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TDMS Study 88122-07 Pathology Tables

NTP Experiment-Test: 88122-07         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                              ELMIRON                                          Date: 09/26/01
Route: GAVAGE                                                                                                     Time: 14:40:32

                                                           FINAL/MICE




       Facility:  Battelle Columbus Laboratory

       Chemical CAS #:  37319-17-8

       Lock Date:  04/14/00

       Cage Range:  All

       Reasons For Removal:    All

       Removal Date Range:     All

       Treatment Groups:       Include All


































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

                                                              Page   1


NTP Experiment-Test: 88122-07         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                              ELMIRON                                          Date: 09/26/01    
Route: GAVAGE                                                                                                     Time: 14:40:32    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE FEMALE                        0 MG/KG      56 MG/KG     168          504                                       
                                                                             MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially In Study                          50           50           50           50                                     
  Early Deaths                                                                                                                      
    Natural Death                                      8            6           10            9                                     
    Moribund Sacrifice                                 4            5            3            7                                     
    Accidently Killed                                  1                                                                            
    Dosing Accident                                                 1                                                               
  Survivors                                                                                                                         
    Terminal Sacrifice                                37           37           37           34                                     
    Natural Death                                                   1                                                               
                                                                                                                                    
  Animals Examined Microscopically                    50           50           50           50                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Esophagus                                          (50)         (50)         (50)         (49)                                   
      Inflammation, Chronic Active                                                            1 (2%)                                
      Necrosis                                                      1 (2%)                                                          
   Gallbladder                                        (39)         (40)         (38)         (38)                                   
      Cyst                                                          2 (5%)       1 (3%)       1 (3%)                                
      Degeneration, Hyaline                            1 (3%)       1 (3%)       3 (8%)       2 (5%)                                
   Intestine Large, Colon                             (45)         (44)         (44)         (46)                                   
      Necrosis                                                                                1 (2%)                                
   Intestine Large, Rectum                            (45)         (45)         (44)         (46)                                   
      Infiltration Cellular, Histiocyte                                          2 (5%)      10 (22%)                               
      Inflammation, Acute                              1 (2%)                                                                       
      Inflammation, Chronic Active                                               2 (5%)      32 (70%)                               
      Metaplasia, Squamous                                                       1 (2%)      26 (57%)                               
      Myxomatous Change                                             3 (7%)      21 (48%)     31 (67%)                               
      Necrosis                                                                   1 (2%)      24 (52%)                               
   Intestine Large, Cecum                             (41)         (43)         (44)         (43)                                   
      Inflammation, Granulomatous                                                1 (2%)                                             
      Necrosis                                                                   1 (2%)                                             
      Ulcer                                                                                   1 (2%)                                
   Intestine Small, Jejunum                           (43)         (44)         (42)         (42)                                   
      Hyperplasia, Lymphoid                            1 (2%)       1 (2%)                                                          
      Inflammation, Acute                              1 (2%)                                 1 (2%)                                
   Intestine Small, Ileum                             (42)         (44)         (42)         (42)                                   
      Infiltration Cellular, Mixed Cell                                                       1 (2%)                                
   Liver                                              (50)         (49)         (50)         (49)                                   
      Angiectasis                                      1 (2%)       1 (2%)       1 (2%)                                             
      Basophilic Focus                                 5 (10%)      6 (12%)      8 (16%)     12 (24%)                               
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    2                                                              
                                                                                                                                   
