SYSTEM                         |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Acute                  |                                                          2               |             
                                            __________________________________________________________________________|             
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Rectum                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Cecum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Jejunum                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Ileum                  | +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Angiectasis                          |                                                                          |             
      Basophilic Focus                     |    X           1              X  X  X                             X      |             
      Clear Cell Focus                     | X        X     X              X                                          |             
      Degeneration, Cystic                 | 2                             1              2                           |             
      Eosinophilic Focus                   |                                                                          |             
      Fatty Change, Diffuse                |          1  1           1  1                                            1|             
      Hepatodiaphragmatic Nodule           |          X                          X                                    |             
      Hyperplasia                          |                                                                          |             
      Leukocytosis                         |                                                                          |             
      Mixed Cell Focus                     |                X                    X           X                        |             
      Necrosis, Focal                      |                                                                          |             
      Bile Duct, Hyperplasia               |    1     1  1  2  2  2  1     2  1  2  1        2  2  1     1  2     1  2|             
                                            __________________________________________________________________________|             
   Mesentery                               |       +                                                                  |             
      Fat, Mineralization                  |       2                                                                  |             
                                            __________________________________________________________________________|             
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Acinus, Hyperplasia                  |                                                       3                  |             
      Artery, Inflammation, Chronic Active |                                                                          |             
                                            __________________________________________________________________________|             
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperkeratosis                       |    2        2                                                            |             
      Hyperplasia, Basal Cell              |    1        2                                                            |             
      Necrosis                             |                                                                   3      |             
      Ulcer                                |    2                                                        3            |             
                                            __________________________________________________________________________|             
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                          |             
      Inflammation, Chronic Active         |                                                                          |             
      Mineralization                       |    2                                                                     |             
                                            __________________________________________________________________________|             
   Tongue                                  |                            +                                             |             
      Inflammation, Acute                  |                            3                                             |             
 _____________________________________________________________________________________________________________________|             
 CARDIOVASCULAR SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cardiomyopathy                       | 2  2  2  2  2  2  2  2  3     2  3  2  2  2  2  2  2  2     2  2  2  2   |             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM                          |                                                                          |             
                                           |                                                                          |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  39                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 6| 6| 4| 4| 7| 6| 6| 4| 4| 7| 7| 7| 6| 5| 7| 7| 7| 6| 1| 7| 7| 6| 5| 4|             
                             DAY ON TEST   | 3| 7| 0| 6| 6| 3| 8| 4| 6| 6| 3| 3| 3| 8| 8| 3| 3| 3| 8| 7| 3| 0| 9| 7| 6|             
                                           | 0| 1| 2| 3| 2| 0| 7| 1| 3| 2| 0| 0| 0| 4| 4| 0| 0| 0| 6| 0| 0| 3| 7| 0| 2|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
    VEHICLE                                | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5|             
    MALE                                   | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM - cont                   |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hypertrophy                          |                2                                                         |             
                                            __________________________________________________________________________|             
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          | 3  2                          1     2     1                 2            |             
      Bilateral, Hyperplasia               |                                  2                                2      |             
                                            __________________________________________________________________________|             
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                          |             
                                            __________________________________________________________________________|             
   Parathyroid Gland                       | +  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  M  +  +  +  +  +|             
      Hyperplasia                          |    3                                                                     |             
      Bilateral, Hyperplasia               |                                                                   2      |             
                                            __________________________________________________________________________|             
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Pars Distalis, Angiectasis           |             2                          3  2                    3  2      |             
      Pars Distalis, Cyst                  |       X                             X              X                     |             
      Pars Distalis, Hyperplasia           |       1        1  2     2     2     3     2        2  3     2           2|             
                                            __________________________________________________________________________|             
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +|             
      C-Cell, Hyperplasia                  | 2                             1                             1  2         |             
      Follicular Cell, Hyperplasia         |                2                                                         |             
 _____________________________________________________________________________________________________________________|             
 GENERAL BODY SYSTEM                       |                                                                          |             
                                           |                                                                          |             
    None                                   |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENITAL SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Epididymis                              | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Preputial Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Necrosis                             |                                                    3                     |             
                                            __________________________________________________________________________|             
   Prostate                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Chronic Active         |                2                                                         |             
                                            __________________________________________________________________________|             
   Seminal Vesicle                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Acute                  |                                                                          |             
                                            __________________________________________________________________________|             
   Testes                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Atrophy                              |                                                                          |             
      Interstitial Cell, Hyperplasia       |    2     2  2           2  2                                            2|             
      Seminiferous Tubule, Atrophy         |                               3           1     3                 2  3   |             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Blood                                   |       +           +              +                 +                     |             
                                            __________________________________________________________________________|             
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Lymph Node                              |       +                                            +           +         |             
      Mediastinal, Angiectasis             |                                                                          |             
      Pancreatic, Pigmentation             |                                                                          |             
                                            __________________________________________________________________________|             
   Lymph Node, Mandibular                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Degeneration                         |                                                                          |             
                                            __________________________________________________________________________|             
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
                                                             Page  40                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 6| 6| 4| 4| 7| 6| 6| 4| 4| 7| 7| 7| 6| 5| 7| 7| 7| 6| 1| 7| 7| 6| 5| 4|             
                             DAY ON TEST   | 3| 7| 0| 6| 6| 3| 8| 4| 6| 6| 3| 3| 3| 8| 8| 3| 3| 3| 8| 7| 3| 0| 9| 7| 6|             
                                           | 0| 1| 2| 3| 2| 0| 7| 1| 3| 2| 0| 0| 0| 4| 4| 0| 0| 0| 6| 0| 0| 3| 7| 0| 2|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
    VEHICLE                                | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5|             
    MALE                                   | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM - cont               |                                                                          |             
                                           |                                                                          |             
      Fibrosis                             |    2                                                                     |             
      Hematopoietic Cell Proliferation     |                                           2                              |             
      Infarct                              |                                                                4         |             
                                            __________________________________________________________________________|             
   Thymus                                  | +  +  +  +  +  M  +  +  +  +  +  +  +  M  M  +  +  +  M  +  +  +  M  +  +|             
      Cyst                                 |                                  X                                       |             
      Epithelial Cell, Hyperplasia         | 2                                2                                       |             
 _____________________________________________________________________________________________________________________|             
 INTEGUMENTARY SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Mammary Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Abscess                              |                                                    4                     |             
      Cyst Epithelial Inclusion            |                                                    X                     |             
      Hyperkeratosis                       |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 MUSCULOSKELETAL SYSTEM                    |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Skeletal Muscle                         |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 NERVOUS SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                1                                                         |             
      Mineralization                       |                1                                                         |             
      Thrombosis                           |                                                                          |             
                                            __________________________________________________________________________|             
   Peripheral Nerve                        |                                        +                                 |             
      Degeneration                         |                                        1                                 |             
      Inflammation, Chronic Active         |                                        1                                 |             
                                            __________________________________________________________________________|             
   Spinal Cord                             |                                        +                                 |             
 _____________________________________________________________________________________________________________________|             
 RESPIRATORY SYSTEM                        |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |       2                                                           1      |             
      Infiltration Cellular, Histiocyte    |    2                                               2                     |             
      Inflammation, Acute                  |    2                                                                     |             
      Alveolar Epithelium, Hyperplasia     |       2                 3                                                |             
      Bronchiole, Inflammation, Acute      |                                                                          |             
                                            __________________________________________________________________________|             
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fungus                               |                2                                                         |             
      Hyperkeratosis                       | 3                                                                        |             
      Inflammation, Acute                  | 3  1           1           2           2                                 |             
                                            __________________________________________________________________________|             
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Ear                                     |                                                                          |             
                                            __________________________________________________________________________|             
   Eye                                     |       +                                                                  |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  41                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 6| 6| 4| 4| 7| 6| 6| 4| 4| 7| 7| 7| 6| 5| 7| 7| 7| 6| 1| 7| 7| 6| 5| 4|             
                             DAY ON TEST   | 3| 7| 0| 6| 6| 3| 8| 4| 6| 6| 3| 3| 3| 8| 8| 3| 3| 3| 8| 7| 3| 0| 9| 7| 6|             
                                           | 0| 1| 2| 3| 2| 0| 7| 1| 3| 2| 0| 0| 0| 4| 4| 0| 0| 0| 6| 0| 0| 3| 7| 0| 2|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
    VEHICLE                                | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5|             
    MALE                                   | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM - cont              |                                                                          |             
                                           |                                                                          |             
      Atrophy                              |                                                                          |             
                                            __________________________________________________________________________|             
   Harderian Gland                         |             +                                                            |             
 _____________________________________________________________________________________________________________________|             
 URINARY SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |    X                                                                     |             
      Developmental Malformation           |                                                                          |             
      Mineralization                       |    1                                                                     |             
      Nephropathy                          | 3  4  2  2  2  2  3  3  2  2  3  3  3  3  2  3  3  3  2     3  3  4  3  2|             
      Pelvis, Transitional Epithelium,     |                                                                          |             
           Hyperplasia                     |                                                                          |             
      Pelvis, Transitional Epithelium,     |                                                                          |             
           Inflammation                    |                                                                          |             
                                            __________________________________________________________________________|             
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Calculus Gross Observation           |                                                                          |             
      Calculus Micro Observation Only      |                                                                          |             
      Hemorrhage                           |                      1                                                   |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  42                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 6| 6| 5| 7| 7| 6| 4| 4| 7| 7| 7| 7| 7| 7| 7| 7| 5| 4| 7| 6| 6| 4| 4|             
                             DAY ON TEST   | 3| 1| 8| 7| 9| 3| 3| 3| 6| 6| 3| 3| 3| 3| 3| 3| 3| 3| 1| 6| 3| 8| 7| 6| 6|             
                                           | 0| 6| 6| 3| 5| 0| 0| 2| 3| 2| 0| 0| 0| 0| 0| 0| 0| 0| 2| 2| 0| 6| 1| 3| 3|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1|             
    VEHICLE                                | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0|             
    MALE                                   | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ALIMENTARY SYSTEM                         |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Acute                  |                                                                          |             
                                            __________________________________________________________________________|             
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Rectum                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Cecum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Jejunum                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Angiectasis                          |                                                                          |             
      Basophilic Focus                     |    X              X     1     X  X     1  X  X              X     X  X   |             
      Clear Cell Focus                     |                            X                       X     X  X            |             
      Degeneration, Cystic                 |       2                             1                                    |             
      Eosinophilic Focus                   |                                  X                                       |             
      Fatty Change, Diffuse                |                            1  1                          1        1  1  1|             
      Hepatodiaphragmatic Nodule           | X  X           X  X              X                       X           X  X|             
      Hyperplasia                          |    3                                                                     |             
      Leukocytosis                         |                3                                                         |             
      Mixed Cell Focus                     |                                        X                                 |             
      Necrosis, Focal                      |                                                          1               |             
      Bile Duct, Hyperplasia               | 2  2  2     2  1  1  3  1     2  1     1  2     1  1  1     2  3     1  1|             
                                            __________________________________________________________________________|             
   Mesentery                               |          +                                                               |             
      Fat, Mineralization                  |                                                                          |             
                                            __________________________________________________________________________|             
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +     +  +  +  +  +|             
      Acinus, Hyperplasia                  |                                     3                                    |             
      Artery, Inflammation, Chronic Active | 2                                                                        |             
                                            __________________________________________________________________________|             
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperkeratosis                       |                                                                          |             
      Hyperplasia, Basal Cell              |                                                                          |             
      Necrosis                             |                                                                          |             
      Ulcer                                |          1                                                               |             
                                            __________________________________________________________________________|             
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                         1|             
      Inflammation, Chronic Active         |                1                                                         |             
      Mineralization                       |                                                                          |             
                                            __________________________________________________________________________|             
   Tongue                                  |                                                                          |             
      Inflammation, Acute                  |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 CARDIOVASCULAR SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cardiomyopathy                       | 2  2  2  2  2  2     2     2  2  2  2  2  2  3  2  2  2  2  2  2  2  2  2|             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM                          |                                                                          |             
                                           |                                                                          |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  43                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 6| 6| 5| 7| 7| 6| 4| 4| 7| 7| 7| 7| 7| 7| 7| 7| 5| 4| 7| 6| 6| 4| 4|             
                             DAY ON TEST   | 3| 1| 8| 7| 9| 3| 3| 3| 6| 6| 3| 3| 3| 3| 3| 3| 3| 3| 1| 6| 3| 8| 7| 6| 6|             
                                           | 0| 6| 6| 3| 5| 0| 0| 2| 3| 2| 0| 0| 0| 0| 0| 0| 0| 0| 2| 2| 0| 6| 1| 3| 3|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1|             
    VEHICLE                                | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0|             
    MALE                                   | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM - cont                   |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hypertrophy                          |    2                                                                     |             
                                            __________________________________________________________________________|             
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |       2        2                       1     1  2                        |             
      Bilateral, Hyperplasia               |                                                                          |             
                                            __________________________________________________________________________|             
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          | 2                                                                        |             
                                            __________________________________________________________________________|             
   Parathyroid Gland                       | +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  M  +  +  +  +  +|             
      Hyperplasia                          |                                                                          |             
      Bilateral, Hyperplasia               |                                                                          |             
                                            __________________________________________________________________________|             
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Pars Distalis, Angiectasis           | 2  3              1                                1              2      |             
      Pars Distalis, Cyst                  |                                                 X                        |             
      Pars Distalis, Hyperplasia           |                   2        1  2  3        2  2  2     2     2            |             
                                            __________________________________________________________________________|             
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      C-Cell, Hyperplasia                  |                      1                    1        1        1            |             
      Follicular Cell, Hyperplasia         |       2                                                                  |             
 _____________________________________________________________________________________________________________________|             
 GENERAL BODY SYSTEM                       |                                                                          |             
                                           |                                                                          |             
    None                                   |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENITAL SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Epididymis                              | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Preputial Gland                         | +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Necrosis                             |                                                                          |             
                                            __________________________________________________________________________|             
   Prostate                                | +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Chronic Active         |                                                                          |             
                                            __________________________________________________________________________|             
   Seminal Vesicle                         | +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Acute                  |                                                                          |             
                                            __________________________________________________________________________|             
   Testes                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Atrophy                              |                         3                                                |             
      Interstitial Cell, Hyperplasia       |             1           2  2                       2  2  2           2  2|             
      Seminiferous Tubule, Atrophy         | 3                 4           2                                          |             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Blood                                   |    +  +  +           +                                                   |             
                                            __________________________________________________________________________|             
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Lymph Node                              |    +  +  +           +        +                       +        +         |             
      Mediastinal, Angiectasis             |                                                                          |             
      Pancreatic, Pigmentation             |                               2                                          |             
                                            __________________________________________________________________________|             
