https://ntp.niehs.nih.gov/go/5435

TDMS Study 88122-06 Pathology Tables

NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01
Route: GAVAGE                                                                                                     Time: 09:22:58
                                                            FINAL#1
       Facility:  Battelle Columbus Laboratory
       Chemical CAS #:  37319-17-8
       Lock Date:  06/01/00
       Cage Range:  All
       Reasons For Removal:    All
       Removal Date Range:     All
       Treatment Groups:       Include All
                                                              Page   1
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 6| 7| 7| 7| 7| 5| 7| 7| 7| 7| 6| 5| 7| 7| 7| 7| 7| 7| 7| 4| 7| 7| 6| 7| 7|             
                             DAY ON TEST   | 0| 2| 2| 2| 2| 9| 2| 2| 2| 2| 5| 9| 3| 3| 3| 2| 2| 1| 3| 0| 3| 2| 2| 3| 3|             
                                           | 0| 9| 6| 9| 9| 6| 8| 9| 9| 9| 1| 6| 0| 0| 0| 9| 9| 9| 0| 6| 0| 9| 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| 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   | 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|             
    0 MG/KG                                | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 ALIMENTARY SYSTEM                         |                                                                          |             
                                           |__________________________________________________________________________|             
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Parasite Metazoan                    |                      X                                                   |             
                                           |__________________________________________________________________________|             
   Intestine Large, Rectum                 | +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Parasite Metazoan                    |                                           X                              |             
                                           |__________________________________________________________________________|             
   Intestine Large, Cecum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Intestine Small, Jejunum                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Peyer's Patch, Hyperplasia, Lymphoid |                                                                          |             
                                           |__________________________________________________________________________|             
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Parasite Metazoan                    |    X                                                                     |             
                                           |__________________________________________________________________________|             
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Basophilic Focus                     | X  X  X  X  X           X  X        X     X  X  X  X  X     X  X     X  X|             
      Clear Cell Focus                     |                      X                 X  X     X              X     X   |             
      Eosinophilic Focus                   |                   X  X              X                 X                  |             
      Hepatodiaphragmatic Nodule           |                                                       X     X            |             
      Inflammation, Granulomatous          |    1  1  1  1           1  1        1  1  1  1  1  1  1  1     1     1   |             
      Mixed Cell Focus                     |    X     X  X  X           X        X  X  X                    X        X|             
      Bile Duct, Hyperplasia               |                   2  2           2              1                 2     1|             
      Centrilobular, Fatty Change          |                                  4                                       |             
                                           |__________________________________________________________________________|             
   Mesentery                               |                         +                             +        +         |             
      Fat, Necrosis                        |                         2                             2        1         |             
                                           |__________________________________________________________________________|             
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Acinus, Atrophy                      |                         1              2        1           1            |             
      Acinus, Hyperplasia, Focal           |             1                                                            |             
                                           |__________________________________________________________________________|             
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Parotid Gland, Atrophy, Focal        |                                                                          |             
 __________________________________________|__________________________________________________________________________|             
                                                             Page   2                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 6| 7| 7| 7| 7| 5| 7| 7| 7| 7| 6| 5| 7| 7| 7| 7| 7| 7| 7| 4| 7| 7| 6| 7| 7|             
                             DAY ON TEST   | 0| 2| 2| 2| 2| 9| 2| 2| 2| 2| 5| 9| 3| 3| 3| 2| 2| 1| 3| 0| 3| 2| 2| 3| 3|             
                                           | 0| 9| 6| 9| 9| 6| 8| 9| 9| 9| 1| 6| 0| 0| 0| 9| 9| 9| 0| 6| 0| 9| 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| 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   | 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|             
    0 MG/KG                                | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 ALIMENTARY SYSTEM - cont                  |                                                                          |             
      Parotid Gland, Hyperplasia, Focal    |          1                                                               |             
                                           |__________________________________________________________________________|             
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Tongue                                  |                         +                                                |             
      Epithelium, Hyperplasia, Focal,      |                                                                          |             
          Squamous                         |                         3                                                |             
 _____________________________________________________________________________________________________________________|             
 CARDIOVASCULAR SYSTEM                     |                                                                          |             
                                           |__________________________________________________________________________|             
   Blood Vessel                            | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Myocardium, Degeneration             | 1  2  2  1  1     1  1     2           1  2  1  1  3        2  1  1  2  1|             
      Myocardium, Inflammation, Chronic,   |                                                                          |             
           Focal                           |                                  3                                       |             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM                          |                                                                          |             
                                           |__________________________________________________________________________|             
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia, Focal                   | 2  2     1  2              3     2  1  1  2  1                    1     1|             
                                           |__________________________________________________________________________|             
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia, Focal                   |                                              3        2                 1|             
                                           |__________________________________________________________________________|             
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                          |             
                                           |__________________________________________________________________________|             
   Parathyroid Gland                       | +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  M|             
                                           |__________________________________________________________________________|             
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Angiectasis                          |                                        2                                 |             
      Cyst                                 | 1           1     1        1     2  1        2     1           1  2     1|             
      Hemorrhage                           |                                                                          |             
      Pars Distalis, Hyperplasia, Focal    |    1        2     2     1  2                          3  1  1            |             
                                           |__________________________________________________________________________|             
 __________________________________________|__________________________________________________________________________|             
                                                             Page   3                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 6| 7| 7| 7| 7| 5| 7| 7| 7| 7| 6| 5| 7| 7| 7| 7| 7| 7| 7| 4| 7| 7| 6| 7| 7|             
                             DAY ON TEST   | 0| 2| 2| 2| 2| 9| 2| 2| 2| 2| 5| 9| 3| 3| 3| 2| 2| 1| 3| 0| 3| 2| 2| 3| 3|             
                                           | 0| 9| 6| 9| 9| 6| 8| 9| 9| 9| 1| 6| 0| 0| 0| 9| 9| 9| 0| 6| 0| 9| 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| 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   | 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|             
    0 MG/KG                                | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 ENDOCRINE SYSTEM - cont                   |                                                                          |             
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      C-Cell, Hyperplasia                  | 2  2  2        1  3     2  2     2        2  2        3     2     2     3|             
 _____________________________________________________________________________________________________________________|             
 GENERAL BODY SYSTEM                       |                                                                          |             
    None                                   |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENITAL SYSTEM                            |                                                                          |             
                                           |__________________________________________________________________________|             
   Clitoral Gland                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |                                                                         2|             
      Fibrosis                             |       1                                                                  |             
      Hyperplasia, Focal                   |             2  2                                      2                  |             
      Hyperplasia                          |                                                                          |             
      Inflammation, Chronic                |                   1           2           1           1                  |             
      Inflammation, Suppurative            |                                                                          |             
                                           |__________________________________________________________________________|             
   Ovary                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |          3                                                               |             
                                           |__________________________________________________________________________|             
   Uterus                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Endometrium, Hyperplasia, Cystic     |                                     1                       1           1|             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM                      |                                                                          |             
                                           |__________________________________________________________________________|             
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Lymph Node                              |       +                                      +                 +         |             
      Deep Cervical, Infiltration Cellular,|                                                                          |             
           Histiocyte                      |                                                                          |             
      Mediastinal, Hyperplasia, Lymphoid   |       1                                                        1         |             
      Mediastinal, Infiltration Cellular,  |                                                                          |             
           Plasma Cell                     |                                                                          |             
      Mediastinal, Infiltration Cellular,  |                                                                          |             
           Histiocyte                      |                                                                          |             
                                           |__________________________________________________________________________|             
   Lymph Node, Mandibular                  | M  M  M  M  M  M  +  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M|             
                                           |__________________________________________________________________________|             
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 __________________________________________|__________________________________________________________________________|             
                                                             Page   4                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 6| 7| 7| 7| 7| 5| 7| 7| 7| 7| 6| 5| 7| 7| 7| 7| 7| 7| 7| 4| 7| 7| 6| 7| 7|             
                             DAY ON TEST   | 0| 2| 2| 2| 2| 9| 2| 2| 2| 2| 5| 9| 3| 3| 3| 2| 2| 1| 3| 0| 3| 2| 2| 3| 3|             
                                           | 0| 9| 6| 9| 9| 6| 8| 9| 9| 9| 1| 6| 0| 0| 0| 9| 9| 9| 0| 6| 0| 9| 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| 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   | 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|             
    0 MG/KG                                | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM - cont               |                                                                          |             
                                           |__________________________________________________________________________|             
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hematopoietic Cell Proliferation     |                1                                         1               |             
      Necrosis, Focal                      |                                                             3            |             
      Lymphoid Follicle, Atrophy           | 2  2     2  2  2        2           2  2  2  3  2  2                 2  3|             
                                           |__________________________________________________________________________|             
   Thymus                                  | +  +  +  +  +  +  +  +  +  M  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +|             
      Epithelial Cell, Hyperplasia         |                                                          2               |             
 _____________________________________________________________________________________________________________________|             
 INTEGUMENTARY SYSTEM                      |                                                                          |             
                                           |__________________________________________________________________________|             
   Mammary Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia, Focal                   | 1              1                                                     4   |             
      Hyperplasia                          |                                  1                                       |             
      Duct, Dilatation                     | 2  1  2     2  1     1           2     2  1  1  2  1        3  2  2  3  2|             
                                           |__________________________________________________________________________|             
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 MUSCULOSKELETAL SYSTEM                    |                                                                          |             
                                           |__________________________________________________________________________|             
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 NERVOUS SYSTEM                            |                                                                          |             
                                           |__________________________________________________________________________|             
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hydrocephalus                        |                1                                                     2   |             
      Cerebrum, Necrosis, Focal            |                                  2                                       |             
      Hypothalamus, Compression            |       2                                                                  |             
 _____________________________________________________________________________________________________________________|             
 RESPIRATORY SYSTEM                        |                                                                          |             
                                           |__________________________________________________________________________|             
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Congestion                           | 2                                                                        |             
      Hemorrhage                           |                                                    2                     |             
      Inflammation, Granulomatous,         |                                                                          |             
          Multifocal                       |                                                 2                        |             
      Metaplasia, Osseous                  |          1                                                               |             
      Alveolar Epithelium, Hyperplasia,    |                                                                          |             
 __________________________________________|__________________________________________________________________________|             
                                                             Page   5                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 6| 7| 7| 7| 7| 5| 7| 7| 7| 7| 6| 5| 7| 7| 7| 7| 7| 7| 7| 4| 7| 7| 6| 7| 7|             
                             DAY ON TEST   | 0| 2| 2| 2| 2| 9| 2| 2| 2| 2| 5| 9| 3| 3| 3| 2| 2| 1| 3| 0| 3| 2| 2| 3| 3|             
                                           | 0| 9| 6| 9| 9| 6| 8| 9| 9| 9| 1| 6| 0| 0| 0| 9| 9| 9| 0| 6| 0| 9| 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| 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   | 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|             
    0 MG/KG                                | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 RESPIRATORY SYSTEM - cont                 |                                                                          |             
           Focal                           |    1              1                                                      |             
      Alveolar Epithelium, Hyperplasia     |                                     2                                    |             
      Alveolus, Emphysema, Focal           |                                                                          |             
      Alveolus, Inflammation, Chronic      |                                                                          |             
          Active, Focal                    |                                        1                                 |             
                                           |__________________________________________________________________________|             
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Chronic                |                                                             1  1  1      |             
                                           |__________________________________________________________________________|             
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM                     |                                                                          |             
                                           |__________________________________________________________________________|             
   Zymbal's Gland                          |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 URINARY SYSTEM                            |                                                                          |             
                                           |__________________________________________________________________________|             
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Infarct                              |                            1     1                                       |             
      Nephropathy                          |                1        1              1        1  1  1     1        1   |             
                                           |__________________________________________________________________________|             
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 __________________________________________|__________________________________________________________________________              
                                                             Page   6                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 7| 1| 5| 7| 6| 6| 7| 7| 6| 4| 6| 7| 7| 7| 7| 5| 7| 6| 7| 7| 7| 4|            |
                             DAY ON TEST   | 2| 3| 3| 2| 9| 5| 2| 2| 7| 2| 3| 9| 2| 7| 3| 0| 3| 2| 0| 2| 0| 2| 3| 2| 6|            |
                                           | 9| 0| 0| 2| 1| 9| 8| 1| 3| 9| 0| 0| 7| 8| 0| 7| 0| 9| 9| 9| 1| 9| 0| 9| 2|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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|      A     |
    0 MG/KG                                | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 ALIMENTARY SYSTEM                         |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Parasite Metazoan                    |                                                                   X      |      2     |
                                           |__________________________________________________________________________|____________|
   Intestine Large, Rectum                 | +  +  +  +  +  +  +  +  +  +  +  A  A  +  +  +  +  +  A  +  +  +  +  +  +|  46        |
      Parasite Metazoan                    |                   X                                                      |      2     |
                                           |__________________________________________________________________________|____________|
   Intestine Large, Cecum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Intestine Small, Jejunum                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Peyer's Patch, Hyperplasia, Lymphoid |          1                                                               |      1  1.0|
                                           |__________________________________________________________________________|____________|
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Parasite Metazoan                    |                                                                          |      1     |
                                           |__________________________________________________________________________|____________|
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Basophilic Focus                     | X  X  X  X     X  X  X  X  X  X  X     X  X  X  X  X  X  X  X  X  X  X   |     39     |
      Clear Cell Focus                     |       X        X                                                         |      8     |
      Eosinophilic Focus                   |          X           X           X     X        X        X  X        X   |     12     |
      Hepatodiaphragmatic Nodule           |       X     X     X     X  X        X                       X            |      9     |
      Inflammation, Granulomatous          | 1  1  2  1     1  1  1     1  1  1  1     1  1     1  1  1  1  1  1     1|     36  1.0|
      Mixed Cell Focus                     | X  X     X                    X           X        X     X        X  X   |     19     |
      Bile Duct, Hyperplasia               |    1     1  1                 2  1        1  1                           |     13  1.4|
      Centrilobular, Fatty Change          |                                                                          |      1  4.0|
                                           |__________________________________________________________________________|____________|
   Mesentery                               | +              +                    +                             +  +   |   8        |
      Fat, Necrosis                        | 2                                   2                             2  1   |      7  1.7|
                                           |__________________________________________________________________________|____________|
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Acinus, Atrophy                      |                                                          1     1        1|      7  1.1|
 _____________________________________________________________________________________________________________________|____________|
  * : 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   7                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 7| 1| 5| 7| 6| 6| 7| 7| 6| 4| 6| 7| 7| 7| 7| 5| 7| 6| 7| 7| 7| 4|            |
                             DAY ON TEST   | 2| 3| 3| 2| 9| 5| 2| 2| 7| 2| 3| 9| 2| 7| 3| 0| 3| 2| 0| 2| 0| 2| 3| 2| 6|            |
                                           | 9| 0| 0| 2| 1| 9| 8| 1| 3| 9| 0| 0| 7| 8| 0| 7| 0| 9| 9| 9| 1| 9| 0| 9| 2|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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|      A     |
    0 MG/KG                                | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 ALIMENTARY SYSTEM - cont                  |                                                                          |            |
      Acinus, Hyperplasia, Focal           |                                                                          |      1  1.0|
                                           |__________________________________________________________________________|____________|
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Parotid Gland, Atrophy, Focal        |       1                                                  1               |      2  1.0|
      Parotid Gland, Hyperplasia, Focal    |                                                                          |      1  1.0|
                                           |__________________________________________________________________________|____________|
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Tongue                                  |                                                                          |   1        |
      Epithelium, Hyperplasia, Focal,      |                                                                          |            |
          Squamous                         |                                                                          |      1  3.0|
 _____________________________________________________________________________________________________________________|            |
 CARDIOVASCULAR SYSTEM                     |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Blood Vessel                            | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Myocardium, Degeneration             |    1  1  1     2  1  1  2        2  1  1  2  2  2  2  1  1  1  1  1     1|     38  1.4|
      Myocardium, Inflammation, Chronic,   |                                                                          |            |
           Focal                           |                                                                          |      1  3.0|
 _____________________________________________________________________________________________________________________|            |
 ENDOCRINE SYSTEM                          |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia, Focal                   |       2  1        1           1  1              2                 1     1|     20  1.5|
                                           |__________________________________________________________________________|____________|
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia, Focal                   |                                           1                       1      |      5  1.6|
                                           |__________________________________________________________________________|____________|
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia                          |                   1                                                      |      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   8                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 7| 1| 5| 7| 6| 6| 7| 7| 6| 4| 6| 7| 7| 7| 7| 5| 7| 6| 7| 7| 7| 4|            |
                             DAY ON TEST   | 2| 3| 3| 2| 9| 5| 2| 2| 7| 2| 3| 9| 2| 7| 3| 0| 3| 2| 0| 2| 0| 2| 3| 2| 6|            |
                                           | 9| 0| 0| 2| 1| 9| 8| 1| 3| 9| 0| 0| 7| 8| 0| 7| 0| 9| 9| 9| 1| 9| 0| 9| 2|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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|      A     |
    0 MG/KG                                | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 ENDOCRINE SYSTEM - cont                   |                                                                          |            |
   Parathyroid Gland                       | M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  46        |
                                           |__________________________________________________________________________|____________|
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Angiectasis                          |                                                                          |      1  2.0|
      Cyst                                 | 2  1  1  1                 1  1     1  1                             1   |     20  1.2|
      Hemorrhage                           |                                     2                                    |      1  2.0|
      Pars Distalis, Hyperplasia, Focal    | 3                 1        1  2           3        3  1              2   |     16  1.8|
                                           |__________________________________________________________________________|____________|
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      C-Cell, Hyperplasia                  | 2     1  1        2  1     2     2     3  2  2  3  4  1  4  1  2  2  2  1|     33  2.1|
 _____________________________________________________________________________________________________________________|            |
 GENERAL BODY SYSTEM                       |                                                                          |            |
    None                                   |                                                                          |            |
 _____________________________________________________________________________________________________________________|            |
 GENITAL SYSTEM                            |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Clitoral Gland                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Cyst                                 |    2                    1                          2                     |      4  1.8|
      Fibrosis                             |                                                                          |      1  1.0|
      Hyperplasia, Focal                   | 3                             2                                          |      5  2.2|
      Hyperplasia                          |                3                                                         |      1  3.0|
      Inflammation, Chronic                |       1                                1                       1         |      7  1.1|
      Inflammation, Suppurative            |    2                                                                     |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Ovary                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Cyst                                 |             1  3                                   1                     |      4  2.0|
                                           |__________________________________________________________________________|____________|
   Uterus                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Endometrium, Hyperplasia, Cystic     |                                           1                              |      4  1.0|
 _____________________________________________________________________________________________________________________|            |
 HEMATOPOIETIC SYSTEM                      |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
 _____________________________________________________________________________________________________________________|____________|
  * : 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: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 7| 1| 5| 7| 6| 6| 7| 7| 6| 4| 6| 7| 7| 7| 7| 5| 7| 6| 7| 7| 7| 4|            |
                             DAY ON TEST   | 2| 3| 3| 2| 9| 5| 2| 2| 7| 2| 3| 9| 2| 7| 3| 0| 3| 2| 0| 2| 0| 2| 3| 2| 6|            |
                                           | 9| 0| 0| 2| 1| 9| 8| 1| 3| 9| 0| 0| 7| 8| 0| 7| 0| 9| 9| 9| 1| 9| 0| 9| 2|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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|      A     |
    0 MG/KG                                | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 HEMATOPOIETIC SYSTEM - cont               |                                                                          |            |
   Lymph Node                              |    +     +                                               +           +   |   7        |
      Deep Cervical, Infiltration Cellular,|                                                                          |            |
           Histiocyte                      |    1                                                                     |      1  1.0|
      Mediastinal, Hyperplasia, Lymphoid   |                                                                          |      2  1.0|
      Mediastinal, Infiltration Cellular,  |                                                                          |            |
           Plasma Cell                     |                                                          3               |      1  3.0|
      Mediastinal, Infiltration Cellular,  |                                                                          |            |
           Histiocyte                      |                                                                      1   |      1  1.0|
                                           |__________________________________________________________________________|____________|
   Lymph Node, Mandibular                  | +  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  +  M  M  M|   3        |
                                           |__________________________________________________________________________|____________|
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hematopoietic Cell Proliferation     | 1  1                                   1        1                        |      6  1.0|
      Necrosis, Focal                      |                                                                          |      1  3.0|
      Lymphoid Follicle, Atrophy           | 3  2  2  2  2  2  2  2  2  3  2  2  2     2     1  2  3  2        2  2  2|     35  2.1|
                                           |__________________________________________________________________________|____________|
   Thymus                                  | +  +  M  +  +  M  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +|  45        |
      Epithelial Cell, Hyperplasia         |                                                                          |      1  2.0|
 _____________________________________________________________________________________________________________________|            |
 INTEGUMENTARY SYSTEM                      |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Mammary Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia, Focal                   | 1                                                        1              1|      6  1.5|
      Hyperplasia                          |          2                                                               |      2  1.5|
      Duct, Dilatation                     | 2  1     2     1  1     1     1           3        1     3     2        2|     29  1.7|
                                           |__________________________________________________________________________|____________|
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
 _____________________________________________________________________________________________________________________|            |
 MUSCULOSKELETAL SYSTEM                    |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
 _____________________________________________________________________________________________________________________|            |
  * : 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: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 7| 1| 5| 7| 6| 6| 7| 7| 6| 4| 6| 7| 7| 7| 7| 5| 7| 6| 7| 7| 7| 4|            |
                             DAY ON TEST   | 2| 3| 3| 2| 9| 5| 2| 2| 7| 2| 3| 9| 2| 7| 3| 0| 3| 2| 0| 2| 0| 2| 3| 2| 6|            |
                                           | 9| 0| 0| 2| 1| 9| 8| 1| 3| 9| 0| 0| 7| 8| 0| 7| 0| 9| 9| 9| 1| 9| 0| 9| 2|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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|      A     |
    0 MG/KG                                | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 NERVOUS SYSTEM                            |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hydrocephalus                        |          3              1        3           3           3              4|      8  2.5|
      Cerebrum, Necrosis, Focal            |                                                                          |      1  2.0|
      Hypothalamus, Compression            |                         1        4           3                          4|      5  2.8|
 _____________________________________________________________________________________________________________________|            |
 RESPIRATORY SYSTEM                        |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Congestion                           |             2                       2                 2     2            |      5  2.0|
      Hemorrhage                           |                                              3                           |      2  2.5|
      Inflammation, Granulomatous,         |                                                                          |            |
          Multifocal                       |                                                                          |      1  2.0|
      Metaplasia, Osseous                  |                            1                                             |      2  1.0|
      Alveolar Epithelium, Hyperplasia,    |                                                                          |            |
           Focal                           |                               1                                          |      3  1.0|
      Alveolar Epithelium, Hyperplasia     |                                                                          |      1  2.0|
      Alveolus, Emphysema, Focal           |                                                       2                  |      1  2.0|
      Alveolus, Inflammation, Chronic      |                                                                          |            |
          Active, Focal                    |                                                 1                        |      2  1.0|
                                           |__________________________________________________________________________|____________|
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Inflammation, Chronic                |                                                 1        2     1         |      6  1.2|
                                           |__________________________________________________________________________|____________|
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
 _____________________________________________________________________________________________________________________|            |
 SPECIAL SENSES SYSTEM                     |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Zymbal's Gland                          |       +                                                                  |   1        |
 _____________________________________________________________________________________________________________________|            |
 URINARY SYSTEM                            |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Infarct                              |                                                                          |      2  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  11                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 7| 1| 5| 7| 6| 6| 7| 7| 6| 4| 6| 7| 7| 7| 7| 5| 7| 6| 7| 7| 7| 4|            |
                             DAY ON TEST   | 2| 3| 3| 2| 9| 5| 2| 2| 7| 2| 3| 9| 2| 7| 3| 0| 3| 2| 0| 2| 0| 2| 3| 2| 6|            |
                                           | 9| 0| 0| 2| 1| 9| 8| 1| 3| 9| 0| 0| 7| 8| 0| 7| 0| 9| 9| 9| 1| 9| 0| 9| 2|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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|      A     |
    0 MG/KG                                | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 URINARY SYSTEM - cont                     |                                                                          |            |
      Nephropathy                          |    1              1                             1  1     1     1  1     1|     16  1.0|
                                           |__________________________________________________________________________|____________|
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
 __________________________________________________________________________________________________________________________________ 
  * : 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  12                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 6| 7| 7| 7| 7| 5| 7| 5| 3| 7| 7| 7| 7| 7| 7|             
                             DAY ON TEST   | 3| 2| 2| 1| 2| 2| 2| 7| 2| 1| 2| 2| 2| 2| 1| 3| 2| 8| 3| 3| 3| 3| 2| 2| 3|             
                                           | 0| 9| 9| 4| 8| 9| 8| 0| 9| 6| 2| 9| 9| 8| 5| 9| 9| 9| 3| 0| 0| 0| 8| 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| 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   | 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|             
    28 MG/KG                               | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 ALIMENTARY SYSTEM                         |                                                                          |             
                                           |__________________________________________________________________________|             
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Parasite Metazoan                    |                                                 X                        |             
                                           |__________________________________________________________________________|             
   Intestine Large, Rectum                 | +  +  +  +  +  +  +  A  +  +  +  +  +  +  A  +  +  A  A  +  +  +  +  +  +|             
      Myxomatous Change                    |                                                                          |             
      Parasite Metazoan                    |                                                             X            |             
                                           |__________________________________________________________________________|             
   Intestine Large, Cecum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Intestine Small, Jejunum                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Basophilic Focus                     |    X        X  X  X        X     X  X  X        X     X  X  X  X  X     X|             
      Clear Cell Focus                     |             X                       X                       X     X      |             
      Eosinophilic Focus                   |             X                                                  X         |             
      Hepatodiaphragmatic Nodule           | X                    X                             X        X            |             
      Inflammation, Granulomatous          |    1        1     1     1  1        1        1  1     1  1  1     2     1|             
      Mixed Cell Focus                     |    X        X     X     X        X                                       |             
      Regeneration                         |                               3                                          |             
      Bile Duct, Hyperplasia               |    1  1  1                    1           1              1  1            |             
      Centrilobular, Fatty Change          |                      4        3                                          |             
                                           |__________________________________________________________________________|             
   Mesentery                               |             +                       +                             +      |             
      Fat, Necrosis                        |             2                       2                             3      |             
                                           |__________________________________________________________________________|             
   Oral Mucosa                             |                                                             +            |             
      Pharyngeal, Hyperplasia, Squamous    |                                                             4            |             
                                           |__________________________________________________________________________|             
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Acinus, Atrophy                      |       2                                      1                    3  2   |             
      Acinus, Hyperplasia, Focal           |                                                                          |             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  13                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 6| 7| 7| 7| 7| 5| 7| 5| 3| 7| 7| 7| 7| 7| 7|             
                             DAY ON TEST   | 3| 2| 2| 1| 2| 2| 2| 7| 2| 1| 2| 2| 2| 2| 1| 3| 2| 8| 3| 3| 3| 3| 2| 2| 3|             
                                           | 0| 9| 9| 4| 8| 9| 8| 0| 9| 6| 2| 9| 9| 8| 5| 9| 9| 9| 3| 0| 0| 0| 8| 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| 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   | 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|             
    28 MG/KG                               | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 ALIMENTARY SYSTEM - cont                  |                                                                          |             
                                           |__________________________________________________________________________|             