NTP Experiment-Test: 88122-07         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                              ELMIRON                                          Date: 09/26/01    
Route: GAVAGE                                                                                                     Time: 14:40:32    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE FEMALE                        0 MG/KG      56 MG/KG     168          504                                       
                                                                             MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Clear Cell Focus                                              4 (8%)       1 (2%)      21 (43%)                               
      Cyst                                             1 (2%)       1 (2%)                                                          
      Eosinophilic Focus                              10 (20%)      6 (12%)      7 (14%)     15 (31%)                               
      Fatty Change                                     4 (8%)       2 (4%)       1 (2%)      12 (24%)                               
      Hematopoietic Cell Proliferation                 3 (6%)       7 (14%)      5 (10%)      7 (14%)                               
      Infarct                                          1 (2%)                                                                       
      Inflammation, Chronic                           40 (80%)     37 (76%)     40 (80%)     38 (78%)                               
      Mineralization                                   1 (2%)                    1 (2%)                                             
      Tension Lipidosis                                             2 (4%)       1 (2%)                                             
      Bile Duct, Hyperplasia                                        1 (2%)                                                          
      Centrilobular, Degeneration                                                1 (2%)       1 (2%)                                
      Centrilobular, Necrosis                                                                 1 (2%)                                
   Mesentery                                          (30)         (34)         (32)         (42)                                   
      Inflammation, Chronic Active                                                            1 (2%)                                
      Inflammation, Suppurative                        1 (3%)                                                                       
      Thrombosis                                                                              1 (2%)                                
      Artery, Inflammation, Chronic Active             1 (3%)                                                                       
      Fat, Necrosis                                   29 (97%)     33 (97%)     31 (97%)     41 (98%)                               
   Pancreas                                           (46)         (45)         (46)         (46)                                   
      Atrophy                                          1 (2%)                                 1 (2%)                                
      Basophilic Focus                                              2 (4%)                    1 (2%)                                
      Inflammation, Acute                              1 (2%)                                                                       
      Lipomatosis                                                   1 (2%)                                                          
      Artery, Inflammation                             1 (2%)                                                                       
   Salivary Glands                                    (49)         (49)         (50)         (48)                                   
      Atrophy                                                                    1 (2%)                                             
      Basophilic Focus                                 1 (2%)       1 (2%)                                                          
      Infiltration Cellular, Lymphocyte                                          2 (4%)                                             
   Stomach, Forestomach                               (47)         (48)         (49)         (48)                                   
      Hyperplasia, Squamous                            2 (4%)       2 (4%)       2 (4%)                                             
      Inflammation, Acute                                           1 (2%)                                                          
      Ulcer                                            3 (6%)                                                                       
      Artery, Inflammation, Chronic Active             1 (2%)                                                                       
   Stomach, Glandular                                 (46)         (45)         (44)         (46)                                   
      Hyperplasia                                                   1 (2%)                                                          
      Mineralization                                   1 (2%)                                                                       
      Necrosis                                                      1 (2%)                                                          
      Artery, Inflammation, Chronic Active             1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Blood Vessel                                       (2)                                                                           
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    3                                                              
                                                                                                                                   
NTP Experiment-Test: 88122-07         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                              ELMIRON                                          Date: 09/26/01    
Route: GAVAGE                                                                                                     Time: 14:40:32    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE FEMALE                        0 MG/KG      56 MG/KG     168          504                                       
                                                                             MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
CARDIOVASCULAR SYSTEM - CONT                                                                                                        
      Aorta, Mineralization                            1 (50%)                                                                      
   Heart                                              (50)         (50)         (50)         (50)                                   
      Cardiomyopathy                                                1 (2%)       1 (2%)       1 (2%)                                
      Inflammation, Chronic Active                     1 (2%)       2 (4%)       1 (2%)                                             
      Inflammation, Suppurative                                     1 (2%)                                                          
      Mineralization                                   1 (2%)       1 (2%)       1 (2%)       1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (49)         (49)         (49)         (48)                                   
      Hematopoietic Cell Proliferation                 1 (2%)                                                                       
      Hyperplasia                                      5 (10%)      3 (6%)       2 (4%)       2 (4%)                                
      Hypertrophy                                      1 (2%)       3 (6%)       3 (6%)      12 (25%)                               
      Necrosis                                                                                1 (2%)                                
   Pituitary Gland                                    (48)         (47)         (45)         (48)                                   
      Hyperplasia                                      1 (2%)                                                                       
      Pars Distalis, Hyperplasia                      11 (23%)      8 (17%)     10 (22%)     11 (23%)                               
      Pars Intermedia, Hypertrophy                     1 (2%)                                                                       
   Thyroid Gland                                      (46)         (47)         (49)         (46)                                   
      Necrosis                                                      1 (2%)                                                          
      Follicular Cell, Hyperplasia                                  1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (39)         (44)         (42)         (35)                                   
      Cyst                                                          1 (2%)                                                          
      Inflammation, Chronic Active                     1 (3%)       1 (2%)                                                          
   Ovary                                              (47)         (46)         (47)         (48)                                   
      Angiectasis                                      1 (2%)                                 2 (4%)                                
      Cyst                                            10 (21%)     12 (26%)      8 (17%)      7 (15%)                               
      Thrombosis                                                    1 (2%)                                                          
   Uterus                                             (48)         (49)         (50)         (50)                                   
      Angiectasis                                      1 (2%)       1 (2%)       1 (2%)       1 (2%)                                
      Hydrometra                                      27 (56%)     21 (43%)     25 (50%)     20 (40%)                               
      Hyperplasia, Cystic                              8 (17%)      9 (18%)      8 (16%)     10 (20%)                               
      Inflammation, Suppurative                        2 (4%)                                                                       
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    4                                                              
                                                                                                                                   
