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TDMS Study 88122-07 Pathology Tables

NTP Experiment-Test: 88122-07  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                              ELMIRON                                          Date: 04/23/01
Route: GAVAGE                                                                                                     Time: 15:05:34

                                                          final#1/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 NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                              ELMIRON                                          Date: 04/23/01  
Route: GAVAGE                                                                                                     Time: 15:05:34  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         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                                                                                                                  
                                                                                                                                    
   Gallbladder                                        (39)         (40)         (38)         (38)                                   
      Sarcoma, Metastatic, Uterus                                                1 (3%)                                             
   Intestine Large, Cecum                             (41)         (43)         (44)         (43)                                   
      Leiomyoma                                                                               1 (2%)                                
   Intestine Small, Duodenum                          (41)         (44)         (42)         (42)                                   
      Polyp Adenomatous                                             2 (5%)                    1 (2%)                                
   Intestine Small, Jejunum                           (43)         (44)         (42)         (42)                                   
      Carcinoma                                        1 (2%)                                                                       
   Intestine Small, Ileum                             (42)         (44)         (42)         (42)                                   
   Liver                                              (50)         (49)         (50)         (49)                                   
      Hemangiosarcoma                                  1 (2%)       1 (2%)       1 (2%)       4 (8%)                                
      Hepatocellular Carcinoma                         3 (6%)       3 (6%)       5 (10%)      3 (6%)                                
      Hepatocellular Adenoma                           6 (12%)      3 (6%)       2 (4%)       9 (18%)                               
      Hepatocellular Adenoma, Multiple                 1 (2%)       2 (4%)       2 (4%)       6 (12%)                               
      Histiocytic Sarcoma                                           3 (6%)       1 (2%)       2 (4%)                                
      Osteosarcoma, Metastatic, Uncertain Primary                                                                                   
          Site                                                                   1 (2%)                                             
      Sarcoma, Metastatic, Skin                        1 (2%)                    2 (4%)                                             
      Sarcoma, Metastatic, Uterus                                                1 (2%)                                             
   Mesentery                                          (30)         (34)         (32)         (42)                                   
      Hemangiosarcoma                                                                         1 (2%)                                
      Histiocytic Sarcoma                                           1 (3%)                    1 (2%)                                
      Sarcoma                                                       1 (3%)                                                          
      Sarcoma, Metastatic, Skin                        1 (3%)       2 (6%)       2 (6%)       1 (2%)                                
      Sarcoma, Metastatic, Uterus                      1 (3%)                    1 (3%)                                             
   Pancreas                                           (46)         (45)         (46)         (46)                                   
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   2                                                               
                                                                                                                                   
NTP Experiment-Test: 88122-07  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                              ELMIRON                                          Date: 04/23/01  
Route: GAVAGE                                                                                                     Time: 15:05:34  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE FEMALE                        0 MG/KG      56 MG/KG     168          504                                       
                                                                             MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - cont                                                                                                            
      Sarcoma, Metastatic, Skin                                                  1 (2%)                                             
   Salivary Glands                                    (49)         (49)         (50)         (48)                                   
   Stomach, Forestomach                               (47)         (48)         (49)         (48)                                   
      Sarcoma, Metastatic, Skin                                                  1 (2%)                                             
   Stomach, Glandular                                 (46)         (45)         (44)         (46)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (50)         (50)         (50)         (50)                                   
      Histiocytic Sarcoma                                           1 (2%)                                                          
      Pericardium, Alveolar/Bronchiolar Carcinoma,                                                                                  
           Metastatic, Lung                                         1 (2%)                                                          
      Pericardium, Sarcoma                                          1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (49)         (49)         (49)         (48)                                   
      Histiocytic Sarcoma                                           1 (2%)                                                          
      Sarcoma, Metastatic, Skin                                     1 (2%)                    1 (2%)                                
      Subcapsular, Carcinoma                                                     1 (2%)                                             
   Adrenal Medulla                                    (49)         (49)         (47)         (47)                                   
      Pheochromocytoma Benign                                       1 (2%)                                                          
   Pituitary Gland                                    (48)         (47)         (45)         (48)                                   
      Pars Distalis, Adenoma                           2 (4%)       3 (6%)       4 (9%)       2 (4%)                                
      Pars Intermedia, Adenoma                                                   1 (2%)       1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   Peritoneum                                                                   (1)                                                 
      Sarcoma, Metastatic, Skin                                                  1 (100%)                                           
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Ovary                                              (47)         (46)         (47)         (48)                                   
      Cystadenoma                                      1 (2%)       1 (2%)       2 (4%)                                             
      Hemangioma                                                                              2 (4%)                                
      Hemangiosarcoma                                                            1 (2%)                                             
      Histiocytic Sarcoma                                           1 (2%)                    1 (2%)                                
      Luteoma                                                       1 (2%)                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   3                                                               
                                                                                                                                   