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Parotid Gland, Atrophy, Focal        |                                                                          |             
                                           |__________________________________________________________________________|             
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Mineralization                       |                                                             1            |             
      Epithelium, Ectasia                  |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 CARDIOVASCULAR SYSTEM                     |                                                                          |             
                                           |__________________________________________________________________________|             
   Blood Vessel                            | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Atrium, Thrombosis                   |                      4                                                   |             
      Myocardium, Degeneration             |    1  2  1     1  1  2  1  1     1     1  2     1  2           1  1     1|             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM                          |                                                                          |             
                                           |__________________________________________________________________________|             
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia, Focal                   | 1  1        1  1     1  1        1  2           2        1     1         |             
                                           |__________________________________________________________________________|             
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia, Focal                   |             1  1                                                         |             
                                           |__________________________________________________________________________|             
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |          2                                                               |             
                                           |__________________________________________________________________________|             
   Parathyroid Gland                       | M  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  M  +  +  M  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Angiectasis                          |                               2           3                              |             
      Cyst                                 | 2        2  1        1     1  2  1              3        2  1     1  1   |             
      Pars Distalis, Hyperplasia, Focal    |    2  1           1        3                 2           2  1            |             
                                           |__________________________________________________________________________|             
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      C-Cell, Hyperplasia                  | 2  4  2  4  2     2     4  4  2  3  3  2     1     1        2  4  4  2  2|             
 _____________________________________________________________________________________________________________________|             
 GENERAL BODY SYSTEM                       |                                                                          |             
    None                                   |                                                                          |             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  14                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 6| 7| 7| 7| 7| 5| 7| 5| 3| 7| 7| 7| 7| 7| 7|             
                             DAY ON TEST   | 3| 2| 2| 1| 2| 2| 2| 7| 2| 1| 2| 2| 2| 2| 1| 3| 2| 8| 3| 3| 3| 3| 2| 2| 3|             
                                           | 0| 9| 9| 4| 8| 9| 8| 0| 9| 6| 2| 9| 9| 8| 5| 9| 9| 9| 3| 0| 0| 0| 8| 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| 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   | 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|             
    28 MG/KG                               | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 GENITAL SYSTEM                            |                                                                          |             
                                           |__________________________________________________________________________|             
   Clitoral Gland                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |                                                                          |             
      Hyperplasia, Focal                   |          2                                                               |             
      Inflammation, Chronic                |                                     1                                    |             
                                           |__________________________________________________________________________|             
   Ovary                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |                2              3                                2         |             
                                           |__________________________________________________________________________|             
   Oviduct                                 |                                                                          |             
      Cyst                                 |                                                                          |             
                                           |__________________________________________________________________________|             
   Uterus                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Ulcer                                |                                                                          |             
      Endometrium, Hyperplasia, Cystic     |                                                                   1      |             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM                      |                                                                          |             
                                           |__________________________________________________________________________|             
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fibrosis                             |                                                                          |             
                                           |__________________________________________________________________________|             
   Lymph Node                              |       +  +     +        +  +              +     +  +        +  +  +  +   |             
      Deep Cervical, Hyperplasia, Lymphoid |                                                 2                        |             
      Mediastinal, Ectasia                 |                         2                                      2         |             
      Mediastinal, Hemorrhage              |                            2                                1     2      |             
      Mediastinal, Hyperplasia, Lymphoid   |                                                             2            |             
      Mediastinal, Necrosis, Lymphoid      |                                           2                              |             
                                           |__________________________________________________________________________|             
   Lymph Node, Mandibular                  | M  M  M  M  M  M  M  M  M  +  +  +  M  M  M  M  M  +  M  +  M  M  M  +  +|             
      Infiltration Cellular, Histiocyte    |                               3                                          |             
      Necrosis, Lymphoid                   |                               3                                          |             
                                           |__________________________________________________________________________|             
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Infiltration Cellular, Histiocyte    |                                                                         1|             
                                           |__________________________________________________________________________|             
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hematopoietic Cell Proliferation     |             1                                                           2|             
      Hyperplasia, Lymphohistiocytic       |                                                                          |             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  15                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 6| 7| 7| 7| 7| 5| 7| 5| 3| 7| 7| 7| 7| 7| 7|             
                             DAY ON TEST   | 3| 2| 2| 1| 2| 2| 2| 7| 2| 1| 2| 2| 2| 2| 1| 3| 2| 8| 3| 3| 3| 3| 2| 2| 3|             
                                           | 0| 9| 9| 4| 8| 9| 8| 0| 9| 6| 2| 9| 9| 8| 5| 9| 9| 9| 3| 0| 0| 0| 8| 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| 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   | 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|             
    28 MG/KG                               | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM - cont               |                                                                          |             
      Lymphoid Follicle, Atrophy           |    2        1     2  4     2     2  2  2     2  2     2     2  2  2     2|             
                                           |__________________________________________________________________________|             
   Thymus                                  | +  +  M  +  +  +  +  M  +  +  +  +  +  +  M  +  M  +  +  +  M  +  M  +  M|             
 _____________________________________________________________________________________________________________________|             
 INTEGUMENTARY SYSTEM                      |                                                                          |             
                                           |__________________________________________________________________________|             
   Mammary Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia, Focal                   |          2                       1                                       |             
      Duct, Dilatation                     | 1        2  1                    1  2              1        1     2      |             
                                           |__________________________________________________________________________|             
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Subcutaneous Tissue, Pigmentation,   |                                                                          |             
           Hemosiderin                     |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 MUSCULOSKELETAL SYSTEM                    |                                                                          |             
                                           |__________________________________________________________________________|             
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Osteopetrosis                        |                               3                                          |             
 _____________________________________________________________________________________________________________________|             
 NERVOUS SYSTEM                            |                                                                          |             
                                           |__________________________________________________________________________|             
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hydrocephalus                        |                                                 3                    2  2|             
      Hypothalamus, Compression            |                                                                         3|             
      Medulla, Compression                 |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 RESPIRATORY SYSTEM                        |                                                                          |             
                                           |__________________________________________________________________________|             
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Congestion                           |                                                       3                  |             
      Hemorrhage                           |                                                       2                  |             
      Alveolar Epithelium, Hyperplasia,    |                                                                          |             
           Focal                           |                1        1                                                |             
      Alveolus, Inflammation, Acute        |                               2                                          |             
      Alveolus, Inflammation, Chronic      |                                                                          |             
          Active, Focal                    | 1     1  1  2           1     2  2  1  1           1        2  1        2|             
                                           |__________________________________________________________________________|             
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  16                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 6| 7| 7| 7| 7| 5| 7| 5| 3| 7| 7| 7| 7| 7| 7|             
                             DAY ON TEST   | 3| 2| 2| 1| 2| 2| 2| 7| 2| 1| 2| 2| 2| 2| 1| 3| 2| 8| 3| 3| 3| 3| 2| 2| 3|             
                                           | 0| 9| 9| 4| 8| 9| 8| 0| 9| 6| 2| 9| 9| 8| 5| 9| 9| 9| 3| 0| 0| 0| 8| 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| 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   | 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|             
    28 MG/KG                               | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 RESPIRATORY SYSTEM - cont                 |                                                                          |             
      Inflammation, Chronic                |       1                          1                                       |             
                                           |__________________________________________________________________________|             
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Chronic                |                                                                          |             
      Peritracheal Tissue, Hemorrhage      |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM                     |                                                                          |             
                                           |__________________________________________________________________________|             
   Eye                                     |                                        +                                 |             
      Cataract                             |                                                                          |             
      Degeneration                         |                                        3                                 |             
 _____________________________________________________________________________________________________________________|             
 URINARY SYSTEM                            |                                                                          |             
                                           |__________________________________________________________________________|             
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Focal, Suppurative     |                               2                                          |             
      Nephropathy                          |                         1     1  1     1        1        1              1|             
      Renal Tubule, Cyst                   |                                                                          |             
                                           |__________________________________________________________________________|             
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 __________________________________________|__________________________________________________________________________              
                                                             Page  17                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 7| 7| 7| 7| 6| 6| 7| 7| 5| 7| 5| 4| 7| 1| 7| 7| 5| 7| 7| 6| 6| 7|            |
                             DAY ON TEST   | 2| 3| 2| 3| 3| 2| 2| 7| 5| 2| 2| 1| 1| 2| 7| 2| 9| 1| 2| 9| 2| 3| 7| 7| 3|            |
                                           | 8| 0| 9| 0| 0| 9| 9| 8| 3| 8| 9| 0| 6| 6| 4| 9| 7| 9| 8| 4| 9| 0| 7| 8| 0|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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| 3|      A     |
    28 MG/KG                               | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 ALIMENTARY SYSTEM                         |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Parasite Metazoan                    |                                     X                                   X|      3     |
                                           |__________________________________________________________________________|____________|
   Intestine Large, Rectum                 | +  +  +  +  +  +  +  +  A  +  +  +  +  A  +  +  +  +  +  +  +  +  A  +  +|  43        |
      Myxomatous Change                    |                                           1                              |      1  1.0|
      Parasite Metazoan                    |          X                 X                                             |      3     |
                                           |__________________________________________________________________________|____________|
   Intestine Large, Cecum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Intestine Small, Jejunum                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Basophilic Focus                     | X  X  X  X  X  X  X  X     X  X     X  X  X  X     X  X     X  X     X  X|     35     |
      Clear Cell Focus                     |                                                                          |      4     |
      Eosinophilic Focus                   |    X  X  X  X     X              X  X              X  X              X   |     12     |
      Hepatodiaphragmatic Nodule           |    X                 X                                   X              X|      8     |
      Inflammation, Granulomatous          | 1  1  1  1  1  1  1  1     1        1     1  2  1  1  1     1  1        1|     31  1.1|
      Mixed Cell Focus                     |             X  X     X              X              X        X           X|     12     |
      Regeneration                         |                                                                          |      1  3.0|
      Bile Duct, Hyperplasia               |    1  1  1                    2  1  1              1                     |     14  1.1|
      Centrilobular, Fatty Change          |                                                                          |      2  3.5|
                                           |__________________________________________________________________________|____________|
   Mesentery                               |                                           +                              |   4        |
      Fat, Necrosis                        |                                           1                              |      4  2.0|
                                           |__________________________________________________________________________|____________|
   Oral Mucosa                             |                                                                          |   1        |
      Pharyngeal, Hyperplasia, Squamous    |                                                                          |      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  18                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 7| 7| 7| 7| 6| 6| 7| 7| 5| 7| 5| 4| 7| 1| 7| 7| 5| 7| 7| 6| 6| 7|            |
                             DAY ON TEST   | 2| 3| 2| 3| 3| 2| 2| 7| 5| 2| 2| 1| 1| 2| 7| 2| 9| 1| 2| 9| 2| 3| 7| 7| 3|            |
                                           | 8| 0| 9| 0| 0| 9| 9| 8| 3| 8| 9| 0| 6| 6| 4| 9| 7| 9| 8| 4| 9| 0| 7| 8| 0|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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| 3|      A     |
    28 MG/KG                               | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 ALIMENTARY SYSTEM - cont                  |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Acinus, Atrophy                      | 3     1  1  1           3                                   1  1        1|     12  1.7|
      Acinus, Hyperplasia, Focal           |                                                    2                     |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Parotid Gland, Atrophy, Focal        |                                                    1                     |      1  1.0|
                                           |__________________________________________________________________________|____________|
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Mineralization                       |                                                                          |      1  1.0|
      Epithelium, Ectasia                  |                               1                                          |      1  1.0|
 _____________________________________________________________________________________________________________________|            |
 CARDIOVASCULAR SYSTEM                     |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Blood Vessel                            | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Atrium, Thrombosis                   |                                                                          |      1  4.0|
      Myocardium, Degeneration             | 1  1     1  1  1  2     1     1        2     2        1        3     1  1|     30  1.3|
 _____________________________________________________________________________________________________________________|            |
 ENDOCRINE SYSTEM                          |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia, Focal                   |                               1              2        3     1  1        1|     17  1.3|
                                           |__________________________________________________________________________|____________|
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia, Focal                   |                                                                          |      2  1.0|
                                           |__________________________________________________________________________|____________|
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia                          |                                                                          |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Parathyroid Gland                       | +  +  M  +  +  +  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +|  44        |
 _____________________________________________________________________________________________________________________|____________|
  * : 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: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 7| 7| 7| 7| 6| 6| 7| 7| 5| 7| 5| 4| 7| 1| 7| 7| 5| 7| 7| 6| 6| 7|            |
                             DAY ON TEST   | 2| 3| 2| 3| 3| 2| 2| 7| 5| 2| 2| 1| 1| 2| 7| 2| 9| 1| 2| 9| 2| 3| 7| 7| 3|            |
                                           | 8| 0| 9| 0| 0| 9| 9| 8| 3| 8| 9| 0| 6| 6| 4| 9| 7| 9| 8| 4| 9| 0| 7| 8| 0|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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| 3|      A     |
    28 MG/KG                               | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 ENDOCRINE SYSTEM - cont                   |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Angiectasis                          |                                                                          |      2  2.5|
      Cyst                                 | 2  1     2     1              1     1     1  1                 2         |     21  1.4|
      Pars Distalis, Hyperplasia, Focal    |       1  1  1           2  2              1                 2           1|     15  1.5|
                                           |__________________________________________________________________________|____________|
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      C-Cell, Hyperplasia                  | 2  2        2  3  2  2  1     3     4     1  3  1     1  1  2  2  1  1  1|     38  2.2|
 _____________________________________________________________________________________________________________________|            |
 GENERAL BODY SYSTEM                       |                                                                          |            |
    None                                   |                                                                          |            |
 _____________________________________________________________________________________________________________________|            |
 GENITAL SYSTEM                            |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Clitoral Gland                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Cyst                                 |                   3                          2                    3  2   |      4  2.5|
      Hyperplasia, Focal                   |                      1     2                                             |      3  1.7|
      Inflammation, Chronic                |          1     1     1  2     1              2     1                 1  1|     10  1.2|
                                           |__________________________________________________________________________|____________|
   Ovary                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Cyst                                 | 3                                                              1         |      5  2.2|
                                           |__________________________________________________________________________|____________|
   Oviduct                                 |                                     +                                    |   1        |
      Cyst                                 |                                     3                                    |      1  3.0|
                                           |__________________________________________________________________________|____________|
   Uterus                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Ulcer                                |                4                                                         |      1  4.0|
      Endometrium, Hyperplasia, Cystic     |          2  2                                      2        1            |      5  1.6|
 _____________________________________________________________________________________________________________________|            |
 HEMATOPOIETIC SYSTEM                      |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Fibrosis                             |                                  1                                       |      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  20                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 7| 7| 7| 7| 6| 6| 7| 7| 5| 7| 5| 4| 7| 1| 7| 7| 5| 7| 7| 6| 6| 7|            |
                             DAY ON TEST   | 2| 3| 2| 3| 3| 2| 2| 7| 5| 2| 2| 1| 1| 2| 7| 2| 9| 1| 2| 9| 2| 3| 7| 7| 3|            |
                                           | 8| 0| 9| 0| 0| 9| 9| 8| 3| 8| 9| 0| 6| 6| 4| 9| 7| 9| 8| 4| 9| 0| 7| 8| 0|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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| 3|      A     |
    28 MG/KG                               | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 HEMATOPOIETIC SYSTEM - cont               |                                                                          |            |
   Lymph Node                              |                +        +     +     +        +     +     +               |  19        |
      Deep Cervical, Hyperplasia, Lymphoid |                                                                          |      1  2.0|
      Mediastinal, Ectasia                 |                                                                          |      2  2.0|
      Mediastinal, Hemorrhage              |                                                                          |      3  1.7|
      Mediastinal, Hyperplasia, Lymphoid   |                                     2        2                           |      3  2.0|
      Mediastinal, Necrosis, Lymphoid      |                                                                          |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Lymph Node, Mandibular                  | M  M  M  M  M  M  M  M  M  M  M  M  M  +  M  M  M  M  M  M  M  M  M  M  M|   8        |
      Infiltration Cellular, Histiocyte    |                                                                          |      1  3.0|
      Necrosis, Lymphoid                   |                                                                          |      1  3.0|
                                           |__________________________________________________________________________|____________|
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Infiltration Cellular, Histiocyte    | 1                                               2                        |      3  1.3|
                                           |__________________________________________________________________________|____________|
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hematopoietic Cell Proliferation     |                                                                          |      2  1.5|
      Hyperplasia, Lymphohistiocytic       |                            2                                             |      1  2.0|
      Lymphoid Follicle, Atrophy           | 2  2        2  2  2  2     2        2  2  2  2  2     3     2  2  2  2   |     32  2.1|
                                           |__________________________________________________________________________|____________|
   Thymus                                  | +  +  +  +  +  +  +  M  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  41        |
 _____________________________________________________________________________________________________________________|            |
 INTEGUMENTARY SYSTEM                      |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Mammary Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia, Focal                   |          1                                                               |      3  1.3|
      Duct, Dilatation                     |    1     1  1           1  1                 1     3                     |     15  1.3|
                                           |__________________________________________________________________________|____________|
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Subcutaneous Tissue, Pigmentation,   |                                                                          |            |
           Hemosiderin                     |                                  3                                       |      1  3.0|
 _____________________________________________________________________________________________________________________|            |
 MUSCULOSKELETAL SYSTEM                    |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
 _____________________________________________________________________________________________________________________|____________|
  * : 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  21                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 7| 7| 7| 7| 6| 6| 7| 7| 5| 7| 5| 4| 7| 1| 7| 7| 5| 7| 7| 6| 6| 7|            |
                             DAY ON TEST   | 2| 3| 2| 3| 3| 2| 2| 7| 5| 2| 2| 1| 1| 2| 7| 2| 9| 1| 2| 9| 2| 3| 7| 7| 3|            |
                                           | 8| 0| 9| 0| 0| 9| 9| 8| 3| 8| 9| 0| 6| 6| 4| 9| 7| 9| 8| 4| 9| 0| 7| 8| 0|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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| 3|      A     |
    28 MG/KG                               | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 MUSCULOSKELETAL SYSTEM - cont             |                                                                          |            |
      Osteopetrosis                        |                                                                          |      1  3.0|
 _____________________________________________________________________________________________________________________|            |
 NERVOUS SYSTEM                            |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hydrocephalus                        |                                                    3  2              3   |      6  2.5|
      Hypothalamus, Compression            |                                                    4                 4   |      3  3.7|
      Medulla, Compression                 |                                                       2                  |      1  2.0|
 _____________________________________________________________________________________________________________________|            |
 RESPIRATORY SYSTEM                        |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Congestion                           |                                        2        2                        |      3  2.3|
      Hemorrhage                           |                                                                          |      1  2.0|
      Alveolar Epithelium, Hyperplasia,    |                                                                          |            |
           Focal                           |             1              1                                             |      4  1.0|
      Alveolus, Inflammation, Acute        |                                                                          |      1  2.0|
      Alveolus, Inflammation, Chronic      |                                                                          |            |
          Active, Focal                    | 2     1     1     1        2     1  1              1  2  1           1  1|     25  1.3|
                                           |__________________________________________________________________________|____________|
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Inflammation, Chronic                |                         1                                                |      3  1.0|
                                           |__________________________________________________________________________|____________|
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Inflammation, Chronic                |    2                                                                     |      1  2.0|
      Peritracheal Tissue, Hemorrhage      |    1                                                                     |      1  1.0|
 _____________________________________________________________________________________________________________________|            |
 SPECIAL SENSES SYSTEM                     |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Eye                                     |                         +                          +                     |   3        |
      Cataract                             |                         3                                                |      1  3.0|
      Degeneration                         |                                                    3                     |      2  3.0|
 _____________________________________________________________________________________________________________________|            |
 URINARY 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  22                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 7| 7| 7| 7| 6| 6| 7| 7| 5| 7| 5| 4| 7| 1| 7| 7| 5| 7| 7| 6| 6| 7|            |
                             DAY ON TEST   | 2| 3| 2| 3| 3| 2| 2| 7| 5| 2| 2| 1| 1| 2| 7| 2| 9| 1| 2| 9| 2| 3| 7| 7| 3|            |
                                           | 8| 0| 9| 0| 0| 9| 9| 8| 3| 8| 9| 0| 6| 6| 4| 9| 7| 9| 8| 4| 9| 0| 7| 8| 0|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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| 3|      A     |
    28 MG/KG                               | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 URINARY SYSTEM - cont                     |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Inflammation, Focal, Suppurative     |                                                                          |      1  2.0|
      Nephropathy                          |             1     1  1        1                    1  1                  |     13  1.0|
      Renal Tubule, Cyst                   |                                                       2                  |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
 __________________________________________________________________________________________________________________________________ 
  * : 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  23                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 4| 7| 6| 7| 7| 6| 7| 3| 4| 7| 7| 7| 4| 6| 6| 7| 7| 7| 7| 5| 7| 1| 7| 6| 7|             
                             DAY ON TEST   | 9| 2| 8| 2| 3| 6| 3| 7| 7| 2| 3| 2| 8| 9| 7| 2| 2| 2| 2| 5| 3| 1| 3| 1| 2|             
                                           | 1| 8| 5| 8| 0| 7| 0| 5| 4| 8| 0| 8| 3| 1| 3| 8| 8| 8| 3| 9| 0| 1| 0| 4| 8|             
 __________________________________________|__________________________________________________________________________|             
                                           | 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   | 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|             
    84 MG/KG                               | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 ALIMENTARY SYSTEM                         |                                                                          |             
                                           |__________________________________________________________________________|             
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Parasite Metazoan                    |                                                    X  X                  |             
                                           |__________________________________________________________________________|             
   Intestine Large, Rectum                 | +  +  +  +  +  A  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  A  +|             
      Inflammation, Chronic                |                                                                          |             
      Myxomatous Change                    |                   1        1     2  1     1     1  1  1                  |             
      Parasite Metazoan                    |                                                                          |             
                                           |__________________________________________________________________________|             
   Intestine Large, Cecum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Intestine Small, Jejunum                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Angiectasis                          |                                                       2                  |             
      Basophilic Focus                     |    X  X  X  X     X     X  X  X  X  X     X  X  X     X     X     X     X|             
      Clear Cell Focus                     |       X                             X                                    |             
      Eosinophilic Focus                   |             X                                   X           X     X      |             
      Fibrosis, Focal                      |                                                    1                     |             
      Hepatodiaphragmatic Nodule           |                      X     X              X  X        X        X        X|             
      Inflammation, Granulomatous          |    1  1  1  1     1  1  1  1  1  1        1  1  2  1  1     1     1      |             
      Mixed Cell Focus                     |          X        X                                X  X                  |             
      Regeneration                         |                                                                         2|             
      Tension Lipidosis                    |                                                                          |             
      Bile Duct, Hyperplasia               | 2           1                          1           1  1                 1|             
      Bile Duct, Inflammation              |                      1                                                   |             
                                           |__________________________________________________________________________|             
   Mesentery                               |                                     +     +              +               |             
      Fat, Necrosis                        |                                     2     3              3               |             
                                           |__________________________________________________________________________|             
   Oral Mucosa                             |                                                                          |             
      Cyst                                 |                                                                          |             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  24                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 4| 7| 6| 7| 7| 6| 7| 3| 4| 7| 7| 7| 4| 6| 6| 7| 7| 7| 7| 5| 7| 1| 7| 6| 7|             
                             DAY ON TEST   | 9| 2| 8| 2| 3| 6| 3| 7| 7| 2| 3| 2| 8| 9| 7| 2| 2| 2| 2| 5| 3| 1| 3| 1| 2|             
                                           | 1| 8| 5| 8| 0| 7| 0| 5| 4| 8| 0| 8| 3| 1| 3| 8| 8| 8| 3| 9| 0| 1| 0| 4| 8|             
 __________________________________________|__________________________________________________________________________|             
                                           | 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   | 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|             
    84 MG/KG                               | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 ALIMENTARY SYSTEM - cont                  |                                                                          |             
                                           |__________________________________________________________________________|             
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Acinus, Atrophy                      |    1  1              1  1  1                          1     1           2|             
                                           |__________________________________________________________________________|             
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Acute                  |                                        1                                 |             
                                           |__________________________________________________________________________|             
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Ulcer                                |                                        2                                 |             
 _____________________________________________________________________________________________________________________|             
 CARDIOVASCULAR SYSTEM                     |                                                                          |             
                                           |__________________________________________________________________________|             
   Blood Vessel                            | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Aorta, Inflammation, Chronic         |                                                                          |             
                                           |__________________________________________________________________________|             
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Myocardium, Degeneration             |    1     2  2        1     1  1  1     1  1  2  2  1     2  2     2  2  1|             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM                          |                                                                          |             
                                           |__________________________________________________________________________|             
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia, Focal                   |             1           1                 1  1  1  1  3     1            |             
                                           |__________________________________________________________________________|             
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia, Focal                   |             1                                      3                     |             
                                           |__________________________________________________________________________|             
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Parathyroid Gland                       | +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  M  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Angiectasis                          |                               1                                          |             
      Cyst                                 | 1  1  1     1     1        1        1              2  1                 1|             
      Pars Distalis, Hyperplasia, Focal    | 1                 1                                         1            |             
                                           |__________________________________________________________________________|             
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  25                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 4| 7| 6| 7| 7| 6| 7| 3| 4| 7| 7| 7| 4| 6| 6| 7| 7| 7| 7| 5| 7| 1| 7| 6| 7|             
                             DAY ON TEST   | 9| 2| 8| 2| 3| 6| 3| 7| 7| 2| 3| 2| 8| 9| 7| 2| 2| 2| 2| 5| 3| 1| 3| 1| 2|             
                                           | 1| 8| 5| 8| 0| 7| 0| 5| 4| 8| 0| 8| 3| 1| 3| 8| 8| 8| 3| 9| 0| 1| 0| 4| 8|             
 __________________________________________|__________________________________________________________________________|             
                                           | 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   | 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|             
    84 MG/KG                               | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 ENDOCRINE SYSTEM - cont                   |                                                                          |             
      Hemorrhage                           |                                                                2         |             
      C-Cell, Hyperplasia                  | 3     4  2  2  2  2     1  1  2  2  2  2     3  3  2        2     2  1  2|             
      Follicle, Hyperplasia                |                                                       3                  |             
 _____________________________________________________________________________________________________________________|             
 GENERAL BODY SYSTEM                       |                                                                          |             
    None                                   |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENITAL SYSTEM                            |                                                                          |             
                                           |__________________________________________________________________________|             
   Clitoral Gland                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |       2                    1                                      2     1|             
      Hyperplasia, Focal                   |                                                             2            |             
      Inflammation, Chronic                | 2     2                       1  1                    1                  |             
      Inflammation, Suppurative            |                                                                          |             
                                           |__________________________________________________________________________|             
   Ovary                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |             1                                      2                     |             
                                           |__________________________________________________________________________|             
   Uterus                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Endometrium, Hyperplasia, Cystic     |                   1                                                      |             