NTP Experiment-Test: 88122-07         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                              ELMIRON                                          Date: 09/26/01    
Route: GAVAGE                                                                                                     Time: 14:40:32    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE FEMALE                        0 MG/KG      56 MG/KG     168          504                                       
                                                                             MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (48)         (50)         (49)                                   
      Atrophy                                                                                 1 (2%)                                
      Necrosis                                                                   1 (2%)                                             
   Lymph Node                                         (6)          (10)         (5)          (10)                                   
      Bronchial, Hyperplasia, Lymphoid                              1 (10%)                                                         
      Mediastinal, Hyperplasia, Lymphoid                            1 (10%)      1 (20%)                                            
      Pancreatic, Hyperplasia, Lymphoid                                                       1 (10%)                               
      Renal, Hyperplasia, Lymphoid                                  1 (10%)                                                         
   Lymph Node, Mandibular                             (33)         (38)         (37)         (39)                                   
      Hyperplasia, Lymphoid                            1 (3%)       1 (3%)       3 (8%)                                             
      Infiltration Cellular, Plasma Cell                            1 (3%)       1 (3%)       2 (5%)                                
      Infiltration Cellular, Histiocyte                                                       3 (8%)                                
   Lymph Node, Mesenteric                             (47)         (44)         (42)         (45)                                   
      Hemorrhage                                                                 1 (2%)       3 (7%)                                
      Hyperplasia, Lymphoid                            3 (6%)       1 (2%)       3 (7%)                                             
      Infiltration Cellular, Plasma Cell               1 (2%)                    1 (2%)       2 (4%)                                
      Infiltration Cellular, Histiocyte                            23 (52%)     35 (83%)     25 (56%)                               
   Spleen                                             (47)         (48)         (47)         (46)                                   
      Congestion                                                    1 (2%)                    1 (2%)                                
      Hematopoietic Cell Proliferation                10 (21%)     19 (40%)     15 (32%)     18 (39%)                               
      Hyperplasia, Lymphoid                            1 (2%)       3 (6%)                                                          
      Infiltration Cellular, Histiocyte                             3 (6%)      12 (26%)     28 (61%)                               
      Metaplasia, Osseous                                                                     2 (4%)                                
   Thymus                                             (43)         (38)         (43)         (36)                                   
      Hyperplasia, Lymphoid                            1 (2%)                                                                       
      Necrosis                                                      1 (3%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (50)         (50)         (50)         (50)                                   
      Edema                                                         1 (2%)                                                          
      Inflammation, Chronic Active                                  1 (2%)                                                          
      Artery, Inflammation, Chronic Active             1 (2%)                                                                       
      Subcutaneous Tissue, Necrosis, Fatty                          1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (50)         (50)         (50)         (50)                                   
      Fibrous Osteodystrophy                           4 (8%)       1 (2%)       5 (10%)      5 (10%)                               
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    5                                                              
                                                                                                                                   