   Lymph Node, Mandibular                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Lymph Node, Mesenteric                  | +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Degeneration                         |                                                 3                        |             
                                            __________________________________________________________________________|             
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
                                                             Page  44                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 6| 6| 5| 7| 7| 6| 4| 4| 7| 7| 7| 7| 7| 7| 7| 7| 5| 4| 7| 6| 6| 4| 4|             
                             DAY ON TEST   | 3| 1| 8| 7| 9| 3| 3| 3| 6| 6| 3| 3| 3| 3| 3| 3| 3| 3| 1| 6| 3| 8| 7| 6| 6|             
                                           | 0| 6| 6| 3| 5| 0| 0| 2| 3| 2| 0| 0| 0| 0| 0| 0| 0| 0| 2| 2| 0| 6| 1| 3| 3|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1|             
    VEHICLE                                | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0|             
    MALE                                   | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM - cont               |                                                                          |             
                                           |                                                                          |             
      Fibrosis                             |                                                                      3   |             
      Hematopoietic Cell Proliferation     |                                                                          |             
      Infarct                              |                                                                          |             
                                            __________________________________________________________________________|             
   Thymus                                  | +  +  +  +  +  +  +  M  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |                                                                          |             
      Epithelial Cell, Hyperplasia         |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 INTEGUMENTARY SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Mammary Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  M|             
                                            __________________________________________________________________________|             
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Abscess                              |                                                                          |             
      Cyst Epithelial Inclusion            |                                                                          |             
      Hyperkeratosis                       |                   3                                3                     |             
 _____________________________________________________________________________________________________________________|             
 MUSCULOSKELETAL SYSTEM                    |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Skeletal Muscle                         |          +                                                               |             
 _____________________________________________________________________________________________________________________|             
 NERVOUS SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                                                       3                  |             
      Mineralization                       |                                                                          |             
      Thrombosis                           |                                                 2                        |             
                                            __________________________________________________________________________|             
   Peripheral Nerve                        |                                                                          |             
      Degeneration                         |                                                                          |             
      Inflammation, Chronic Active         |                                                                          |             
                                            __________________________________________________________________________|             
   Spinal Cord                             |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 RESPIRATORY SYSTEM                        |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                                                                          |             
      Infiltration Cellular, Histiocyte    |                                                                          |             
      Inflammation, Acute                  |                                                                          |             
      Alveolar Epithelium, Hyperplasia     |    2                                                                     |             
      Bronchiole, Inflammation, Acute      |                                                                          |             
                                            __________________________________________________________________________|             
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fungus                               | 2                                               2              2         |             
      Hyperkeratosis                       |                                                                          |             
      Inflammation, Acute                  | 2  1                                      1     2              2         |             
                                            __________________________________________________________________________|             
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Ear                                     |                         +                                                |             
                                            __________________________________________________________________________|             
   Eye                                     | +                                                                        |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  45                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 6| 6| 5| 7| 7| 6| 4| 4| 7| 7| 7| 7| 7| 7| 7| 7| 5| 4| 7| 6| 6| 4| 4|             
                             DAY ON TEST   | 3| 1| 8| 7| 9| 3| 3| 3| 6| 6| 3| 3| 3| 3| 3| 3| 3| 3| 1| 6| 3| 8| 7| 6| 6|             
                                           | 0| 6| 6| 3| 5| 0| 0| 2| 3| 2| 0| 0| 0| 0| 0| 0| 0| 0| 2| 2| 0| 6| 1| 3| 3|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1|             
    VEHICLE                                | 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0|             
    MALE                                   | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM - cont              |                                                                          |             
                                           |                                                                          |             
      Atrophy                              | 4                                                                        |             
                                            __________________________________________________________________________|             
   Harderian Gland                         |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 URINARY SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |                                           X  X                           |             
      Developmental Malformation           |                                                                          |             
      Mineralization                       |                                                                          |             
      Nephropathy                          | 3  2  2  3  1  3  3  2  2  1  3  3  3  3  3  3  2  3  1  2  2  3  3  1  2|             
      Pelvis, Transitional Epithelium,     |                                                                          |             
           Hyperplasia                     |       2                                                                  |             
      Pelvis, Transitional Epithelium,     |                                                                          |             
           Inflammation                    |       3                                                                  |             
                                            __________________________________________________________________________|             
   Urinary Bladder                         | +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Calculus Gross Observation           |                                                                   X      |             
      Calculus Micro Observation Only      |                                                                   X      |             
      Hemorrhage                           |                                                                          |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  46                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 6| 6| 6| 5| 5| 7| 7| 6| 6| 6|                                            |            |
                             DAY ON TEST   | 9| 8| 1| 8| 6| 3| 3| 9| 6| 1|                                            |            |
                                           | 1| 6| 2| 2| 1| 0| 0| 7| 0| 0|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      T     |
                               ANIMAL ID   | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1|                                            |      A     |
    VEHICLE                                | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2|                                            |      L     |
    MALE                                   | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 ALIMENTARY SYSTEM                         |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Esophagus                               | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Inflammation, Acute                  |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +                                             |  59        |
                                            __________________________________________________________________________|____________|
   Intestine Large, Rectum                 | +  +  +  +  A  +  +  +  +  +                                             |  57        |
                                            __________________________________________________________________________|____________|
   Intestine Large, Cecum                  | +  +  +  +  A  +  +  +  +  +                                             |  57        |
                                            __________________________________________________________________________|____________|
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +                                             |  59        |
                                            __________________________________________________________________________|____________|
   Intestine Small, Jejunum                | +  +  +  +  A  +  +  +  +  +                                             |  57        |
                                            __________________________________________________________________________|____________|
   Intestine Small, Ileum                  | +  +  +  +  A  +  +  +  +  +                                             |  56        |
                                            __________________________________________________________________________|____________|
   Liver                                   | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Angiectasis                          |    3        1                                                            |      2  2.0|
      Basophilic Focus                     |    X           1  X                                                      |     20  1.0|
      Clear Cell Focus                     |                                                                          |      8     |
      Degeneration, Cystic                 |                                                                          |      5  1.6|
      Eosinophilic Focus                   |                   X                                                      |      2     |
      Fatty Change, Diffuse                |                   1  1                                                   |     13  1.0|
      Hepatodiaphragmatic Nodule           |          X                                                               |     11     |
      Hyperplasia                          |                                                                          |      1  3.0|
      Leukocytosis                         |                                                                          |      1  3.0|
      Mixed Cell Focus                     |                                                                          |      4     |
      Necrosis, Focal                      |                                                                          |      1  1.0|
      Bile Duct, Hyperplasia               | 2  2  3  2  2  1     2  1  2                                             |     46  1.6|
                                            __________________________________________________________________________|____________|
   Mesentery                               |                                                                          |   2        |
      Fat, Mineralization                  |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Pancreas                                | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Acinus, Hyperplasia                  |                                                                          |      2  3.0|
      Artery, Inflammation, Chronic Active |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +                                             |  60        |
                                            __________________________________________________________________________|____________|
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Hyperkeratosis                       |                                                                          |      2  2.0|
      Hyperplasia, Basal Cell              |                   1  2  1                                                |      5  1.4|
      Necrosis                             |                   3  3                                                   |      3  3.0|
      Ulcer                                |                         2                                                |      4  2.0|
                                            __________________________________________________________________________|____________|
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Hyperplasia                          |                                                                          |      1  1.0|
      Inflammation, Chronic Active         |                                                                          |      1  1.0|
      Mineralization                       |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Tongue                                  |                                                                          |   1        |
      Inflammation, Acute                  |                                                                          |      1  3.0|
 _____________________________________________________________________________________________________________________|            |
 CARDIOVASCULAR SYSTEM                     |                                                                          |            |
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page  47                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 6| 6| 6| 5| 5| 7| 7| 6| 6| 6|                                            |            |
                             DAY ON TEST   | 9| 8| 1| 8| 6| 3| 3| 9| 6| 1|                                            |            |
                                           | 1| 6| 2| 2| 1| 0| 0| 7| 0| 0|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      T     |
                               ANIMAL ID   | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1|                                            |      A     |
    VEHICLE                                | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2|                                            |      L     |
    MALE                                   | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 CARDIOVASCULAR SYSTEM - cont              |                                                                          |            |
                                           |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Heart                                   | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Cardiomyopathy                       | 3  2  2  2  2  3     2  2                                                |     53  2.1|
 _____________________________________________________________________________________________________________________|            |
 ENDOCRINE SYSTEM                          |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Hypertrophy                          |                                                                          |      2  2.0|
                                            __________________________________________________________________________|____________|
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Hyperplasia                          |                   1     2                                                |     13  1.7|
      Bilateral, Hyperplasia               |                                                                          |      2  2.0|
                                            __________________________________________________________________________|____________|
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Hyperplasia                          |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Parathyroid Gland                       | +  +  +  +  +  +  +  +  +  +                                             |  56        |
      Hyperplasia                          |                                                                          |      1  3.0|
      Bilateral, Hyperplasia               |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Pars Distalis, Angiectasis           |    2                    2                                                |     12  2.1|
      Pars Distalis, Cyst                  |                                                                          |      4     |
      Pars Distalis, Hyperplasia           | 2              2                                                         |     22  2.0|
                                            __________________________________________________________________________|____________|
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      C-Cell, Hyperplasia                  |                   2                                                      |      9  1.3|
      Follicular Cell, Hyperplasia         |       2                                                                  |      3  2.0|
 _____________________________________________________________________________________________________________________|            |
 GENERAL BODY SYSTEM                       |                                                                          |            |
                                           |                                                                          |            |
    None                                   |                                                                          |            |
 _____________________________________________________________________________________________________________________|            |
 GENITAL SYSTEM                            |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Epididymis                              | +  +  +  +  +  +  +  +  +  +                                             |  60        |
                                            __________________________________________________________________________|____________|
   Preputial Gland                         | +  +  +  +  +  +  +  +  +  M                                             |  58        |
      Necrosis                             |                                                                          |      1  3.0|
                                            __________________________________________________________________________|____________|
   Prostate                                | +  +  +  +  +  M  +  +  +  +                                             |  58        |
      Inflammation, Chronic Active         |                   4                                                      |      2  3.0|
                                            __________________________________________________________________________|____________|
   Seminal Vesicle                         | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Inflammation, Acute                  |                   4                                                      |      1  4.0|
                                            __________________________________________________________________________|____________|
   Testes                                  | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Atrophy                              |                                                                          |      1  3.0|
      Interstitial Cell, Hyperplasia       |                                                                          |     14  1.9|
      Seminiferous Tubule, Atrophy         | 3  3  4              3     2                                             |     13  2.8|
 _____________________________________________________________________________________________________________________|            |
 HEMATOPOIETIC SYSTEM                      |                                                                          |            |
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page  48                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 6| 6| 6| 5| 5| 7| 7| 6| 6| 6|                                            |            |
                             DAY ON TEST   | 9| 8| 1| 8| 6| 3| 3| 9| 6| 1|                                            |            |
                                           | 1| 6| 2| 2| 1| 0| 0| 7| 0| 0|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      T     |
                               ANIMAL ID   | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1|                                            |      A     |
    VEHICLE                                | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2|                                            |      L     |
    MALE                                   | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 HEMATOPOIETIC SYSTEM - cont               |                                                                          |            |
                                           |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Blood                                   |       +  +                 +                                             |  11        |
                                            __________________________________________________________________________|____________|
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +                                             |  60        |
                                            __________________________________________________________________________|____________|
   Lymph Node                              | +     +  +              +  +                                             |  15        |
      Mediastinal, Angiectasis             |                         3                                                |      1  3.0|
      Pancreatic, Pigmentation             |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Lymph Node, Mandibular                  | +  +  +  +  +  +  +  +  +  +                                             |  60        |
                                            __________________________________________________________________________|____________|
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Degeneration                         |                                                                          |      1  3.0|
                                            __________________________________________________________________________|____________|
   Spleen                                  | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Fibrosis                             |       2                                                                  |      3  2.3|
      Hematopoietic Cell Proliferation     |                   3                                                      |      2  2.5|
      Infarct                              |                                                                          |      1  4.0|
                                            __________________________________________________________________________|____________|
   Thymus                                  | +  M  +  +  +  +  M  +  +  +                                             |  51        |
      Cyst                                 |                                                                          |      1     |
      Epithelial Cell, Hyperplasia         |       1                                                                  |      3  1.7|
 _____________________________________________________________________________________________________________________|            |
 INTEGUMENTARY SYSTEM                      |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Mammary Gland                           | +  +  +  M  +  +  +  +  +  +                                             |  58        |
                                            __________________________________________________________________________|____________|
   Skin                                    | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Abscess                              |                                                                          |      1  4.0|
      Cyst Epithelial Inclusion            |                                                                          |      1     |
      Hyperkeratosis                       |                                                                          |      2  3.0|
 _____________________________________________________________________________________________________________________|            |
 MUSCULOSKELETAL SYSTEM                    |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Bone                                    | +  +  +  +  +  +  +  +  +  +                                             |  60        |
                                            __________________________________________________________________________|____________|
   Skeletal Muscle                         |                                                                          |   1        |
 _____________________________________________________________________________________________________________________|            |
 NERVOUS SYSTEM                            |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Brain                                   | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Hemorrhage                           |                                                                          |      2  2.0|
      Mineralization                       |                                                                          |      1  1.0|
      Thrombosis                           |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Peripheral Nerve                        |                                                                          |   1        |
      Degeneration                         |                                                                          |      1  1.0|
      Inflammation, Chronic Active         |                                                                          |      1  1.0|
                                            __________________________________________________________________________|____________|
   Spinal Cord                             |                                                                          |   1        |
 _____________________________________________________________________________________________________________________|            |
 RESPIRATORY SYSTEM                        |                                                                          |            |
                                           |                                                                          |            |
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page  49                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 6| 6| 6| 5| 5| 7| 7| 6| 6| 6|                                            |            |
                             DAY ON TEST   | 9| 8| 1| 8| 6| 3| 3| 9| 6| 1|                                            |            |
                                           | 1| 6| 2| 2| 1| 0| 0| 7| 0| 0|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      T     |
                               ANIMAL ID   | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1|                                            |      A     |
    VEHICLE                                | 1| 1| 1| 1| 1| 2| 2| 2| 2| 2|                                            |      L     |
    MALE                                   | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 RESPIRATORY SYSTEM - cont                 |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Lung                                    | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Hemorrhage                           |                   1                                                      |      3  1.3|
      Infiltration Cellular, Histiocyte    |                                                                          |      2  2.0|
      Inflammation, Acute                  |                                                                          |      1  2.0|
      Alveolar Epithelium, Hyperplasia     |                                                                          |      3  2.3|
      Bronchiole, Inflammation, Acute      |                   1                                                      |      1  1.0|
                                            __________________________________________________________________________|____________|
   Nose                                    | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Fungus                               | 2        2        1                                                      |      7  1.9|
      Hyperkeratosis                       |                                                                          |      1  3.0|
      Inflammation, Acute                  | 2        1        3                                                      |     13  1.8|
                                            __________________________________________________________________________|____________|
   Trachea                                 | +  +  +  +  +  +  +  +  +  +                                             |  60        |
 _____________________________________________________________________________________________________________________|            |
 SPECIAL SENSES SYSTEM                     |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Ear                                     |                                                                          |   1        |