      Endometrium, Inflammation, Chronic   |                                                                          |             
                                           |__________________________________________________________________________|             
   Vagina                                  |                                     +                                    |             
      Hyperplasia                          |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM                      |                                                                          |             
                                           |__________________________________________________________________________|             
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fibrosis                             |                                                                          |             
                                           |__________________________________________________________________________|             
   Lymph Node                              | +           +  +                       +     +        +                  |             
      Mediastinal, Ectasia                 |             2                                                            |             
      Mediastinal, Hemorrhage              |                                                       1                  |             
      Mediastinal, Hyperplasia, Lymphoid   |                                                       1                  |             
      Mediastinal, Infiltration Cellular,  |                                                                          |             
           Histiocyte                      |                                              2                           |             
                                           |__________________________________________________________________________|             
   Lymph Node, Mandibular                  | M  M  M  M  M  M  M  M  M  M  M  +  M  M  M  M  M  M  M  M  M  M  M  M  M|             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  26                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 4| 7| 6| 7| 7| 6| 7| 3| 4| 7| 7| 7| 4| 6| 6| 7| 7| 7| 7| 5| 7| 1| 7| 6| 7|             
                             DAY ON TEST   | 9| 2| 8| 2| 3| 6| 3| 7| 7| 2| 3| 2| 8| 9| 7| 2| 2| 2| 2| 5| 3| 1| 3| 1| 2|             
                                           | 1| 8| 5| 8| 0| 7| 0| 5| 4| 8| 0| 8| 3| 1| 3| 8| 8| 8| 3| 9| 0| 1| 0| 4| 8|             
 __________________________________________|__________________________________________________________________________|             
                                           | 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   | 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|             
    84 MG/KG                               | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM - cont               |                                                                          |             
                                           |__________________________________________________________________________|             
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia, Lymphoid                |                                                                          |             
      Infiltration Cellular, Histiocyte    |          1     2  2           1  1  1     1  1  2  1        1            |             
                                           |__________________________________________________________________________|             
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hematopoietic Cell Proliferation     |                                     2                 2                  |             
      Hemorrhage                           |                                                                          |             
      Hyperplasia, Lymphohistiocytic       |    3     2                                                               |             
      Lymphoid Follicle, Atrophy           |    3        2     2  2  2  1  2  2        2  3  2  2        2        2  3|             
                                           |__________________________________________________________________________|             
   Thymus                                  | +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 INTEGUMENTARY SYSTEM                      |                                                                          |             
                                           |__________________________________________________________________________|             
   Mammary Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia, Focal                   |                                     2     2                              |             
      Duct, Dilatation                     | 2        1     1  1                 1  1  2        1  2  1           1  2|             
                                           |__________________________________________________________________________|             
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 MUSCULOSKELETAL SYSTEM                    |                                                                          |             
                                           |__________________________________________________________________________|             
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Skeletal Muscle                         |                                     +                                    |             
 _____________________________________________________________________________________________________________________|             
 NERVOUS SYSTEM                            |                                                                          |             
                                           |__________________________________________________________________________|             
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hydrocephalus                        |                1                       1     2                          2|             
      Cerebrum, Degeneration, Focal        |                                                                          |             
      Cerebrum, Gliosis, Focal             |                                                                          |             
      Hypothalamus, Compression            |                2                                                         |             
                                           |__________________________________________________________________________|             
   Peripheral Nerve                        |                                                                          |             
                                           |__________________________________________________________________________|             
   Spinal Cord                             |                                                                          |             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  27                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 4| 7| 6| 7| 7| 6| 7| 3| 4| 7| 7| 7| 4| 6| 6| 7| 7| 7| 7| 5| 7| 1| 7| 6| 7|             
                             DAY ON TEST   | 9| 2| 8| 2| 3| 6| 3| 7| 7| 2| 3| 2| 8| 9| 7| 2| 2| 2| 2| 5| 3| 1| 3| 1| 2|             
                                           | 1| 8| 5| 8| 0| 7| 0| 5| 4| 8| 0| 8| 3| 1| 3| 8| 8| 8| 3| 9| 0| 1| 0| 4| 8|             
 __________________________________________|__________________________________________________________________________|             
                                           | 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   | 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|             
    84 MG/KG                               | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 RESPIRATORY SYSTEM                        |                                                                          |             
                                           |__________________________________________________________________________|             
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Congestion                           |                                                                      2   |             
      Hemorrhage                           |                                                                          |             
      Infiltration Cellular, Histiocyte    |                                                    2                     |             
      Inflammation, Chronic Active, Focal  |                                                       1                  |             
      Metaplasia, Osseous                  |    1                                                                     |             
      Alveolar Epithelium, Hyperplasia,    |                                                                          |             
           Focal                           |                                                       1     1            |             
      Alveolus, Inflammation, Chronic      |                                                                          |             
          Active, Focal                    |    1  2  3  1     2        1  2  1  2     1  2  1                    1  2|             
                                           |__________________________________________________________________________|             
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Chronic                |                            1                 1     1  1        1         |             
                                           |__________________________________________________________________________|             
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM                     |                                                                          |             
                                           |__________________________________________________________________________|             
   Eye                                     |       +                                                                  |             
      Cataract                             |       4                                                                  |             
 _____________________________________________________________________________________________________________________|             
 URINARY SYSTEM                            |                                                                          |             
                                           |__________________________________________________________________________|             
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Nephropathy                          |          1  1           1  1     1           1     1              1     1|             
      Pelvis, Inflammation, Suppurative    | 2                                                                        |             
      Renal Tubule, Pigmentation,          |                                                                          |             
          Lipofuscin                       | 2                                                                        |             
                                           |__________________________________________________________________________|             
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 __________________________________________|__________________________________________________________________________              
                                                             Page  28                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 6| 6| 7| 5| 6| 7| 4| 6| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7|            |
                             DAY ON TEST   | 5| 7| 2| 4| 4| 2| 0| 6| 1| 3| 1| 2| 2| 1| 3| 6| 3| 2| 2| 2| 3| 2| 2| 2| 3|            |
                                           | 3| 8| 8| 5| 5| 9| 5| 4| 1| 0| 5| 8| 8| 3| 0| 7| 0| 9| 9| 9| 0| 9| 9| 9| 0|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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|      A     |
    84 MG/KG                               | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 ALIMENTARY SYSTEM                         |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Parasite Metazoan                    |                                              X                           |      3     |
                                           |__________________________________________________________________________|____________|
   Intestine Large, Rectum                 | +  +  +  A  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  44        |
      Inflammation, Chronic                |                                                                      2   |      1  2.0|
      Myxomatous Change                    |                1                    1                 1           1      |     12  1.1|
      Parasite Metazoan                    |                X                                                         |      1     |
                                           |__________________________________________________________________________|____________|
   Intestine Large, Cecum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Intestine Small, Jejunum                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Angiectasis                          |                                                                   2      |      2  2.0|
      Basophilic Focus                     | X  X  X  X  X  X        X  X  X  X  X  X  X  X  X  X  X  X  X  X  X  X  X|     40     |
      Clear Cell Focus                     | X                          X  X  X  X        X                           |      8     |
      Eosinophilic Focus                   |    X  X  X              X  X        X  X        X        X        X      |     14     |
      Fibrosis, Focal                      |                                                                          |      1  1.0|
      Hepatodiaphragmatic Nodule           |          X     X              X                                   X      |     11     |
      Inflammation, Granulomatous          |    1  1  1     1        2  1  1  1  1  1  1     1  1  1  1  1  1  1  1  1|     37  1.1|
      Mixed Cell Focus                     |       X                       X  X           X        X     X            |     10     |
      Regeneration                         |                                                                          |      1  2.0|
      Tension Lipidosis                    |                                           X                              |      1     |
      Bile Duct, Hyperplasia               |    1        2           2        1                                      1|     11  1.3|
      Bile Duct, Inflammation              |                                                                          |      1  1.0|
                                           |__________________________________________________________________________|____________|
   Mesentery                               |          +                 +           +                                 |   6        |
 _____________________________________________________________________________________________________________________|____________|
  * : 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: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 6| 6| 7| 5| 6| 7| 4| 6| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7|            |
                             DAY ON TEST   | 5| 7| 2| 4| 4| 2| 0| 6| 1| 3| 1| 2| 2| 1| 3| 6| 3| 2| 2| 2| 3| 2| 2| 2| 3|            |
                                           | 3| 8| 8| 5| 5| 9| 5| 4| 1| 0| 5| 8| 8| 3| 0| 7| 0| 9| 9| 9| 0| 9| 9| 9| 0|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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|      A     |
    84 MG/KG                               | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 ALIMENTARY SYSTEM - cont                  |                                                                          |            |
      Fat, Necrosis                        |          2                 2           3                                 |      6  2.5|
                                           |__________________________________________________________________________|____________|
   Oral Mucosa                             |                                                                   +      |   1        |
      Cyst                                 |                                                                   2      |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Acinus, Atrophy                      |                   1           1                                   1      |     11  1.1|
                                           |__________________________________________________________________________|____________|
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Inflammation, Acute                  |                                                                          |      1  1.0|
                                           |__________________________________________________________________________|____________|
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Ulcer                                |                                                                          |      1  2.0|
 _____________________________________________________________________________________________________________________|            |
 CARDIOVASCULAR SYSTEM                     |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Blood Vessel                            | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Aorta, Inflammation, Chronic         |                                                                   2      |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Myocardium, Degeneration             | 1              1     1  2  1        2  1  1  3     1  1           1  1  1|     31  1.4|
 _____________________________________________________________________________________________________________________|            |
 ENDOCRINE SYSTEM                          |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia, Focal                   |    2                             1     1  2  4  1     1  1     1         |     17  1.4|
                                           |__________________________________________________________________________|____________|
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia, Focal                   |                1                             3                           |      4  2.0|
                                           |__________________________________________________________________________|____________|
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
 _____________________________________________________________________________________________________________________|____________|
  * : 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  30                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 6| 6| 7| 5| 6| 7| 4| 6| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7|            |
                             DAY ON TEST   | 5| 7| 2| 4| 4| 2| 0| 6| 1| 3| 1| 2| 2| 1| 3| 6| 3| 2| 2| 2| 3| 2| 2| 2| 3|            |
                                           | 3| 8| 8| 5| 5| 9| 5| 4| 1| 0| 5| 8| 8| 3| 0| 7| 0| 9| 9| 9| 0| 9| 9| 9| 0|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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|      A     |
    84 MG/KG                               | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 ENDOCRINE SYSTEM - cont                   |                                                                          |            |
   Parathyroid Gland                       | +  M  +  +  +  +  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +|  46        |
                                           |__________________________________________________________________________|____________|
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Angiectasis                          |                                                                   2      |      2  1.5|
      Cyst                                 |             1  1           1        1        1        1              1  1|     18  1.1|
      Pars Distalis, Hyperplasia, Focal    |             2  1                    2     2  1     1  1                  |     10  1.3|
                                           |__________________________________________________________________________|____________|
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hemorrhage                           |                                                                          |      1  2.0|
      C-Cell, Hyperplasia                  | 2  2        1  4  2        4     2  2     1  2  2           2  2  2     2|     34  2.1|
      Follicle, Hyperplasia                |                                                                2         |      2  2.5|
 _____________________________________________________________________________________________________________________|            |
 GENERAL BODY SYSTEM                       |                                                                          |            |
    None                                   |                                                                          |            |
 _____________________________________________________________________________________________________________________|            |
 GENITAL SYSTEM                            |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Clitoral Gland                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Cyst                                 |                                                                          |      4  1.5|
      Hyperplasia, Focal                   |       1                                                                  |      2  1.5|
      Inflammation, Chronic                |                         2           1     1     1  1        1            |     11  1.3|
      Inflammation, Suppurative            |                            1                                             |      1  1.0|
                                           |__________________________________________________________________________|____________|
   Ovary                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Cyst                                 |                   2           3           1           2        3         |      7  2.0|
                                           |__________________________________________________________________________|____________|
   Uterus                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Endometrium, Hyperplasia, Cystic     |                            1                    2                        |      3  1.3|
      Endometrium, Inflammation, Chronic   |       4                                                                  |      1  4.0|
                                           |__________________________________________________________________________|____________|
   Vagina                                  |                                              +                           |   2        |
      Hyperplasia                          |                                              4                           |      1  4.0|
 _____________________________________________________________________________________________________________________|            |
 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  31                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 6| 6| 7| 5| 6| 7| 4| 6| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7|            |
                             DAY ON TEST   | 5| 7| 2| 4| 4| 2| 0| 6| 1| 3| 1| 2| 2| 1| 3| 6| 3| 2| 2| 2| 3| 2| 2| 2| 3|            |
                                           | 3| 8| 8| 5| 5| 9| 5| 4| 1| 0| 5| 8| 8| 3| 0| 7| 0| 9| 9| 9| 0| 9| 9| 9| 0|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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|      A     |
    84 MG/KG                               | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 HEMATOPOIETIC SYSTEM - cont               |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Fibrosis                             | 2                                                                        |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Lymph Node                              | +        +  +              +     +              +     +              +   |  14        |
      Mediastinal, Ectasia                 |                                                 2     2                  |      3  2.0|
      Mediastinal, Hemorrhage              |          2                                                               |      2  1.5|
      Mediastinal, Hyperplasia, Lymphoid   |                            2     2                                       |      3  1.7|
      Mediastinal, Infiltration Cellular,  |                                                                          |            |
           Histiocyte                      |                            2     2                                   1   |      4  1.8|
                                           |__________________________________________________________________________|____________|
   Lymph Node, Mandibular                  | M  M  M  M  M  +  M  M  M  M  M  M  +  M  M  M  M  M  M  M  M  M  M  M  M|   3        |
                                           |__________________________________________________________________________|____________|
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia, Lymphoid                |                                        2     1                           |      2  1.5|
      Infiltration Cellular, Histiocyte    |       1        1  2        1  2  2  2  2  1     1     1  1  1  2  1     1|     27  1.3|
                                           |__________________________________________________________________________|____________|
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hematopoietic Cell Proliferation     |                               1              3                           |      4  2.0|
      Hemorrhage                           |                      3                                                   |      1  3.0|
      Hyperplasia, Lymphohistiocytic       |                                                                          |      2  2.5|
      Lymphoid Follicle, Atrophy           |    2  2        3           2  2  2  2  2  2  4  2        3  1  2  2  2   |     31  2.2|
                                           |__________________________________________________________________________|____________|
   Thymus                                  | M  +  +  +  +  +  +  +  M  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  46        |
 _____________________________________________________________________________________________________________________|            |
 INTEGUMENTARY SYSTEM                      |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Mammary Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia, Focal                   |                      1                                                   |      3  1.7|
      Duct, Dilatation                     | 2                    1     2     2           3     1     1           1   |     20  1.5|
                                           |__________________________________________________________________________|____________|
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
 _____________________________________________________________________________________________________________________|            |
 MUSCULOSKELETAL 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  32                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 6| 6| 7| 5| 6| 7| 4| 6| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7|            |
                             DAY ON TEST   | 5| 7| 2| 4| 4| 2| 0| 6| 1| 3| 1| 2| 2| 1| 3| 6| 3| 2| 2| 2| 3| 2| 2| 2| 3|            |
                                           | 3| 8| 8| 5| 5| 9| 5| 4| 1| 0| 5| 8| 8| 3| 0| 7| 0| 9| 9| 9| 0| 9| 9| 9| 0|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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|      A     |
    84 MG/KG                               | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 MUSCULOSKELETAL SYSTEM - cont             |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Skeletal Muscle                         |                                                                          |   1        |
 _____________________________________________________________________________________________________________________|            |
 NERVOUS SYSTEM                            |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hydrocephalus                        |    2  1                 3              3                                 |      8  1.9|
      Cerebrum, Degeneration, Focal        |                                                                         1|      1  1.0|
      Cerebrum, Gliosis, Focal             |                                                                         2|      1  2.0|
      Hypothalamus, Compression            |    3                    4  2           4                                 |      5  3.0|
                                           |__________________________________________________________________________|____________|
   Peripheral Nerve                        |                   +                                                      |   1        |
                                           |__________________________________________________________________________|____________|
   Spinal Cord                             |                   +                                                      |   1        |
 _____________________________________________________________________________________________________________________|            |
 RESPIRATORY SYSTEM                        |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Congestion                           |                                                                          |      1  2.0|
      Hemorrhage                           |          3                                                               |      1  3.0|
      Infiltration Cellular, Histiocyte    |                                                                          |      1  2.0|
      Inflammation, Chronic Active, Focal  |                                                                          |      1  1.0|
      Metaplasia, Osseous                  |                                                                          |      1  1.0|
      Alveolar Epithelium, Hyperplasia,    |                                                                          |            |
           Focal                           |                                        2              1                 1|      5  1.2|
      Alveolus, Inflammation, Chronic      |                                                                          |            |
          Active, Focal                    |       2  2     1        1        1  3     2     3  1     1  1  1     1   |     27  1.6|
                                           |__________________________________________________________________________|____________|
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Inflammation, Chronic                |                                                 1        1               |      7  1.0|
                                           |__________________________________________________________________________|____________|
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
 _____________________________________________________________________________________________________________________|____________|
  * : 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  33                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 6| 6| 7| 5| 6| 7| 4| 6| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| 7| 7| 7| 7| 7|            |
                             DAY ON TEST   | 5| 7| 2| 4| 4| 2| 0| 6| 1| 3| 1| 2| 2| 1| 3| 6| 3| 2| 2| 2| 3| 2| 2| 2| 3|            |
                                           | 3| 8| 8| 5| 5| 9| 5| 4| 1| 0| 5| 8| 8| 3| 0| 7| 0| 9| 9| 9| 0| 9| 9| 9| 0|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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|      A     |
    84 MG/KG                               | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 RESPIRATORY SYSTEM - cont                 |                                                                          |            |
      Hemorrhage                           |          3                                                               |      1  3.0|
 _____________________________________________________________________________________________________________________|            |
 SPECIAL SENSES SYSTEM                     |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Eye                                     |                                                                          |   1        |
      Cataract                             |                                                                          |      1  4.0|
 _____________________________________________________________________________________________________________________|            |
 URINARY SYSTEM                            |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Nephropathy                          |    1                                         1                           |     11  1.0|
      Pelvis, Inflammation, Suppurative    |                                                                          |      1  2.0|
      Renal Tubule, Pigmentation,          |                                                                          |            |
          Lipofuscin                       |                                                                          |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
 __________________________________________________________________________________________________________________________________ 
  * : 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  34                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 1| 2| 6| 6| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 3| 7| 7| 5| 7| 6| 7| 7|             
                             DAY ON TEST   | 2| 3| 2| 1| 1| 5| 7| 2| 2| 2| 2| 3| 3| 0| 2| 2| 3| 2| 2| 3| 2| 2| 0| 3| 2|             
                                           | 9| 0| 8| 1| 6| 1| 2| 8| 8| 7| 8| 0| 0| 6| 4| 8| 0| 9| 9| 0| 5| 9| 3| 0| 8|             
 __________________________________________|__________________________________________________________________________|             
                                           | 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   | 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|             
    252                                    | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7|             
    MG/KG                                  | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 ALIMENTARY SYSTEM                         |                                                                          |             
                                           |__________________________________________________________________________|             
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Muscularis, Inflammation, Chronic    | 2                                                                        |             
                                           |__________________________________________________________________________|             
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Parasite Metazoan                    |                               X              X                           |             
                                           |__________________________________________________________________________|             
   Intestine Large, Rectum                 | +  +  +  A  A  +  A  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +|             
      Infiltration Cellular, Histiocyte    | 1  1                    2  1           1     1  1     1                  |             
      Inflammation, Acute, Focal           |                                                                          |             
      Inflammation, Chronic                |                                        1                                 |             
      Myxomatous Change                    |    2  1        1        1  2  1  1  1  1     1  1     1  1  1  1  1  2   |             
                                           |__________________________________________________________________________|             
   Intestine Large, Cecum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Intestine Small, Jejunum                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Angiectasis                          |                                                          1               |             
      Basophilic Focus                     | X  X  X           X  X  X     X  X  X  X     X  X     X  X     X  X  X  X|             
      Clear Cell Focus                     |                         X     X                                         X|             
      Eosinophilic Focus                   |    X  X           X           X     X  X     X        X        X         |             
      Hepatodiaphragmatic Nodule           | X  X                             X     X           X           X     X   |             
      Inflammation, Granulomatous          | 1  1  1  1     1  1     1     1  1  1        1  1  1  2  2  1  1     1  1|             
      Mixed Cell Focus                     |    X  X                 X                             X                 X|             
      Necrosis, Focal                      |                                                                          |             
      Bile Duct, Hyperplasia               |    1                 1  1              1     1                    1      |             
                                           |__________________________________________________________________________|             
   Mesentery                               |                            +  +  +  +                                    |             
      Fat, Necrosis                        |                            2  3  2  1                                    |             
                                           |__________________________________________________________________________|             
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Acinus, Atrophy                      |                         1                             1  1  1     1  1   |             
                                           |__________________________________________________________________________|             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  35                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 1| 2| 6| 6| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 3| 7| 7| 5| 7| 6| 7| 7|             
                             DAY ON TEST   | 2| 3| 2| 1| 1| 5| 7| 2| 2| 2| 2| 3| 3| 0| 2| 2| 3| 2| 2| 3| 2| 2| 0| 3| 2|             
                                           | 9| 0| 8| 1| 6| 1| 2| 8| 8| 7| 8| 0| 0| 6| 4| 8| 0| 9| 9| 0| 5| 9| 3| 0| 8|             
 __________________________________________|__________________________________________________________________________|             
                                           | 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   | 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|             
    252                                    | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7|             
    MG/KG                                  | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 ALIMENTARY SYSTEM - cont                  |                                                                          |             
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Parotid Gland, Atrophy, Diffuse      |                                                                          |             
                                           |__________________________________________________________________________|             
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Chronic, Focal         |                               1                                          |             
      Epithelium, Hyperplasia, Squamous    |                                                                          |             
      Epithelium, Inflammation, Focal,     |                                                                          |             
           Suppurative                     |                            1                                             |             
                                           |__________________________________________________________________________|             
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Chronic, Focal         |                            1                                             |             
      Mineralization                       |                                                                          |             
      Pigmentation, Hemosiderin            |                                                                          |             
      Ulcer                                |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 CARDIOVASCULAR SYSTEM                     |                                                                          |             
                                           |__________________________________________________________________________|             
   Blood Vessel                            | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Aorta, Inflammation, Chronic         | 2                                                                        |             
                                           |__________________________________________________________________________|             
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Artery, Hyperplasia, Focal           |                                                                2         |             
      Myocardium, Degeneration             | 1  2  1        1  1  1  2        1  2     2        1  2  1  1  1     1  1|             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM                          |                                                                          |             
                                           |__________________________________________________________________________|             
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia, Focal                   |       2        2           1     1  1     1  1  1     2        1     1   |             
                                           |__________________________________________________________________________|             
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia, Focal                   |    1                          1        1                                 |             
      Necrosis                             |                                                                          |             
                                           |__________________________________________________________________________|             
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                          |             
                                           |__________________________________________________________________________|             
   Parathyroid Gland                       | +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  36                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 1| 2| 6| 6| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 3| 7| 7| 5| 7| 6| 7| 7|             
                             DAY ON TEST   | 2| 3| 2| 1| 1| 5| 7| 2| 2| 2| 2| 3| 3| 0| 2| 2| 3| 2| 2| 3| 2| 2| 0| 3| 2|             
                                           | 9| 0| 8| 1| 6| 1| 2| 8| 8| 7| 8| 0| 0| 6| 4| 8| 0| 9| 9| 0| 5| 9| 3| 0| 8|             
 __________________________________________|__________________________________________________________________________|             
                                           | 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   | 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|             
    252                                    | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7|             
    MG/KG                                  | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 ENDOCRINE SYSTEM - cont                   |                                                                          |             
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Angiectasis                          |                                  3        3                              |             
      Cyst                                 | 1  1           1        1     1        2     2                 1  1     2|             
      Pars Distalis, Hyperplasia, Focal    |                2        2     1  3     2                 1              1|             
      Pars Distalis, Mineralization        |                                                                          |             
                                           |__________________________________________________________________________|             
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                                                    3                     |             
      C-Cell, Hyperplasia                  | 2  1                 1  1     2  2  2  2     1  4     2  4     2  1     1|             
 _____________________________________________________________________________________________________________________|             
 GENERAL BODY SYSTEM                       |                                                                          |             
    None                                   |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENITAL SYSTEM                            |                                                                          |             
                                           |__________________________________________________________________________|             
   Clitoral Gland                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |       2                             3                                    |             
      Hyperplasia, Focal                   |                                           1                    2         |             
      Inflammation, Chronic                |    2                          1                 1              1         |             
      Inflammation, Suppurative            |                                                                         1|             
                                           |__________________________________________________________________________|             
   Ovary                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |       2  3                                                           3  2|             
      Inflammation, Granulomatous          |                                                                          |             
                                           |__________________________________________________________________________|             
   Uterus                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Suppurative            |                1                                                         |             
      Cervix, Endometrium, Hyperplasia     |                                                                          |             
      Endometrium, Hyperplasia, Cystic     |                      1                                                   |             
                                           |__________________________________________________________________________|             
   Vagina                                  |                                                                          |             
      Infiltration Cellular,               |                                                                          |             
          Polymorphonuclear                |                                                                          |             
      Epithelium, Vacuolization Cytoplasmic|                                                                          |             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM                      |                                                                          |             
                                           |__________________________________________________________________________|             
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  37                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 1| 2| 6| 6| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 3| 7| 7| 5| 7| 6| 7| 7|             
                             DAY ON TEST   | 2| 3| 2| 1| 1| 5| 7| 2| 2| 2| 2| 3| 3| 0| 2| 2| 3| 2| 2| 3| 2| 2| 0| 3| 2|             
                                           | 9| 0| 8| 1| 6| 1| 2| 8| 8| 7| 8| 0| 0| 6| 4| 8| 0| 9| 9| 0| 5| 9| 3| 0| 8|             
 __________________________________________|__________________________________________________________________________|             
                                           | 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   | 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|             