NTP Experiment-Test: 88122-07         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                              ELMIRON                                          Date: 09/26/01    
Route: GAVAGE                                                                                                     Time: 14:40:32    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE FEMALE                        0 MG/KG      56 MG/KG     168          504                                       
                                                                             MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
MUSCULOSKELETAL SYSTEM - CONT                                                                                                       
   Skeletal Muscle                                    (2)                       (2)                                                 
      Degeneration                                                               1 (50%)                                            
      Mineralization                                                             1 (50%)                                            
      Artery, Inflammation, Chronic Active             1 (50%)                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (49)         (50)         (50)                                   
      Artery, Inflammation, Chronic Active             1 (2%)                                                                       
      Meninges, Infiltration Cellular, Mononuclear                                                                                  
          Cell                                                                   1 (2%)                                             
      Meninges, Inflammation, Chronic                                                         1 (2%)                                
   Peripheral Nerve                                                                          (1)                                    
      Infiltration Cellular, Mast Cell                                                        1 (100%)                              
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (50)         (50)         (50)                                   
      Infiltration Cellular, Lymphocyte                             1 (2%)                                                          
      Inflammation, Chronic Active                                  1 (2%)                    1 (2%)                                
      Thrombosis                                                    1 (2%)                    1 (2%)                                
      Alveolar Epithelium, Hyperplasia                 5 (10%)      3 (6%)       1 (2%)       1 (2%)                                
      Alveolus, Infiltration Cellular, Histiocyte                                2 (4%)       2 (4%)                                
      Mediastinum, Inflammation, Acute                              1 (2%)                                                          
   Nose                                               (50)         (50)         (50)         (50)                                   
      Inflammation, Suppurative                        2 (4%)                    2 (4%)       2 (4%)                                
      Olfactory Epithelium, Atrophy                                 1 (2%)       1 (2%)       1 (2%)                                
      Olfactory Epithelium, Metaplasia                              2 (4%)                    1 (2%)                                
   Trachea                                            (46)         (48)         (46)         (48)                                   
      Metaplasia, Squamous                                          1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                                          (1)          (2)                                    
      Degeneration                                                               1 (100%)                                           
      Cornea, Inflammation, Acute                                                             1 (50%)                               
      Cornea, Inflammation, Chronic                                                           1 (50%)                               
   Harderian Gland                                    (48)         (41)         (50)         (46)                                   
      Atrophy                                          1 (2%)       1 (2%)                                                          
      Hyperplasia                                      3 (6%)       3 (7%)       2 (4%)       4 (9%)                                
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    6                                                              
                                                                                                                                   
NTP Experiment-Test: 88122-07         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                              ELMIRON                                          Date: 09/26/01    
Route: GAVAGE                                                                                                     Time: 14:40:32    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE FEMALE                        0 MG/KG      56 MG/KG     168          504                                       
                                                                             MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
SPECIAL SENSES SYSTEM - CONT                                                                                                        
      Inflammation, Chronic                                                                   1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (48)         (49)         (48)         (46)                                   
      Cyst                                                          1 (2%)                                                          
      Hydronephrosis                                   1 (2%)                                                                       
      Infarct                                                       1 (2%)       1 (2%)       1 (2%)                                
      Infiltration Cellular, Lymphocyte                                          1 (2%)                                             
      Metaplasia, Osseous                                                                     3 (7%)                                
      Mineralization                                   3 (6%)       2 (4%)       1 (2%)       1 (2%)                                
      Nephropathy                                     19 (40%)     17 (35%)     22 (46%)     27 (59%)                               
      Artery, Inflammation, Chronic Active             1 (2%)                                                                       
      Renal Tubule, Accumulation, Hyaline Droplet                   1 (2%)                                                          
      Renal Tubule, Vacuolization Cytoplasmic                                                 1 (2%)                                
   Urinary Bladder                                    (43)         (46)         (47)         (46)                                   
      Artery, Inflammation, Chronic Active             1 (2%)                                                                       
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page    7                                                              
                                                                                                                                   
NTP Experiment-Test: 88122-07         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                              ELMIRON                                          Date: 09/26/01    
Route: GAVAGE                                                                                                     Time: 14:40:32    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE MALE                          0 MG/KG      56 MG/KG     168          504                                       
                                                                             MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially In Study                          50           50           50           50                                     
  Early Deaths                                                                                                                      
    Natural Death                                      4            5            8           15                                     
    Moribund Sacrifice                                 7            4            4            3                                     
    Dosing Accident                                                 1                         2                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                39           40           38           30                                     
                                                                                                                                    