                                            __________________________________________________________________________|____________|
   Eye                                     |                                                                          |   2        |
      Atrophy                              |                                                                          |      1  4.0|
                                            __________________________________________________________________________|____________|
   Harderian Gland                         |                                                                          |   1        |
 _____________________________________________________________________________________________________________________|            |
 URINARY SYSTEM                            |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Kidney                                  | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Cyst                                 |                                                                          |      3     |
      Developmental Malformation           |          X                                                               |      1     |
      Mineralization                       |                         1                                                |      2  1.0|
      Nephropathy                          | 3  2  3  2  2  3  4  4  4  2                                             |     59  2.6|
      Pelvis, Transitional Epithelium,     |                                                                          |            |
           Hyperplasia                     |                                                                          |      1  2.0|
      Pelvis, Transitional Epithelium,     |                                                                          |            |
           Inflammation                    |                                                                          |      1  3.0|
                                            __________________________________________________________________________|____________|
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Calculus Gross Observation           |                                                                          |      1     |
      Calculus Micro Observation Only      |                                                                          |      1     |
      Hemorrhage                           |                                                                          |      1  1.0|
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page  50                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 6| 6| 4| 7| 7| 5| 4| 4| 7| 6| 5| 5| 4| 7| 7| 7| 5| 5| 7| 6| 5| 4| 1|             
                             DAY ON TEST   | 3| 3| 5| 4| 6| 3| 3| 8| 6| 6| 3| 8| 5| 2| 6| 3| 3| 1| 7| 6| 3| 5| 2| 6| 9|             
                                           | 0| 0| 5| 7| 3| 0| 0| 9| 3| 2| 0| 1| 5| 5| 3| 0| 0| 6| 8| 8| 0| 8| 9| 2| 2|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1|             
    8.3                                    | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ALIMENTARY SYSTEM                         |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                                                                          |             
      Inflammation, Acute                  |                                                                         3|             
                                            __________________________________________________________________________|             
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Artery, Inflammation, Chronic Active |                   2                                                      |             
                                            __________________________________________________________________________|             
   Intestine Large, Rectum                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Cecum                  | +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  A|             
                                            __________________________________________________________________________|             
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Jejunum                | +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Necrosis                             |                                                                2         |             
                                            __________________________________________________________________________|             
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Angiectasis                          | 2     2           2                                         1            |             
      Basophilic Focus                     | X  X     1        X  X        X  1     X     1  1  X  1     1  X     X   |             
      Clear Cell Focus                     | 1              X                             X  1                        |             
      Degeneration, Cystic                 |                   2           1                                          |             
      Eosinophilic Focus                   |                      2                          1           1            |             
      Fatty Change, Diffuse                |             2           1  1              1     1           1        1   |             
      Fibrosis                             |                                                                          |             
      Hepatodiaphragmatic Nodule           |                                                                          |             
      Infarct                              |                                        2                                 |             
      Mixed Cell Focus                     |                                                                          |             
      Necrosis, Focal                      |                                           1                              |             
      Thrombosis                           |                   1                    2                                 |             
      Artery, Necrosis                     |                   2                                                      |             
      Bile Duct, Hyperplasia               | 1  3  3  3  1     2  3  1  2     3     3  2        1     2     3     2   |             
                                            __________________________________________________________________________|             
   Mesentery                               |                   +              +                                   +   |             
      Artery, Inflammation, Chronic Active |                                                                          |             
      Fat, Hemorrhage                      |                   4                                                      |             
      Fat, Necrosis                        |                                                                          |             
      Fat, Pigmentation                    |                                  3                                       |             
                                            __________________________________________________________________________|             
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Acinus, Hyperplasia                  |                                                 2                        |             
      Artery, Fibrosis                     |                3                                                         |             
      Artery, Inflammation, Chronic Active |                2  2                                                      |             
                                            __________________________________________________________________________|             
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Duct, Metaplasia, Squamous           | 1           1                                                            |             
                                            __________________________________________________________________________|             
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperkeratosis                       |                                                    2                     |             
      Hyperplasia, Basal Cell              |                                                    2                     |             
      Hyperplasia, Squamous                |                                                                          |             
      Mineralization                       |                               2                                          |             
      Necrosis                             |                                                    3                     |             
                                            __________________________________________________________________________|             
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
                                                             Page  51                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 6| 6| 4| 7| 7| 5| 4| 4| 7| 6| 5| 5| 4| 7| 7| 7| 5| 5| 7| 6| 5| 4| 1|             
                             DAY ON TEST   | 3| 3| 5| 4| 6| 3| 3| 8| 6| 6| 3| 8| 5| 2| 6| 3| 3| 1| 7| 6| 3| 5| 2| 6| 9|             
                                           | 0| 0| 5| 7| 3| 0| 0| 9| 3| 2| 0| 1| 5| 5| 3| 0| 0| 6| 8| 8| 0| 8| 9| 2| 2|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1|             
    8.3                                    | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ALIMENTARY SYSTEM - cont                  |                                                                          |             
                                           |                                                                          |             
      Erosion                              |                                                                2         |             
      Mineralization                       |                   2           2                    1        2  2         |             
                                            __________________________________________________________________________|             
   Tongue                                  |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 CARDIOVASCULAR SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cardiomyopathy                       |                2  2     2     2     2  2  2  2     2  2     2     2      |             
      Inflammation, Acute                  |                                                                          |             
      Mineralization                       |                               3                             1            |             
      Thrombosis                           |                               3                                          |             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM                          |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                          |             
                                            __________________________________________________________________________|             
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |       1              2           2              2           1            |             
                                            __________________________________________________________________________|             
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Parathyroid Gland                       | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  M|             
      Hyperplasia                          |                   2           3                       1                  |             
                                            __________________________________________________________________________|             
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Pars Distalis, Angiectasis           |       2              2        2                                          |             
      Pars Distalis, Cyst                  |                                                             X            |             
      Pars Distalis, Hyperplasia           | 2              2  2        2  2                                      3   |             
                                            __________________________________________________________________________|             
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  A|             
      C-Cell, Hyperplasia                  |          1                                                               |             
      Follicle, Cyst                       |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENERAL BODY SYSTEM                       |                                                                          |             
                                           |                                                                          |             
    None                                   |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENITAL SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Epididymis                              | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Preputial Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                          |             
      Necrosis                             |                                                                   2      |             
                                            __________________________________________________________________________|             
   Prostate                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Chronic Active         |                                                                          |             
                                            __________________________________________________________________________|             
   Seminal Vesicle                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Acute                  |                                                                          |             
                                            __________________________________________________________________________|             
   Testes                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Interstitial Cell, Hyperplasia       |    2  1     2           2  2        2  2  1              1        2  2   |             
      Seminiferous Tubule, Atrophy         |    3                                                        3            |             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM                      |                                                                          |             
                                           |                                                                          |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  52                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 6| 6| 4| 7| 7| 5| 4| 4| 7| 6| 5| 5| 4| 7| 7| 7| 5| 5| 7| 6| 5| 4| 1|             
                             DAY ON TEST   | 3| 3| 5| 4| 6| 3| 3| 8| 6| 6| 3| 8| 5| 2| 6| 3| 3| 1| 7| 6| 3| 5| 2| 6| 9|             
                                           | 0| 0| 5| 7| 3| 0| 0| 9| 3| 2| 0| 1| 5| 5| 3| 0| 0| 6| 8| 8| 0| 8| 9| 2| 2|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1|             
    8.3                                    | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM - cont               |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Blood                                   |    +  +              +  +        +  +                    +               |             
                                            __________________________________________________________________________|             
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Lymph Node                              |    +  +  +           +              +                    +     +         |             
      Renal, Angiectasis                   |                                                                          |             
                                            __________________________________________________________________________|             
   Lymph Node, Mandibular                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Infiltration Cellular, Histiocyte    |                                                                          |             
                                            __________________________________________________________________________|             
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fibrosis                             |    2                 2                                   2     1         |             
      Hematopoietic Cell Proliferation     |                                                                          |             
      Infarct                              |                                        3                                 |             
                                            __________________________________________________________________________|             
   Thymus                                  | +  +  +  +  +  +  +  +  +  M  +  +  +  +  +  M  +  +  +  +  +  M  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 INTEGUMENTARY SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Mammary Gland                           | +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst Epithelial Inclusion            |                   X                                                      |             
      Necrosis                             |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 MUSCULOSKELETAL SYSTEM                    |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Skeletal Muscle                         |                                     +                    +     +         |             
      Necrosis                             |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 NERVOUS SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 RESPIRATORY SYSTEM                        |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Edema                                |                                                                2         |             
      Fibrosis                             |                               1                                          |             
      Hemorrhage                           |                   2                          X              1     2      |             
      Infiltration Cellular, Histiocyte    |                                        3                          2      |             
      Inflammation, Acute                  |                                                             1            |             
      Alveolar Epithelium, Hyperplasia     |                                                                          |             
      Artery, Inflammation, Chronic Active |                                                                          |             
                                            __________________________________________________________________________|             
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fungus                               |                                           2                    3         |             
      Hyperkeratosis                       |                                                                          |             
      Inflammation, Acute                  |                                           2                    2        2|             
                                            __________________________________________________________________________|             
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Ear                                     |                                                                          |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  53                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 6| 6| 4| 7| 7| 5| 4| 4| 7| 6| 5| 5| 4| 7| 7| 7| 5| 5| 7| 6| 5| 4| 1|             
                             DAY ON TEST   | 3| 3| 5| 4| 6| 3| 3| 8| 6| 6| 3| 8| 5| 2| 6| 3| 3| 1| 7| 6| 3| 5| 2| 6| 9|             
                                           | 0| 0| 5| 7| 3| 0| 0| 9| 3| 2| 0| 1| 5| 5| 3| 0| 0| 6| 8| 8| 0| 8| 9| 2| 2|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1|             
    8.3                                    | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM - cont              |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Eye                                     |                                                                          |             
      Lens, Cataract                       |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 URINARY SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 | X                 X                          X                           |             
      Hemorrhage                           |                                              2                           |             
      Mineralization                       |                                                             1            |             
      Nephropathy                          | 3  2  2  4  2  3  4  2  3  2  4  3  1  1  1  3  3  3  4  1  4  3  1  1   |             
      Renal Tubule, Hyperplasia            |                                                       2                  |             
                                            __________________________________________________________________________|             
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  A|             
 _____________________________________________________________________________________________________________________|             
                                                             Page  54                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 4| 7| 7| 6| 5| 5| 4| 7| 6| 4| 4| 4| 7| 6| 6| 5| 2| 7| 6| 6| 5| 5|             
                             DAY ON TEST   | 3| 3| 0| 9| 3| 2| 9| 8| 0| 6| 0| 4| 9| 6| 6| 2| 5| 2| 6| 5| 3| 5| 1| 6| 2|             
                                           | 0| 0| 4| 1| 0| 4| 6| 9| 1| 3| 0| 1| 7| 3| 3| 9| 4| 3| 8| 9| 0| 6| 2| 3| 5|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2|             
    8.3                                    | 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ALIMENTARY SYSTEM                         |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                                                                          |             
      Inflammation, Acute                  |                                                                          |             
                                            __________________________________________________________________________|             
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  A  +  +  +  +  +  +  +  +  +|             
      Artery, Inflammation, Chronic Active |                               2                                          |             
                                            __________________________________________________________________________|             
   Intestine Large, Rectum                 | +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  A  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Cecum                  | +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  A  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  A  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Jejunum                | +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  A  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  A  +  +  +  +  +  +  +  +  +|             
      Necrosis                             |                                                                          |             
                                            __________________________________________________________________________|             
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Angiectasis                          | 1  2                                         2                           |             
      Basophilic Focus                     | X  X  X        X              X  X                 1        X     X  1   |             
      Clear Cell Focus                     |          X  X                          X                                 |             
      Degeneration, Cystic                 |                1                                            1            |             
      Eosinophilic Focus                   |                               X                                          |             
      Fatty Change, Diffuse                |                            1  1     2  1  1                              |             
      Fibrosis                             |                               2                                          |             
      Hepatodiaphragmatic Nodule           |                                                          X               |             
      Infarct                              |                                                    4                     |             
      Mixed Cell Focus                     |             X                 X                                          |             
      Necrosis, Focal                      |                                                                          |             
      Thrombosis                           |                                                                          |             
      Artery, Necrosis                     |                                                                          |             
      Bile Duct, Hyperplasia               | 2  2  2  2  2  3     2           3     1  2  3  2     3     1  3  3     2|             
                                            __________________________________________________________________________|             
   Mesentery                               |    +           +              +                                   +      |             
      Artery, Inflammation, Chronic Active |                2                                                         |             
      Fat, Hemorrhage                      |                3              4                                          |             
      Fat, Necrosis                        |    2                                                              2      |             
      Fat, Pigmentation                    |                                                                          |             
                                            __________________________________________________________________________|             
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Acinus, Hyperplasia                  |                                                                          |             
      Artery, Fibrosis                     |                                                                          |             
      Artery, Inflammation, Chronic Active |                                                                          |             
                                            __________________________________________________________________________|             
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Duct, Metaplasia, Squamous           |                                                                          |             
                                            __________________________________________________________________________|             
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperkeratosis                       | 3           2                                                            |             
      Hyperplasia, Basal Cell              | 1           3                                               1            |             
      Hyperplasia, Squamous                | 3                                                                        |             
      Mineralization                       |                                                                          |             
      Necrosis                             |             2                       2        3                           |             
                                            __________________________________________________________________________|             
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
                                                             Page  55                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 4| 7| 7| 6| 5| 5| 4| 7| 6| 4| 4| 4| 7| 6| 6| 5| 2| 7| 6| 6| 5| 5|             
                             DAY ON TEST   | 3| 3| 0| 9| 3| 2| 9| 8| 0| 6| 0| 4| 9| 6| 6| 2| 5| 2| 6| 5| 3| 5| 1| 6| 2|             
                                           | 0| 0| 4| 1| 0| 4| 6| 9| 1| 3| 0| 1| 7| 3| 3| 9| 4| 3| 8| 9| 0| 6| 2| 3| 5|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2|             
    8.3                                    | 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ALIMENTARY SYSTEM - cont                  |                                                                          |             
                                           |                                                                          |             
      Erosion                              |                                                                          |             
      Mineralization                       |    2              2                                         2            |             
                                            __________________________________________________________________________|             
   Tongue                                  |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 CARDIOVASCULAR SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cardiomyopathy                       | 2  2  2  2  3  2  2  2  2  2  2        1  2  2  2  3           2  2  2  2|             
      Inflammation, Acute                  |                                                                          |             
      Mineralization                       |    2           1                                                         |             
      Thrombosis                           |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM                          |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |             3                                                            |             
                                            __________________________________________________________________________|             
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          | 2  1  2              1                          2  2           1         |             
                                            __________________________________________________________________________|             
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Parathyroid Gland                       | +  +  +  +  +  +  +  +  +  +  +  +  +  +  M  +  +  +  M  +  +  +  +  +  +|             
      Hyperplasia                          |    2              3                                         3            |             
                                            __________________________________________________________________________|             
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Pars Distalis, Angiectasis           |             3                       2              3  2                  |             
      Pars Distalis, Cyst                  |       X                                                                  |             
      Pars Distalis, Hyperplasia           | 3        2                                   2  2  2                     |             
                                            __________________________________________________________________________|             