    252                                    | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7|             
    MG/KG                                  | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM - cont               |                                                                          |             
                                           |__________________________________________________________________________|             
   Lymph Node                              | +  +                    +                             +     +  +         |             
      Deep Cervical, Hemorrhage            |    2                                                                     |             
      Deep Cervical, Hyperplasia, Lymphoid |    2                                                                     |             
      Mediastinal, Congestion              |                                                                          |             
      Mediastinal, Ectasia                 |                                                                          |             
      Mediastinal, Hemorrhage              |                         1                                   2            |             
      Mediastinal, Hyperplasia, Lymphoid   | 1                       2                                      1         |             
      Mediastinal, Infiltration Cellular,  |                                                                          |             
           Mast Cell                       |                                                       3                  |             
      Mediastinal, Infiltration Cellular,  |                                                                          |             
           Plasma Cell                     |                                                       2                  |             
      Pancreatic, Infiltration Cellular,   |                                                                          |             
           Histiocyte                      |    3                                                                     |             
      Pancreatic, Pigmentation, Hemosiderin|    3                                                                     |             
                                           |__________________________________________________________________________|             
   Lymph Node, Mandibular                  | M  M  M  M  M  M  M  M  M  M  M  M  M  M  +  M  M  M  M  M  M  M  M  M  M|             
                                           |__________________________________________________________________________|             
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +     +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Ectasia                              |                                                                          |             
      Hyperplasia, Lymphoid                |                                                                          |             
      Infiltration Cellular, Histiocyte    | 2  2  1  2  2  2  2  2     1  1  1  1  1  1  1  2     1  2  1  1  2  3  1|             
                                           |__________________________________________________________________________|             
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hematopoietic Cell Proliferation     |                                                                          |             
      Hyperplasia, Lymphohistiocytic       |    4                                                  3                  |             
      Lymphoid Follicle, Atrophy           |          4  3     2              2  2        2  2        2     3     1  2|             
      Lymphoid Follicle, Hyperplasia       |                                                                          |             
                                           |__________________________________________________________________________|             
   Thymus                                  | +  +  +  +  +  +  +  +  +  M  +  +  +  +  +  M  +  +  +  +  +  +  +  M  +|             
 _____________________________________________________________________________________________________________________|             
 INTEGUMENTARY SYSTEM                      |                                                                          |             
                                           |__________________________________________________________________________|             
   Mammary Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia, Focal                   |                                                                          |             
      Duct, Dilatation                     | 1     2                 3  1     2  2     2  1        1     1  4  1  1  1|             
                                           |__________________________________________________________________________|             
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  38                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 1| 2| 6| 6| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 3| 7| 7| 5| 7| 6| 7| 7|             
                             DAY ON TEST   | 2| 3| 2| 1| 1| 5| 7| 2| 2| 2| 2| 3| 3| 0| 2| 2| 3| 2| 2| 3| 2| 2| 0| 3| 2|             
                                           | 9| 0| 8| 1| 6| 1| 2| 8| 8| 7| 8| 0| 0| 6| 4| 8| 0| 9| 9| 0| 5| 9| 3| 0| 8|             
 __________________________________________|__________________________________________________________________________|             
                                           | 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   | 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|             
    252                                    | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7|             
    MG/KG                                  | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 INTEGUMENTARY SYSTEM - cont               |                                                                          |             
      Ulcer                                |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 MUSCULOSKELETAL SYSTEM                    |                                                                          |             
                                           |__________________________________________________________________________|             
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 NERVOUS SYSTEM                            |                                                                          |             
                                           |__________________________________________________________________________|             
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hydrocephalus                        |                   2  3                          2           2        2   |             
      Hypothalamus, Compression            |                   4  4                          4           4            |             
                                           |__________________________________________________________________________|             
   Peripheral Nerve                        |                                                                          |             
                                           |__________________________________________________________________________|             
   Spinal Cord                             |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 RESPIRATORY SYSTEM                        |                                                                          |             
                                           |__________________________________________________________________________|             
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |          4                                                               |             
      Metaplasia, Osseous                  |                                              1                           |             
      Alveolar Epithelium, Hyperplasia,    |                                                                          |             
           Focal                           | 1                 1                                                      |             
      Alveolus, Inflammation, Acute        |                                                                          |             
      Alveolus, Inflammation, Chronic      |                                                                          |             
          Active, Focal                    |    3                 3  1  2  3  1  3     2  1  3     3  2  2  2  3     1|             
                                           |__________________________________________________________________________|             
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Chronic                |                            1                             1               |             
                                           |__________________________________________________________________________|             
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM                     |                                                                          |             
                                           |__________________________________________________________________________|             
   Eye                                     |                      +                                                  +|             
      Cataract                             |                                                                         3|             
      Cornea, Fibrosis                     |                      2                                                   |             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  39                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 1| 2| 6| 6| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 3| 7| 7| 5| 7| 6| 7| 7|             
                             DAY ON TEST   | 2| 3| 2| 1| 1| 5| 7| 2| 2| 2| 2| 3| 3| 0| 2| 2| 3| 2| 2| 3| 2| 2| 0| 3| 2|             
                                           | 9| 0| 8| 1| 6| 1| 2| 8| 8| 7| 8| 0| 0| 6| 4| 8| 0| 9| 9| 0| 5| 9| 3| 0| 8|             
 __________________________________________|__________________________________________________________________________|             
                                           | 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   | 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|             
    252                                    | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7|             
    MG/KG                                  | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 URINARY SYSTEM                            |                                                                          |             
                                           |__________________________________________________________________________|             
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Infarct                              |                                  2                                       |             
      Nephropathy                          |    2  1           1  1              1           1     1     2     1      |             
      Renal Tubule, Necrosis               |                                                                          |             
                                           |__________________________________________________________________________|             
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                                                                          |             
 __________________________________________|__________________________________________________________________________              
                                                             Page  40                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 4| 7| 7| 7| 5| 6| 2| 6| 7| 6| 1| 3| 7| 7| 7| 7| 6| 7| 7| 7| 5| 6|            |
                             DAY ON TEST   | 3| 2| 2| 9| 3| 2| 3| 8| 7| 7| 8| 2| 6| 3| 7| 2| 2| 2| 3| 5| 2| 2| 2| 1| 6|            |
                                           | 0| 8| 9| 5| 0| 9| 0| 8| 8| 3| 0| 9| 0| 9| 9| 9| 8| 9| 0| 6| 8| 0| 3| 8| 7|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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| 4|      A     |
    252                                    | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0|      L     |
    MG/KG                                  | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 ALIMENTARY SYSTEM                         |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Muscularis, Inflammation, Chronic    |                                                                          |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Parasite Metazoan                    |                                        X                                 |      3     |
                                           |__________________________________________________________________________|____________|
   Intestine Large, Rectum                 | +  +  +  A  +  +  +  +  +  +  +  +  +  A  A  +  +  +  +  A  +  +  +  +  +|  42        |
      Infiltration Cellular, Histiocyte    | 1     1     2        2           1           1        1        1  1     1|     18  1.2|
      Inflammation, Acute, Focal           |                                                 2                        |      1  2.0|
      Inflammation, Chronic                |                                                                          |      1  1.0|
      Myxomatous Change                    | 1  1  1     1  1  1  2  1        1  1        1  1  1  1     1  1  1     1|     35  1.1|
                                           |__________________________________________________________________________|____________|
   Intestine Large, Cecum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Intestine Small, Duodenum               | +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  49        |
                                           |__________________________________________________________________________|____________|
   Intestine Small, Jejunum                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Angiectasis                          |                                                                          |      1  1.0|
      Basophilic Focus                     | X  X  X     X  X  X  X  X     X     X           X  X  X     X     X     X|     34     |
      Clear Cell Focus                     | X              X              X                                          |      6     |
      Eosinophilic Focus                   |                                                                   X      |     10     |
      Hepatodiaphragmatic Nodule           |          X  X              X     X                       X        X  X   |     14     |
      Inflammation, Granulomatous          | 1  1  1     1  1  1  1  1  1  1  1     1  1     1  2  1     1  1  1     1|     39  1.1|
      Mixed Cell Focus                     |       X              X           X                             X         |      9     |
      Necrosis, Focal                      |                                           2                              |      1  2.0|
      Bile Duct, Hyperplasia               |       1                 1           2     1  1              1  1  1      |     14  1.1|
                                           |__________________________________________________________________________|____________|
   Mesentery                               |                            +              +                    +  +  +   |   9        |
      Fat, Necrosis                        |                            2              2                    1  3  3   |      9  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  41                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 4| 7| 7| 7| 5| 6| 2| 6| 7| 6| 1| 3| 7| 7| 7| 7| 6| 7| 7| 7| 5| 6|            |
                             DAY ON TEST   | 3| 2| 2| 9| 3| 2| 3| 8| 7| 7| 8| 2| 6| 3| 7| 2| 2| 2| 3| 5| 2| 2| 2| 1| 6|            |
                                           | 0| 8| 9| 5| 0| 9| 0| 8| 8| 3| 0| 9| 0| 9| 9| 9| 8| 9| 0| 6| 8| 0| 3| 8| 7|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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| 4|      A     |
    252                                    | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0|      L     |
    MG/KG                                  | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 ALIMENTARY SYSTEM - cont                  |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Acinus, Atrophy                      |                                           1                 1            |      8  1.0|
                                           |__________________________________________________________________________|____________|
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Parotid Gland, Atrophy, Diffuse      |                                     3                                    |      1  3.0|
                                           |__________________________________________________________________________|____________|
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Inflammation, Chronic, Focal         |                                                                          |      1  1.0|
      Epithelium, Hyperplasia, Squamous    |                         3                                                |      1  3.0|
      Epithelium, Inflammation, Focal,     |                                                                          |            |
           Suppurative                     |                                                                          |      1  1.0|
                                           |__________________________________________________________________________|____________|
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Inflammation, Chronic, Focal         |                                                                          |      1  1.0|
      Mineralization                       |    1                                                                     |      1  1.0|
      Pigmentation, Hemosiderin            |                                        1                                 |      1  1.0|
      Ulcer                                |          3                                               3        3      |      3  3.0|
 _____________________________________________________________________________________________________________________|            |
 CARDIOVASCULAR SYSTEM                     |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Blood Vessel                            | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Aorta, Inflammation, Chronic         |                                                                          |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Artery, Hyperplasia, Focal           |                                                                          |      1  2.0|
      Myocardium, Degeneration             | 2  1     2  2     2  1     1  2  1     1  1  1     2  1  2     1        1|     34  1.4|
 _____________________________________________________________________________________________________________________|            |
 ENDOCRINE SYSTEM                          |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia, Focal                   |    1  1     2           1        2                    2     1     1      |     19  1.3|
                                           |__________________________________________________________________________|____________|
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
 _____________________________________________________________________________________________________________________|____________|
  * : 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  42                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 4| 7| 7| 7| 5| 6| 2| 6| 7| 6| 1| 3| 7| 7| 7| 7| 6| 7| 7| 7| 5| 6|            |
                             DAY ON TEST   | 3| 2| 2| 9| 3| 2| 3| 8| 7| 7| 8| 2| 6| 3| 7| 2| 2| 2| 3| 5| 2| 2| 2| 1| 6|            |
                                           | 0| 8| 9| 5| 0| 9| 0| 8| 8| 3| 0| 9| 0| 9| 9| 9| 8| 9| 0| 6| 8| 0| 3| 8| 7|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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| 4|      A     |
    252                                    | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0|      L     |
    MG/KG                                  | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 ENDOCRINE SYSTEM - cont                   |                                                                          |            |
      Hyperplasia, Focal                   |                                                    1                     |      4  1.0|
      Necrosis                             |          4                                                               |      1  4.0|
                                           |__________________________________________________________________________|____________|
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia                          | 2                                                                        |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Parathyroid Gland                       | +  +  M  +  +  +  +  M  +  +  +  +  +  +  M  +  M  +  +  +  +  +  +  +  +|  45        |
                                           |__________________________________________________________________________|____________|
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Angiectasis                          |                                                                          |      2  3.0|
      Cyst                                 | 2  1     1  1  2                    1           1  2  1  2           2  1|     22  1.4|
      Pars Distalis, Hyperplasia, Focal    |                1                    2                 2  1  2        1   |     13  1.6|
      Pars Distalis, Mineralization        |                                                                2         |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hemorrhage                           |                                                                          |      1  3.0|
      C-Cell, Hyperplasia                  | 2     2     2  2  3  2  1        2     1     2     3  3        2  2  2  2|     31  2.0|
 _____________________________________________________________________________________________________________________|            |
 GENERAL BODY SYSTEM                       |                                                                          |            |
    None                                   |                                                                          |            |
 _____________________________________________________________________________________________________________________|            |
 GENITAL SYSTEM                            |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Clitoral Gland                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  M  +  +  +  +|  49        |
      Cyst                                 |                                                          2               |      3  2.3|
      Hyperplasia, Focal                   |       2                                                                  |      3  1.7|
      Inflammation, Chronic                | 1                 2  2           1                                       |      8  1.4|
      Inflammation, Suppurative            |       2                                                                  |      2  1.5|
                                           |__________________________________________________________________________|____________|
   Ovary                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Cyst                                 |                               3                                          |      5  2.6|
      Inflammation, Granulomatous          |                               2                                          |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Uterus                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
 _____________________________________________________________________________________________________________________|____________|
  * : 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  43                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 4| 7| 7| 7| 5| 6| 2| 6| 7| 6| 1| 3| 7| 7| 7| 7| 6| 7| 7| 7| 5| 6|            |
                             DAY ON TEST   | 3| 2| 2| 9| 3| 2| 3| 8| 7| 7| 8| 2| 6| 3| 7| 2| 2| 2| 3| 5| 2| 2| 2| 1| 6|            |
                                           | 0| 8| 9| 5| 0| 9| 0| 8| 8| 3| 0| 9| 0| 9| 9| 9| 8| 9| 0| 6| 8| 0| 3| 8| 7|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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| 4|      A     |
    252                                    | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0|      L     |
    MG/KG                                  | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 GENITAL SYSTEM - cont                     |                                                                          |            |
      Inflammation, Suppurative            |                                                                          |      1  1.0|
      Cervix, Endometrium, Hyperplasia     |                   3                                                      |      1  3.0|
      Endometrium, Hyperplasia, Cystic     |                            1                 1     1              1     1|      6  1.0|
                                           |__________________________________________________________________________|____________|
   Vagina                                  |                                     +                          +         |   2        |
      Infiltration Cellular,               |                                                                          |            |
          Polymorphonuclear                |                                     2                                    |      1  2.0|
      Epithelium, Vacuolization Cytoplasmic|                                     3                                    |      1  3.0|
 _____________________________________________________________________________________________________________________|            |
 HEMATOPOIETIC SYSTEM                      |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Lymph Node                              |          +  +  +                 +  +                                +  +|  13        |
      Deep Cervical, Hemorrhage            |                                                                          |      1  2.0|
      Deep Cervical, Hyperplasia, Lymphoid |                                                                          |      1  2.0|
      Mediastinal, Congestion              |          3                                                               |      1  3.0|
      Mediastinal, Ectasia                 |             2                                                            |      1  2.0|
      Mediastinal, Hemorrhage              |                                                                         2|      3  1.7|
      Mediastinal, Hyperplasia, Lymphoid   |             2  2                                                        2|      6  1.7|
      Mediastinal, Infiltration Cellular,  |                                                                          |            |
           Mast Cell                       |                                                                          |      1  3.0|
      Mediastinal, Infiltration Cellular,  |                                                                          |            |
           Plasma Cell                     |                                                                          |      1  2.0|
      Pancreatic, Infiltration Cellular,   |                                                                          |            |
           Histiocyte                      |                                                                          |      1  3.0|
      Pancreatic, Pigmentation, Hemosiderin|                                                                          |      1  3.0|
                                           |__________________________________________________________________________|____________|
   Lymph Node, Mandibular                  | M  M  M  M  M  +  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M|   2        |
                                           |__________________________________________________________________________|____________|
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  49        |
      Ectasia                              |                               1                                          |      1  1.0|
      Hyperplasia, Lymphoid                |                               2        3                                 |      2  2.5|
      Infiltration Cellular, Histiocyte    | 1  2  1     2  2  2  1  1     1  2        1  2  1  1  1     3  1  1     2|     42  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  44                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 4| 7| 7| 7| 5| 6| 2| 6| 7| 6| 1| 3| 7| 7| 7| 7| 6| 7| 7| 7| 5| 6|            |
                             DAY ON TEST   | 3| 2| 2| 9| 3| 2| 3| 8| 7| 7| 8| 2| 6| 3| 7| 2| 2| 2| 3| 5| 2| 2| 2| 1| 6|            |
                                           | 0| 8| 9| 5| 0| 9| 0| 8| 8| 3| 0| 9| 0| 9| 9| 9| 8| 9| 0| 6| 8| 0| 3| 8| 7|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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| 4|      A     |
    252                                    | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0|      L     |
    MG/KG                                  | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 HEMATOPOIETIC SYSTEM - cont               |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hematopoietic Cell Proliferation     |                      1                                1  2     2  1      |      5  1.4|
      Hyperplasia, Lymphohistiocytic       |                   3                                3                     |      4  3.3|
      Lymphoid Follicle, Atrophy           | 2  2  2     2        2  2  4  3  2  2  2  3  2     2        2  1  1      |     28  2.2|
      Lymphoid Follicle, Hyperplasia       |                1                                                         |      1  1.0|
                                           |__________________________________________________________________________|____________|
   Thymus                                  | +  +  +  M  M  +  +  M  +  +  +  +  +  +  +  +  +  +  +  M  +  +  +  M  M|  41        |
 _____________________________________________________________________________________________________________________|            |
 INTEGUMENTARY SYSTEM                      |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Mammary Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia, Focal                   |                               2                                      1   |      2  1.5|
      Duct, Dilatation                     |          1                    3  4  2           1     1  2  1        1   |     23  1.7|
                                           |__________________________________________________________________________|____________|
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Ulcer                                |                                     2                                    |      1  2.0|
 _____________________________________________________________________________________________________________________|            |
 MUSCULOSKELETAL SYSTEM                    |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
 _____________________________________________________________________________________________________________________|            |
 NERVOUS SYSTEM                            |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hydrocephalus                        |       3              3  3        1                                2      |     10  2.3|
      Hypothalamus, Compression            |       3              3           2                                1      |      8  3.1|
                                           |__________________________________________________________________________|____________|
   Peripheral Nerve                        |                                                                         +|   1        |
                                           |__________________________________________________________________________|____________|
   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  45                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 4| 7| 7| 7| 5| 6| 2| 6| 7| 6| 1| 3| 7| 7| 7| 7| 6| 7| 7| 7| 5| 6|            |
                             DAY ON TEST   | 3| 2| 2| 9| 3| 2| 3| 8| 7| 7| 8| 2| 6| 3| 7| 2| 2| 2| 3| 5| 2| 2| 2| 1| 6|            |
                                           | 0| 8| 9| 5| 0| 9| 0| 8| 8| 3| 0| 9| 0| 9| 9| 9| 8| 9| 0| 6| 8| 0| 3| 8| 7|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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| 4|      A     |
    252                                    | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0|      L     |
    MG/KG                                  | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 RESPIRATORY SYSTEM - cont                 |                                                                          |            |
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hemorrhage                           |                            3  3        4                                 |      4  3.5|
      Metaplasia, Osseous                  |                                                                          |      1  1.0|
      Alveolar Epithelium, Hyperplasia,    |                                                                          |            |
           Focal                           |                                                          1               |      3  1.0|
      Alveolus, Inflammation, Acute        |                               3                                          |      1  3.0|
      Alveolus, Inflammation, Chronic      |                                                                          |            |
          Active, Focal                    | 1  2  1  1  3  1  3     2        1  3        2  1  3  1        3  4  2  2|     34  2.1|
                                           |__________________________________________________________________________|____________|
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Inflammation, Chronic                | 1  1  1                                                                  |      5  1.0|
                                           |__________________________________________________________________________|____________|
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
 _____________________________________________________________________________________________________________________|            |
 SPECIAL SENSES SYSTEM                     |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Eye                                     |             +                                                            |   3        |
      Cataract                             |             3                                                            |      2  3.0|
      Cornea, Fibrosis                     |                                                                          |      1  2.0|
 _____________________________________________________________________________________________________________________|            |
 URINARY SYSTEM                            |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Infarct                              |                                                                          |      1  2.0|
      Nephropathy                          | 1  1        1     1              1           1              1            |     16  1.1|
      Renal Tubule, Necrosis               |                1                                                         |      1  1.0|
                                           |__________________________________________________________________________|____________|
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hemorrhage                           |                                                                         3|      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  46                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 5| 7| 5| 7| 7| 7| 7| 7| 5| 7| 6| 7| 6| 5| 7| 7| 6| 6| 5| 7| 7| 7| 6| 7| 7|             
                             DAY ON TEST   | 4| 2| 0| 2| 2| 2| 2| 2| 8| 2| 4| 2| 6| 2| 2| 2| 3| 8| 1| 2| 2| 2| 0| 2| 2|             
                                           | 7| 8| 5| 7| 8| 8| 7| 8| 9| 8| 0| 8| 1| 6| 4| 1| 0| 5| 9| 4| 8| 8| 0| 7| 7|             
 __________________________________________|__________________________________________________________________________|             
                                           | 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|             
    0 MG/KG                                | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 ALIMENTARY SYSTEM                         |                                                                          |             
                                           |__________________________________________________________________________|             
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Periesophageal Tissue, Hemorrhage    |                                                                   3      |             
                                           |__________________________________________________________________________|             
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Parasite Metazoan                    |             X                                                            |             
                                           |__________________________________________________________________________|             
   Intestine Large, Rectum                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +  +|             
      Inflammation, Chronic                |       2                                                                  |             
      Parasite Metazoan                    |                X           X                                   X         |             
                                           |__________________________________________________________________________|             
   Intestine Large, Cecum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Intestine Small, Jejunum                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Basophilic Focus                     |    X     X  X  X  X  X     X     X                 X        X  X     X  X|             
      Clear Cell Focus                     |          X  X  X  X  X                                      X  X     X  X|             
      Eosinophilic Focus                   |                   X        X     X        X     X           X            |             
      Hepatodiaphragmatic Nodule           |                                                    X                     |             
      Inflammation, Granulomatous          |    1  1  2  1  1  1  1     1     1     1              1     1  1     1  1|             
      Mixed Cell Focus                     |                   X        X                          X                 X|             
      Necrosis, Focal                      |                                                                          |             
      Bile Duct, Hyperplasia               |    2     2  1  2  2  2  2  2     1  2  1  4  2  1     1  2  2  1  1  1  1|             
      Centrilobular, Degeneration          |                                                                          |             
      Centrilobular, Necrosis              |                                                                          |             
                                           |__________________________________________________________________________|             
   Mesentery                               | +           +                                +              +  +         |             
      Fat, Necrosis                        | 2           2                                               2  2         |             
                                           |__________________________________________________________________________|             
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Acinus, Atrophy                      |    2  1           1        3  1           2                          1   |             
                                           |__________________________________________________________________________|             
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  47                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 5| 7| 5| 7| 7| 7| 7| 7| 5| 7| 6| 7| 6| 5| 7| 7| 6| 6| 5| 7| 7| 7| 6| 7| 7|             
                             DAY ON TEST   | 4| 2| 0| 2| 2| 2| 2| 2| 8| 2| 4| 2| 6| 2| 2| 2| 3| 8| 1| 2| 2| 2| 0| 2| 2|             
                                           | 7| 8| 5| 7| 8| 8| 7| 8| 9| 8| 0| 8| 1| 6| 4| 1| 0| 5| 9| 4| 8| 8| 0| 7| 7|             
 __________________________________________|__________________________________________________________________________|             
                                           | 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|             
    0 MG/KG                                | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 ALIMENTARY SYSTEM - cont                  |                                                                          |             
      Parotid Gland, Atrophy, Focal        |                                                                          |             
      Sublingual Gland, Hypertrophy, Focal |                                                                          |             
                                           |__________________________________________________________________________|             
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Mineralization                       |                                                    3                     |             
      Ulcer                                |                                              2                           |             
                                           |__________________________________________________________________________|             
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Mineralization                       |                                                    3                     |             
      Ulcer                                |                                              2                           |             
      Epithelium, Hyperplasia, Focal       |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 CARDIOVASCULAR SYSTEM                     |                                                                          |             
                                           |__________________________________________________________________________|             
   Blood Vessel                            | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Aorta, Mineralization                |                                                    3                     |             
                                           |__________________________________________________________________________|             
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Atrium, Thrombosis                   |                                              3                           |             
      Myocardium, Degeneration             | 3  2     2  3  1  2  2  3  3     3     1  1     1  2  1  2  2  2  3  2  1|             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM                          |                                                                          |             
                                           |__________________________________________________________________________|             
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia, Diffuse                 |                                                                          |             
      Hyperplasia, Focal                   |    1     1  2  1  1              1                          1        1   |             
                                           |__________________________________________________________________________|             
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia, Diffuse                 |                                                                          |             
      Hyperplasia, Focal                   |                   1     1           2        2           2  1            |             
      Necrosis, Acute                      |                                                                          |             
                                           |__________________________________________________________________________|             
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                          |             
                                           |__________________________________________________________________________|             
   Parathyroid Gland                       | +  +  +  +  +  +  +  M  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst, Multiple                       |    2                                                                     |             
                                           |__________________________________________________________________________|             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  48                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 5| 7| 5| 7| 7| 7| 7| 7| 5| 7| 6| 7| 6| 5| 7| 7| 6| 6| 5| 7| 7| 7| 6| 7| 7|             
                             DAY ON TEST   | 4| 2| 0| 2| 2| 2| 2| 2| 8| 2| 4| 2| 6| 2| 2| 2| 3| 8| 1| 2| 2| 2| 0| 2| 2|             
                                           | 7| 8| 5| 7| 8| 8| 7| 8| 9| 8| 0| 8| 1| 6| 4| 1| 0| 5| 9| 4| 8| 8| 0| 7| 7|             
 __________________________________________|__________________________________________________________________________|             
                                           | 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|             
    0 MG/KG                                | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 ENDOCRINE SYSTEM - cont                   |                                                                          |             
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |                                                 1        1               |             
      Pars Distalis, Hyperplasia, Focal    | 1                 1  1     1  1                             2        2   |             
                                           |__________________________________________________________________________|             
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      C-Cell, Hyperplasia                  |    2  1  2     2  2        2  2  1  2  2  2  3        2  2     2        2|             
 _____________________________________________________________________________________________________________________|             
 GENERAL BODY SYSTEM                       |                                                                          |             
                                           |__________________________________________________________________________|             
   Tissue NOS                              |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENITAL SYSTEM                            |                                                                          |             
                                           |__________________________________________________________________________|             
   Coagulating Gland                       |                                                                          |             
                                           |__________________________________________________________________________|             
   Epididymis                              | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Granuloma Sperm                      |                                                                          |             
                                           |__________________________________________________________________________|             
   Preputial Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                            2                                             |             
      Inflammation, Chronic                | 2  2        1  2  1  2  1     2  1  2  1  1  1  1           1  1     1  1|             
      Inflammation, Suppurative            |                                                       2                  |             
                                           |__________________________________________________________________________|             
   Prostate                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                2                                                         |             
      Inflammation, Acute                  |                                                    4                     |             