  Animals Examined Microscopically                    50           50           50           50                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Esophagus                                          (50)         (50)         (50)         (50)                                   
      Hyperplasia, Squamous                            1 (2%)                                                                       
      Inflammation, Acute                                           1 (2%)                                                          
      Inflammation, Chronic Active                     1 (2%)                                                                       
   Gallbladder                                        (40)         (38)         (39)         (34)                                   
      Cyst                                                          1 (3%)       1 (3%)                                             
      Degeneration, Hyaline                            3 (8%)       1 (3%)                    1 (3%)                                
      Inflammation, Chronic Active                     1 (3%)                                                                       
      Epithelium, Hyperplasia                                                    1 (3%)                                             
   Intestine Large, Colon                             (50)         (47)         (47)         (42)                                   
      Necrosis                                                                   1 (2%)                                             
   Intestine Large, Rectum                            (49)         (47)         (46)         (44)                                   
      Infiltration Cellular, Histiocyte                                                       6 (14%)                               
      Inflammation, Acute                                                        1 (2%)                                             
      Inflammation, Chronic Active                                               1 (2%)       8 (18%)                               
      Metaplasia, Squamous                                                                    5 (11%)                               
      Myxomatous Change                                                                      13 (30%)                               
      Necrosis                                                                                5 (11%)                               
   Intestine Large, Cecum                             (49)         (47)         (46)         (39)                                   
      Inflammation, Chronic Active                                                            2 (5%)                                
      Necrosis                                                                                1 (3%)                                
   Intestine Small, Jejunum                           (47)         (47)         (44)         (38)                                   
      Hyperplasia, Lymphoid                                                                   1 (3%)                                
      Mineralization                                                1 (2%)                                                          
      Necrosis                                                      1 (2%)                                                          
   Intestine Small, Ileum                             (46)         (47)         (43)         (38)                                   
      Inflammation, Acute                                                                     1 (3%)                                
   Liver                                              (50)         (50)         (50)         (50)                                   
      Basophilic Focus                                14 (28%)     10 (20%)      5 (10%)     10 (20%)                               
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    8                                                              
                                                                                                                                   
NTP Experiment-Test: 88122-07         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                              ELMIRON                                          Date: 09/26/01    
Route: GAVAGE                                                                                                     Time: 14:40:32    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE MALE                          0 MG/KG      56 MG/KG     168          504                                       
                                                                             MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Clear Cell Focus                                21 (42%)     23 (46%)     19 (38%)     15 (30%)                               
      Eosinophilic Focus                              13 (26%)     11 (22%)      9 (18%)     12 (24%)                               
      Fatty Change                                     9 (18%)     12 (24%)      8 (16%)     13 (26%)                               
      Hematopoietic Cell Proliferation                              1 (2%)       1 (2%)                                             
      Infarct                                                                    1 (2%)                                             
      Inflammation, Chronic                           11 (22%)     15 (30%)     23 (46%)     33 (66%)                               
      Mineralization                                   1 (2%)                                                                       
      Necrosis                                         2 (4%)       2 (4%)       2 (4%)       5 (10%)                               
      Tension Lipidosis                                2 (4%)       2 (4%)       2 (4%)                                             
      Vacuolization Cytoplasmic, Focal                 1 (2%)                                                                       
      Bile Duct, Cyst                                  1 (2%)                                                                       
      Centrilobular, Degeneration                                   1 (2%)       3 (6%)       4 (8%)                                
   Mesentery                                          (10)         (4)          (20)         (10)                                   
      Mineralization                                   1 (10%)                                                                      
      Fat, Necrosis                                   10 (100%)     3 (75%)     19 (95%)     10 (100%)                              
   Pancreas                                           (50)         (50)         (49)         (50)                                   
      Atrophy                                                       1 (2%)       1 (2%)       1 (2%)                                
      Cyst                                                                       1 (2%)                                             
      Artery, Inflammation                                          1 (2%)                                                          
   Stomach, Forestomach                               (49)         (50)         (50)         (50)                                   
      Hyperplasia, Squamous                            6 (12%)                   2 (4%)       3 (6%)                                
      Inflammation, Acute                              1 (2%)                                 1 (2%)                                
      Ulcer                                                         1 (2%)                    1 (2%)                                
   Stomach, Glandular                                 (49)         (49)         (48)         (46)                                   
      Hyperplasia                                                   1 (2%)                                                          
      Inflammation, Chronic Active                                                            1 (2%)                                
      Mineralization                                                                          1 (2%)                                
      Necrosis                                                                   1 (2%)       1 (2%)                                
   Tooth                                              (33)         (27)         (30)         (23)                                   
      Inflammation, Chronic Active                     6 (18%)      6 (22%)      5 (17%)      6 (26%)                               
      Malformation                                    29 (88%)     22 (81%)     27 (90%)     20 (87%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Blood Vessel                                                    (1)                       (1)                                    
      Angiectasis                                                   1 (100%)                                                        
      Thrombosis                                                    1 (100%)                                                        
   Heart                                              (50)         (50)         (50)         (50)                                   
      Cardiomyopathy                                   3 (6%)                    1 (2%)       2 (4%)                                
      Inflammation, Suppurative                                                  1 (2%)                                             
      Mineralization                                   1 (2%)                    1 (2%)       2 (4%)                                
      Artery, Inflammation, Chronic Active                                       3 (6%)                                             
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    9                                                              
                                                                                                                                   