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      C-Cell, Hyperplasia                  |                      1                                                   |             
      Follicle, Cyst                       |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENERAL BODY SYSTEM                       |                                                                          |             
                                           |                                                                          |             
    None                                   |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENITAL SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Epididymis                              | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Preputial Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                          |             
      Necrosis                             |                                                                          |             
                                            __________________________________________________________________________|             
   Prostate                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Chronic Active         |                                                             3            |             
                                            __________________________________________________________________________|             
   Seminal Vesicle                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Acute                  |                                                             1            |             
                                            __________________________________________________________________________|             
   Testes                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Interstitial Cell, Hyperplasia       | 2                          2           2  2           2                 2|             
      Seminiferous Tubule, Atrophy         |             3                    3                          3            |             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM                      |                                                                          |             
                                           |                                                                          |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  56                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 4| 7| 7| 6| 5| 5| 4| 7| 6| 4| 4| 4| 7| 6| 6| 5| 2| 7| 6| 6| 5| 5|             
                             DAY ON TEST   | 3| 3| 0| 9| 3| 2| 9| 8| 0| 6| 0| 4| 9| 6| 6| 2| 5| 2| 6| 5| 3| 5| 1| 6| 2|             
                                           | 0| 0| 4| 1| 0| 4| 6| 9| 1| 3| 0| 1| 7| 3| 3| 9| 4| 3| 8| 9| 0| 6| 2| 3| 5|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2|             
    8.3                                    | 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM - cont               |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Blood                                   | +           +                    +                             +         |             
                                            __________________________________________________________________________|             
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Lymph Node                              |    +        +        +  +        +           +                 +  +     +|             
      Renal, Angiectasis                   |    2                                                                     |             
                                            __________________________________________________________________________|             
   Lymph Node, Mandibular                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Infiltration Cellular, Histiocyte    |                                                                          |             
                                            __________________________________________________________________________|             
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fibrosis                             |             2                                                            |             
      Hematopoietic Cell Proliferation     |                                                    3                     |             
      Infarct                              |                                                                          |             
                                            __________________________________________________________________________|             
   Thymus                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 INTEGUMENTARY SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Mammary Gland                           | +  +  +  M  +  +  +  +  +  +  +  +  M  M  M  +  +  +  +  +  +  M  +  +  +|             
                                            __________________________________________________________________________|             
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst Epithelial Inclusion            |                                                                          |             
      Necrosis                             |                3                                                         |             
 _____________________________________________________________________________________________________________________|             
 MUSCULOSKELETAL SYSTEM                    |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Skeletal Muscle                         |          +                                         +           +         |             
      Necrosis                             |                                                    4                     |             
 _____________________________________________________________________________________________________________________|             
 NERVOUS SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 RESPIRATORY SYSTEM                        |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Edema                                |    2                                         1                           |             
      Fibrosis                             |                                                                          |             
      Hemorrhage                           |    2              1     2                    1        1        2        1|             
      Infiltration Cellular, Histiocyte    |                                              2        1                  |             
      Inflammation, Acute                  |          3                                                               |             
      Alveolar Epithelium, Hyperplasia     |                                                                          |             
      Artery, Inflammation, Chronic Active |                               1                                          |             
                                            __________________________________________________________________________|             
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fungus                               |    2     2           2                                                   |             
      Hyperkeratosis                       |          2                                                               |             
      Inflammation, Acute                  |    2     1     1     2  1     2           2                              |             
                                            __________________________________________________________________________|             
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Ear                                     |                                                                          |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  57                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 4| 7| 7| 6| 5| 5| 4| 7| 6| 4| 4| 4| 7| 6| 6| 5| 2| 7| 6| 6| 5| 5|             
                             DAY ON TEST   | 3| 3| 0| 9| 3| 2| 9| 8| 0| 6| 0| 4| 9| 6| 6| 2| 5| 2| 6| 5| 3| 5| 1| 6| 2|             
                                           | 0| 0| 4| 1| 0| 4| 6| 9| 1| 3| 0| 1| 7| 3| 3| 9| 4| 3| 8| 9| 0| 6| 2| 3| 5|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2|             
    8.3                                    | 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM - cont              |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Eye                                     |    +                          +                                          |             
      Lens, Cataract                       |    2                                                                     |             
 _____________________________________________________________________________________________________________________|             
 URINARY SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |                                                                          |             
      Hemorrhage                           |                                                                          |             
      Mineralization                       |    2           2  1                                                      |             
      Nephropathy                          | 3  4  3  1  3  2  4  2  1  2  4  3  2  1  2  3  2  2  2     4  2  1     1|             
      Renal Tubule, Hyperplasia            | 4                             4                                          |             
                                            __________________________________________________________________________|             
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
                                                             Page  58                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 6| 6| 7| 5| 4| 4| 1|                                            |            |
                             DAY ON TEST   | 3| 3| 2| 7| 7| 3| 7| 6| 6| 8|                                            |            |
                                           | 0| 0| 5| 5| 5| 0| 0| 2| 2| 4|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      T     |
                               ANIMAL ID   | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2|                                            |      A     |
    8.3                                    | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4|                                            |      L     |
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 ALIMENTARY SYSTEM                         |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Esophagus                               | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Hemorrhage                           |                            2                                             |      1  2.0|
      Inflammation, Acute                  |                                                                          |      1  3.0|
                                            __________________________________________________________________________|____________|
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +                                             |  57        |
      Artery, Inflammation, Chronic Active |                                                                          |      2  2.0|
                                            __________________________________________________________________________|____________|
   Intestine Large, Rectum                 | +  +  +  +  +  +  +  +  +  +                                             |  58        |
                                            __________________________________________________________________________|____________|
   Intestine Large, Cecum                  | +  +  +  +  +  +  +  +  +  +                                             |  56        |
                                            __________________________________________________________________________|____________|
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +                                             |  58        |
                                            __________________________________________________________________________|____________|
   Intestine Small, Jejunum                | +  +  A  +  +  +  +  +  +  +                                             |  56        |
                                            __________________________________________________________________________|____________|
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  +  +                                             |  57        |
      Necrosis                             |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Liver                                   | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Angiectasis                          |                                                                          |      7  1.7|
      Basophilic Focus                     | X  1  1  1  1        X  X                                                |     32  1.0|
      Clear Cell Focus                     |                                                                          |      7  1.0|
      Degeneration, Cystic                 |                                                                          |      4  1.3|
      Eosinophilic Focus                   |                   4                                                      |      5  2.0|
      Fatty Change, Diffuse                |                1     1  1                                                |     15  1.1|
      Fibrosis                             |                                                                          |      1  2.0|
      Hepatodiaphragmatic Nodule           |                                                                          |      1     |
      Infarct                              |                                                                          |      2  3.0|
      Mixed Cell Focus                     |                X                                                         |      3     |
      Necrosis, Focal                      |                                                                          |      1  1.0|
      Thrombosis                           |                                                                          |      2  1.5|
      Artery, Necrosis                     |                                                                          |      1  2.0|
      Bile Duct, Hyperplasia               | 2  2           2  3  2  2                                                |     39  2.2|
                                            __________________________________________________________________________|____________|
   Mesentery                               |                                                                          |   7        |
      Artery, Inflammation, Chronic Active |                                                                          |      1  2.0|
      Fat, Hemorrhage                      |                                                                          |      3  3.7|
      Fat, Necrosis                        |                                                                          |      2  2.0|
      Fat, Pigmentation                    |                                                                          |      1  3.0|
                                            __________________________________________________________________________|____________|
   Pancreas                                | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Acinus, Hyperplasia                  |                                                                          |      1  2.0|
      Artery, Fibrosis                     |                                                                          |      1  3.0|
      Artery, Inflammation, Chronic Active |                1                                                         |      3  1.7|
                                            __________________________________________________________________________|____________|
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Duct, Metaplasia, Squamous           |                                                                          |      2  1.0|
                                            __________________________________________________________________________|____________|
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Hyperkeratosis                       | 2        2                                                               |      5  2.2|
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page  59                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 6| 6| 7| 5| 4| 4| 1|                                            |            |
                             DAY ON TEST   | 3| 3| 2| 7| 7| 3| 7| 6| 6| 8|                                            |            |
                                           | 0| 0| 5| 5| 5| 0| 0| 2| 2| 4|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      T     |
                               ANIMAL ID   | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2|                                            |      A     |
    8.3                                    | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4|                                            |      L     |
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 ALIMENTARY SYSTEM - cont                  |                                                                          |            |
                                           |                                                                          |            |
      Hyperplasia, Basal Cell              | 2  1     2                                                               |      7  1.7|
      Hyperplasia, Squamous                |                                                                          |      1  3.0|
      Mineralization                       |                                                                          |      1  2.0|
      Necrosis                             | 1        3                                                               |      6  2.3|
                                            __________________________________________________________________________|____________|
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Erosion                              |                                                                          |      1  2.0|
      Mineralization                       |    1  1                                                                  |     10  1.7|
                                            __________________________________________________________________________|____________|
   Tongue                                  | +                                                                        |   1        |
 _____________________________________________________________________________________________________________________|            |
 CARDIOVASCULAR SYSTEM                     |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Heart                                   | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Cardiomyopathy                       |    X  2     2  2  2  2  2                                                |     39  2.0|
      Inflammation, Acute                  |                            1                                             |      1  1.0|
      Mineralization                       |    X  2                                                                  |      6  1.8|
      Thrombosis                           |                                                                          |      1  3.0|
 _____________________________________________________________________________________________________________________|            |
 ENDOCRINE SYSTEM                          |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Hyperplasia                          |             1                                                            |      2  2.0|
                                            __________________________________________________________________________|____________|
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Hyperplasia                          | 1  2           1                                                         |     15  1.5|
                                            __________________________________________________________________________|____________|
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +                                             |  60        |
                                            __________________________________________________________________________|____________|
   Parathyroid Gland                       | +  +  +  +  +  +  +  +  +  +                                             |  57        |
      Hyperplasia                          |       2        2                                                         |      8  2.3|
                                            __________________________________________________________________________|____________|
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Pars Distalis, Angiectasis           |                                                                          |      7  2.3|
      Pars Distalis, Cyst                  |       X                                                                  |      3     |
      Pars Distalis, Hyperplasia           |       2  2        2                                                      |     14  2.1|
                                            __________________________________________________________________________|____________|
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      C-Cell, Hyperplasia                  |                                                                          |      2  1.0|
      Follicle, Cyst                       | X                                                                        |      1     |
 _____________________________________________________________________________________________________________________|            |
 GENERAL BODY SYSTEM                       |                                                                          |            |
                                           |                                                                          |            |
    None                                   |                                                                          |            |
 _____________________________________________________________________________________________________________________|            |
 GENITAL SYSTEM                            |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Epididymis                              | +  +  +  +  +  +  +  +  +  +                                             |  60        |
                                            __________________________________________________________________________|____________|
   Preputial Gland                         | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Hyperplasia                          |          2     2                                                         |      2  2.0|
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page  60                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 6| 6| 7| 5| 4| 4| 1|                                            |            |
                             DAY ON TEST   | 3| 3| 2| 7| 7| 3| 7| 6| 6| 8|                                            |            |
                                           | 0| 0| 5| 5| 5| 0| 0| 2| 2| 4|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      T     |
                               ANIMAL ID   | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2|                                            |      A     |
    8.3                                    | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4|                                            |      L     |
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 GENITAL SYSTEM - cont                     |                                                                          |            |
                                           |                                                                          |            |
      Necrosis                             |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Prostate                                | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Inflammation, Chronic Active         |                                                                          |      1  3.0|
                                            __________________________________________________________________________|____________|
   Seminal Vesicle                         | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Inflammation, Acute                  |                                                                          |      1  1.0|
                                            __________________________________________________________________________|____________|
   Testes                                  | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Interstitial Cell, Hyperplasia       |                   2  2  1                                                |     20  1.8|
      Seminiferous Tubule, Atrophy         |                                                                          |      5  3.0|
 _____________________________________________________________________________________________________________________|            |
 HEMATOPOIETIC SYSTEM                      |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Blood                                   |                   +                                                      |  12        |
                                            __________________________________________________________________________|____________|
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +                                             |  60        |
                                            __________________________________________________________________________|____________|
   Lymph Node                              |                                                                          |  16        |
      Renal, Angiectasis                   |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Lymph Node, Mandibular                  | +  +  +  +  +  +  +  +  +  +                                             |  60        |
                                            __________________________________________________________________________|____________|
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Infiltration Cellular, Histiocyte    |                            2                                             |      1  2.0|
                                            __________________________________________________________________________|____________|
   Spleen                                  | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Fibrosis                             |                   3                                                      |      6  2.0|
      Hematopoietic Cell Proliferation     |                                                                          |      1  3.0|
      Infarct                              |                                                                          |      1  3.0|
                                            __________________________________________________________________________|____________|
   Thymus                                  | M  M  +  +  +  M  +  +  +  +                                             |  53        |
 _____________________________________________________________________________________________________________________|            |
 INTEGUMENTARY SYSTEM                      |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Mammary Gland                           | M  +  +  +  +  +  M  +  +  +                                             |  52        |
                                            __________________________________________________________________________|____________|
   Skin                                    | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Cyst Epithelial Inclusion            |                                                                          |      1     |
      Necrosis                             |                                                                          |      1  3.0|
 _____________________________________________________________________________________________________________________|            |
 MUSCULOSKELETAL SYSTEM                    |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Bone                                    | +  +  +  +  +  +  +  +  +  +                                             |  60        |
                                            __________________________________________________________________________|____________|
   Skeletal Muscle                         |                                                                          |   6        |
      Necrosis                             |                                                                          |      1  4.0|
 _____________________________________________________________________________________________________________________|            |
 NERVOUS SYSTEM                            |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Brain                                   | +  +  +  +  +  +  +  +  +  +                                             |  60        |
 _____________________________________________________________________________________________________________________|            |
 RESPIRATORY SYSTEM                        |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Lung                                    | +  +  +  +  +  +  +  +  +  +                                             |  60        |
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page  61                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 6| 6| 7| 5| 4| 4| 1|                                            |            |
                             DAY ON TEST   | 3| 3| 2| 7| 7| 3| 7| 6| 6| 8|                                            |            |
                                           | 0| 0| 5| 5| 5| 0| 0| 2| 2| 4|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      T     |
                               ANIMAL ID   | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2|                                            |      A     |
    8.3                                    | 3| 3| 3| 3| 3| 4| 4| 4| 4| 4|                                            |      L     |
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 RESPIRATORY SYSTEM - cont                 |                                                                          |            |
                                           |                                                                          |            |
      Edema                                |       2                                                                  |      4  1.8|
      Fibrosis                             |                                                                          |      1  1.0|
      Hemorrhage                           |                                                                          |     11  1.5|
      Infiltration Cellular, Histiocyte    |                                                                          |      4  2.0|
      Inflammation, Acute                  |                                                                          |      2  2.0|
      Alveolar Epithelium, Hyperplasia     |                      2                                                   |      1  2.0|
      Artery, Inflammation, Chronic Active |                                                                          |      1  1.0|
                                            __________________________________________________________________________|____________|
   Nose                                    | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Fungus                               |                                                                          |      5  2.2|