      Inflammation, Chronic Active         | 1        1  1        1           1                                1  1   |             
                                           |__________________________________________________________________________|             
   Seminal Vesicle                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Atrophy                              |                   3                                                      |             
      Hyperplasia                          |    3        3                                      3                     |             
                                           |__________________________________________________________________________|             
   Testes                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Germinal Epithelium, Atrophy         |                   4                                4                     |             
      Interstitial Cell, Hyperplasia       |                               1        1                                 |             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM                      |                                                                          |             
                                           |__________________________________________________________________________|             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  49                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 5| 7| 5| 7| 7| 7| 7| 7| 5| 7| 6| 7| 6| 5| 7| 7| 6| 6| 5| 7| 7| 7| 6| 7| 7|             
                             DAY ON TEST   | 4| 2| 0| 2| 2| 2| 2| 2| 8| 2| 4| 2| 6| 2| 2| 2| 3| 8| 1| 2| 2| 2| 0| 2| 2|             
                                           | 7| 8| 5| 7| 8| 8| 7| 8| 9| 8| 0| 8| 1| 6| 4| 1| 0| 5| 9| 4| 8| 8| 0| 7| 7|             
 __________________________________________|__________________________________________________________________________|             
                                           | 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|             
    0 MG/KG                                | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM - cont               |                                                                          |             
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fibrosis                             |                         1           3                                    |             
      Infiltration Cellular, Lymphocyte    |                                                                          |             
      Infiltration Cellular, Histiocyte    |                                                                          |             
                                           |__________________________________________________________________________|             
   Lymph Node                              |             +           +                    +  +        +  +            |             
      Deep Cervical, Hyperplasia, Lymphoid |                                                                          |             
      Mediastinal, Hemorrhage              |                         2                    1                           |             
      Mediastinal, Hyperplasia, Lymphoid   |             1                                                            |             
                                           |__________________________________________________________________________|             
   Lymph Node, Mandibular                  | +  M  M  M  M  M  M  M  M  M  +  M  M  M  M  M  M  M  +  +  M  M  M  M  M|             
      Infiltration Cellular, Plasma Cell   |                               3                                          |             
                                           |__________________________________________________________________________|             
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Infiltration Cellular, Histiocyte    |                                              2                           |             
                                           |__________________________________________________________________________|             
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hematopoietic Cell Proliferation     |                                              2                           |             
      Hyperplasia, Lymphohistiocytic       |                      2                                                   |             
      Capsule, Fibrosis, Focal             |                                                                          |             
      Lymphoid Follicle, Atrophy           |       1        2     2           2     1        2  2  2              2  2|             
      Lymphoid Follicle, Hyperplasia       |                                                                          |             
      Lymphoid Follicle, Necrosis          |                                                                          |             
                                           |__________________________________________________________________________|             
   Thymus                                  | +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 INTEGUMENTARY SYSTEM                      |                                                                          |             
                                           |__________________________________________________________________________|             
   Mammary Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                   1  1  1     1  1  1  1  1  1  1  1           1  1     1|             
      Duct, Dilatation                     |    2  2     2                 1        1  1              1               |             
                                           |__________________________________________________________________________|             
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Epidermis, Cyst, Squamous            |                                                                          |             
      Epidermis, Epidermis, Cyst           |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 MUSCULOSKELETAL SYSTEM                    |                                                                          |             
                                           |__________________________________________________________________________|             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  50                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 5| 7| 5| 7| 7| 7| 7| 7| 5| 7| 6| 7| 6| 5| 7| 7| 6| 6| 5| 7| 7| 7| 6| 7| 7|             
                             DAY ON TEST   | 4| 2| 0| 2| 2| 2| 2| 2| 8| 2| 4| 2| 6| 2| 2| 2| 3| 8| 1| 2| 2| 2| 0| 2| 2|             
                                           | 7| 8| 5| 7| 8| 8| 7| 8| 9| 8| 0| 8| 1| 6| 4| 1| 0| 5| 9| 4| 8| 8| 0| 7| 7|             
 __________________________________________|__________________________________________________________________________|             
                                           | 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|             
    0 MG/KG                                | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 MUSCULOSKELETAL SYSTEM - cont             |                                                                          |             
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |                                  1                                       |             
      Femur, Hyperostosis                  |                                     3                                    |             
 _____________________________________________________________________________________________________________________|             
 NERVOUS SYSTEM                            |                                                                          |             
                                           |__________________________________________________________________________|             
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hydrocephalus                        |       3                                3              4                  |             
      Hypothalamus, Compression            |    2  3                                2              4                  |             
 _____________________________________________________________________________________________________________________|             
 RESPIRATORY SYSTEM                        |                                                                          |             
                                           |__________________________________________________________________________|             
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                                                                          |             
      Alveolar Epithelium, Hyperplasia,    |                                                                          |             
           Focal                           |                                                       1                  |             
      Alveolar Epithelium, Hyperplasia     |                2  1        2                                   1         |             
      Alveolus, Inflammation, Acute        |                                                                   3      |             
                                           |__________________________________________________________________________|             
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Foreign Body                         |                                                                X         |             
      Inflammation, Chronic                | 1                          1              1  1                           |             
      Ulcer                                |                                                                          |             
                                           |__________________________________________________________________________|             
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Chronic                |                                                                   1      |             
      Epithelium, Metaplasia, Squamous     |                                                                   3      |             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM                     |                                                                          |             
    None                                   |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 URINARY SYSTEM                            |                                                                          |             
                                           |__________________________________________________________________________|             
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hydronephrosis                       |                                                    3                     |             
      Infarct                              |                                           3                              |             
      Nephropathy                          |    3  1  1  1  2  1  2     3  1  3     1  1  2  1     2  1  1  1     2  1|             
      Artery, Thrombosis                   |                                                                          |             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  51                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 5| 7| 5| 7| 7| 7| 7| 7| 5| 7| 6| 7| 6| 5| 7| 7| 6| 6| 5| 7| 7| 7| 6| 7| 7|             
                             DAY ON TEST   | 4| 2| 0| 2| 2| 2| 2| 2| 8| 2| 4| 2| 6| 2| 2| 2| 3| 8| 1| 2| 2| 2| 0| 2| 2|             
                                           | 7| 8| 5| 7| 8| 8| 7| 8| 9| 8| 0| 8| 1| 6| 4| 1| 0| 5| 9| 4| 8| 8| 0| 7| 7|             
 __________________________________________|__________________________________________________________________________|             
                                           | 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|             
    0 MG/KG                                | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 URINARY SYSTEM - cont                     |                                                                          |             
      Renal Tubule, Necrosis, Focal        |                                                    3                     |             
      Vein, Inflammation, Chronic          |                                                    3                     |             
                                           |__________________________________________________________________________|             
   Ureter                                  |                               +                                          |             
                                           |__________________________________________________________________________|             
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Acute                  |                                                                          |             
      Mineralization                       |                                                    3                     |             
      Ulcer                                |                                                    4                     |             
 __________________________________________|__________________________________________________________________________              
                                                             Page  52                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 6| 7| 7| 7| 6| 7| 1| 7| 7| 7| 7| 5| 4| 5| 7| 7| 6| 7| 7| 7| 7| 7| 7| 5|            |
                             DAY ON TEST   | 2| 9| 2| 0| 2| 8| 2| 1| 2| 2| 2| 2| 0| 7| 7| 1| 2| 4| 2| 2| 2| 2| 2| 2| 1|            |
                                           | 9| 9| 8| 7| 4| 6| 8| 1| 9| 9| 8| 9| 3| 5| 3| 7| 7| 0| 9| 7| 7| 8| 7| 7| 9|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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|      A     |
    0 MG/KG                                | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 ALIMENTARY SYSTEM                         |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Periesophageal Tissue, Hemorrhage    |                                                                          |      1  3.0|
                                           |__________________________________________________________________________|____________|
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Parasite Metazoan                    |                X                 X                                   X   |      4     |
                                           |__________________________________________________________________________|____________|
   Intestine Large, Rectum                 | +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  48        |
      Inflammation, Chronic                |                                                                          |      1  2.0|
      Parasite Metazoan                    |                               X  X                                       |      5     |
                                           |__________________________________________________________________________|____________|
   Intestine Large, Cecum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Intestine Small, Jejunum                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Basophilic Focus                     |          X     X  X     X  X  X  X     X           X  X  X  X  X     X   |     27     |
      Clear Cell Focus                     |                         X  X  X  X  X           X        X     X  X      |     18     |
      Eosinophilic Focus                   | X                                                        X        X      |      9     |
      Hepatodiaphragmatic Nodule           |                      X           X  X                             X      |      5     |
      Inflammation, Granulomatous          |                1  1     1  1  1  1  1  1        1  1  1  1  1  1  1      |     30  1.0|
      Mixed Cell Focus                     |                                                       X  X  X  X         |      8     |
      Necrosis, Focal                      |          2                                                               |      1  2.0|
      Bile Duct, Hyperplasia               | 2     3  1  2  2  1     2  2  2  2  1  1  1  2  2  1  1  2  1  1  2  1  2|     44  1.6|
      Centrilobular, Degeneration          |             2                                                            |      1  2.0|
      Centrilobular, Necrosis              |    2                                                                     |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Mesentery                               |    +                       +        +     +                              |   9        |
      Fat, Necrosis                        |                            3        1     3                              |      7  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  53                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 6| 7| 7| 7| 6| 7| 1| 7| 7| 7| 7| 5| 4| 5| 7| 7| 6| 7| 7| 7| 7| 7| 7| 5|            |
                             DAY ON TEST   | 2| 9| 2| 0| 2| 8| 2| 1| 2| 2| 2| 2| 0| 7| 7| 1| 2| 4| 2| 2| 2| 2| 2| 2| 1|            |
                                           | 9| 9| 8| 7| 4| 6| 8| 1| 9| 9| 8| 9| 3| 5| 3| 7| 7| 0| 9| 7| 7| 8| 7| 7| 9|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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|      A     |
    0 MG/KG                                | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 ALIMENTARY SYSTEM - cont                  |                                                                          |            |
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Acinus, Atrophy                      |             1                       1                 1  3     1         |     12  1.5|
                                           |__________________________________________________________________________|____________|
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Parotid Gland, Atrophy, Focal        |                                                                2         |      1  2.0|
      Sublingual Gland, Hypertrophy, Focal |                                                                1         |      1  1.0|
                                           |__________________________________________________________________________|____________|
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Mineralization                       |                                                                          |      1  3.0|
      Ulcer                                |                                                                          |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Mineralization                       |          2                                                               |      2  2.5|
      Ulcer                                |                                                                          |      1  2.0|
      Epithelium, Hyperplasia, Focal       |                         2                                                |      1  2.0|
 _____________________________________________________________________________________________________________________|            |
 CARDIOVASCULAR SYSTEM                     |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Blood Vessel                            | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Aorta, Mineralization                |                                                                          |      1  3.0|
                                           |__________________________________________________________________________|____________|
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Atrium, Thrombosis                   |             3                                                            |      2  3.0|
      Myocardium, Degeneration             | 1  2  1        2  2     1  2  2  1  1  1  2  2  3  1  1  2  2  2     3   |     41  1.9|
 _____________________________________________________________________________________________________________________|            |
 ENDOCRINE SYSTEM                          |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia, Diffuse                 |                                                    3                     |      1  3.0|
      Hyperplasia, Focal                   |                1        1     1                 1           1        1   |     14  1.1|
                                           |__________________________________________________________________________|____________|
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia, Diffuse                 |                                                 2  2                     |      2  2.0|
      Hyperplasia, Focal                   |       1  2  2  1                                                         |     10  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  54                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 6| 7| 7| 7| 6| 7| 1| 7| 7| 7| 7| 5| 4| 5| 7| 7| 6| 7| 7| 7| 7| 7| 7| 5|            |
                             DAY ON TEST   | 2| 9| 2| 0| 2| 8| 2| 1| 2| 2| 2| 2| 0| 7| 7| 1| 2| 4| 2| 2| 2| 2| 2| 2| 1|            |
                                           | 9| 9| 8| 7| 4| 6| 8| 1| 9| 9| 8| 9| 3| 5| 3| 7| 7| 0| 9| 7| 7| 8| 7| 7| 9|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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|      A     |
    0 MG/KG                                | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 ENDOCRINE SYSTEM - cont                   |                                                                          |            |
      Necrosis, Acute                      | 4                                                                        |      1  4.0|
                                           |__________________________________________________________________________|____________|
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia                          |             2                                                            |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Parathyroid Gland                       | +  +  +  +  +  +  +  +  +  +  M  M  +  +  +  +  +  +  +  +  +  +  +  +  +|  46        |
      Cyst, Multiple                       |                                                                          |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Cyst                                 |                                                                1         |      3  1.0|
      Pars Distalis, Hyperplasia, Focal    |          1  2                                1              1           1|     12  1.3|
                                           |__________________________________________________________________________|____________|
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      C-Cell, Hyperplasia                  | 1        1  1  2  1     3  2     2  2  2     3     2  2  3        2      |     31  1.9|
 _____________________________________________________________________________________________________________________|            |
 GENERAL BODY SYSTEM                       |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Tissue NOS                              |       +                                                                  |   1        |
 _____________________________________________________________________________________________________________________|            |
 GENITAL SYSTEM                            |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Coagulating Gland                       |    +                                                                     |   1        |
                                           |__________________________________________________________________________|____________|
   Epididymis                              | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Granuloma Sperm                      |          3                                                               |      1  3.0|
                                           |__________________________________________________________________________|____________|
   Preputial Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia                          |                                                                          |      1  2.0|
      Inflammation, Chronic                |    1  2  1  2     1     1  1  1  1  1     1  1  1     1  1  1           2|     35  1.3|
      Inflammation, Suppurative            |                                                                          |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Prostate                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia                          |                                                                          |      1  2.0|
      Inflammation, Acute                  |                                                                          |      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  55                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 6| 7| 7| 7| 6| 7| 1| 7| 7| 7| 7| 5| 4| 5| 7| 7| 6| 7| 7| 7| 7| 7| 7| 5|            |
                             DAY ON TEST   | 2| 9| 2| 0| 2| 8| 2| 1| 2| 2| 2| 2| 0| 7| 7| 1| 2| 4| 2| 2| 2| 2| 2| 2| 1|            |
                                           | 9| 9| 8| 7| 4| 6| 8| 1| 9| 9| 8| 9| 3| 5| 3| 7| 7| 0| 9| 7| 7| 8| 7| 7| 9|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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|      A     |
    0 MG/KG                                | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 GENITAL SYSTEM - cont                     |                                                                          |            |
      Inflammation, Chronic Active         |    1     1     2  1        1  1  1  2        2           1              1|     18  1.2|
                                           |__________________________________________________________________________|____________|
   Seminal Vesicle                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Atrophy                              |                                                                          |      1  3.0|
      Hyperplasia                          |                                     1                                    |      4  2.5|
                                           |__________________________________________________________________________|____________|
   Testes                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Germinal Epithelium, Atrophy         |                                              4                           |      3  4.0|
      Interstitial Cell, Hyperplasia       |                                                       2              2  2|      5  1.6|
 _____________________________________________________________________________________________________________________|            |
 HEMATOPOIETIC SYSTEM                      |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Fibrosis                             |                                                                          |      2  2.0|
      Infiltration Cellular, Lymphocyte    |                                                             2            |      1  2.0|
      Infiltration Cellular, Histiocyte    |                                                             2            |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Lymph Node                              |             +                             +  +           +           +   |  11        |
      Deep Cervical, Hyperplasia, Lymphoid |                                                          1               |      1  1.0|
      Mediastinal, Hemorrhage              |                                                                          |      2  1.5|
      Mediastinal, Hyperplasia, Lymphoid   |                                                                      2   |      2  1.5|
                                           |__________________________________________________________________________|____________|
   Lymph Node, Mandibular                  | M  M  M  M  M  M  M  +  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M|   5        |
      Infiltration Cellular, Plasma Cell   |                                                                          |      1  3.0|
                                           |__________________________________________________________________________|____________|
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Infiltration Cellular, Histiocyte    |                                                                          |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hematopoietic Cell Proliferation     |          1                                                               |      2  1.5|
      Hyperplasia, Lymphohistiocytic       |                                                             2            |      2  2.0|
      Capsule, Fibrosis, Focal             |             1                                                            |      1  1.0|
      Lymphoid Follicle, Atrophy           |                1        1        2  1              3     1  2  2  2  2   |     20  1.8|
      Lymphoid Follicle, Hyperplasia       |                                        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  56                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 6| 7| 7| 7| 6| 7| 1| 7| 7| 7| 7| 5| 4| 5| 7| 7| 6| 7| 7| 7| 7| 7| 7| 5|            |
                             DAY ON TEST   | 2| 9| 2| 0| 2| 8| 2| 1| 2| 2| 2| 2| 0| 7| 7| 1| 2| 4| 2| 2| 2| 2| 2| 2| 1|            |
                                           | 9| 9| 8| 7| 4| 6| 8| 1| 9| 9| 8| 9| 3| 5| 3| 7| 7| 0| 9| 7| 7| 8| 7| 7| 9|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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|      A     |
    0 MG/KG                                | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 HEMATOPOIETIC SYSTEM - cont               |                                                                          |            |
      Lymphoid Follicle, Necrosis          |    3                                                                     |      1  3.0|
                                           |__________________________________________________________________________|____________|
   Thymus                                  | +  +  +  +  +  +  +  +  +  M  +  M  +  +  +  +  +  M  +  +  +  +  +  +  M|  45        |
 _____________________________________________________________________________________________________________________|            |
 INTEGUMENTARY SYSTEM                      |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Mammary Gland                           | +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  49        |
      Hyperplasia                          |    1  1           1     1     1        1     2        1        1     2  1|     25  1.1|
      Duct, Dilatation                     |                1                             2     3        1        1   |     12  1.5|
                                           |__________________________________________________________________________|____________|
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Epidermis, Cyst, Squamous            | 2                                                                        |      1  2.0|
      Epidermis, Epidermis, Cyst           |                               4                                          |      1  4.0|
 _____________________________________________________________________________________________________________________|            |
 MUSCULOSKELETAL SYSTEM                    |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Cyst                                 |          1                                                               |      2  1.0|
      Femur, Hyperostosis                  |                                                                          |      1  3.0|
 _____________________________________________________________________________________________________________________|            |
 NERVOUS SYSTEM                            |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hydrocephalus                        |       2        1  1                 3              2                     |      8  2.4|
      Hypothalamus, Compression            |                                     3              3                     |      6  2.8|
 _____________________________________________________________________________________________________________________|            |
 RESPIRATORY SYSTEM                        |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hemorrhage                           |                      3                                            2      |      2  2.5|
      Alveolar Epithelium, Hyperplasia,    |                                                                          |            |
           Focal                           |                                                 1                 1      |      3  1.0|
      Alveolar Epithelium, Hyperplasia     |                            2           1                                 |      6  1.5|
      Alveolus, Inflammation, Acute        |                                                                          |      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  57                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 6| 7| 7| 7| 6| 7| 1| 7| 7| 7| 7| 5| 4| 5| 7| 7| 6| 7| 7| 7| 7| 7| 7| 5|            |
                             DAY ON TEST   | 2| 9| 2| 0| 2| 8| 2| 1| 2| 2| 2| 2| 0| 7| 7| 1| 2| 4| 2| 2| 2| 2| 2| 2| 1|            |
                                           | 9| 9| 8| 7| 4| 6| 8| 1| 9| 9| 8| 9| 3| 5| 3| 7| 7| 0| 9| 7| 7| 8| 7| 7| 9|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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|      A     |
    0 MG/KG                                | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 RESPIRATORY SYSTEM - cont                 |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Foreign Body                         |                                                                          |      1     |
      Inflammation, Chronic                | 2  2                       1              1                 2            |      9  1.3|
      Ulcer                                |    2                                                        1            |      2  1.5|
                                           |__________________________________________________________________________|____________|
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Inflammation, Chronic                |                                                                          |      1  1.0|
      Epithelium, Metaplasia, Squamous     |                                                                          |      1  3.0|
 _____________________________________________________________________________________________________________________|            |
 SPECIAL SENSES SYSTEM                     |                                                                          |            |
    None                                   |                                                                          |            |
 _____________________________________________________________________________________________________________________|            |
 URINARY SYSTEM                            |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hydronephrosis                       |          3                                                               |      2  3.0|
      Infarct                              |             1                                                            |      2  2.0|
      Nephropathy                          | 1     1  1  2  1  1     1  1  1  2  1        1  1  3  1  2  1  1     1  1|     40  1.4|
      Artery, Thrombosis                   |             1                                                            |      1  1.0|
      Renal Tubule, Necrosis, Focal        |          2                                                               |      2  2.5|
      Vein, Inflammation, Chronic          |                                                                          |      1  3.0|
                                           |__________________________________________________________________________|____________|
   Ureter                                  |                                                                          |   1        |
                                           |__________________________________________________________________________|____________|
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Inflammation, Acute                  |          2                                                               |      1  2.0|
      Mineralization                       |                                                                          |      1  3.0|
      Ulcer                                |          2                                                               |      2  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  58                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 6| 4| 6| 7| 5| 7| 7| 2| 5| 7| 7| 7| 7| 6| 7| 7| 7| 3| 7| 7| 7| 7|             
                             DAY ON TEST   | 2| 2| 2| 5| 7| 4| 1| 3| 2| 1| 2| 7| 2| 2| 2| 2| 6| 2| 2| 2| 1| 2| 2| 2| 2|             
                                           | 9| 9| 9| 4| 8| 5| 9| 3| 8| 7| 3| 4| 8| 7| 8| 7| 8| 8| 8| 8| 3| 8| 7| 8| 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 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|             
    14 MG/KG                               | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 ALIMENTARY SYSTEM                         |                                                                          |             
                                           |__________________________________________________________________________|             
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Muscularis, Periesophageal Tissue,   |                                                                          |             
           Inflammation, Chronic           |                                                                          |             
                                           |__________________________________________________________________________|             
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Parasite Metazoan                    |       X                                                                  |             
                                           |__________________________________________________________________________|             
   Intestine Large, Rectum                 | +  +  +  +  +  +  A  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Myxomatous Change                    |                                                                          |             
      Parasite Metazoan                    | X  X           X                             X           X               |             
                                           |__________________________________________________________________________|             
   Intestine Large, Cecum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Epithelium, Cyst                     |                                                    1                     |             
      Epithelium, Necrosis                 |                                           1                              |             
                                           |__________________________________________________________________________|             
   Intestine Small, Jejunum                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Peyer's Patch, Hyperplasia           |                                                                          |             
                                           |__________________________________________________________________________|             
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Basophilic Focus                     | X  X  X           X     X           X  X  X  X     X  X  X     X        X|             
      Clear Cell Focus                     | X  X  X                                X  X  X     X     X     X  X  X  X|             
      Eosinophilic Focus                   | X                                   X        X        X                  |             
      Fibrosis, Focal                      |                                                                          |             
      Hepatodiaphragmatic Nodule           |                                  X                                      X|             
      Inflammation, Granulomatous          |    1  1     1     1  1              1  1  1  1     1  1  1     1  1     1|             
      Mixed Cell Focus                     | X                 X     X           X     X        X     X        X     X|             
      Artery, Hyperplasia, Focal           |                                                                          |             
      Bile Duct, Hyperplasia               | 2  1  1  2  1  2  1  1  2  2     2  2     1  2     1  2  1     2     1  1|             
      Centrilobular, Degeneration          |                                  3                                       |             
      Centrilobular, Necrosis              |          3                                                               |             
                                           |__________________________________________________________________________|             
   Mesentery                               | +     +                                               +                 +|             
      Fat, Necrosis                        | 3                                                     2                 2|             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  59                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 6| 4| 6| 7| 5| 7| 7| 2| 5| 7| 7| 7| 7| 6| 7| 7| 7| 3| 7| 7| 7| 7|             
                             DAY ON TEST   | 2| 2| 2| 5| 7| 4| 1| 3| 2| 1| 2| 7| 2| 2| 2| 2| 6| 2| 2| 2| 1| 2| 2| 2| 2|             
                                           | 9| 9| 9| 4| 8| 5| 9| 3| 8| 7| 3| 4| 8| 7| 8| 7| 8| 8| 8| 8| 3| 8| 7| 8| 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 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|             
    14 MG/KG                               | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 ALIMENTARY SYSTEM - cont                  |                                                                          |             
                                           |__________________________________________________________________________|             
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fibrosis                             |                                        1                                 |             
      Acinus, Atrophy                      |       1  1     1                                         1     1  2      |             
      Acinus, Hyperplasia, Focal           |                                                                          |             
                                           |__________________________________________________________________________|             
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Edema                                |                                                                          |             
      Inflammation, Acute                  |          1                                                               |             
      Ulcer                                |             3                                   3                        |             
                                           |__________________________________________________________________________|             
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Ulcer                                |          3           2                          3                        |             
                                           |__________________________________________________________________________|             
   Tongue                                  |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 CARDIOVASCULAR SYSTEM                     |                                                                          |             
                                           |__________________________________________________________________________|             
   Blood Vessel                            | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Atrium, Thrombosis                   |          3                       3                                       |             
      Myocardium, Degeneration             | 2  1  1     2        3  1  1     3  2  3  3  2  2  2  2           3  2  2|             
      Myocardium, Necrosis, Focal          |          1                                                               |             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM                          |                                                                          |             
                                           |__________________________________________________________________________|             
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia, Focal                   | 1        1              1           1  2     1           2               |             
      Necrosis, Focal                      |                                  2                                       |             
                                           |__________________________________________________________________________|             
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia, Focal                   | 1        1  3  1           1           3     1  2              2     1   |             
                                           |__________________________________________________________________________|             
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                                                          |             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  60                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 6| 4| 6| 7| 5| 7| 7| 2| 5| 7| 7| 7| 7| 6| 7| 7| 7| 3| 7| 7| 7| 7|             
                             DAY ON TEST   | 2| 2| 2| 5| 7| 4| 1| 3| 2| 1| 2| 7| 2| 2| 2| 2| 6| 2| 2| 2| 1| 2| 2| 2| 2|             
                                           | 9| 9| 9| 4| 8| 5| 9| 3| 8| 7| 3| 4| 8| 7| 8| 7| 8| 8| 8| 8| 3| 8| 7| 8| 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 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|             
    14 MG/KG                               | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 ENDOCRINE SYSTEM - cont                   |                                                                          |             
                                           |__________________________________________________________________________|             
   Parathyroid Gland                       | +  M  +  M  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Angiectasis                          |                                        2                                 |             
      Cyst                                 |    2                                   2                                 |             
      Pars Distalis, Hyperplasia, Focal    |    2                                   2     1                       2   |             
                                           |__________________________________________________________________________|             
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      C-Cell, Hyperplasia                  |    1  2     1     1  1           2  3  1  1     1  1  4  2  1  3  2  4  2|             
 _____________________________________________________________________________________________________________________|             
 GENERAL BODY SYSTEM                       |                                                                          |             
    None                                   |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENITAL SYSTEM                            |                                                                          |             
                                           |__________________________________________________________________________|             
   Epididymis                              | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Preputial Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                     2                 1                  |             
      Inflammation, Chronic                | 1  2  2  2  1  2  2  1  2  2  2  1  2     2  2  2  2     2     2  2  2  2|             
                                           |__________________________________________________________________________|             
   Prostate                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Chronic Active         |             3     2  1              1        1                 1         |             
                                           |__________________________________________________________________________|             
   Seminal Vesicle                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Atrophy                              |                                                                          |             