NTP Experiment-Test: 88122-07         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                              ELMIRON                                          Date: 09/26/01    
Route: GAVAGE                                                                                                     Time: 14:40:32    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE MALE                          0 MG/KG      56 MG/KG     168          504                                       
                                                                             MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (50)         (50)         (50)         (49)                                   
      Hyperplasia                                      5 (10%)      8 (16%)      8 (16%)     13 (27%)                               
      Hypertrophy                                     27 (54%)     27 (54%)     23 (46%)     15 (31%)                               
   Adrenal Medulla                                    (50)         (50)         (50)         (49)                                   
      Hyperplasia                                                   3 (6%)                    1 (2%)                                
      Vacuolization Cytoplasmic                                                  1 (2%)                                             
   Pituitary Gland                                    (47)         (48)         (49)         (48)                                   
      Pars Distalis, Hyperplasia                                                 3 (6%)       2 (4%)                                
   Thyroid Gland                                      (48)         (49)         (50)         (49)                                   
      Follicular Cell, Hyperplasia                                                            1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Preputial Gland                                    (49)         (50)         (49)         (50)                                   
      Ectasia                                          3 (6%)       3 (6%)       5 (10%)      3 (6%)                                
      Infiltration Cellular, Histiocyte                                                       1 (2%)                                
      Inflammation, Chronic Active                     1 (2%)       2 (4%)       2 (4%)       3 (6%)                                
   Prostate, NOS                                      (50)         (49)         (50)         (50)                                   
      Inflammation, Chronic Active                                               1 (2%)       1 (2%)                                
      Inflammation, Suppurative                                     1 (2%)                                                          
   Seminal Vesicle                                    (50)         (50)         (50)         (49)                                   
      Congestion                                                    1 (2%)                                                          
      Dilatation                                                                 5 (10%)                                            
      Inflammation, Chronic Active                                               1 (2%)       2 (4%)                                
      Inflammation, Suppurative                                     1 (2%)                                                          
   Testes                                             (50)         (50)         (49)         (50)                                   
      Atrophy                                          1 (2%)                                                                       
      Germinal Epithelium, Degeneration                                          1 (2%)       1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (50)         (49)         (50)                                   
      Angiectasis                                                   1 (2%)                    1 (2%)                                
   Lymph Node                                         (1)          (1)          (1)          (1)                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page   10                                                              
                                                                                                                                   