      Hyperkeratosis                       |                                                                          |      1  2.0|
      Inflammation, Acute                  |                            2                                             |     11  1.7|
                                            __________________________________________________________________________|____________|
   Trachea                                 | +  +  +  +  +  +  +  +  +  +                                             |  60        |
 _____________________________________________________________________________________________________________________|            |
 SPECIAL SENSES SYSTEM                     |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Ear                                     |             +                                                            |   1        |
                                            __________________________________________________________________________|____________|
   Eye                                     |                                                                          |   2        |
      Lens, Cataract                       |                                                                          |      1  2.0|
 _____________________________________________________________________________________________________________________|            |
 URINARY SYSTEM                            |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Kidney                                  | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Cyst                                 |                                                                          |      3     |
      Hemorrhage                           |                                                                          |      1  2.0|
      Mineralization                       |    2  3                                                                  |      6  1.8|
      Nephropathy                          | 2  3  4  4  3  4  2  2  2                                                |     56  2.5|
      Renal Tubule, Hyperplasia            |       4     2                                                            |      5  3.2|
                                            __________________________________________________________________________|____________|
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +                                             |  58        |
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page  62                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 6| 5| 5| 4| 7| 6| 5| 5| 4| 7| 7| 6| 5| 4| 7| 7| 6| 4| 4| 7| 7| 6| 6| 5|             
                             DAY ON TEST   | 2| 1| 9| 8| 6| 2| 6| 7| 2| 6| 2| 0| 6| 9| 7| 2| 0| 6| 6| 0| 2| 2| 7| 2| 5|             
                                           | 5| 6| 7| 2| 3| 2| 5| 5| 0| 3| 5| 1| 6| 8| 9| 5| 0| 6| 2| 1| 5| 5| 3| 5| 0|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2|             
    16.6                                   | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ALIMENTARY SYSTEM                         |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Esophagus                               | +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                                                                          |             
      Hyperkeratosis                       |                                                                          |             
                                            __________________________________________________________________________|             
   Intestine Large, Colon                  | +  +  +  +  +  +  A  +  A  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Rectum                 | +  +  A  +  +  +  A  +  A  +  +  +  +  A  +  +  A  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Cecum                  | +  +  A  +  +  +  A  +  A  +  +  +  +  A  +  +  A  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                               2                                          |             
                                            __________________________________________________________________________|             
   Intestine Small, Duodenum               | +  +  A  +  +  +  +  +  A  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Jejunum                | +  +  +  +  +  A  A  +  A  +  +  +  +  A  +  +  A  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Ileum                  | +  +  A  +  +  +  A  +  A  +  +  +  +  A  +  +  A  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Angiectasis                          |                                     2                                    |             
      Basophilic Focus                     | 2        1                          X        X  X           1  2         |             
      Clear Cell Focus                     | X                          X                                1  2     1   |             
      Degeneration, Cystic                 |                2                             2  2                        |             
      Eosinophilic Focus                   | 4                    3        X                                1         |             
      Fatty Change, Diffuse                | 1           2  1           2        2        1        2  1     1     1  1|             
      Hematopoietic Cell Proliferation     |                                                                         2|             
      Hepatodiaphragmatic Nodule           |                                                                          |             
      Mixed Cell Focus                     | X                             X                                X         |             
      Necrosis                             |                1  3                             2                        |             
      Bile Duct, Cyst                      |                                                                          |             
      Bile Duct, Hyperplasia               |    2     1     1     3           2  2                          1        1|             
      Centrilobular, Hypertrophy           |                                                                          |             
                                            __________________________________________________________________________|             
   Mesentery                               |                                                                          |             
      Fat, Hemorrhage                      |                                                                          |             
      Fat, Mineralization                  |                                                                          |             
      Fat, Necrosis                        |                                                                          |             
                                            __________________________________________________________________________|             
   Pancreas                                | +  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Duct, Metaplasia, Squamous           |                                                                          |             
                                            __________________________________________________________________________|             
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperkeratosis                       |                   2                                                      |             
      Hyperplasia, Basal Cell              |                   2                                               1      |             
      Inflammation, Acute                  |                                                                          |             
      Necrosis                             |                                              3                           |             
      Ulcer                                |                   3                                                      |             
                                            __________________________________________________________________________|             
   Stomach, Glandular                      | +  +  A  +  +  +  +  +  A  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
      Mineralization                       |                2                                2                        |             
 _____________________________________________________________________________________________________________________|             
 CARDIOVASCULAR SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cardiomyopathy                       |       2  2  2  3  2  2  2     2  2  2  2     2  2           2  2  2  2   |             
      Inflammation, Acute                  |                                                                          |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  63                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 6| 5| 5| 4| 7| 6| 5| 5| 4| 7| 7| 6| 5| 4| 7| 7| 6| 4| 4| 7| 7| 6| 6| 5|             
                             DAY ON TEST   | 2| 1| 9| 8| 6| 2| 6| 7| 2| 6| 2| 0| 6| 9| 7| 2| 0| 6| 6| 0| 2| 2| 7| 2| 5|             
                                           | 5| 6| 7| 2| 3| 2| 5| 5| 0| 3| 5| 1| 6| 8| 9| 5| 0| 6| 2| 1| 5| 5| 3| 5| 0|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2|             
    16.6                                   | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 CARDIOVASCULAR SYSTEM - cont              |                                                                          |             
                                           |                                                                          |             
      Mineralization                       |                2                                2                        |             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM                          |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Accessory Adrenal Cortical Nodule    |                   X                                                      |             
                                            __________________________________________________________________________|             
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          | 2        1     1  2              1  2                                    |             
                                            __________________________________________________________________________|             
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                          |             
                                            __________________________________________________________________________|             
   Parathyroid Gland                       | +  M  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  M  +  +  +  +  +  +|             
      Hyperplasia                          | 2              2                 3  3           2                        |             
                                            __________________________________________________________________________|             
   Pituitary Gland                         | +  +  +  +  +  +  M  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +|             
      Pars Distalis, Angiectasis           |          2                                                     2         |             
      Pars Distalis, Cyst                  |                X                    X                                    |             
      Pars Distalis, Fibrosis              |                                                                          |             
      Pars Distalis, Hyperplasia           | 2  2           3           3        1                       3     2      |             
      Pars Nervosa, Cyst                   |                                                                          |             
                                            __________________________________________________________________________|             
   Thyroid Gland                           | +  +  +  +  +  +  M  +  A  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +|             
      C-Cell, Hyperplasia                  |                                  1                                       |             
      Follicle, Cyst                       |                                                                          |             
      Follicular Cell, Hyperplasia         |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENERAL BODY SYSTEM                       |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Tissue NOS                              |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENITAL SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Epididymis                              | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Preputial Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  M|             
      Hyperplasia                          |                                                                2         |             
      Necrosis                             |                                                                          |             
                                            __________________________________________________________________________|             
   Prostate                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                               3                                          |             
      Inflammation, Chronic Active         |                                                                          |             
      Mineralization                       |                                                                          |             
                                            __________________________________________________________________________|             
   Seminal Vesicle                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Testes                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Interstitial Cell, Hyperplasia       |          2  2              2              3           2  1               |             
      Seminiferous Tubule, Atrophy         |                                     2                                    |             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Blood                                   |    +                 +           +                 +              +      |             
                                            __________________________________________________________________________|             
   Bone Marrow                             | +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Lymph Node                              |    +                 +  +        +        +        +              +      |             
      Mediastinal, Angiectasis             |                                                                          |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  64                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 6| 5| 5| 4| 7| 6| 5| 5| 4| 7| 7| 6| 5| 4| 7| 7| 6| 4| 4| 7| 7| 6| 6| 5|             
                             DAY ON TEST   | 2| 1| 9| 8| 6| 2| 6| 7| 2| 6| 2| 0| 6| 9| 7| 2| 0| 6| 6| 0| 2| 2| 7| 2| 5|             
                                           | 5| 6| 7| 2| 3| 2| 5| 5| 0| 3| 5| 1| 6| 8| 9| 5| 0| 6| 2| 1| 5| 5| 3| 5| 0|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2|             
    16.6                                   | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM - cont               |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Lymph Node, Mandibular                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Spleen                                  | +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fibrosis                             |                                              3     1                     |             
      Hematopoietic Cell Proliferation     |                                     3                                   3|             
      Infarct                              |                                                                          |             
                                            __________________________________________________________________________|             
   Thymus                                  | M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Ectopic Parathyroid Gland            |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 INTEGUMENTARY SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Mammary Gland                           | +  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  M  M  +  +  M  M|             
                                            __________________________________________________________________________|             
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 MUSCULOSKELETAL SYSTEM                    |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 NERVOUS SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Peripheral Nerve                        |                                  +                          +            |             
 _____________________________________________________________________________________________________________________|             
 RESPIRATORY SYSTEM                        |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Edema                                |                                                 2                        |             
      Fibrosis                             |                                                                1         |             
      Hemorrhage                           |                                                 3                        |             
      Inflammation, Acute                  |                                                                          |             
      Mediastinum, Inflammation, Chronic   |                                                                          |             
          Active                           |                                                                          |             
                                            __________________________________________________________________________|             
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fungus                               |                                                                          |             
      Inflammation, Acute                  | 1                                                                       2|             
                                            __________________________________________________________________________|             
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Eye                                     |                                                    +                     |             
      Lens, Cataract                       |                                                    2                     |             
 _____________________________________________________________________________________________________________________|             
 URINARY SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |                                                                          |             
      Hydronephrosis                       |                2                                                         |             
      Mineralization                       |                2                                2                        |             
      Nephropathy                          | 4  2  1  2  2  4  4  2     2  3  3  4  2  2  4  4  2  2  1  3  3  2  3  2|             
                                            __________________________________________________________________________|             
   Urinary Bladder                         | +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                          |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  65                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 6| 6| 6| 7| 6| 6| 4| 1| 7| 6| 6| 6| 5| 7| 7| 6| 5| 4| 7| 7| 6| 5| 4|             
                             DAY ON TEST   | 2| 2| 4| 2| 1| 0| 9| 7| 6| 8| 2| 9| 9| 5| 9| 2| 1| 6| 3| 6| 0| 0| 4| 3| 6|             
                                           | 5| 5| 2| 6| 6| 4| 7| 3| 3| 4| 5| 4| 1| 6| 9| 5| 5| 5| 6| 2| 2| 0| 7| 2| 2|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3|             
    16.6                                   | 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ALIMENTARY SYSTEM                         |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                            3                                             |             
      Hyperkeratosis                       |                                           2                              |             
                                            __________________________________________________________________________|             
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  A  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Rectum                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  A  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Cecum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  A  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                          |             
                                            __________________________________________________________________________|             
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Jejunum                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  A  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Ileum                  | +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Angiectasis                          |                            2                                             |             
      Basophilic Focus                     |    1           X  X     X  X  1  1     X     X  1  1  X     X  X  X      |             
      Clear Cell Focus                     |    1                    X                                   X            |             
      Degeneration, Cystic                 |                1                             2                 1         |             
      Eosinophilic Focus                   |                                              3                           |             
      Fatty Change, Diffuse                |    1  1     1           1                       1        2  1  1         |             
      Hematopoietic Cell Proliferation     |                                                                          |             
      Hepatodiaphragmatic Nodule           |             X                                                            |             
      Mixed Cell Focus                     |    X              X        X  X                                X         |             
      Necrosis                             |                                                    2           1         |             
      Bile Duct, Cyst                      |                                                                   1      |             
      Bile Duct, Hyperplasia               | 2     2           2  2  2     2              3           2        3  2   |             
      Centrilobular, Hypertrophy           |                                                                         1|             
                                            __________________________________________________________________________|             
   Mesentery                               |                   +  +                                                   |             
      Fat, Hemorrhage                      |                                                                          |             
      Fat, Mineralization                  |                   2                                                      |             
      Fat, Necrosis                        |                   4  4                                                   |             
                                            __________________________________________________________________________|             
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Duct, Metaplasia, Squamous           |                                                          1               |             
                                            __________________________________________________________________________|             
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperkeratosis                       |                                                                          |             
      Hyperplasia, Basal Cell              |                                                                          |             
      Inflammation, Acute                  |                                                                          |             
      Necrosis                             |                3                                                         |             
      Ulcer                                |                                                                          |             
                                            __________________________________________________________________________|             
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Mineralization                       |    2  1        2                                   2           2         |             
 _____________________________________________________________________________________________________________________|             
 CARDIOVASCULAR SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cardiomyopathy                       | 2  2  2  2  2  2  2  3  2     3  2  2     2  2  2  2  2  2  3  2  2  2  2|             
      Inflammation, Acute                  |                            2                                             |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  66                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 6| 6| 6| 7| 6| 6| 4| 1| 7| 6| 6| 6| 5| 7| 7| 6| 5| 4| 7| 7| 6| 5| 4|             
                             DAY ON TEST   | 2| 2| 4| 2| 1| 0| 9| 7| 6| 8| 2| 9| 9| 5| 9| 2| 1| 6| 3| 6| 0| 0| 4| 3| 6|             
                                           | 5| 5| 2| 6| 6| 4| 7| 3| 3| 4| 5| 4| 1| 6| 9| 5| 5| 5| 6| 2| 2| 0| 7| 2| 2|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3|             
    16.6                                   | 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 CARDIOVASCULAR SYSTEM - cont              |                                                                          |             
                                           |                                                                          |             
      Mineralization                       |    1                                               3           1         |             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM                          |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Adrenal Cortex                          | +     +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Accessory Adrenal Cortical Nodule    |                                                                          |             
                                            __________________________________________________________________________|             
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |    3  2              2           1                 2  1                  |             
                                            __________________________________________________________________________|             
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                2     2   |             
                                            __________________________________________________________________________|             
   Parathyroid Gland                       | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                               2                                2         |             
                                            __________________________________________________________________________|             
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Pars Distalis, Angiectasis           |             2                                                  2         |             
      Pars Distalis, Cyst                  |                                                                   X  X   |             
      Pars Distalis, Fibrosis              |                                                                          |             
      Pars Distalis, Hyperplasia           |       2  3        3           3                             2            |             
      Pars Nervosa, Cyst                   |                                                                          |             
                                            __________________________________________________________________________|             
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  A  +  +  +  +  +  +  +|             
      C-Cell, Hyperplasia                  |                                                                          |             
      Follicle, Cyst                       |                                                                          |             
      Follicular Cell, Hyperplasia         |                         2                                                |             
 _____________________________________________________________________________________________________________________|             
 GENERAL BODY SYSTEM                       |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Tissue NOS                              |                                     +                                    |             
 _____________________________________________________________________________________________________________________|             
 GENITAL SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Epididymis                              | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Preputial Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                          |             
      Necrosis                             |                   3                    3                                 |             
                                            __________________________________________________________________________|             
   Prostate                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |    2     1                                                               |             
      Inflammation, Chronic Active         |                                                 3                        |             
      Mineralization                       |                                                 2                        |             
                                            __________________________________________________________________________|             
   Seminal Vesicle                         | +  +  +  +  +  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Testes                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Interstitial Cell, Hyperplasia       |                         2                 2              2     2        2|             
      Seminiferous Tubule, Atrophy         |                                  4              3                        |             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Blood                                   |                   +           +                       +           +  +   |             
                                            __________________________________________________________________________|             
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Lymph Node                              |                      +                                +           +  +   |             