      Fibrosis                             |                                  1                                       |             
                                           |__________________________________________________________________________|             
   Testes                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Germinal Epithelium, Atrophy         |                            4                                             |             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM                      |                                                                          |             
                                           |__________________________________________________________________________|             
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fibrosis                             |                                  3                                       |             
                                           |__________________________________________________________________________|             
   Lymph Node                              |          +     +     +  +                       +     +     +            |             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  61                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 6| 4| 6| 7| 5| 7| 7| 2| 5| 7| 7| 7| 7| 6| 7| 7| 7| 3| 7| 7| 7| 7|             
                             DAY ON TEST   | 2| 2| 2| 5| 7| 4| 1| 3| 2| 1| 2| 7| 2| 2| 2| 2| 6| 2| 2| 2| 1| 2| 2| 2| 2|             
                                           | 9| 9| 9| 4| 8| 5| 9| 3| 8| 7| 3| 4| 8| 7| 8| 7| 8| 8| 8| 8| 3| 8| 7| 8| 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 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|             
    14 MG/KG                               | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM - cont               |                                                                          |             
      Mediastinal, Ectasia                 |                                                                          |             
      Mediastinal, Hyperplasia, Lymphoid   |                         1                             1                  |             
      Pancreatic, Ectasia                  |          3                                                               |             
      Pancreatic, Hemorrhage               |                                                                          |             
                                           |__________________________________________________________________________|             
   Lymph Node, Mandibular                  | M  M  +  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M|             
                                           |__________________________________________________________________________|             
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Ectasia                              | 2        3                                                               |             
      Fibrosis                             |                                  3                                       |             
      Hemorrhage                           |          2                                                               |             
      Hyperplasia, Lymphoid                |                                                                          |             
      Infiltration Cellular, Histiocyte    |                                                          2               |             
      Necrosis, Lymphoid                   |                                  3                                       |             
      Endothelial Cell, Hyperplasia        |          2                                                               |             
                                           |__________________________________________________________________________|             
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fibrosis, Focal                      |                                  3                                       |             
      Hematopoietic Cell Proliferation     |                                        1                                 |             
      Hyperplasia, Lymphohistiocytic       |                                                    2                     |             
      Necrosis, Focal                      |                                  3                                       |             
      Lymphoid Follicle, Atrophy           | 3  2  2  2        2     3        3  2  2  2        1  2  2           2  2|             
      Lymphoid Follicle, Hyperplasia       |                                                                2         |             
                                           |__________________________________________________________________________|             
   Thymus                                  | +  +  +  M  +  +  +  +  +  +  +  +  M  M  +  +  +  +  +  +  +  +  +  +  M|             
 _____________________________________________________________________________________________________________________|             
 INTEGUMENTARY SYSTEM                      |                                                                          |             
                                           |__________________________________________________________________________|             
   Mammary Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |          1  1  1  1     1  1  1        1     1  1     1     1  1  2  1   |             
      Duct, Dilatation, Diffuse            |                                                                          |             
      Duct, Dilatation                     |       1  2  1     3     1  1           1        1        1     1  1  1   |             
                                           |__________________________________________________________________________|             
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Metaplasia, Osseous                  |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 MUSCULOSKELETAL SYSTEM                    |                                                                          |             
                                           |__________________________________________________________________________|             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  62                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 6| 4| 6| 7| 5| 7| 7| 2| 5| 7| 7| 7| 7| 6| 7| 7| 7| 3| 7| 7| 7| 7|             
                             DAY ON TEST   | 2| 2| 2| 5| 7| 4| 1| 3| 2| 1| 2| 7| 2| 2| 2| 2| 6| 2| 2| 2| 1| 2| 2| 2| 2|             
                                           | 9| 9| 9| 4| 8| 5| 9| 3| 8| 7| 3| 4| 8| 7| 8| 7| 8| 8| 8| 8| 3| 8| 7| 8| 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 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|             
    14 MG/KG                               | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 MUSCULOSKELETAL SYSTEM - cont             |                                                                          |             
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 NERVOUS SYSTEM                            |                                                                          |             
                                           |__________________________________________________________________________|             
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hydrocephalus                        |       2  2  3                                                     2      |             
      Hippocampus, Cerebrum, Degeneration  |                                                                          |             
      Hypothalamus, Compression            |             4                                                            |             
 _____________________________________________________________________________________________________________________|             
 RESPIRATORY SYSTEM                        |                                                                          |             
                                           |__________________________________________________________________________|             
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Emphysema, Focal                     |                                                                          |             
      Hemorrhage                           |                               3                                          |             
      Metaplasia, Osseous                  |                                                    1                     |             
      Thrombosis                           |                                                                          |             
      Alveolar Epithelium, Hyperplasia,    |                                                                          |             
           Focal                           | 1                       1                                                |             
      Alveolus, Emphysema, Focal           |                                           2                              |             
      Alveolus, Inflammation, Acute        |                                                                          |             
      Alveolus, Inflammation, Chronic      |                                                                          |             
          Active, Focal                    |                                              1     1                    1|             
      Mediastinum, Inflammation, Chronic   |                                                                          |             
                                           |__________________________________________________________________________|             
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Chronic                |          1                                      1                        |             
      Ulcer                                |                                                                          |             
                                           |__________________________________________________________________________|             
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM                     |                                                                          |             
                                           |__________________________________________________________________________|             
   Eye                                     |                                                                          |             
      Cataract                             |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 URINARY SYSTEM                            |                                                                          |             
                                           |__________________________________________________________________________|             
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  63                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 7| 7| 7| 6| 4| 6| 7| 5| 7| 7| 2| 5| 7| 7| 7| 7| 6| 7| 7| 7| 3| 7| 7| 7| 7|             
                             DAY ON TEST   | 2| 2| 2| 5| 7| 4| 1| 3| 2| 1| 2| 7| 2| 2| 2| 2| 6| 2| 2| 2| 1| 2| 2| 2| 2|             
                                           | 9| 9| 9| 4| 8| 5| 9| 3| 8| 7| 3| 4| 8| 7| 8| 7| 8| 8| 8| 8| 3| 8| 7| 8| 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 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|             
    14 MG/KG                               | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 URINARY SYSTEM - cont                     |                                                                          |             
      Glomerulosclerosis                   |          2                                                               |             
      Nephropathy                          | 1  1  1  1  2  1  1  1  1  1     1  1     1  1  1  1  1  1     1     1  1|             
      Renal Tubule, Necrosis, Focal        |          1                                                               |             
      Renal Tubule, Pigmentation,          |                                                                          |             
          Lipofuscin                       |                                                                          |             
                                           |__________________________________________________________________________|             
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                      3                                                   |             
 __________________________________________|__________________________________________________________________________              
                                                             Page  64                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 1| 7| 7| 7| 7| 5| 7| 7| 7| 7| 7| 6| 7| 7| 5| 7| 7| 7| 7| 5| 7| 6|            |
                             DAY ON TEST   | 2| 2| 2| 3| 0| 2| 2| 2| 5| 2| 1| 2| 2| 2| 4| 2| 2| 0| 2| 1| 2| 2| 7| 1| 7|            |
                                           | 8| 7| 8| 1| 5| 8| 7| 7| 1| 7| 3| 8| 8| 8| 5| 7| 4| 3| 9| 3| 9| 8| 7| 5| 4|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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| 1|      A     |
    14 MG/KG                               | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 ALIMENTARY SYSTEM                         |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Muscularis, Periesophageal Tissue,   |                                                                          |            |
           Inflammation, Chronic           |                                                                   3      |      1  3.0|
                                           |__________________________________________________________________________|____________|
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Parasite Metazoan                    |                                                                          |      1     |
                                           |__________________________________________________________________________|____________|
   Intestine Large, Rectum                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  48        |
      Myxomatous Change                    |                                           2                              |      1  2.0|
      Parasite Metazoan                    |                      X              X        X                           |      8     |
                                           |__________________________________________________________________________|____________|
   Intestine Large, Cecum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Epithelium, Cyst                     |                                                                          |      1  1.0|
      Epithelium, Necrosis                 |                                                                          |      1  1.0|
                                           |__________________________________________________________________________|____________|
   Intestine Small, Jejunum                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Peyer's Patch, Hyperplasia           |                                              2                           |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Basophilic Focus                     | X  X  X           X  X           X  X  X     X        X     X  X  X      |     27     |
      Clear Cell Focus                     | X              X  X  X           X  X  X              X        X        X|     22     |
      Eosinophilic Focus                   |       X              X     X        X  X              X     X  X         |     12     |
      Fibrosis, Focal                      |                         2                                                |      1  2.0|
      Hepatodiaphragmatic Nodule           |                            X           X           X                     |      5     |
      Inflammation, Granulomatous          | 1     2           1        1     1  1  1     1        1        1        1|     26  1.0|
      Mixed Cell Focus                     | X                          X     X  X  X     X        X        X         |     17     |
      Artery, Hyperplasia, Focal           |    2                                                                     |      1  2.0|
      Bile Duct, Hyperplasia               | 2  1  1     2  1  1  1     1  2  1  2  2     2  2     1  2  2  2  1  3  1|     41  1.5|
      Centrilobular, Degeneration          |                                                                          |      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  65                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 1| 7| 7| 7| 7| 5| 7| 7| 7| 7| 7| 6| 7| 7| 5| 7| 7| 7| 7| 5| 7| 6|            |
                             DAY ON TEST   | 2| 2| 2| 3| 0| 2| 2| 2| 5| 2| 1| 2| 2| 2| 4| 2| 2| 0| 2| 1| 2| 2| 7| 1| 7|            |
                                           | 8| 7| 8| 1| 5| 8| 7| 7| 1| 7| 3| 8| 8| 8| 5| 7| 4| 3| 9| 3| 9| 8| 7| 5| 4|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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| 1|      A     |
    14 MG/KG                               | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 ALIMENTARY SYSTEM - cont                  |                                                                          |            |
      Centrilobular, Necrosis              |                                                                          |      1  3.0|
                                           |__________________________________________________________________________|____________|
   Mesentery                               |             +        +        +     +           +     +  +               |  11        |
      Fat, Necrosis                        |             3        3        2     4           3     2  2               |     10  2.6|
                                           |__________________________________________________________________________|____________|
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Fibrosis                             |                                                                          |      1  1.0|
      Acinus, Atrophy                      | 1     1              2  1  1        2     3                             1|     14  1.4|
      Acinus, Hyperplasia, Focal           |                1                                      2                  |      2  1.5|
                                           |__________________________________________________________________________|____________|
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Edema                                |                                                                   3      |      1  3.0|
      Inflammation, Acute                  |                                                                          |      1  1.0|
      Ulcer                                |                                                                          |      2  3.0|
                                           |__________________________________________________________________________|____________|
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Ulcer                                |                                                                          |      3  2.7|
                                           |__________________________________________________________________________|____________|
   Tongue                                  |                               +                                          |   1        |
 _____________________________________________________________________________________________________________________|            |
 CARDIOVASCULAR SYSTEM                     |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Blood Vessel                            | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Atrium, Thrombosis                   |             3                 3                                          |      4  3.0|
      Myocardium, Degeneration             | 3  3  2     3  2  2  2  2  3  2  2  3  3  2  3     3  2  2  1  2  2  2  2|     41  2.2|
      Myocardium, Necrosis, Focal          |                                                                          |      1  1.0|
 _____________________________________________________________________________________________________________________|            |
 ENDOCRINE SYSTEM                          |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
 _____________________________________________________________________________________________________________________|____________|
  * : 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  66                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 1| 7| 7| 7| 7| 5| 7| 7| 7| 7| 7| 6| 7| 7| 5| 7| 7| 7| 7| 5| 7| 6|            |
                             DAY ON TEST   | 2| 2| 2| 3| 0| 2| 2| 2| 5| 2| 1| 2| 2| 2| 4| 2| 2| 0| 2| 1| 2| 2| 7| 1| 7|            |
                                           | 8| 7| 8| 1| 5| 8| 7| 7| 1| 7| 3| 8| 8| 8| 5| 7| 4| 3| 9| 3| 9| 8| 7| 5| 4|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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| 1|      A     |
    14 MG/KG                               | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 ENDOCRINE SYSTEM - cont                   |                                                                          |            |
      Hyperplasia, Focal                   |    1        2  1  1                          1                 1  1  1  1|     16  1.2|
      Necrosis, Focal                      |                                                                          |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia, Focal                   |             2     2                 1        2  2        2           3   |     17  1.8|
                                           |__________________________________________________________________________|____________|
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia                          |                                                                   1      |      1  1.0|
                                           |__________________________________________________________________________|____________|
   Parathyroid Gland                       | +  +  M  +  M  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +|  44        |
                                           |__________________________________________________________________________|____________|
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Angiectasis                          |                                                                          |      1  2.0|
      Cyst                                 |                                                                1         |      3  1.7|
      Pars Distalis, Hyperplasia, Focal    |                   1  1        1  1        2  2        1           1      |     12  1.4|
                                           |__________________________________________________________________________|____________|
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      C-Cell, Hyperplasia                  |    2  1     1     1  2     1  2  3  2  3  1  4  4     3  2        1  3  2|     36  2.0|
 _____________________________________________________________________________________________________________________|            |
 GENERAL BODY SYSTEM                       |                                                                          |            |
    None                                   |                                                                          |            |
 _____________________________________________________________________________________________________________________|            |
 GENITAL SYSTEM                            |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Epididymis                              | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Preputial Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia                          |                                                                          |      2  1.5|
      Inflammation, Chronic                | 2  2  2     2  2  2  2  1  1  2     1  2  2  1  2     2  1  2  2  1  2  2|     44  1.8|
                                           |__________________________________________________________________________|____________|
   Prostate                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Inflammation, Chronic Active         |                      1        2        2        2     1  1  1     1  1  1|     16  1.4|
                                           |__________________________________________________________________________|____________|
   Seminal Vesicle                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
 _____________________________________________________________________________________________________________________|____________|
  * : 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  67                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 1| 7| 7| 7| 7| 5| 7| 7| 7| 7| 7| 6| 7| 7| 5| 7| 7| 7| 7| 5| 7| 6|            |
                             DAY ON TEST   | 2| 2| 2| 3| 0| 2| 2| 2| 5| 2| 1| 2| 2| 2| 4| 2| 2| 0| 2| 1| 2| 2| 7| 1| 7|            |
                                           | 8| 7| 8| 1| 5| 8| 7| 7| 1| 7| 3| 8| 8| 8| 5| 7| 4| 3| 9| 3| 9| 8| 7| 5| 4|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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| 1|      A     |
    14 MG/KG                               | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 GENITAL SYSTEM - cont                     |                                                                          |            |
      Atrophy                              |                            2                                             |      1  2.0|
      Fibrosis                             |                                                                          |      1  1.0|
                                           |__________________________________________________________________________|____________|
   Testes                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Germinal Epithelium, Atrophy         |                                                                          |      1  4.0|
 _____________________________________________________________________________________________________________________|            |
 HEMATOPOIETIC SYSTEM                      |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Fibrosis                             |                                                                          |      1  3.0|
                                           |__________________________________________________________________________|____________|
   Lymph Node                              | +        +                    +     +  +  +     +        +     +     +   |  17        |
      Mediastinal, Ectasia                 | 1                                      1                                 |      2  1.0|
      Mediastinal, Hyperplasia, Lymphoid   | 1        2                          1  1                       1         |      7  1.1|
      Pancreatic, Ectasia                  |                                                                          |      1  3.0|
      Pancreatic, Hemorrhage               |                                                                      3   |      1  3.0|
                                           |__________________________________________________________________________|____________|
   Lymph Node, Mandibular                  | M  M  M  M  M  M  M  +  M  M  M  M  M  M  M  +  M  M  M  +  +  M  M  M  M|   5        |
                                           |__________________________________________________________________________|____________|
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Ectasia                              |                                                                          |      2  2.5|
      Fibrosis                             |                                                                          |      1  3.0|
      Hemorrhage                           |                                                                          |      1  2.0|
      Hyperplasia, Lymphoid                |                                                                   3      |      1  3.0|
      Infiltration Cellular, Histiocyte    |                                                                          |      1  2.0|
      Necrosis, Lymphoid                   |                                                                          |      1  3.0|
      Endothelial Cell, Hyperplasia        |                                                                          |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Fibrosis, Focal                      |                               2                                          |      2  2.5|
      Hematopoietic Cell Proliferation     |                                                                   1      |      2  1.0|
      Hyperplasia, Lymphohistiocytic       |                                                                      2   |      2  2.0|
      Necrosis, Focal                      |                                                                          |      1  3.0|
      Lymphoid Follicle, Atrophy           | 3  2  2  2        2     3  2     1     2              2                  |     25  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  68                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 1| 7| 7| 7| 7| 5| 7| 7| 7| 7| 7| 6| 7| 7| 5| 7| 7| 7| 7| 5| 7| 6|            |
                             DAY ON TEST   | 2| 2| 2| 3| 0| 2| 2| 2| 5| 2| 1| 2| 2| 2| 4| 2| 2| 0| 2| 1| 2| 2| 7| 1| 7|            |
                                           | 8| 7| 8| 1| 5| 8| 7| 7| 1| 7| 3| 8| 8| 8| 5| 7| 4| 3| 9| 3| 9| 8| 7| 5| 4|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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| 1|      A     |
    14 MG/KG                               | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 HEMATOPOIETIC SYSTEM - cont               |                                                                          |            |
      Lymphoid Follicle, Hyperplasia       |                                                                          |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Thymus                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  M  M  +  +  +  +  +  +  +  +  +|  44        |
 _____________________________________________________________________________________________________________________|            |
 INTEGUMENTARY SYSTEM                      |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Mammary Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  49        |
      Hyperplasia                          | 1  1  1  1  1     1  1  1  1        1  1  1  1  1  1  1  1  3  1  1  1  2|     37  1.1|
      Duct, Dilatation, Diffuse            |    1                                                                     |      1  1.0|
      Duct, Dilatation                     | 1     2     1  1  1           1     2  1  2  1           1     1         |     24  1.3|
                                           |__________________________________________________________________________|____________|
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Metaplasia, Osseous                  |       4                                                                  |      1  4.0|
 _____________________________________________________________________________________________________________________|            |
 MUSCULOSKELETAL SYSTEM                    |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
 _____________________________________________________________________________________________________________________|            |
 NERVOUS SYSTEM                            |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hydrocephalus                        |                                     1     2     2                        |      7  2.0|
      Hippocampus, Cerebrum, Degeneration  |          3                                                               |      1  3.0|
      Hypothalamus, Compression            |             2                                                            |      2  3.0|
 _____________________________________________________________________________________________________________________|            |
 RESPIRATORY SYSTEM                        |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Emphysema, Focal                     |                                        1                                 |      1  1.0|
      Hemorrhage                           |                                                                          |      1  3.0|
      Metaplasia, Osseous                  |                                     1                 1                  |      3  1.0|
      Thrombosis                           |                         4                                                |      1  4.0|
      Alveolar Epithelium, Hyperplasia,    |                                                                          |            |
           Focal                           |                                  1  1                                    |      4  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  69                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 7| 1| 7| 7| 7| 7| 5| 7| 7| 7| 7| 7| 6| 7| 7| 5| 7| 7| 7| 7| 5| 7| 6|            |
                             DAY ON TEST   | 2| 2| 2| 3| 0| 2| 2| 2| 5| 2| 1| 2| 2| 2| 4| 2| 2| 0| 2| 1| 2| 2| 7| 1| 7|            |
                                           | 8| 7| 8| 1| 5| 8| 7| 7| 1| 7| 3| 8| 8| 8| 5| 7| 4| 3| 9| 3| 9| 8| 7| 5| 4|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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| 1|      A     |
    14 MG/KG                               | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 RESPIRATORY SYSTEM - cont                 |                                                                          |            |
      Alveolus, Emphysema, Focal           |                                                                          |      1  2.0|
      Alveolus, Inflammation, Acute        |                         4                                                |      1  4.0|
      Alveolus, Inflammation, Chronic      |                                                                          |            |
          Active, Focal                    |                      1                                   1     1         |      6  1.0|
      Mediastinum, Inflammation, Chronic   |                                                                      2   |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Inflammation, Chronic                |                   1                       1     1        1        2      |      7  1.1|
      Ulcer                                |                                                          1               |      1  1.0|
                                           |__________________________________________________________________________|____________|
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
 _____________________________________________________________________________________________________________________|            |
 SPECIAL SENSES SYSTEM                     |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Eye                                     |                                                          +               |   1        |
      Cataract                             |                                                          3               |      1  3.0|
 _____________________________________________________________________________________________________________________|            |
 URINARY SYSTEM                            |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Glomerulosclerosis                   |                                                                          |      1  2.0|
      Nephropathy                          | 1  1  1     2  1  1  1  1  1  1     1  1  1     1     1  1  1  1  1  3  1|     42  1.1|
      Renal Tubule, Necrosis, Focal        |                                                                          |      1  1.0|
      Renal Tubule, Pigmentation,          |                                                                          |            |
          Lipofuscin                       |                                                                      3   |      1  3.0|
                                           |__________________________________________________________________________|____________|
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hemorrhage                           |                                                                          |      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  70                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 7| 5| 7| 6| 7| 6| 7| 7| 6| 7| 7| 6| 6| 4| 7| 7| 7| 4| 5| 4| 7| 7| 6| 5| 6|             
                             DAY ON TEST   | 2| 8| 2| 3| 2| 8| 2| 2| 9| 2| 2| 7| 8| 8| 2| 1| 2| 9| 8| 6| 2| 2| 7| 6| 3|             
                                           | 7| 2| 8| 0| 8| 6| 7| 7| 5| 7| 7| 4| 6| 4| 7| 6| 8| 2| 6| 2| 8| 9| 4| 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 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|             
    42 MG/KG                               | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 ALIMENTARY SYSTEM                         |                                                                          |             
                                           |__________________________________________________________________________|             
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Intestine Large, Rectum                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Erosion                              |                                        3                                 |             
      Inflammation, Chronic                |                                        3                                 |             
      Myxomatous Change                    |                                                    2        1            |             
      Parasite Metazoan                    |                            X                       X        X            |             
                                           |__________________________________________________________________________|             
   Intestine Large, Cecum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Intestine Small, Jejunum                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Chronic, Focal         |                               1                                          |             
                                           |__________________________________________________________________________|             
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Parasite Metazoan                    |                                                                   X      |             
                                           |__________________________________________________________________________|             
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Basophilic Focus                     | X     X  X        X  X     X     X              X           X  X         |             
      Clear Cell Focus                     |             X     X  X  X  X                    X           X  X        X|             
      Eosinophilic Focus                   |          X     X                                                         |             
      Fatty Change, Focal                  |                         1                                                |             
      Fibrosis, Focal                      |                         2                                                |             
      Hepatodiaphragmatic Nodule           |                         X                                            X   |             
      Inflammation, Granulomatous          | 1     1  1  1  1  1  1  1  1  1  1              1     1  1  1  1         |             
      Mixed Cell Focus                     | X                          X  X                             X            |             
      Bile Duct, Hyperplasia               | 2     1  2  1        2  2     2  2  1  2  3     1  1  1     1  1        2|             
      Centrilobular, Degeneration          |                                                                         2|             
      Centrilobular, Fatty Change          |                                                                          |             
      Centrilobular, Necrosis              |                                                                      3   |             
                                           |__________________________________________________________________________|             
   Mesentery                               |                +                    +  +                       +        +|             
      Fat, Necrosis                        |                2                    3  3                       2        3|             
                                           |__________________________________________________________________________|             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  71                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 7| 5| 7| 6| 7| 6| 7| 7| 6| 7| 7| 6| 6| 4| 7| 7| 7| 4| 5| 4| 7| 7| 6| 5| 6|             
                             DAY ON TEST   | 2| 8| 2| 3| 2| 8| 2| 2| 9| 2| 2| 7| 8| 8| 2| 1| 2| 9| 8| 6| 2| 2| 7| 6| 3|             
                                           | 7| 2| 8| 0| 8| 6| 7| 7| 5| 7| 7| 4| 6| 4| 7| 6| 8| 2| 6| 2| 8| 9| 4| 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 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|             
    42 MG/KG                               | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 ALIMENTARY SYSTEM - cont                  |                                                                          |             
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Acinus, Atrophy                      | 2     2     2        1                    1                              |             
      Acinus, Hyperplasia, Focal           |                                                                          |             
      Duct, Necrosis                       |                                        3                                 |             
                                           |__________________________________________________________________________|             
   Salivary Glands                         | +  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Duct, Parotid Gland, Sublingual      |                                                                          |             
          Gland, Mineralization            |                                                                      2   |             
      Parotid Gland, Atrophy, Focal        |                                                                      3   |             
      Sublingual Gland, Atrophy, Focal     |                                                                          |             
                                           |__________________________________________________________________________|             
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia, Focal, Squamous         |                                              2                       2   |             
      Inflammation, Chronic                |                                                                      2   |             
      Ulcer                                |                4                       3                                 |             
                                           |__________________________________________________________________________|             
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Mineralization                       |                                                             1            |             
      Ulcer                                |    2                                         1                       2   |             
      Epithelium, Hyperplasia, Focal       |    1                                                                     |             
 _____________________________________________________________________________________________________________________|             
 CARDIOVASCULAR SYSTEM                     |                                                                          |             
                                           |__________________________________________________________________________|             
   Blood Vessel                            | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Atrium, Inflammation, Chronic        |                                                                          |             
      Myocardium, Degeneration             | 2  1  1  3  2  2  3     2  3  2  3  2     2     2  2  3  1  3     1  2  3|             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM                          |                                                                          |             
                                           |__________________________________________________________________________|             
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia, Focal                   | 1     1                       2  2  2  1                             4   |             
      Necrosis, Acute                      |                                                                      4   |             
                                           |__________________________________________________________________________|             
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fibrosis                             |                                                                      2   |             
      Hyperplasia, Focal                   |    3        3              1        3     1           1           1  3   |             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  72                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 7| 5| 7| 6| 7| 6| 7| 7| 6| 7| 7| 6| 6| 4| 7| 7| 7| 4| 5| 4| 7| 7| 6| 5| 6|             
                             DAY ON TEST   | 2| 8| 2| 3| 2| 8| 2| 2| 9| 2| 2| 7| 8| 8| 2| 1| 2| 9| 8| 6| 2| 2| 7| 6| 3|             
                                           | 7| 2| 8| 0| 8| 6| 7| 7| 5| 7| 7| 4| 6| 4| 7| 6| 8| 2| 6| 2| 8| 9| 4| 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 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|             
    42 MG/KG                               | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 ENDOCRINE SYSTEM - cont                   |                                                                          |             
      Necrosis, Focal                      |                                                                      1   |             
                                           |__________________________________________________________________________|             
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |                                              1                           |             
                                           |__________________________________________________________________________|             
   Parathyroid Gland                       | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  M  +  +  +  M  +|             
                                           |__________________________________________________________________________|             
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 | 1                             2                             1            |             
      Pars Distalis, Hyperplasia, Focal    |       1     2                    2  1     1     1                        |             
                                           |__________________________________________________________________________|             
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      C-Cell, Hyperplasia                  | 2  3  3  2  2  2  3  1  1  2  2  2  2  2     1     2  2  2  1     1  2  1|             
      Follicle, Cyst                       |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENERAL BODY SYSTEM                       |                                                                          |             
                                           |__________________________________________________________________________|             
   Peritoneum                              |                                        +                                 |             
      Inflammation, Chronic                |                                        3                                 |             
 _____________________________________________________________________________________________________________________|             
 GENITAL SYSTEM                            |                                                                          |             
                                           |__________________________________________________________________________|             