NTP Experiment-Test: 88122-07         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                              ELMIRON                                          Date: 09/26/01    
Route: GAVAGE                                                                                                     Time: 14:40:32    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE MALE                          0 MG/KG      56 MG/KG     168          504                                       
                                                                             MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Mediastinal, Infiltration Cellular,                                                                                           
          Histiocyte                                                                          1 (100%)                              
   Lymph Node, Mesenteric                             (48)         (46)         (45)         (41)                                   
      Angiectasis                                      3 (6%)                    3 (7%)                                             
      Hematopoietic Cell Proliferation                                           1 (2%)                                             
      Hemorrhage                                                                 1 (2%)                                             
      Infiltration Cellular, Histiocyte                            15 (33%)     34 (76%)     37 (90%)                               
   Spleen                                             (49)         (50)         (49)         (49)                                   
      Amyloid Deposition                                                                      1 (2%)                                
      Hematopoietic Cell Proliferation                10 (20%)      8 (16%)     15 (31%)     15 (31%)                               
      Infiltration Cellular, Mast Cell                                                        1 (2%)                                
      Infiltration Cellular, Histiocyte                             1 (2%)       1 (2%)      23 (47%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (49)         (50)         (50)         (50)                                   
      Inflammation, Chronic Active                                                            1 (2%)                                
      Subcutaneous Tissue, Edema                                    1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (50)         (50)         (50)                                   
      Hemorrhage                                                                              1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (50)         (50)         (50)                                   
      Hemorrhage                                                    1 (2%)       1 (2%)       1 (2%)                                
      Inflammation, Chronic Active                     1 (2%)                    1 (2%)                                             
      Mineralization                                                                          1 (2%)                                
      Thrombosis                                                                 1 (2%)                                             
      Alveolar Epithelium, Hyperplasia                 3 (6%)       7 (14%)      4 (8%)       4 (8%)                                
      Alveolus, Infiltration Cellular, Histiocyte      1 (2%)                    1 (2%)       2 (4%)                                
      Mediastinum, Hemorrhage                                                                 1 (2%)                                
      Mediastinum, Inflammation, Acute                              1 (2%)                    1 (2%)                                
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page   11                                                              
                                                                                                                                   
NTP Experiment-Test: 88122-07         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                              ELMIRON                                          Date: 09/26/01    
Route: GAVAGE                                                                                                     Time: 14:40:32    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE MALE                          0 MG/KG      56 MG/KG     168          504                                       
                                                                             MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
RESPIRATORY SYSTEM - CONT                                                                                                           
   Nose                                               (50)         (50)         (50)         (47)                                   
      Inflammation, Suppurative                        5 (10%)                  11 (22%)      2 (4%)                                
      Polyp, Inflammatory                              1 (2%)                                                                       
      Glands, Degeneration, Hyaline                                              1 (2%)                                             
      Olfactory Epithelium, Atrophy                                 3 (6%)       1 (2%)                                             
      Olfactory Epithelium, Hyperplasia                                          1 (2%)                                             
      Olfactory Epithelium, Metaplasia                              3 (6%)       1 (2%)       1 (2%)                                
      Sinus, Inflammation, Chronic Active                                        1 (2%)                                             
   Trachea                                            (50)         (50)         (49)         (50)                                   
      Mineralization                                   1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                             (1)          (2)          (1)                                    
      Cornea, Inflammation, Chronic                                 1 (100%)     2 (100%)                                           
   Harderian Gland                                    (49)         (48)         (49)         (48)                                   
      Atrophy                                                       1 (2%)       1 (2%)                                             
      Hyperplasia                                      1 (2%)       1 (2%)       1 (2%)       1 (2%)                                
      Inflammation, Acute                                           1 (2%)       2 (4%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (50)         (50)         (49)                                   
      Cyst                                                                       3 (6%)       1 (2%)                                
      Hydronephrosis                                                             1 (2%)       1 (2%)                                
      Infarct                                          1 (2%)       3 (6%)       4 (8%)                                             
      Infiltration Cellular, Mast Cell                                                        1 (2%)                                
      Inflammation, Suppurative                                     3 (6%)       3 (6%)       1 (2%)                                
      Metaplasia, Osseous                              1 (2%)       1 (2%)                                                          
      Mineralization                                   1 (2%)                                                                       
      Nephropathy                                     43 (86%)     41 (82%)     47 (94%)     41 (84%)                               
      Papilla, Necrosis                                             1 (2%)                                                          
      Renal Tubule, Hyperplasia                                                  2 (4%)                                             
   Urinary Bladder                                    (50)         (49)         (49)         (49)                                   
      Artery, Inflammation, Chronic Active                                       1 (2%)                                             
      Transitional Epithelium, Hyperplasia                          1 (2%)                                                          
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   12                                                              
                                                                                                                                   
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                             ----------              END OF REPORT             ----------                                           
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