      Mediastinal, Angiectasis             |                                                                          |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  67                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 6| 6| 6| 7| 6| 6| 4| 1| 7| 6| 6| 6| 5| 7| 7| 6| 5| 4| 7| 7| 6| 5| 4|             
                             DAY ON TEST   | 2| 2| 4| 2| 1| 0| 9| 7| 6| 8| 2| 9| 9| 5| 9| 2| 1| 6| 3| 6| 0| 0| 4| 3| 6|             
                                           | 5| 5| 2| 6| 6| 4| 7| 3| 3| 4| 5| 4| 1| 6| 9| 5| 5| 5| 6| 2| 2| 0| 7| 2| 2|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3|             
    16.6                                   | 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM - cont               |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Lymph Node, Mandibular                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fibrosis                             |                      1                                                   |             
      Hematopoietic Cell Proliferation     |                                                                          |             
      Infarct                              |          2                                                           2   |             
                                            __________________________________________________________________________|             
   Thymus                                  | +  +  +  +  +  M  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +|             
      Ectopic Parathyroid Gland            | X                                                                        |             
 _____________________________________________________________________________________________________________________|             
 INTEGUMENTARY SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Mammary Gland                           | +  +  M  +  +  +  +  M  +  +  +  +  +  M  +  +  +  +  +  +  M  +  M  +  +|             
                                            __________________________________________________________________________|             
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 MUSCULOSKELETAL SYSTEM                    |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 NERVOUS SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Peripheral Nerve                        |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 RESPIRATORY SYSTEM                        |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +     +  +  +  +  +  +  +  +  +  +  +  +|             
      Edema                                |    2                                                                     |             
      Fibrosis                             |                                                                          |             
      Hemorrhage                           |    2                                               2                     |             
      Inflammation, Acute                  |                                                 1                        |             
      Mediastinum, Inflammation, Chronic   |                                                                          |             
          Active                           |                            3                                             |             
                                            __________________________________________________________________________|             
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fungus                               |                                                                         2|             
      Inflammation, Acute                  |                            1     1              3                       3|             
                                            __________________________________________________________________________|             
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Eye                                     |                                                             +            |             
      Lens, Cataract                       |                                                             3            |             
 _____________________________________________________________________________________________________________________|             
 URINARY SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |                X                                               X         |             
      Hydronephrosis                       |                                                             2            |             
      Mineralization                       |    2                                               3           2         |             
      Nephropathy                          | 2  4  4  3  3  4  3  3  3     3  3  3  3  3  3  3  4  2  2  4  4  3  2  2|             
                                            __________________________________________________________________________|             
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                           1                              |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  68                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 5| 5| 4| 4| 6| 5| 5| 4| 4|                                            |            |
                             DAY ON TEST   | 1| 7| 5| 6| 6| 3| 7| 2| 6| 6|                                            |            |
                                           | 8| 1| 5| 3| 3| 9| 0| 2| 2| 2|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      T     |
                               ANIMAL ID   | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3|                                            |      A     |
    16.6                                   | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6|                                            |      L     |
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 ALIMENTARY SYSTEM                         |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Esophagus                               | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Hemorrhage                           |                                                                          |      1  3.0|
      Hyperkeratosis                       |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Intestine Large, Colon                  | +  +  A  +  +  +  +  +  +  +                                             |  54        |
                                            __________________________________________________________________________|____________|
   Intestine Large, Rectum                 | A  +  A  +  +  +  +  +  M  +                                             |  50        |
                                            __________________________________________________________________________|____________|
   Intestine Large, Cecum                  | +  +  A  +  +  +  +  +  +  +                                             |  52        |
      Hyperplasia                          |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +                                             |  56        |
                                            __________________________________________________________________________|____________|
   Intestine Small, Jejunum                | A  +  A  +  +  A  +  +  +  +                                             |  50        |
                                            __________________________________________________________________________|____________|
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  +  +                                             |  53        |
                                            __________________________________________________________________________|____________|
   Liver                                   | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Angiectasis                          |                                                                          |      2  2.0|
      Basophilic Focus                     | X        X     1                                                         |     25  1.2|
      Clear Cell Focus                     |                                                                          |      8  1.3|
      Degeneration, Cystic                 | 1                                                                        |      7  1.6|
      Eosinophilic Focus                   |                                                                          |      5  2.8|
      Fatty Change, Diffuse                | 1        2  2  1        2  2                                             |     25  1.4|
      Hematopoietic Cell Proliferation     |                                                                          |      1  2.0|
      Hepatodiaphragmatic Nodule           |                                                                          |      1     |
      Mixed Cell Focus                     |                                                                          |      8     |
      Necrosis                             |                                                                          |      5  1.8|
      Bile Duct, Cyst                      |                                                                          |      1  1.0|
      Bile Duct, Hyperplasia               |             2     2  1     2                                             |     22  1.9|
      Centrilobular, Hypertrophy           |                                                                          |      1  1.0|
                                            __________________________________________________________________________|____________|
   Mesentery                               | +                                                                        |   3        |
      Fat, Hemorrhage                      | 4                                                                        |      1  4.0|
      Fat, Mineralization                  |                                                                          |      1  2.0|
      Fat, Necrosis                        |                                                                          |      2  4.0|
                                            __________________________________________________________________________|____________|
   Pancreas                                | +  +  +  +  +  +  +  +  +  +                                             |  59        |
                                            __________________________________________________________________________|____________|
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Duct, Metaplasia, Squamous           |                                                                          |      1  1.0|
                                            __________________________________________________________________________|____________|
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Hyperkeratosis                       |                                                                          |      1  2.0|
      Hyperplasia, Basal Cell              |                                                                          |      2  1.5|
      Inflammation, Acute                  |                2                                                         |      1  2.0|
      Necrosis                             |                                                                          |      2  3.0|
      Ulcer                                |                                                                          |      1  3.0|
                                            __________________________________________________________________________|____________|
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +                                             |  57        |
      Mineralization                       |                1                                                         |      8  1.8|
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page  69                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 5| 5| 4| 4| 6| 5| 5| 4| 4|                                            |            |
                             DAY ON TEST   | 1| 7| 5| 6| 6| 3| 7| 2| 6| 6|                                            |            |
                                           | 8| 1| 5| 3| 3| 9| 0| 2| 2| 2|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      T     |
                               ANIMAL ID   | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3|                                            |      A     |
    16.6                                   | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6|                                            |      L     |
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 ALIMENTARY SYSTEM - cont                  |                                                                          |            |
                                           |                                                                          |            |
 _____________________________________________________________________________________________________________________|            |
 CARDIOVASCULAR SYSTEM                     |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Heart                                   | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Cardiomyopathy                       | 2     2     2  2  2        2                                             |     46  2.1|
      Inflammation, Acute                  |                                                                          |      1  2.0|
      Mineralization                       |                                                                          |      5  1.8|
 _____________________________________________________________________________________________________________________|            |
 ENDOCRINE SYSTEM                          |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Accessory Adrenal Cortical Nodule    |                                                                          |      1     |
                                            __________________________________________________________________________|____________|
   Adrenal Medulla                         | +  +  M  +  +  +  +  +  +  +                                             |  59        |
      Hyperplasia                          |                   2  2                                                   |     14  1.7|
                                            __________________________________________________________________________|____________|
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Hyperplasia                          |                                                                          |      2  2.0|
                                            __________________________________________________________________________|____________|
   Parathyroid Gland                       | +  +  +  +  +  +  +  +  +  +                                             |  57        |
      Hyperplasia                          |                2                                                         |      8  2.3|
                                            __________________________________________________________________________|____________|
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +                                             |  58        |
      Pars Distalis, Angiectasis           |       3     2                                                            |      6  2.2|
      Pars Distalis, Cyst                  |                                                                          |      4     |
      Pars Distalis, Fibrosis              |    2                                                                     |      1  2.0|
      Pars Distalis, Hyperplasia           | 2  1        3        2                                                   |     16  2.3|
      Pars Nervosa, Cyst                   |    X                                                                     |      1     |
                                            __________________________________________________________________________|____________|
   Thyroid Gland                           | +  +  A  +  +  +  +  +  +  +                                             |  54        |
      C-Cell, Hyperplasia                  |                                                                          |      1  1.0|
      Follicle, Cyst                       | X                                                                        |      1     |
      Follicular Cell, Hyperplasia         |                                                                          |      1  2.0|
 _____________________________________________________________________________________________________________________|            |
 GENERAL BODY SYSTEM                       |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Tissue NOS                              |                                                                          |   1        |
 _____________________________________________________________________________________________________________________|            |
 GENITAL SYSTEM                            |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Epididymis                              | +  +  +  +  +  +  +  +  +  +                                             |  60        |
                                            __________________________________________________________________________|____________|
   Preputial Gland                         | +  +  +  +  +  +  +  +  +  +                                             |  58        |
      Hyperplasia                          |                                                                          |      1  2.0|
      Necrosis                             |                                                                          |      2  3.0|
                                            __________________________________________________________________________|____________|
   Prostate                                | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Hyperplasia                          |                                                                          |      3  2.0|
      Inflammation, Chronic Active         |                                                                          |      1  3.0|
      Mineralization                       |                                                                          |      1  2.0|
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page  70                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 5| 5| 4| 4| 6| 5| 5| 4| 4|                                            |            |
                             DAY ON TEST   | 1| 7| 5| 6| 6| 3| 7| 2| 6| 6|                                            |            |
                                           | 8| 1| 5| 3| 3| 9| 0| 2| 2| 2|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      T     |
                               ANIMAL ID   | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3|                                            |      A     |
    16.6                                   | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6|                                            |      L     |
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 GENITAL SYSTEM - cont                     |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Seminal Vesicle                         | +  +  +  +  +  +  +  +  +  +                                             |  59        |
                                            __________________________________________________________________________|____________|
   Testes                                  | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Interstitial Cell, Hyperplasia       |    2     2  2  2  1  2  2  2                                             |     19  1.9|
      Seminiferous Tubule, Atrophy         |                                                                          |      3  3.0|
 _____________________________________________________________________________________________________________________|            |
 HEMATOPOIETIC SYSTEM                      |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Blood                                   |    +              +  +                                                   |  13        |
                                            __________________________________________________________________________|____________|
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +                                             |  58        |
                                            __________________________________________________________________________|____________|
   Lymph Node                              | +  +              +  +                                                   |  15        |
      Mediastinal, Angiectasis             | 2                                                                        |      1  2.0|
                                            __________________________________________________________________________|____________|
   Lymph Node, Mandibular                  | +  +  +  M  +  +  +  +  +  +                                             |  59        |
                                            __________________________________________________________________________|____________|
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +                                             |  60        |
                                            __________________________________________________________________________|____________|
   Spleen                                  | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Fibrosis                             |    2                                                                     |      4  1.8|
      Hematopoietic Cell Proliferation     |                                                                          |      2  3.0|
      Infarct                              |                                                                          |      2  2.0|
                                            __________________________________________________________________________|____________|
   Thymus                                  | +  +  +  +  +  +  +  M  +  +                                             |  56        |
      Ectopic Parathyroid Gland            |                                                                          |      1     |
 _____________________________________________________________________________________________________________________|            |
 INTEGUMENTARY SYSTEM                      |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Mammary Gland                           | M  +  +  +  +  M  +  +  +  M                                             |  47        |
                                            __________________________________________________________________________|____________|
   Skin                                    | +  +  +  +  +  +  +  +  +  +                                             |  60        |
 _____________________________________________________________________________________________________________________|            |
 MUSCULOSKELETAL SYSTEM                    |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Bone                                    | +  +  +  +  +  +  +  +  +  +                                             |  60        |
 _____________________________________________________________________________________________________________________|            |
 NERVOUS SYSTEM                            |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Brain                                   | +  +  +  +  +  +  +  +  +  +                                             |  60        |
                                            __________________________________________________________________________|____________|
   Peripheral Nerve                        |                                                                          |   2        |
 _____________________________________________________________________________________________________________________|            |
 RESPIRATORY SYSTEM                        |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Lung                                    | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Edema                                |                2                                                         |      3  2.0|
      Fibrosis                             |                                                                          |      1  1.0|
      Hemorrhage                           |                                                                          |      3  2.3|
      Inflammation, Acute                  |                3                                                         |      2  2.0|
      Mediastinum, Inflammation, Chronic   |                                                                          |            |
          Active                           |                                                                          |      1  3.0|
                                            __________________________________________________________________________|____________|
   Nose                                    | +  +  +  +  +  +  +  +  +  +                                             |  60        |
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page  71                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 5| 5| 4| 4| 6| 5| 5| 4| 4|                                            |            |
                             DAY ON TEST   | 1| 7| 5| 6| 6| 3| 7| 2| 6| 6|                                            |            |
                                           | 8| 1| 5| 3| 3| 9| 0| 2| 2| 2|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      T     |
                               ANIMAL ID   | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3|                                            |      A     |
    16.6                                   | 5| 5| 5| 5| 5| 6| 6| 6| 6| 6|                                            |      L     |
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 RESPIRATORY SYSTEM - cont                 |                                                                          |            |
                                           |                                                                          |            |
      Fungus                               |                                                                          |      1  2.0|
      Inflammation, Acute                  |       1        3                                                         |      8  1.9|
                                            __________________________________________________________________________|____________|
   Trachea                                 | +  +  +  +  +  +  +  +  +  +                                             |  60        |
 _____________________________________________________________________________________________________________________|            |
 SPECIAL SENSES SYSTEM                     |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Eye                                     |                                                                          |   2        |
      Lens, Cataract                       |                                                                          |      2  2.5|
 _____________________________________________________________________________________________________________________|            |
 URINARY SYSTEM                            |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Kidney                                  | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Cyst                                 |                                                                          |      2     |
      Hydronephrosis                       |                                                                          |      2  2.0|
      Mineralization                       |                                                                          |      5  2.2|
      Nephropathy                          | 4  2  2  2  1  4  2  2  2  2                                             |     58  2.7|
                                            __________________________________________________________________________|____________|
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Hyperplasia                          |                                                                          |      1  1.0|
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page  72                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 6| 6| 6| 5| 6| 5| 5| 4| 1| 6| 6| 4| 4| 0| 6| 5| 5| 4| 3| 2| 7| 7| 6| 4|             
                             DAY ON TEST   | 1| 5| 5| 0| 6| 2| 9| 6| 6| 3| 7| 2| 6| 6| 4| 6| 8| 6| 6| 6| 8| 1| 1| 1| 6|             
                                           | 7| 8| 6| 4| 8| 5| 2| 2| 3| 8| 5| 4| 3| 2| 9| 7| 4| 5| 2| 5| 8| 7| 7| 7| 2|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4|             
    33.3                                   | 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ALIMENTARY SYSTEM                         |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperkeratosis                       |                                                                          |             
      Inflammation, Acute                  |                                                                          |             
      Necrosis                             |                                                                          |             
                                            __________________________________________________________________________|             
   Intestine Large, Colon                  | +  +  +  A  A  +  +  +  +  A  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Rectum                 | +  +  +  +  A  +  A  +  +  A  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Cecum                  | +  +  +  A  A  +  A  +  +  A  M  +  +  +  +  +  +  A  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Duodenum               | +  +  +  A  A  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Jejunum                | +  +  +  A  A  +  A  +  +  A  +  +  +  +  +  A  +  A  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Ileum                  | +  +  +  A  A  +  A  +  +  A  +  +  +  +  +  A  +  A  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Basophilic Focus                     | X  X  X  X     X  X           1  X           X  X              X  2      |             
      Clear Cell Focus                     |                X        X           X           1              X  X      |             
      Degeneration, Cystic                 |                                  2           2  2                        |             
      Eosinophilic Focus                   |    3              2                                                      |             
      Fatty Change, Diffuse                |       1  2  1  1  1     1     2     2  2     2  2  1  2     2  1  1  3  2|             
      Fatty Change, Focal                  |                                                                          |             
      Hepatodiaphragmatic Nodule           |                                                                          |             
      Hyperplasia                          |                2                                                         |             
      Mixed Cell Focus                     |       X  X        X  X        X                                          |             
      Necrosis, Focal                      |                         2                                                |             
      Necrosis                             | 2                                                                        |             
      Thrombosis                           |                                                                          |             
      Bile Duct, Hyperplasia               |    3           2                 2           2                           |             