   Epididymis                              | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Granuloma Sperm                      |                                                                          |             
                                           |__________________________________________________________________________|             
   Preputial Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |                                                                      2   |             
      Inflammation, Chronic                | 2  2  2  1  1  1     1     2  1  1  1  1  1  2  2  1  2  1  1  1  2  2  1|             
      Inflammation, Suppurative            |                                                                          |             
                                           |__________________________________________________________________________|             
   Prostate                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia, Focal                   |                   1                                                      |             
      Inflammation, Chronic Active         |    3     2  1  2  1     2     1     1  1     1           2               |             
                                           |__________________________________________________________________________|             
   Seminal Vesicle                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fibrosis                             |                                                                          |             
      Hyperplasia                          |                                                    2     2               |             
                                           |__________________________________________________________________________|             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  73                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 7| 5| 7| 6| 7| 6| 7| 7| 6| 7| 7| 6| 6| 4| 7| 7| 7| 4| 5| 4| 7| 7| 6| 5| 6|             
                             DAY ON TEST   | 2| 8| 2| 3| 2| 8| 2| 2| 9| 2| 2| 7| 8| 8| 2| 1| 2| 9| 8| 6| 2| 2| 7| 6| 3|             
                                           | 7| 2| 8| 0| 8| 6| 7| 7| 5| 7| 7| 4| 6| 4| 7| 6| 8| 2| 6| 2| 8| 9| 4| 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 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|             
    42 MG/KG                               | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 GENITAL SYSTEM - cont                     |                                                                          |             
   Testes                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |             4                             4                              |             
      Artery, Necrosis                     |                                                                          |             
      Germinal Epithelium, Atrophy         |                2                                                         |             
      Interstitial Cell, Hyperplasia       |                                     2                                    |             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM                      |                                                                          |             
                                           |__________________________________________________________________________|             
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Lymph Node                              |    +                                +           +                 +      |             
      Mediastinal, Ectasia                 |                                                                          |             
      Mediastinal, Hyperplasia, Lymphoid   |                                                                          |             
      Mediastinal, Infiltration Cellular,  |                                                                          |             
           Histiocyte                      |                                                 2                        |             
      Renal, Ectasia                       |                                                                          |             
      Renal, Infiltration Cellular, Plasma |                                                                          |             
          Cell                             |                                                                          |             
                                           |__________________________________________________________________________|             
   Lymph Node, Mandibular                  | M  M  M  M  M  +  M  +  M  +  +  M  M  M  M  M  M  M  M  M  M  +  M  M  M|             
      Ectasia                              |                               3                                          |             
                                           |__________________________________________________________________________|             
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Ectasia                              |                                                                          |             
      Hemorrhage                           |                                              3                           |             
      Hyperplasia, Lymphoid                |                                        2                                 |             
      Infiltration Cellular, Histiocyte    |       1  1  1  1  1     1        1                 2        1     1  3   |             
                                           |__________________________________________________________________________|             
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hematopoietic Cell Proliferation     |                                        1                                2|             
      Hyperplasia, Lymphohistiocytic       |          2                                                               |             
      Lymphoid Follicle, Atrophy           |                2     3  2  3  2        2        1  2  2  3  2  3     4   |             
      Lymphoid Follicle, Hyperplasia       |                                                                         2|             
                                           |__________________________________________________________________________|             
   Thymus                                  | +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  M  M  +|             
 _____________________________________________________________________________________________________________________|             
 INTEGUMENTARY SYSTEM                      |                                                                          |             
                                           |__________________________________________________________________________|             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  74                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 7| 5| 7| 6| 7| 6| 7| 7| 6| 7| 7| 6| 6| 4| 7| 7| 7| 4| 5| 4| 7| 7| 6| 5| 6|             
                             DAY ON TEST   | 2| 8| 2| 3| 2| 8| 2| 2| 9| 2| 2| 7| 8| 8| 2| 1| 2| 9| 8| 6| 2| 2| 7| 6| 3|             
                                           | 7| 2| 8| 0| 8| 6| 7| 7| 5| 7| 7| 4| 6| 4| 7| 6| 8| 2| 6| 2| 8| 9| 4| 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 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|             
    42 MG/KG                               | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 INTEGUMENTARY SYSTEM - cont               |                                                                          |             
   Mammary Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          | 1  1  1  1  1     1  1     1  1  1     1        1  1        1     1  1  1|             
      Duct, Dilatation                     |    1  1  1  1  1  1  1  2     1     2     1     1     2  2        1      |             
                                           |__________________________________________________________________________|             
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 MUSCULOSKELETAL SYSTEM                    |                                                                          |             
                                           |__________________________________________________________________________|             
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Skeletal Muscle                         |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 NERVOUS SYSTEM                            |                                                                          |             
                                           |__________________________________________________________________________|             
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hydrocephalus                        |          1     3  2     3                             4  1           1   |             
      Cerebrum, Degeneration, Focal        |    2                                                                     |             
      Hypothalamus, Compression            |                3        4                             4  3               |             
      Medulla, Degeneration, Focal         |          2                                                               |             
 _____________________________________________________________________________________________________________________|             
 RESPIRATORY SYSTEM                        |                                                                          |             
                                           |__________________________________________________________________________|             
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                                                                          |             
      Alveolar Epithelium, Hyperplasia,    |                                                                          |             
           Focal                           |                               1                                1         |             
      Alveolus, Inflammation, Chronic      |                                                                          |             
          Active, Focal                    |          1        1                    1     1                    1      |             
                                           |__________________________________________________________________________|             
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Chronic                |             1     1                 1                 1     1     1      |             
                                           |__________________________________________________________________________|             
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM                     |                                                                          |             
    None                                   |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 URINARY SYSTEM                            |                                                                          |             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  75                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 7| 5| 7| 6| 7| 6| 7| 7| 6| 7| 7| 6| 6| 4| 7| 7| 7| 4| 5| 4| 7| 7| 6| 5| 6|             
                             DAY ON TEST   | 2| 8| 2| 3| 2| 8| 2| 2| 9| 2| 2| 7| 8| 8| 2| 1| 2| 9| 8| 6| 2| 2| 7| 6| 3|             
                                           | 7| 2| 8| 0| 8| 6| 7| 7| 5| 7| 7| 4| 6| 4| 7| 6| 8| 2| 6| 2| 8| 9| 4| 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 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|             
    42 MG/KG                               | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2|             
                                           | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 URINARY SYSTEM - cont                     |                                                                          |             
                                           |__________________________________________________________________________|             
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                                                                          |             
      Infarct                              |    1                                                                     |             
      Nephropathy                          |    1  2     1  3  2  1  2  2  1  1  1     1  1  1  1  1     1  1     3  2|             
      Pelvis, Inflammation, Suppurative    |                                                                      3   |             
      Renal Tubule, Necrosis, Focal        |                      1                                                   |             
      Renal Tubule, Pigmentation,          |                                                                          |             
          Lipofuscin                       |    3                                                              2      |             
                                           |__________________________________________________________________________|             
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 __________________________________________|__________________________________________________________________________              
                                                             Page  76                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 5| 5| 7| 4| 7| 6| 7| 5| 7| 7| 7| 7| 7| 5| 7| 7| 5| 7| 7| 6| 7| 5| 6| 7|            |
                             DAY ON TEST   | 2| 7| 2| 2| 1| 2| 7| 2| 8| 2| 2| 2| 2| 2| 8| 2| 1| 3| 2| 2| 8| 2| 2| 3| 2|            |
                                           | 7| 4| 6| 7| 9| 8| 9| 9| 2| 7| 7| 7| 7| 7| 7| 7| 7| 3| 7| 8| 5| 8| 1| 0| 8|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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|      A     |
    42 MG/KG                               | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 ALIMENTARY SYSTEM                         |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Intestine Large, Rectum                 | +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  49        |
      Erosion                              |                         2                                                |      2  2.5|
      Inflammation, Chronic                |                                                                          |      1  3.0|
      Myxomatous Change                    | 1                                                                        |      3  1.3|
      Parasite Metazoan                    | X                                                                        |      4     |
                                           |__________________________________________________________________________|____________|
   Intestine Large, Cecum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Intestine Small, Jejunum                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Inflammation, Chronic, Focal         |                                                                          |      1  1.0|
                                           |__________________________________________________________________________|____________|
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Parasite Metazoan                    |                                                                          |      1     |
                                           |__________________________________________________________________________|____________|
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Basophilic Focus                     |          X           X     X  X  X  X  X     X     X  X  X              X|     22     |
      Clear Cell Focus                     | X  X     X           X     X  X  X  X  X  X  X        X  X     X         |     23     |
      Eosinophilic Focus                   |                      X                                   X              X|      5     |
      Fatty Change, Focal                  |                                                                          |      1  1.0|
      Fibrosis, Focal                      |                                                                          |      1  2.0|
      Hepatodiaphragmatic Nodule           |    X     X  X                       X                          X         |      7     |
      Inflammation, Granulomatous          | 1  1     1     1     1     1  1  1  1  1  1  1        1  1     1        1|     32  1.0|
      Mixed Cell Focus                     | X                 X        X        X        X        X  X     X        X|     13     |
      Bile Duct, Hyperplasia               | 1        1     2           1  1  1  1  1  1  1        1  1  2  2        1|     32  1.4|
      Centrilobular, Degeneration          |                                                                          |      1  2.0|
      Centrilobular, Fatty Change          |                   3                                                      |      1  3.0|
      Centrilobular, Necrosis              |                                                             3            |      2  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  77                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 5| 5| 7| 4| 7| 6| 7| 5| 7| 7| 7| 7| 7| 5| 7| 7| 5| 7| 7| 6| 7| 5| 6| 7|            |
                             DAY ON TEST   | 2| 7| 2| 2| 1| 2| 7| 2| 8| 2| 2| 2| 2| 2| 8| 2| 1| 3| 2| 2| 8| 2| 2| 3| 2|            |
                                           | 7| 4| 6| 7| 9| 8| 9| 9| 2| 7| 7| 7| 7| 7| 7| 7| 7| 3| 7| 8| 5| 8| 1| 0| 8|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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|      A     |
    42 MG/KG                               | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 ALIMENTARY SYSTEM - cont                  |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Mesentery                               |                +              +                    +        +            |   9        |
      Fat, Necrosis                        |                4              3                    2        2            |      9  2.7|
                                           |__________________________________________________________________________|____________|
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Acinus, Atrophy                      |    1     2                          2     1  1        1  1     1        2|     14  1.4|
      Acinus, Hyperplasia, Focal           |                2                                                         |      1  2.0|
      Duct, Necrosis                       |                                                                          |      1  3.0|
                                           |__________________________________________________________________________|____________|
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  49        |
      Duct, Parotid Gland, Sublingual      |                                                                          |            |
          Gland, Mineralization            |                                                                          |      1  2.0|
      Parotid Gland, Atrophy, Focal        |                                                                          |      1  3.0|
      Sublingual Gland, Atrophy, Focal     |                                                                2         |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia, Focal, Squamous         |                                                                          |      2  2.0|
      Inflammation, Chronic                |                                                                          |      1  2.0|
      Ulcer                                |                   4     3                                                |      4  3.5|
                                           |__________________________________________________________________________|____________|
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Mineralization                       |                                                                          |      1  1.0|
      Ulcer                                |                         3                                   2            |      5  2.0|
      Epithelium, Hyperplasia, Focal       |                                              1                           |      2  1.0|
 _____________________________________________________________________________________________________________________|            |
 CARDIOVASCULAR SYSTEM                     |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Blood Vessel                            | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Atrium, Inflammation, Chronic        |                                                             2            |      1  2.0|
      Myocardium, Degeneration             | 3  1  1     2  3  2  3  1  1  2  3  2  3     1  1  1  2  2     1  2  3   |     42  2.0|
 _____________________________________________________________________________________________________________________|            |
 ENDOCRINE 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  78                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 5| 5| 7| 4| 7| 6| 7| 5| 7| 7| 7| 7| 7| 5| 7| 7| 5| 7| 7| 6| 7| 5| 6| 7|            |
                             DAY ON TEST   | 2| 7| 2| 2| 1| 2| 7| 2| 8| 2| 2| 2| 2| 2| 8| 2| 1| 3| 2| 2| 8| 2| 2| 3| 2|            |
                                           | 7| 4| 6| 7| 9| 8| 9| 9| 2| 7| 7| 7| 7| 7| 7| 7| 7| 3| 7| 8| 5| 8| 1| 0| 8|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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|      A     |
    42 MG/KG                               | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 ENDOCRINE SYSTEM - cont                   |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia, Focal                   |    1           1  1                 1        1     1     1  1  4        1|     17  1.5|
      Necrosis, Acute                      |                                                                          |      1  4.0|
                                           |__________________________________________________________________________|____________|
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Fibrosis                             |                                  4  3                                    |      3  3.0|
      Hyperplasia, Focal                   |       1                             2                    2  2            |     12  1.9|
      Necrosis, Focal                      |                                                                          |      1  1.0|
                                           |__________________________________________________________________________|____________|
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia                          |                                                                          |      1  1.0|
                                           |__________________________________________________________________________|____________|
   Parathyroid Gland                       | +  +  +  M  +  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  M  +  +|  45        |
                                           |__________________________________________________________________________|____________|
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Cyst                                 |       1                                                              2   |      5  1.4|
      Pars Distalis, Hyperplasia, Focal    |             1           1  1  1     1     2  1     1  2        1     1   |     17  1.2|
                                           |__________________________________________________________________________|____________|
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      C-Cell, Hyperplasia                  | 1  1  2        1  2        2  4     2  4  1  2  1  2     2     2  1  1  2|     40  1.9|
      Follicle, Cyst                       |                               2                                          |      1  2.0|
 _____________________________________________________________________________________________________________________|            |
 GENERAL BODY SYSTEM                       |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Peritoneum                              |                                                                          |   1        |
      Inflammation, Chronic                |                                                                          |      1  3.0|
 _____________________________________________________________________________________________________________________|            |
 GENITAL SYSTEM                            |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Epididymis                              | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Granuloma Sperm                      |                         1                                                |      1  1.0|
                                           |__________________________________________________________________________|____________|
   Preputial Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
 _____________________________________________________________________________________________________________________|____________|
  * : 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  79                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 5| 5| 7| 4| 7| 6| 7| 5| 7| 7| 7| 7| 7| 5| 7| 7| 5| 7| 7| 6| 7| 5| 6| 7|            |
                             DAY ON TEST   | 2| 7| 2| 2| 1| 2| 7| 2| 8| 2| 2| 2| 2| 2| 8| 2| 1| 3| 2| 2| 8| 2| 2| 3| 2|            |
                                           | 7| 4| 6| 7| 9| 8| 9| 9| 2| 7| 7| 7| 7| 7| 7| 7| 7| 3| 7| 8| 5| 8| 1| 0| 8|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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|      A     |
    42 MG/KG                               | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 GENITAL SYSTEM - cont                     |                                                                          |            |
      Cyst                                 | 2                          3                                             |      3  2.3|
      Inflammation, Chronic                | 2  2     2     1  2  1  1     1     2     1  2  2  1  2  2     2  1  1  2|     42  1.5|
      Inflammation, Suppurative            |                                  2     3                                 |      2  2.5|
                                           |__________________________________________________________________________|____________|
   Prostate                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia, Focal                   |                                                                          |      1  1.0|
      Inflammation, Chronic Active         |          1     2        1        2     3                    1        2  1|     19  1.6|
                                           |__________________________________________________________________________|____________|
   Seminal Vesicle                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Fibrosis                             |                                                 3                        |      1  3.0|
      Hyperplasia                          |                                                                          |      2  2.0|
                                           |__________________________________________________________________________|____________|
   Testes                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Cyst                                 |                                                                          |      2  4.0|
      Artery, Necrosis                     |                                        3                                 |      1  3.0|
      Germinal Epithelium, Atrophy         |                                                                          |      1  2.0|
      Interstitial Cell, Hyperplasia       |                                                                          |      1  2.0|
 _____________________________________________________________________________________________________________________|            |
 HEMATOPOIETIC SYSTEM                      |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Lymph Node                              |                +        +        +     +                 +           +   |  10        |
      Mediastinal, Ectasia                 |                2                       2                                 |      2  2.0|
      Mediastinal, Hyperplasia, Lymphoid   |                                  2                       2               |      2  2.0|
      Mediastinal, Infiltration Cellular,  |                                                                          |            |
           Histiocyte                      |                                                                          |      1  2.0|
      Renal, Ectasia                       |                                        3                                 |      1  3.0|
      Renal, Infiltration Cellular, Plasma |                                                                          |            |
          Cell                             |                                        4                                 |      1  4.0|
                                           |__________________________________________________________________________|____________|
   Lymph Node, Mandibular                  | M  M  M  M  M  M  M  M  M  +  +  M  M  M  M  M  M  M  M  M  +  M  M  M  +|   9        |
      Ectasia                              |                                                                          |      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  80                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 5| 5| 7| 4| 7| 6| 7| 5| 7| 7| 7| 7| 7| 5| 7| 7| 5| 7| 7| 6| 7| 5| 6| 7|            |
                             DAY ON TEST   | 2| 7| 2| 2| 1| 2| 7| 2| 8| 2| 2| 2| 2| 2| 8| 2| 1| 3| 2| 2| 8| 2| 2| 3| 2|            |
                                           | 7| 4| 6| 7| 9| 8| 9| 9| 2| 7| 7| 7| 7| 7| 7| 7| 7| 3| 7| 8| 5| 8| 1| 0| 8|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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|      A     |
    42 MG/KG                               | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 HEMATOPOIETIC SYSTEM - cont               |                                                                          |            |
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Ectasia                              |          2                                                     2         |      2  2.0|
      Hemorrhage                           |                                                                          |      1  3.0|
      Hyperplasia, Lymphoid                |                                                                          |      1  2.0|
      Infiltration Cellular, Histiocyte    | 1              1  1              1  1  1              1                  |     18  1.2|
                                           |__________________________________________________________________________|____________|
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hematopoietic Cell Proliferation     |                                                    1                     |      3  1.3|
      Hyperplasia, Lymphohistiocytic       |          2                                                               |      2  2.0|
      Lymphoid Follicle, Atrophy           | 1  2     4  3     2  2        2  2  2  2  2           2     2  2  2     2|     29  2.2|
      Lymphoid Follicle, Hyperplasia       |                                                                          |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Thymus                                  | +  +  +  +  +  +  +  M  +  +  +  M  M  +  +  +  +  M  +  +  +  +  +  +  +|  43        |
 _____________________________________________________________________________________________________________________|            |
 INTEGUMENTARY SYSTEM                      |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Mammary Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia                          |       1  1  1     1     1     1     1        1  1           1  1  1  1  1|     31  1.0|
      Duct, Dilatation                     | 1        1           2        1  2     2     1  2        1     1     1  2|     27  1.3|
                                           |__________________________________________________________________________|____________|
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
 _____________________________________________________________________________________________________________________|            |
 MUSCULOSKELETAL SYSTEM                    |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Skeletal Muscle                         |                                                    +                     |   1        |
 _____________________________________________________________________________________________________________________|            |
 NERVOUS SYSTEM                            |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hydrocephalus                        |                3                       2                                 |      9  2.2|
      Cerebrum, Degeneration, Focal        |                                                                          |      1  2.0|
      Hypothalamus, Compression            |                3                                                         |      5  3.4|
 _____________________________________________________________________________________________________________________|____________|
  * : 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: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 5| 5| 7| 4| 7| 6| 7| 5| 7| 7| 7| 7| 7| 5| 7| 7| 5| 7| 7| 6| 7| 5| 6| 7|            |
                             DAY ON TEST   | 2| 7| 2| 2| 1| 2| 7| 2| 8| 2| 2| 2| 2| 2| 8| 2| 1| 3| 2| 2| 8| 2| 2| 3| 2|            |
                                           | 7| 4| 6| 7| 9| 8| 9| 9| 2| 7| 7| 7| 7| 7| 7| 7| 7| 3| 7| 8| 5| 8| 1| 0| 8|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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|      A     |
    42 MG/KG                               | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 5|      L     |
                                           | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 NERVOUS SYSTEM - cont                     |                                                                          |            |
      Medulla, Degeneration, Focal         |                                                                          |      1  2.0|
 _____________________________________________________________________________________________________________________|            |
 RESPIRATORY SYSTEM                        |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hemorrhage                           |                                           3                              |      1  3.0|
      Alveolar Epithelium, Hyperplasia,    |                                                                          |            |
           Focal                           |                                                                   1      |      3  1.0|
      Alveolus, Inflammation, Chronic      |                                                                          |            |
          Active, Focal                    | 2  1                 2     1                 1                 3         |     11  1.4|
                                           |__________________________________________________________________________|____________|
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Inflammation, Chronic                |                                                 1                       1|      8  1.0|
                                           |__________________________________________________________________________|____________|
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
 _____________________________________________________________________________________________________________________|            |
 SPECIAL SENSES SYSTEM                     |                                                                          |            |
    None                                   |                                                                          |            |
 _____________________________________________________________________________________________________________________|            |
 URINARY SYSTEM                            |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hemorrhage                           |                            1                                             |      1  1.0|
      Infarct                              |                         1                                                |      2  1.0|
      Nephropathy                          | 1     1  3     1  3  2  1  1  1  2  2  3     1  1  1  1  2  1  1     1  1|     41  1.5|
      Pelvis, Inflammation, Suppurative    |                                                                          |      1  3.0|
      Renal Tubule, Necrosis, Focal        |                                                             1            |      2  1.0|
      Renal Tubule, Pigmentation,          |                                                                          |            |
          Lipofuscin                       |                         2                                                |      3  2.3|
                                           |__________________________________________________________________________|____________|
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
 __________________________________________________________________________________________________________________________________ 
  * : 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: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 6| 6| 3| 7| 7| 7| 6| 7| 7| 7| 7| 6| 7| 4| 7| 7| 7| 7| 6| 6| 1| 7| 7| 7| 1|             
                             DAY ON TEST   | 2| 2| 5| 2| 2| 2| 9| 2| 0| 2| 2| 4| 2| 3| 2| 2| 2| 2| 6| 8| 2| 0| 2| 0| 6|             
                                           | 9| 2| 2| 7| 8| 8| 1| 7| 7| 9| 7| 0| 7| 3| 8| 8| 8| 7| 9| 9| 0| 9| 8| 8| 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 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|             
    126                                    | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7|             
    MG/KG                                  | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 ALIMENTARY SYSTEM                         |                                                                          |             
                                           |__________________________________________________________________________|             
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Periesophageal Tissue, Hemorrhage    |                                                                          |             
                                           |__________________________________________________________________________|             
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Parasite Metazoan                    |                                                                   X      |             
                                           |__________________________________________________________________________|             
   Intestine Large, Rectum                 | A  +  A  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +  +  +  +|             
      Erosion                              |                               2                                   2      |             
      Infiltration Cellular, Histiocyte    |                1     1  1                                                |             
      Inflammation, Chronic                |          2     2                                                         |             
      Myxomatous Change                    |          1  1        1  1  1     1  1     1  1           1        1      |             
      Parasite Metazoan                    |          X                                                               |             
      Ulcer                                |                            1                                             |             
                                           |__________________________________________________________________________|             
   Intestine Large, Cecum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Intestine Small, Jejunum                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Angiectasis                          |             1                                                            |             
      Basophilic Focus                     |          X  X              X  X  X  X     X  X  X                        |             
      Clear Cell Focus                     |             X              X  X        X     X  X  X           X         |             
      Eosinophilic Focus                   |                      X                                         X         |             
      Fibrosis, Focal                      |                                        2                                 |             
      Hepatodiaphragmatic Nodule           | X                                         X  X  X     X     X            |             
      Inflammation, Granulomatous          | 1  1     2  1           1  2     1  1     1  1  1  1                 1   |             
      Mixed Cell Focus                     |             X                       X     X  X     X              X      |             
      Bile Duct, Hyperplasia               | 2  1        2  3  4  2  2  1  1  1  1  1  1  1  1  1  1  2     1  2  1   |             
      Centrilobular, Degeneration          |                                                                          |             
      Centrilobular, Fatty Change          |    3                                                                     |             
      Centrilobular, Necrosis              |       3                                                              1   |             
                                           |__________________________________________________________________________|             
   Mesentery                               | +  +                                            +                 +      |             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  83                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 6| 6| 3| 7| 7| 7| 6| 7| 7| 7| 7| 6| 7| 4| 7| 7| 7| 7| 6| 6| 1| 7| 7| 7| 1|             
                             DAY ON TEST   | 2| 2| 5| 2| 2| 2| 9| 2| 0| 2| 2| 4| 2| 3| 2| 2| 2| 2| 6| 8| 2| 0| 2| 0| 6|             
                                           | 9| 2| 2| 7| 8| 8| 1| 7| 7| 9| 7| 0| 7| 3| 8| 8| 8| 7| 9| 9| 0| 9| 8| 8| 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 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|             
    126                                    | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7|             
    MG/KG                                  | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 ALIMENTARY SYSTEM - cont                  |                                                                          |             
      Accessory Spleen                     |                                                                          |             
      Hemorrhage                           |                                                                          |             
      Fat, Inflammation, Granulomatous     |                                                                          |             
      Fat, Necrosis                        | 3                                               2                 3      |             
                                           |__________________________________________________________________________|             
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Acinus, Atrophy                      |    1                       1  3     1     1        1                     |             
                                           |__________________________________________________________________________|             
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia, Focal, Squamous         |                                                                          |             
      Ulcer                                |                                        3                                 |             
                                           |__________________________________________________________________________|             
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Mineralization                       |                                                                          |             
      Ulcer                                |                                           1                          3   |             
      Epithelium, Hyperplasia, Focal       |                                                          2               |             
 _____________________________________________________________________________________________________________________|             
 CARDIOVASCULAR SYSTEM                     |                                                                          |             
                                           |__________________________________________________________________________|             
   Blood Vessel                            | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Atrium, Thrombosis                   |                                                                          |             
      Myocardium, Degeneration             | 2  2  2     2  1  3     4  2  2  2  2     3  1  2  2  2  1     3  2  1   |             
      Vein, Thrombosis                     |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 ENDOCRINE SYSTEM                          |                                                                          |             
                                           |__________________________________________________________________________|             
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia, Focal                   |    1     1     3  2  1  2  2     2        1                          3   |             
      Hyperplasia                          |                                                                          |             
                                           |__________________________________________________________________________|             
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia, Focal                   |          3  1        2     2                    2                 1      |             
                                           |__________________________________________________________________________|             
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  84                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 6| 6| 3| 7| 7| 7| 6| 7| 7| 7| 7| 6| 7| 4| 7| 7| 7| 7| 6| 6| 1| 7| 7| 7| 1|             
                             DAY ON TEST   | 2| 2| 5| 2| 2| 2| 9| 2| 0| 2| 2| 4| 2| 3| 2| 2| 2| 2| 6| 8| 2| 0| 2| 0| 6|             
                                           | 9| 2| 2| 7| 8| 8| 1| 7| 7| 9| 7| 0| 7| 3| 8| 8| 8| 7| 9| 9| 0| 9| 8| 8| 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 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|             
    126                                    | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7|             
    MG/KG                                  | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 ENDOCRINE SYSTEM - cont                   |                                                                          |             
      Hyperplasia                          |    1                                                                     |             
                                           |__________________________________________________________________________|             
   Parathyroid Gland                       | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Angiectasis                          |                                              1                           |             
      Cyst                                 |                                                                          |             
      Hyperplasia                          |                                                                          |             
      Necrosis, Focal                      |                   3                                                      |             
      Pars Distalis, Hyperplasia, Focal    |                      1                 1        1                        |             
                                           |__________________________________________________________________________|             
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      C-Cell, Hyperplasia                  | 1  3     1  3        2  1        1  2  2  2  2  2  2           2  2  4   |             
      Follicle, Hyperplasia                |                               3                                          |             