      Centrilobular, Hypertrophy           |                         1              1              1                 1|             
                                            __________________________________________________________________________|             
   Mesentery                               |    +     +                                                     +         |             
      Fat, Fibrosis                        |                                                                2         |             
      Fat, Inflammation, Chronic Active    |                                                                2         |             
      Fat, Necrosis                        |    2                                                                     |             
                                            __________________________________________________________________________|             
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Pharynx                                 | +                                                                        |             
      Inflammation, Acute                  | 3                                                                        |             
      Palate, Inflammation, Acute          |                                                                          |             
                                            __________________________________________________________________________|             
   Salivary Glands                         | +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Duct, Metaplasia, Squamous           |                         1                                                |             
                                            __________________________________________________________________________|             
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst Epithelial Inclusion            |                                                                          |             
      Hyperkeratosis                       |                               2                                          |             
      Hyperplasia, Basal Cell              |                               2                                          |             
      Hyperplasia, Squamous                |                                                                          |             
      Necrosis                             |                                                 2                        |             
      Ulcer                                |                   2                                                      |             
                                            __________________________________________________________________________|             
   Stomach, Glandular                      | +  +  +  A  A  +  +  +  +  A  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +|             
      Necrosis                             |       2                       2                                          |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  73                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 6| 6| 6| 5| 6| 5| 5| 4| 1| 6| 6| 4| 4| 0| 6| 5| 5| 4| 3| 2| 7| 7| 6| 4|             
                             DAY ON TEST   | 1| 5| 5| 0| 6| 2| 9| 6| 6| 3| 7| 2| 6| 6| 4| 6| 8| 6| 6| 6| 8| 1| 1| 1| 6|             
                                           | 7| 8| 6| 4| 8| 5| 2| 2| 3| 8| 5| 4| 3| 2| 9| 7| 4| 5| 2| 5| 8| 7| 7| 7| 2|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4|             
    33.3                                   | 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ALIMENTARY SYSTEM - cont                  |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Tongue                                  |                                        +                                 |             
      Hyperkeratosis                       |                                        1                                 |             
 _____________________________________________________________________________________________________________________|             
 CARDIOVASCULAR SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cardiomyopathy                       | 2     2  3  2  3  2  2        2  2  2  2  1  2  2  2  2  2     2  2  2   |             
      Congestion                           |                                                                          |             
      Mineralization                       |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM                          |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          | 1  1  1              2                          2                        |             
                                            __________________________________________________________________________|             
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                     2                             3      |             
                                            __________________________________________________________________________|             
   Parathyroid Gland                       | +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                      2        2              2                           |             
                                            __________________________________________________________________________|             
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Pars Distalis, Angiectasis           |                                                 2                        |             
      Pars Distalis, Hyperplasia           | 2              3                             1  3                        |             
      Pars Distalis, Infarct               |                                                                          |             
                                            __________________________________________________________________________|             
   Thyroid Gland                           | +  +  +  M  A  +  A  +  +  A  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +|             
      C-Cell, Hyperplasia                  |                      1                                                   |             
      Follicle, Cyst                       |                                                                X         |             
      Follicular Cell, Hyperplasia         |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENERAL BODY SYSTEM                       |                                                                          |             
                                           |                                                                          |             
    None                                   |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENITAL SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Epididymis                              | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Preputial Gland                         | +  +  +  +  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                          |             
                                            __________________________________________________________________________|             
   Prostate                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Chronic Active         | 2                                                                        |             
                                            __________________________________________________________________________|             
   Seminal Vesicle                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Testes                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Interstitial Cell, Hyperplasia       |    2                    2           2  2           2  2  1  1           2|             
      Seminiferous Tubule, Atrophy         |       3                                         2                 3      |             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Blood                                   |    +                                                                     |             
                                            __________________________________________________________________________|             
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Lymph Node                              |    +                                                     +               |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  74                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 6| 6| 6| 5| 6| 5| 5| 4| 1| 6| 6| 4| 4| 0| 6| 5| 5| 4| 3| 2| 7| 7| 6| 4|             
                             DAY ON TEST   | 1| 5| 5| 0| 6| 2| 9| 6| 6| 3| 7| 2| 6| 6| 4| 6| 8| 6| 6| 6| 8| 1| 1| 1| 6|             
                                           | 7| 8| 6| 4| 8| 5| 2| 2| 3| 8| 5| 4| 3| 2| 9| 7| 4| 5| 2| 5| 8| 7| 7| 7| 2|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4|             
    33.3                                   | 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM - cont               |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Lymph Node, Mandibular                  | +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |                                                                          |             
      Fibrosis                             |       2                                         1                        |             
                                            __________________________________________________________________________|             
   Thymus                                  | +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 INTEGUMENTARY SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Mammary Gland                           | +  +  +  +  +  +  +  +  M  M  +  +  +  +  M  M  +  +  +  M  +  +  +  +  +|             
      Galactocele                          |       X  X                                                               |             
      Acinus, Hyperplasia                  |                                                                   2      |             
                                            __________________________________________________________________________|             
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Acanthosis                           |                                                                          |             
      Hyperkeratosis                       |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 MUSCULOSKELETAL SYSTEM                    |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Skeletal Muscle                         |                                                                          |             
      Edema                                |                                                                          |             
      Hemorrhage                           |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 NERVOUS SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 RESPIRATORY SYSTEM                        |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Edema                                |                3                             2                           |             
      Hemorrhage                           |                                                                          |             
      Infiltration Cellular, Histiocyte    |                                                                          |             
      Inflammation, Acute                  |                3                             3                           |             
      Mediastinum, Inflammation, Chronic   |                                                                          |             
          Active                           |                                                                          |             
                                            __________________________________________________________________________|             
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fungus                               | 2  2  2                 2                                                |             
      Inflammation, Acute                  | 3  3  3                 1                    3                           |             
                                            __________________________________________________________________________|             
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Erosion                              |                                                                          |             
      Inflammation, Acute                  |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Eye                                     |                            +                                             |             
                                            __________________________________________________________________________|             
   Zymbal's Gland                          |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 URINARY SYSTEM                            |                                                                          |             
                                           |                                                                          |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  75                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 6| 6| 6| 5| 6| 5| 5| 4| 1| 6| 6| 4| 4| 0| 6| 5| 5| 4| 3| 2| 7| 7| 6| 4|             
                             DAY ON TEST   | 1| 5| 5| 0| 6| 2| 9| 6| 6| 3| 7| 2| 6| 6| 4| 6| 8| 6| 6| 6| 8| 1| 1| 1| 6|             
                                           | 7| 8| 6| 4| 8| 5| 2| 2| 3| 8| 5| 4| 3| 2| 9| 7| 4| 5| 2| 5| 8| 7| 7| 7| 2|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4|             
    33.3                                   | 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 URINARY SYSTEM - cont                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |       X                       X                                          |             
      Hemorrhage                           |                                                                          |             
      Mineralization                       |                                                                          |             
      Nephropathy                          | 3  2  4  3  2  2  2  4  2     3  4  3  3     4  4  2  2  2     3  3  3  2|             
      Renal Tubule, Hyperplasia            |                                  2                                       |             
                                            __________________________________________________________________________|             
   Urinary Bladder                         | +  +  +  +  A  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Calculus Gross Observation           |                                                          X               |             
      Calculus Micro Observation Only      |                                                          X               |             
      Dilatation                           |                                                                          |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  76                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 6| 5| 4| 6| 6| 6| 5| 4| 7| 6| 6| 6| 5| 7| 6| 6| 5| 4| 7| 7| 6| 6| 4|             
                             DAY ON TEST   | 1| 1| 1| 7| 6| 5| 2| 0| 9| 6| 1| 8| 6| 3| 5| 1| 9| 5| 4| 5| 1| 1| 6| 0| 6|             
                                           | 7| 5| 2| 6| 2| 8| 4| 2| 2| 2| 7| 0| 6| 2| 5| 7| 3| 7| 1| 8| 7| 7| 7| 8| 2|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4|             
    33.3                                   | 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ALIMENTARY SYSTEM                         |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Esophagus                               | +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperkeratosis                       |       2                                                  1           2   |             
      Inflammation, Acute                  |    3                                                                     |             
      Necrosis                             |    4                                                                     |             
                                            __________________________________________________________________________|             
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  A  +  +  +  +  +  A  +  +  +  A  A  +  +  +  A  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Rectum                 | +  +  +  A  +  +  +  +  A  +  +  +  +  +  A  +  +  +  A  A  +  +  +  A  +|             
                                            __________________________________________________________________________|             
   Intestine Large, Cecum                  | +  +  +  A  +  +  +  +  A  +  +  +  +  +  A  +  +  +  A  A  +  +  +  A  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  A  A  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Jejunum                | +  +  +  A  +  +  +  +  A  +  +  +  +  +  A  +  +  +  A  A  +  +  +  A  +|             
                                            __________________________________________________________________________|             
   Intestine Small, Ileum                  | +  +  +  A  +  +  +  +  A  +  +  +  +  +  A  +  +  +  A  A  +  +  +  A  +|             
                                            __________________________________________________________________________|             
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Basophilic Focus                     |             1           X        X           X     X        1     1      |             
      Clear Cell Focus                     | X                             1                                   X      |             
      Degeneration, Cystic                 |                                                 2                        |             
      Eosinophilic Focus                   |                                                 4              1         |             
      Fatty Change, Diffuse                | 2  1        3           1  3        1  2     1     1  2  2     2  1     3|             
      Fatty Change, Focal                  |          1                                                               |             
      Hepatodiaphragmatic Nodule           |                                                                          |             
      Hyperplasia                          |                                                                          |             
      Mixed Cell Focus                     | X                 1     X     X                    X        X            |             
      Necrosis, Focal                      |                                                                          |             
      Necrosis                             |                                                                          |             
      Thrombosis                           |       2                                                                  |             
      Bile Duct, Hyperplasia               |       3  1     3  2  2  2  1                    3                        |             
      Centrilobular, Hypertrophy           |             1              1                                            1|             
                                            __________________________________________________________________________|             
   Mesentery                               |                                                                          |             
      Fat, Fibrosis                        |                                                                          |             
      Fat, Inflammation, Chronic Active    |                                                                          |             
      Fat, Necrosis                        |                                                                          |             
                                            __________________________________________________________________________|             
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Pharynx                                 |                                  +                                       |             
      Inflammation, Acute                  |                                                                          |             
      Palate, Inflammation, Acute          |                                  3                                       |             
                                            __________________________________________________________________________|             
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Duct, Metaplasia, Squamous           |                            1                                             |             
                                            __________________________________________________________________________|             
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst Epithelial Inclusion            |                               X                                          |             
      Hyperkeratosis                       |    2     3                    3                                          |             
      Hyperplasia, Basal Cell              |    2     2                 2  2                                          |             
      Hyperplasia, Squamous                |                                        4                                 |             
      Necrosis                             |                                                                          |             
      Ulcer                                |    2                                   3                          2      |             
                                            __________________________________________________________________________|             
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +|             
      Necrosis                             |                                                                          |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  77                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 6| 5| 4| 6| 6| 6| 5| 4| 7| 6| 6| 6| 5| 7| 6| 6| 5| 4| 7| 7| 6| 6| 4|             
                             DAY ON TEST   | 1| 1| 1| 7| 6| 5| 2| 0| 9| 6| 1| 8| 6| 3| 5| 1| 9| 5| 4| 5| 1| 1| 6| 0| 6|             
                                           | 7| 5| 2| 6| 2| 8| 4| 2| 2| 2| 7| 0| 6| 2| 5| 7| 3| 7| 1| 8| 7| 7| 7| 8| 2|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4|             
    33.3                                   | 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 ALIMENTARY SYSTEM - cont                  |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Tongue                                  |                                                                          |             
      Hyperkeratosis                       |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 CARDIOVASCULAR SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cardiomyopathy                       | 3  2  2  2  2  2  2     2  2  2  2     2     2  2  2  2  2  3  2  2  2  2|             
      Congestion                           |                                     3                                    |             
      Mineralization                       |    1                                                                     |             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM                          |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                      1                 1                       2         |             
                                            __________________________________________________________________________|             
   Islets, Pancreatic                      | +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                   1                                                      |             
                                            __________________________________________________________________________|             
   Parathyroid Gland                       | +  +  M  +  +  M  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                          |             
                                            __________________________________________________________________________|             
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Pars Distalis, Angiectasis           |                                     2  2                                 |             
      Pars Distalis, Hyperplasia           |                         2           2              2                     |             
      Pars Distalis, Infarct               |                                  3                                       |             
                                            __________________________________________________________________________|             
   Thyroid Gland                           | +  +  +  A  +  +  +  +  +  +  +  +  +  +  A  +  +  A  A  A  +  +  +  +  +|             
      C-Cell, Hyperplasia                  |                                                                          |             
      Follicle, Cyst                       |                                                                          |             
      Follicular Cell, Hyperplasia         |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENERAL BODY SYSTEM                       |                                                                          |             
                                           |                                                                          |             
    None                                   |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENITAL SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Epididymis                              | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Preputial Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                          |             
                                            __________________________________________________________________________|             
   Prostate                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  M  +|             
      Inflammation, Chronic Active         |    2                                                                     |             
                                            __________________________________________________________________________|             
   Seminal Vesicle                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Testes                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Interstitial Cell, Hyperplasia       |             2              2                                1           2|             
      Seminiferous Tubule, Atrophy         |    3           3                                3           2  3         |             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Blood                                   |       +        +  +  +           +              +                        |             
                                            __________________________________________________________________________|             
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Lymph Node                              |                +  +                                                      |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  78                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 6| 5| 4| 6| 6| 6| 5| 4| 7| 6| 6| 6| 5| 7| 6| 6| 5| 4| 7| 7| 6| 6| 4|             
                             DAY ON TEST   | 1| 1| 1| 7| 6| 5| 2| 0| 9| 6| 1| 8| 6| 3| 5| 1| 9| 5| 4| 5| 1| 1| 6| 0| 6|             
                                           | 7| 5| 2| 6| 2| 8| 4| 2| 2| 2| 7| 0| 6| 2| 5| 7| 3| 7| 1| 8| 7| 7| 7| 8| 2|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4|             
    33.3                                   | 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM - cont               |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Lymph Node, Mandibular                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  +|             
                                            __________________________________________________________________________|             
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |                                                             X            |             
      Fibrosis                             |       2                                2                                 |             
                                            __________________________________________________________________________|             
   Thymus                                  | +  +  +  +  +  +  +  +  +  +  M  M  +  +  +  +  +  +  +  +  +  +  +  A  +|             
 _____________________________________________________________________________________________________________________|             
 INTEGUMENTARY SYSTEM                      |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Mammary Gland                           | +  +  +  +  M  +  +  +  +  M  +  +  +  +  +  M  +  M  +  +  +  +  M  +  M|             
      Galactocele                          |                                                                          |             
      Acinus, Hyperplasia                  |                                                                          |             
                                            __________________________________________________________________________|             
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Acanthosis                           |                                                    2                     |             
      Hyperkeratosis                       |                                                    4                     |             
 _____________________________________________________________________________________________________________________|             
 MUSCULOSKELETAL SYSTEM                    |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                            __________________________________________________________________________|             
   Skeletal Muscle                         |                                                                   +      |             
      Edema                                |                                                                   2      |             
      Hemorrhage                           |                                                                   3      |             
 _____________________________________________________________________________________________________________________|             
 NERVOUS SYSTEM                            |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 RESPIRATORY SYSTEM                        |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Edema                                |                                                    3              2      |             
      Hemorrhage                           |                                                                          |             
      Infiltration Cellular, Histiocyte    |                                                    2                     |             
      Inflammation, Acute                  |    2                                                              3      |             
      Mediastinum, Inflammation, Chronic   |                                                                          |             
          Active                           |                                        2                                 |             
                                            __________________________________________________________________________|             
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fungus                               |                                        2                                 |             
      Inflammation, Acute                  |    3                                   1                          2      |             
                                            __________________________________________________________________________|             
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Erosion                              |                                                                   4      |             
      Inflammation, Acute                  |                                                                   2      |             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Eye                                     |             I                                                            |             
                                            __________________________________________________________________________|             
   Zymbal's Gland                          |                                                 +                        |             
 _____________________________________________________________________________________________________________________|             
 URINARY SYSTEM                            |                                                                          |             
                                           |                                                                          |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  79                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 6| 5| 4| 6| 6| 6| 5| 4| 7| 6| 6| 6| 5| 7| 6| 6| 5| 4| 7| 7| 6| 6| 4|             
                             DAY ON TEST   | 1| 1| 1| 7| 6| 5| 2| 0| 9| 6| 1| 8| 6| 3| 5| 1| 9| 5| 4| 5| 1| 1| 6| 0| 6|             
                                           | 7| 5| 2| 6| 2| 8| 4| 2| 2| 2| 7| 0| 6| 2| 5| 7| 3| 7| 1| 8| 7| 7| 7| 8| 2|             
 _____________________________________________________________________________________________________________________|             
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|             
                               ANIMAL ID   | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4|             
    33.3                                   | 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6|             
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|             
 _____________________________________________________________________________________________________________________|             
 URINARY SYSTEM - cont                     |                                                                          |             
                                           |                                                                          |             
                                            __________________________________________________________________________|             
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |                                     X                                    |             
      Hemorrhage                           |                   4                                                      |             
      Mineralization                       |                                                                          |             
      Nephropathy                          | 3  4  2  2  1  3  3  2  3  2  3  3  3  4  2  2  3  3  1  1  3  4  4  2  1|             
      Renal Tubule, Hyperplasia            |                                                                          |             
                                            __________________________________________________________________________|             
   Urinary Bladder                         | +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Calculus Gross Observation           |                                                                          |             
      Calculus Micro Observation Only      |                                                                          |             
      Dilatation                           |                                                                          |             
 _____________________________________________________________________________________________________________________|             
                                                             Page  80                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 6| 4| 2| 6| 7| 6| 5| 0|                                            |            |
                             DAY ON TEST   | 1| 0| 3| 6| 8| 2| 1| 2| 8| 5|                                            |            |
                                           | 7| 8| 9| 3| 9| 0| 7| 4| 3| 3|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      T     |
                               ANIMAL ID   | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4|                                            |      A     |
    33.3                                   | 7| 7| 7| 7| 7| 8| 8| 8| 8| 8|                                            |      L     |
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 ALIMENTARY SYSTEM                         |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Esophagus                               | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Hyperkeratosis                       |                                                                          |      3  1.7|
      Inflammation, Acute                  |                                                                          |      1  3.0|
      Necrosis                             |                                                                          |      1  4.0|
                                            __________________________________________________________________________|____________|
   Intestine Large, Colon                  | +  +  +  +  A  A  +  +  +  +                                             |  49        |
                                            __________________________________________________________________________|____________|
   Intestine Large, Rectum                 | +  +  +  +  A  A  +  +  A  +                                             |  47        |
                                            __________________________________________________________________________|____________|
   Intestine Large, Cecum                  | +  +  +  +  A  A  +  +  A  +                                             |  45        |
                                            __________________________________________________________________________|____________|
   Intestine Small, Duodenum               | +  +  +  +  A  +  +  +  +  +                                             |  53        |
                                            __________________________________________________________________________|____________|
   Intestine Small, Jejunum                | +  +  +  +  A  A  +  +  A  +                                             |  45        |
                                            __________________________________________________________________________|____________|
   Intestine Small, Ileum                  | +  +  +  +  A  A  +  +  A  +                                             |  45        |
                                            __________________________________________________________________________|____________|
   Liver                                   | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Basophilic Focus                     | X  1     X           1                                                   |     23  1.1|
      Clear Cell Focus                     | X              X  X  X                                                   |     13  1.0|
      Degeneration, Cystic                 |                                                                          |      4  2.0|
      Eosinophilic Focus                   |                                                                          |      4  2.5|
      Fatty Change, Diffuse                |       2  2  2     3  2                                                   |     37  1.8|
      Fatty Change, Focal                  |                                                                          |      1  1.0|
      Hepatodiaphragmatic Nodule           |             X                                                            |      1     |
      Hyperplasia                          |                                                                          |      1  2.0|
      Mixed Cell Focus                     |                                                                          |     11  1.0|
      Necrosis, Focal                      |                                                                          |      1  2.0|
      Necrosis                             |                                                                          |      1  2.0|
      Thrombosis                           |                                                                          |      1  2.0|
      Bile Duct, Hyperplasia               |                                                                          |     12  2.2|
      Centrilobular, Hypertrophy           |          1                                                               |      8  1.0|
                                            __________________________________________________________________________|____________|
   Mesentery                               |                                                                          |   3        |
      Fat, Fibrosis                        |                                                                          |      1  2.0|
      Fat, Inflammation, Chronic Active    |                                                                          |      1  2.0|
      Fat, Necrosis                        |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Pancreas                                | +  +  +  +  +  +  +  +  +  +                                             |  60        |
                                            __________________________________________________________________________|____________|
   Pharynx                                 |                                                                          |   2        |
      Inflammation, Acute                  |                                                                          |      1  3.0|
      Palate, Inflammation, Acute          |                                                                          |      1  3.0|
                                            __________________________________________________________________________|____________|
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Duct, Metaplasia, Squamous           |                                                                          |      2  1.0|
                                            __________________________________________________________________________|____________|
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Cyst Epithelial Inclusion            |                                                                          |      1     |
      Hyperkeratosis                       |                                                                          |      4  2.5|
      Hyperplasia, Basal Cell              |                            2                                             |      6  2.0|
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page  81                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 6| 4| 2| 6| 7| 6| 5| 0|                                            |            |
                             DAY ON TEST   | 1| 0| 3| 6| 8| 2| 1| 2| 8| 5|                                            |            |
                                           | 7| 8| 9| 3| 9| 0| 7| 4| 3| 3|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      T     |
                               ANIMAL ID   | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4|                                            |      A     |
    33.3                                   | 7| 7| 7| 7| 7| 8| 8| 8| 8| 8|                                            |      L     |
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 ALIMENTARY SYSTEM - cont                  |                                                                          |            |
                                           |                                                                          |            |
      Hyperplasia, Squamous                |                                                                          |      1  4.0|
      Necrosis                             |                                                                          |      1  2.0|
      Ulcer                                |                                                                          |      4  2.3|
                                            __________________________________________________________________________|____________|
   Stomach, Glandular                      | +  +  +  +  A  +  +  +  +  +                                             |  54        |
      Necrosis                             |                                                                          |      2  2.0|
                                            __________________________________________________________________________|____________|
   Tongue                                  |                                                                          |   1        |
      Hyperkeratosis                       |                                                                          |      1  1.0|
 _____________________________________________________________________________________________________________________|            |
 CARDIOVASCULAR SYSTEM                     |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Heart                                   | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Cardiomyopathy                       | 2  2  2  1  2  2  2  2  2  1                                             |     52  2.0|
      Congestion                           |                                                                          |      1  3.0|
      Mineralization                       |    1                                                                     |      2  1.0|
 _____________________________________________________________________________________________________________________|            |
 ENDOCRINE SYSTEM                          |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +                                             |  60        |
                                            __________________________________________________________________________|____________|
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +                                             |  59        |
      Hyperplasia                          |                   2                                                      |      9  1.4|
                                            __________________________________________________________________________|____________|
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +                                             |  58        |
      Hyperplasia                          |                                                                          |      3  2.0|
                                            __________________________________________________________________________|____________|
   Parathyroid Gland                       | +  +  +  +  +  +  +  +  +  +                                             |  56        |
      Hyperplasia                          |                                                                          |      3  2.0|
                                            __________________________________________________________________________|____________|
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  I                                             |  59        |
      Pars Distalis, Angiectasis           |                                                                          |      3  2.0|
      Pars Distalis, Hyperplasia           |          2     1                                                         |      9  2.0|
      Pars Distalis, Infarct               |                                                                          |      1  3.0|
                                            __________________________________________________________________________|____________|
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +                                             |  50        |
      C-Cell, Hyperplasia                  |                                                                          |      1  1.0|
      Follicle, Cyst                       |                                                                          |      1     |
      Follicular Cell, Hyperplasia         |                      2                                                   |      1  2.0|
 _____________________________________________________________________________________________________________________|            |
 GENERAL BODY SYSTEM                       |                                                                          |            |
                                           |                                                                          |            |
    None                                   |                                                                          |            |
 _____________________________________________________________________________________________________________________|            |
 GENITAL SYSTEM                            |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Epididymis                              | +  +  +  +  +  +  +  +  +  +                                             |  60        |
                                            __________________________________________________________________________|____________|
   Preputial Gland                         | +  +  +  M  +  +  +  +  +  +                                             |  58        |
      Hyperplasia                          |                      2                                                   |      1  2.0|
                                            __________________________________________________________________________|____________|
   Prostate                                | M  +  M  +  +  +  +  +  +  +                                             |  57        |
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page  82                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 6| 4| 2| 6| 7| 6| 5| 0|                                            |            |
                             DAY ON TEST   | 1| 0| 3| 6| 8| 2| 1| 2| 8| 5|                                            |            |
                                           | 7| 8| 9| 3| 9| 0| 7| 4| 3| 3|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      T     |
                               ANIMAL ID   | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4|                                            |      A     |
    33.3                                   | 7| 7| 7| 7| 7| 8| 8| 8| 8| 8|                                            |      L     |
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 GENITAL SYSTEM - cont                     |                                                                          |            |
                                           |                                                                          |            |
      Inflammation, Chronic Active         |                                                                          |      2  2.0|
                                            __________________________________________________________________________|____________|
   Seminal Vesicle                         | +  +  +  +  +  +  +  +  +  +                                             |  60        |
                                            __________________________________________________________________________|____________|
   Testes                                  | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Interstitial Cell, Hyperplasia       |          2                                                               |     14  1.8|
      Seminiferous Tubule, Atrophy         |                                                                          |      8  2.8|
 _____________________________________________________________________________________________________________________|            |
 HEMATOPOIETIC SYSTEM                      |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Blood                                   |                                                                          |   7        |
                                            __________________________________________________________________________|____________|
   Bone Marrow                             | +  +  M  +  +  +  +  +  +  +                                             |  59        |
                                            __________________________________________________________________________|____________|
   Lymph Node                              |    +                                                                     |   5        |
                                            __________________________________________________________________________|____________|
   Lymph Node, Mandibular                  | +  +  +  +  +  +  +  +  +  +                                             |  59        |
                                            __________________________________________________________________________|____________|
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +                                             |  59        |
                                            __________________________________________________________________________|____________|
   Spleen                                  | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Cyst                                 |                                                                          |      1     |
      Fibrosis                             |                                                                          |      4  1.8|
                                            __________________________________________________________________________|____________|
   Thymus                                  | +  +  +  +  +  +  M  +  +  +                                             |  55        |
 _____________________________________________________________________________________________________________________|            |
 INTEGUMENTARY SYSTEM                      |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Mammary Gland                           | +  +  +  M  M  +  +  +  +  M                                             |  46        |
      Galactocele                          |                                                                          |      2     |
      Acinus, Hyperplasia                  |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Skin                                    | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Acanthosis                           |                                                                          |      1  2.0|
      Hyperkeratosis                       |                                                                          |      1  4.0|
 _____________________________________________________________________________________________________________________|            |
 MUSCULOSKELETAL SYSTEM                    |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Bone                                    | +  +  M  +  +  +  +  +  +  +                                             |  59        |
                                            __________________________________________________________________________|____________|
   Skeletal Muscle                         |                                                                          |   1        |
      Edema                                |                                                                          |      1  2.0|
      Hemorrhage                           |                                                                          |      1  3.0|
 _____________________________________________________________________________________________________________________|            |
 NERVOUS SYSTEM                            |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Brain                                   | +  +  +  +  +  +  +  +  +  +                                             |  60        |
 _____________________________________________________________________________________________________________________|            |
 RESPIRATORY SYSTEM                        |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Lung                                    | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Edema                                |                         1                                                |      5  2.2|
      Hemorrhage                           |                         2                                                |      1  2.0|
      Infiltration Cellular, Histiocyte    |                                                                          |      1  2.0|
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page  83                                                               
NTP Experiment-Test: 05108-01                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                     PROMETHAZINE HYDROCHLORIDE                                Date: 04/25/97  
Route: GAVAGE                                                                                                     Time: 08:43:56  
                                                                                                                                    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 6| 4| 2| 6| 7| 6| 5| 0|                                            |            |
                             DAY ON TEST   | 1| 0| 3| 6| 8| 2| 1| 2| 8| 5|                                            |            |
                                           | 7| 8| 9| 3| 9| 0| 7| 4| 3| 3|                                            |      T (*) |
 _____________________________________________________________________________________________________________________|            |
                                           | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      O     |
   FISCHER 344 RATS MALE                   | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0|                                            |      T     |
                               ANIMAL ID   | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4|                                            |      A     |
    33.3                                   | 7| 7| 7| 7| 7| 8| 8| 8| 8| 8|                                            |      L     |
    MG/KG                                  | 1| 2| 3| 4| 5| 1| 2| 3| 4| 5|                                            |            |
 __________________________________________________________________________________________________________________________________ 
 RESPIRATORY SYSTEM - cont                 |                                                                          |            |
                                           |                                                                          |            |
      Inflammation, Acute                  |                                                                          |      4  2.8|
      Mediastinum, Inflammation, Chronic   |                                                                          |            |
          Active                           |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Nose                                    | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Fungus                               |                                                                          |      5  2.0|
      Inflammation, Acute                  |                            1                                             |      9  2.2|
                                            __________________________________________________________________________|____________|
   Trachea                                 | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Erosion                              |                                                                          |      1  4.0|
      Inflammation, Acute                  |                                                                          |      1  2.0|
 _____________________________________________________________________________________________________________________|            |
 SPECIAL SENSES SYSTEM                     |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Eye                                     |                            +                                             |   2        |
                                            __________________________________________________________________________|____________|
   Zymbal's Gland                          |                                                                          |   1        |
 _____________________________________________________________________________________________________________________|            |
 URINARY SYSTEM                            |                                                                          |            |
                                           |                                                                          |            |
                                            __________________________________________________________________________|____________|
   Kidney                                  | +  +  +  +  +  +  +  +  +  +                                             |  60        |
      Cyst                                 |    X                                                                     |      4     |
      Hemorrhage                           |                                                                          |      1  4.0|
      Mineralization                       |    2                                                                     |      1  2.0|
      Nephropathy                          | 3  4  3  2  1  3  3  3  2                                                |     56  2.7|
      Renal Tubule, Hyperplasia            |                                                                          |      1  2.0|
                                            __________________________________________________________________________|____________|
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +                                             |  57        |
      Calculus Gross Observation           |                                                                          |      1     |
      Calculus Micro Observation Only      |                                                                          |      1     |
      Dilatation                           |                         2                                                |      1  2.0|
 __________________________________________________________________________________________________________________________________ 
  * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade                         
  + : Tissue examined microscopically                M : Missing tissue                        1-4 : Lesion qualified as:           
  X : Lesion present but not qualified               A : Autolysis precludes examination               1) Minimal  3) Moderate      
  I : Insufficient tissue                        BLANK : Not examined                                  2) Mild     4) Marked        
                                                             Page  84                                                               
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                             ----------              END OF REPORT             ----------                                           
                             ------------------------------------------------------------                                           
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.