 _____________________________________________________________________________________________________________________|             
 GENERAL BODY SYSTEM                       |                                                                          |             
    None                                   |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 GENITAL SYSTEM                            |                                                                          |             
                                           |__________________________________________________________________________|             
   Coagulating Gland                       |                                                                          |             
      Inflammation, Chronic                |                                                                          |             
                                           |__________________________________________________________________________|             
   Epididymis                              | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fibrosis                             |                                        3                                 |             
      Granuloma Sperm                      |                      1                                                   |             
      Inflammation, Acute                  |                                                                          |             
                                           |__________________________________________________________________________|             
   Preputial Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Cyst                                 |          2           3                                                   |             
      Inflammation, Chronic                |    1     1  2  2  2     2  1  1  1     1  2  1  2  2           1  2  2  1|             
      Inflammation, Suppurative            |                                                                          |             
                                           |__________________________________________________________________________|             
   Prostate                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  M  +  +  +  +  +|             
      Inflammation, Chronic Active         | 2     1        1                 3  1     1  1                    1  1   |             
                                           |__________________________________________________________________________|             
   Seminal Vesicle                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  M  +  +  +  +  +|             
      Hyperplasia                          |                            2                                2            |             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  85                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 6| 6| 3| 7| 7| 7| 6| 7| 7| 7| 7| 6| 7| 4| 7| 7| 7| 7| 6| 6| 1| 7| 7| 7| 1|             
                             DAY ON TEST   | 2| 2| 5| 2| 2| 2| 9| 2| 0| 2| 2| 4| 2| 3| 2| 2| 2| 2| 6| 8| 2| 0| 2| 0| 6|             
                                           | 9| 2| 2| 7| 8| 8| 1| 7| 7| 9| 7| 0| 7| 3| 8| 8| 8| 7| 9| 9| 0| 9| 8| 8| 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 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|             
    126                                    | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7|             
    MG/KG                                  | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 GENITAL SYSTEM - cont                     |                                                                          |             
                                           |__________________________________________________________________________|             
   Testes                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Germinal Epithelium, Atrophy         |                                        4                                 |             
      Interstitial Cell, Hyperplasia       | 1                          2                                             |             
 _____________________________________________________________________________________________________________________|             
 HEMATOPOIETIC SYSTEM                      |                                                                          |             
                                           |__________________________________________________________________________|             
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fibrosis                             |                                                                          |             
                                           |__________________________________________________________________________|             
   Lymph Node                              |          +     +     +     +        +                    +        +      |             
      Deep Cervical, Angiectasis           |                                     3                                    |             
      Mediastinal, Angiectasis             |                            2                                             |             
      Mediastinal, Ectasia                 |                                                                          |             
      Mediastinal, Hemorrhage              |                                                                          |             
      Mediastinal, Hyperplasia, Lymphoid   |          1                                                               |             
      Mediastinal, Hyperplasia, Plasma Cell|                                                                          |             
                                           |__________________________________________________________________________|             
   Lymph Node, Mandibular                  | M  M  M  M  M  M  M  M  M  M  M  M  M  M  +  M  M  M  M  M  M  +  M  M  M|             
      Ectasia                              |                                           3                              |             
                                           |__________________________________________________________________________|             
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  A  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                                                                          |             
      Hyperplasia, Lymphoid                |       3                                                                  |             
      Infiltration Cellular, Histiocyte    |    1  2  2  1        2  2  2  1  2  1  2  1  2  2  2           1  1  2   |             
      Inflammation, Granulomatous          |                                     1                                    |             
                                           |__________________________________________________________________________|             
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Fibrosis, Focal                      |                                                                          |             
      Hematopoietic Cell Proliferation     |    2  1                                                              1   |             
      Hyperplasia, Lymphohistiocytic       |          4  3              3        3           1  3                     |             
      Capsule, Fibrosis, Focal             |                                     1                                    |             
      Lymphoid Follicle, Atrophy           |    3  2  2  2              2  2  3  3  2  2                 4        3  2|             
                                           |__________________________________________________________________________|             
   Thymus                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  M  +  M  M  M  +|             
 _____________________________________________________________________________________________________________________|             
 INTEGUMENTARY SYSTEM                      |                                                                          |             
                                           |__________________________________________________________________________|             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  86                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 6| 6| 3| 7| 7| 7| 6| 7| 7| 7| 7| 6| 7| 4| 7| 7| 7| 7| 6| 6| 1| 7| 7| 7| 1|             
                             DAY ON TEST   | 2| 2| 5| 2| 2| 2| 9| 2| 0| 2| 2| 4| 2| 3| 2| 2| 2| 2| 6| 8| 2| 0| 2| 0| 6|             
                                           | 9| 2| 2| 7| 8| 8| 1| 7| 7| 9| 7| 0| 7| 3| 8| 8| 8| 7| 9| 9| 0| 9| 8| 8| 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 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|             
    126                                    | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7|             
    MG/KG                                  | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 INTEGUMENTARY SYSTEM - cont               |                                                                          |             
   Mammary Gland                           | +  +  M  +  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hyperplasia                          |    1           2  1                       2  1     2           1  1      |             
      Duct, Dilatation                     | 2              2           1  1        1  3                       1  2   |             
                                           |__________________________________________________________________________|             
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Sebaceous Gland, Hyperplasia, Focal  |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 MUSCULOSKELETAL SYSTEM                    |                                                                          |             
                                           |__________________________________________________________________________|             
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
                                           |__________________________________________________________________________|             
   Skeletal Muscle                         |       +                                                                  |             
      Hemorrhage                           |       4                                                                  |             
      Inflammation, Acute                  |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 NERVOUS SYSTEM                            |                                                                          |             
                                           |__________________________________________________________________________|             
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hydrocephalus                        | 3                                3        3                          4   |             
      Hypothalamus, Compression            | 3                                4        3                          3   |             
 _____________________________________________________________________________________________________________________|             
 RESPIRATORY SYSTEM                        |                                                                          |             
                                           |__________________________________________________________________________|             
   Larynx                                  |                                                                          |             
      Hemorrhage                           |                                                                          |             
                                           |__________________________________________________________________________|             
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                                                             4  3        4|             
      Infiltration Cellular, Histiocyte    |                                              3                           |             
      Myxomatous Change                    |                            1                                             |             
      Alveolar Epithelium, Hyperplasia,    |                                                                          |             
           Focal                           |                      4        1                                          |             
      Alveolar Epithelium, Hyperplasia     |                                                                          |             
      Alveolar Epithelium, Metaplasia,     |                                                                          |             
           Squamous                        |                               1                                          |             
      Alveolus, Emphysema, Focal           |                                                                          |             
      Alveolus, Inflammation, Acute        |       4                                                              2   |             
      Alveolus, Inflammation, Chronic      |                                                                          |             
 __________________________________________|__________________________________________________________________________|             
                                                             Page  87                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 _____________________________________________________________________________________________________________________              
                                           | 6| 6| 3| 7| 7| 7| 6| 7| 7| 7| 7| 6| 7| 4| 7| 7| 7| 7| 6| 6| 1| 7| 7| 7| 1|             
                             DAY ON TEST   | 2| 2| 5| 2| 2| 2| 9| 2| 0| 2| 2| 4| 2| 3| 2| 2| 2| 2| 6| 8| 2| 0| 2| 0| 6|             
                                           | 9| 2| 2| 7| 8| 8| 1| 7| 7| 9| 7| 0| 7| 3| 8| 8| 8| 7| 9| 9| 0| 9| 8| 8| 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 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|             
    126                                    | 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7|             
    MG/KG                                  | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5|             
 __________________________________________|__________________________________________________________________________|             
 RESPIRATORY SYSTEM - cont                 |                                                                          |             
          Active, Focal                    |          2           3  2              2              1           1      |             
      Artery, Thrombosis                   |                                                             4            |             
      Interstitium, Fibrosis, Focal        |                               1                                          |             
      Interstitium, Alveolus, Inflammation |                                                                          |             
                                           |__________________________________________________________________________|             
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Inflammation, Chronic                |             1  2  2                    1           1                     |             
      Thrombosis                           |    3                                                                     |             
                                           |__________________________________________________________________________|             
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Hemorrhage                           |                                                                          |             
      Inflammation, Chronic                |       2     1  2                 1                                       |             
      Ulcer                                |             2                                                            |             
      Epithelium, Metaplasia, Squamous     |       1                                                                  |             
 _____________________________________________________________________________________________________________________|             
 SPECIAL SENSES SYSTEM                     |                                                                          |             
                                           |__________________________________________________________________________|             
   Eye                                     |                                                                          |             
      Cataract                             |                                                                          |             
 _____________________________________________________________________________________________________________________|             
 URINARY SYSTEM                            |                                                                          |             
                                           |__________________________________________________________________________|             
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|             
      Nephropathy                          |          1     2     2  1  2  1  1  1  2  3  2     1     1        2  3   |             
                                           |__________________________________________________________________________|             
   Urethra                                 |                                                                          |             
      Inflammation, Suppurative            |                                                                          |             
                                           |__________________________________________________________________________|             
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  M  +  +  +  +  +|             
 __________________________________________|__________________________________________________________________________              
                                                             Page  88                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 6| 7| 4| 7| 7| 7| 6| 2| 2| 7| 7| 7| 7| 7| 7| 7| 7| 4| 7| 6| 6| 7| 7|            |
                             DAY ON TEST   | 2| 2| 6| 2| 8| 2| 2| 2| 7| 6| 3| 2| 2| 2| 2| 2| 2| 2| 2| 5| 2| 6| 0| 2| 2|            |
                                           | 0| 8| 1| 9| 4| 7| 8| 8| 9| 1| 7| 7| 8| 9| 9| 7| 7| 7| 8| 6| 7| 0| 4| 7| 7|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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| 2|      A     |
    126                                    | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0|      L     |
    MG/KG                                  | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 ALIMENTARY SYSTEM                         |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Esophagus                               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Periesophageal Tissue, Hemorrhage    |                                                          3               |      1  3.0|
                                           |__________________________________________________________________________|____________|
   Intestine Large, Colon                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Parasite Metazoan                    |                                                       X     X            |      3     |
                                           |__________________________________________________________________________|____________|
   Intestine Large, Rectum                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  A  +  +  +|  45        |
      Erosion                              |                                                                          |      2  2.0|
      Infiltration Cellular, Histiocyte    |                                                                   1      |      4  1.0|
      Inflammation, Chronic                |                2           2                    1                        |      5  1.8|
      Myxomatous Change                    | 1  1     1     1           1     1  1  1  1     1     1     1     1     1|     25  1.0|
      Parasite Metazoan                    |                X                                X                        |      3     |
      Ulcer                                |                                                                          |      1  1.0|
                                           |__________________________________________________________________________|____________|
   Intestine Large, Cecum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Intestine Small, Duodenum               | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Intestine Small, Jejunum                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Intestine Small, Ileum                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Liver                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Angiectasis                          |                                                                          |      1  1.0|
      Basophilic Focus                     |          X        X              X     X  X  X  X     X     X        X   |     19     |
      Clear Cell Focus                     |          X        X              X        X        X  X     X        X   |     16     |
      Eosinophilic Focus                   |                         X                                               X|      4     |
      Fibrosis, Focal                      |                                                                          |      1  2.0|
      Hepatodiaphragmatic Nodule           |                            X                       X        X            |      9     |
      Inflammation, Granulomatous          | 1  1  1  1        1              1  1  1  1  1     1  1     1     1      |     27  1.1|
      Mixed Cell Focus                     |    X  X           X                 X              X                     |     11     |
      Bile Duct, Hyperplasia               | 1  2     1  2  2  2  4  2        1  1     1  1  2        1  2     1  1  2|     39  1.6|
      Centrilobular, Degeneration          |                                                                   1      |      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  89                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 6| 7| 4| 7| 7| 7| 6| 2| 2| 7| 7| 7| 7| 7| 7| 7| 7| 4| 7| 6| 6| 7| 7|            |
                             DAY ON TEST   | 2| 2| 6| 2| 8| 2| 2| 2| 7| 6| 3| 2| 2| 2| 2| 2| 2| 2| 2| 5| 2| 6| 0| 2| 2|            |
                                           | 0| 8| 1| 9| 4| 7| 8| 8| 9| 1| 7| 7| 8| 9| 9| 7| 7| 7| 8| 6| 7| 0| 4| 7| 7|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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| 2|      A     |
    126                                    | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0|      L     |
    MG/KG                                  | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 ALIMENTARY SYSTEM - cont                  |                                                                          |            |
      Centrilobular, Fatty Change          |                                                                          |      1  3.0|
      Centrilobular, Necrosis              |                                                          2               |      3  2.0|
                                           |__________________________________________________________________________|____________|
   Mesentery                               | +           +     +     +        +           +  +           +     +      |  13        |
      Accessory Spleen                     |                                              X                           |      1     |
      Hemorrhage                           |                                  2                                       |      1  2.0|
      Fat, Inflammation, Granulomatous     |                                                 2           2            |      2  2.0|
      Fat, Necrosis                        | 3           3     2     3                                         2      |      8  2.6|
                                           |__________________________________________________________________________|____________|
   Pancreas                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Acinus, Atrophy                      | 1     2  1              2           1        2  2     1     1  1         |     16  1.4|
                                           |__________________________________________________________________________|____________|
   Salivary Glands                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Stomach, Forestomach                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia, Focal, Squamous         |                            2                                             |      1  2.0|
      Ulcer                                |                                                                          |      1  3.0|
                                           |__________________________________________________________________________|____________|
   Stomach, Glandular                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Mineralization                       |                                                                   1      |      1  1.0|
      Ulcer                                |                                                                          |      2  2.0|
      Epithelium, Hyperplasia, Focal       |                                                                          |      1  2.0|
 _____________________________________________________________________________________________________________________|            |
 CARDIOVASCULAR SYSTEM                     |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Blood Vessel                            | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Heart                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Atrium, Thrombosis                   |                                              2                           |      1  2.0|
      Myocardium, Degeneration             | 2  1  2  2  1  1  2     2        3  3  1     2  2  1  2  1  3  3  1  2  3|     41  2.0|
      Vein, Thrombosis                     |    2                                                                     |      1  2.0|
 _____________________________________________________________________________________________________________________|            |
 ENDOCRINE 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  90                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 6| 7| 4| 7| 7| 7| 6| 2| 2| 7| 7| 7| 7| 7| 7| 7| 7| 4| 7| 6| 6| 7| 7|            |
                             DAY ON TEST   | 2| 2| 6| 2| 8| 2| 2| 2| 7| 6| 3| 2| 2| 2| 2| 2| 2| 2| 2| 5| 2| 6| 0| 2| 2|            |
                                           | 0| 8| 1| 9| 4| 7| 8| 8| 9| 1| 7| 7| 8| 9| 9| 7| 7| 7| 8| 6| 7| 0| 4| 7| 7|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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| 2|      A     |
    126                                    | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0|      L     |
    MG/KG                                  | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 ENDOCRINE SYSTEM - cont                   |                                                                          |            |
   Adrenal Cortex                          | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia, Focal                   |    1  1  2              1           1              1                    2|     17  1.6|
      Hyperplasia                          |                      2                                                   |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Adrenal Medulla                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia, Focal                   | 1     2  2              1                 1  2                       1   |     13  1.6|
                                           |__________________________________________________________________________|____________|
   Islets, Pancreatic                      | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hyperplasia                          |                               1                                          |      2  1.0|
                                           |__________________________________________________________________________|____________|
   Parathyroid Gland                       | +  M  M  +  +  +  +  +  +  +  +  +  +  M  +  +  +  +  +  +  +  +  +  +  +|  47        |
                                           |__________________________________________________________________________|____________|
   Pituitary Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Angiectasis                          |                                                                          |      1  1.0|
      Cyst                                 |                                                 4                 1      |      2  2.5|
      Hyperplasia                          |                                                             3           3|      2  3.0|
      Necrosis, Focal                      |                                                                          |      1  3.0|
      Pars Distalis, Hyperplasia, Focal    |       1  1  1     2        1                    2                        |      9  1.2|
                                           |__________________________________________________________________________|____________|
   Thyroid Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      C-Cell, Hyperplasia                  |       4  3  1  2  3  3  2  2     3  2     2  2  2  2  2     2  1  2     2|     35  2.1|
      Follicle, Hyperplasia                |                                                                          |      1  3.0|
 _____________________________________________________________________________________________________________________|            |
 GENERAL BODY SYSTEM                       |                                                                          |            |
    None                                   |                                                                          |            |
 _____________________________________________________________________________________________________________________|            |
 GENITAL SYSTEM                            |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Coagulating Gland                       |                                     +                                    |   1        |
      Inflammation, Chronic                |                                     2                                    |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Epididymis                              | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Fibrosis                             |                                                                          |      1  3.0|
      Granuloma Sperm                      |                                                                          |      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  91                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 6| 7| 4| 7| 7| 7| 6| 2| 2| 7| 7| 7| 7| 7| 7| 7| 7| 4| 7| 6| 6| 7| 7|            |
                             DAY ON TEST   | 2| 2| 6| 2| 8| 2| 2| 2| 7| 6| 3| 2| 2| 2| 2| 2| 2| 2| 2| 5| 2| 6| 0| 2| 2|            |
                                           | 0| 8| 1| 9| 4| 7| 8| 8| 9| 1| 7| 7| 8| 9| 9| 7| 7| 7| 8| 6| 7| 0| 4| 7| 7|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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| 2|      A     |
    126                                    | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0|      L     |
    MG/KG                                  | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 GENITAL SYSTEM - cont                     |                                                                          |            |
      Inflammation, Acute                  |                               3                                          |      1  3.0|
                                           |__________________________________________________________________________|____________|
   Preputial Gland                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Cyst                                 |                                                                          |      2  2.5|
      Inflammation, Chronic                |       1  1  2  1  1  2  2        1  1  1  1  2  2  2     1  1     2  2  2|     37  1.5|
      Inflammation, Suppurative            |    1                                                                     |      1  1.0|
                                           |__________________________________________________________________________|____________|
   Prostate                                | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  49        |
      Inflammation, Chronic Active         | 3  1        1     1     1           1           2           1     2      |     18  1.4|
                                           |__________________________________________________________________________|____________|
   Seminal Vesicle                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  49        |
      Hyperplasia                          |                                                                          |      2  2.0|
                                           |__________________________________________________________________________|____________|
   Testes                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Germinal Epithelium, Atrophy         |                                                                          |      1  4.0|
      Interstitial Cell, Hyperplasia       |                                                                          |      2  1.5|
 _____________________________________________________________________________________________________________________|            |
 HEMATOPOIETIC SYSTEM                      |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Bone Marrow                             | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Fibrosis                             |                         1                                                |      1  1.0|
                                           |__________________________________________________________________________|____________|
   Lymph Node                              | +                    +        +        +  +                             +|  13        |
      Deep Cervical, Angiectasis           |                                                                          |      1  3.0|
      Mediastinal, Angiectasis             |                                                                          |      1  2.0|
      Mediastinal, Ectasia                 |                                           1                              |      1  1.0|
      Mediastinal, Hemorrhage              |                               2                                          |      1  2.0|
      Mediastinal, Hyperplasia, Lymphoid   |                                                                          |      1  1.0|
      Mediastinal, Hyperplasia, Plasma Cell| 2                                                                        |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Lymph Node, Mandibular                  | M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M  M|   2        |
      Ectasia                              |                                                                          |      1  3.0|
                                           |__________________________________________________________________________|____________|
   Lymph Node, Mesenteric                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  49        |
 _____________________________________________________________________________________________________________________|____________|
  * : 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  92                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 6| 7| 4| 7| 7| 7| 6| 2| 2| 7| 7| 7| 7| 7| 7| 7| 7| 4| 7| 6| 6| 7| 7|            |
                             DAY ON TEST   | 2| 2| 6| 2| 8| 2| 2| 2| 7| 6| 3| 2| 2| 2| 2| 2| 2| 2| 2| 5| 2| 6| 0| 2| 2|            |
                                           | 0| 8| 1| 9| 4| 7| 8| 8| 9| 1| 7| 7| 8| 9| 9| 7| 7| 7| 8| 6| 7| 0| 4| 7| 7|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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| 2|      A     |
    126                                    | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0|      L     |
    MG/KG                                  | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 HEMATOPOIETIC SYSTEM - cont               |                                                                          |            |
      Hemorrhage                           |       1                                                                  |      1  1.0|
      Hyperplasia, Lymphoid                |                                                                          |      1  3.0|
      Infiltration Cellular, Histiocyte    | 1  1  2  1  1     1        1  2  2  2  1  1  1  2  1  1  1  2  1  3  2   |     39  1.5|
      Inflammation, Granulomatous          |                                     2                             2      |      3  1.7|
                                           |__________________________________________________________________________|____________|
   Spleen                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Fibrosis, Focal                      |                                           1                              |      1  1.0|
      Hematopoietic Cell Proliferation     |                                                                   1      |      4  1.3|
      Hyperplasia, Lymphohistiocytic       | 3                                         2                              |      8  2.8|
      Capsule, Fibrosis, Focal             |                                                                          |      1  1.0|
      Lymphoid Follicle, Atrophy           |       2  2        2        1  4  2  3  2        2     2  4           2   |     25  2.4|
                                           |__________________________________________________________________________|____________|
   Thymus                                  | M  M  +  +  M  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  43        |
 _____________________________________________________________________________________________________________________|            |
 INTEGUMENTARY SYSTEM                      |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Mammary Gland                           | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  48        |
      Hyperplasia                          | 1     1           1        1  1  1                       1  1  1         |     17  1.2|
      Duct, Dilatation                     | 1                 1  2                 2        1     2        1         |     15  1.5|
                                           |__________________________________________________________________________|____________|
   Skin                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Sebaceous Gland, Hyperplasia, Focal  |                                                    2                     |      1  2.0|
 _____________________________________________________________________________________________________________________|            |
 MUSCULOSKELETAL SYSTEM                    |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Bone                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
                                           |__________________________________________________________________________|____________|
   Skeletal Muscle                         |                               +                                          |   2        |
      Hemorrhage                           |                                                                          |      1  4.0|
      Inflammation, Acute                  |                               4                                          |      1  4.0|
 _____________________________________________________________________________________________________________________|            |
 NERVOUS SYSTEM                            |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Brain                                   | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
 _____________________________________________________________________________________________________________________|____________|
  * : 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  93                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 6| 7| 4| 7| 7| 7| 6| 2| 2| 7| 7| 7| 7| 7| 7| 7| 7| 4| 7| 6| 6| 7| 7|            |
                             DAY ON TEST   | 2| 2| 6| 2| 8| 2| 2| 2| 7| 6| 3| 2| 2| 2| 2| 2| 2| 2| 2| 5| 2| 6| 0| 2| 2|            |
                                           | 0| 8| 1| 9| 4| 7| 8| 8| 9| 1| 7| 7| 8| 9| 9| 7| 7| 7| 8| 6| 7| 0| 4| 7| 7|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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| 2|      A     |
    126                                    | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0|      L     |
    MG/KG                                  | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 NERVOUS SYSTEM - cont                     |                                                                          |            |
      Hydrocephalus                        |                                        2        1                        |      6  2.7|
      Hypothalamus, Compression            |                                                                          |      4  3.3|
 _____________________________________________________________________________________________________________________|            |
 RESPIRATORY SYSTEM                        |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Larynx                                  |                                                          +               |   1        |
      Hemorrhage                           |                                                          3               |      1  3.0|
                                           |__________________________________________________________________________|____________|
   Lung                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hemorrhage                           |                                                          3               |      4  3.5|
      Infiltration Cellular, Histiocyte    |                                                                          |      1  3.0|
      Myxomatous Change                    |                                                                          |      1  1.0|
      Alveolar Epithelium, Hyperplasia,    |                                                                          |            |
           Focal                           |                                                          1               |      3  2.0|
      Alveolar Epithelium, Hyperplasia     |                   1                                                      |      1  1.0|
      Alveolar Epithelium, Metaplasia,     |                                                                          |            |
           Squamous                        |                                              1                           |      2  1.0|
      Alveolus, Emphysema, Focal           |                                     2                                    |      1  2.0|
      Alveolus, Inflammation, Acute        |                                                                          |      2  3.0|
      Alveolus, Inflammation, Chronic      |                                                                          |            |
          Active, Focal                    |       1                          1        2  2  1           1  1     3   |     14  1.6|
      Artery, Thrombosis                   |                                                                          |      1  4.0|
      Interstitium, Fibrosis, Focal        |                                                                          |      1  1.0|
      Interstitium, Alveolus, Inflammation |             2                                                            |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Nose                                    | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Inflammation, Chronic                |                      2              1  1              1                  |      9  1.3|
      Thrombosis                           |                                                                          |      1  3.0|
                                           |__________________________________________________________________________|____________|
   Trachea                                 | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Hemorrhage                           |                                                          3               |      1  3.0|
      Inflammation, Chronic                |                                                                          |      4  1.5|
      Ulcer                                |                                                                          |      1  2.0|
      Epithelium, Metaplasia, Squamous     |                                                                          |      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  94                                                               
NTP Experiment-Test: 88122-06                  NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL                         Report: PEIRPT09  
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01    
Route: GAVAGE                                                                                                     Time: 09:22:58    
 __________________________________________________________________________________________________________________________________ 
                                           | 7| 7| 6| 7| 4| 7| 7| 7| 6| 2| 2| 7| 7| 7| 7| 7| 7| 7| 7| 4| 7| 6| 6| 7| 7|            |
                             DAY ON TEST   | 2| 2| 6| 2| 8| 2| 2| 2| 7| 6| 3| 2| 2| 2| 2| 2| 2| 2| 2| 5| 2| 6| 0| 2| 2|            |
                                           | 0| 8| 1| 9| 4| 7| 8| 8| 9| 1| 7| 7| 8| 9| 9| 7| 7| 7| 8| 6| 7| 0| 4| 7| 7|            |
 __________________________________________|__________________________________________________________________________|      T (*) |
                                           | 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|      O     |
   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|      T     |
                               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| 2|      A     |
    126                                    | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0|      L     |
    MG/KG                                  | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0|            |
 _____________________________________________________________________________________________________________________|____________|
 SPECIAL SENSES SYSTEM                     |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Eye                                     |                                              +                           |   1        |
      Cataract                             |                                              1                           |      1  1.0|
 _____________________________________________________________________________________________________________________|            |
 URINARY SYSTEM                            |                                                                          |            |
                                           |__________________________________________________________________________|____________|
   Kidney                                  | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  50        |
      Nephropathy                          | 1  1  1  1  1  1  1  1  2        2  1  3  1  1  2  1  2     2  2  1  1  3|     37  1.5|
                                           |__________________________________________________________________________|____________|
   Urethra                                 |                                     +                                    |   1        |
      Inflammation, Suppurative            |                                     2                                    |      1  2.0|
                                           |__________________________________________________________________________|____________|
   Urinary Bladder                         | +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +|  49        |
 __________________________________________________________________________________________________________________________________ 
  * : 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  95                                                               
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