NTP Experiment-Test: 88122-07  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                              ELMIRON                                          Date: 04/23/01  
Route: GAVAGE                                                                                                     Time: 15:05:34  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE FEMALE                        0 MG/KG      56 MG/KG     168          504                                       
                                                                             MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
GENITAL SYSTEM - cont                                                                                                               
      Sarcoma, Metastatic, Mesentery                                1 (2%)                                                          
   Uterus                                             (48)         (49)         (50)         (50)                                   
      Histiocytic Sarcoma                                           2 (4%)                                                          
      Polyp Stromal                                    3 (6%)       1 (2%)       2 (4%)       2 (4%)                                
      Sarcoma                                          1 (2%)                    1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (48)         (50)         (49)                                   
      Hemangiosarcoma                                               1 (2%)                                                          
      Histiocytic Sarcoma                                           1 (2%)       1 (2%)       3 (6%)                                
   Lymph Node                                         (6)          (10)         (5)          (10)                                   
      Bronchial, Histiocytic Sarcoma                                2 (20%)                                                         
      Bronchial, Osteosarcoma, Metastatic,                                                                                          
          Uncertain Primary Site                                                 1 (20%)                                            
      Lumbar, Histiocytic Sarcoma                                   1 (10%)                                                         
      Mediastinal, Histiocytic Sarcoma                              2 (20%)                                                         
      Mediastinal, Osteosarcoma, Metastatic,                                                                                        
          Uncertain Primary Site                                                 1 (20%)                                            
      Mediastinal, Sarcoma, Metastatic, Skin           1 (17%)                                                                      
      Pancreatic, Sarcoma, Metastatic, Skin            1 (17%)                                                                      
      Renal, Sarcoma, Metastatic, Skin                              1 (10%)                                                         
   Lymph Node, Mandibular                             (33)         (38)         (37)         (39)                                   
      Histiocytic Sarcoma                                           1 (3%)                                                          
   Lymph Node, Mesenteric                             (47)         (44)         (42)         (45)                                   
      Histiocytic Sarcoma                                           1 (2%)                    1 (2%)                                
      Sarcoma, Metastatic, Mesentery                                1 (2%)                                                          
   Spleen                                             (47)         (48)         (47)         (46)                                   
      Hemangiosarcoma                                               1 (2%)                                                          
      Histiocytic Sarcoma                                           1 (2%)       1 (2%)       1 (2%)                                
   Thymus                                             (43)         (38)         (43)         (36)                                   
      Osteosarcoma, Metastatic, Uncertain Primary                                                                                   
          Site                                                                   1 (2%)                                             
      Sarcoma, Metastatic, Skin                                                               1 (3%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (50)         (50)         (50)         (50)                                   
      Basal Cell Adenoma                               1 (2%)                                                                       
      Sarcoma, Metastatic, Uterus                                                1 (2%)                                             
      Subcutaneous Tissue, Hemangioma                                                         1 (2%)                                
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   4                                                               
                                                                                                                                   
NTP Experiment-Test: 88122-07  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                              ELMIRON                                          Date: 04/23/01  
Route: GAVAGE                                                                                                     Time: 15:05:34  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE FEMALE                        0 MG/KG      56 MG/KG     168          504                                       
                                                                             MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
INTEGUMENTARY SYSTEM - cont                                                                                                         
      Subcutaneous Tissue, Hemangiosarcoma                                       1 (2%)                                             
      Subcutaneous Tissue, Histiocytic Sarcoma                      1 (2%)                    1 (2%)                                
      Subcutaneous Tissue, Liposarcoma                                                        1 (2%)                                
      Subcutaneous Tissue, Myxoma                                                             1 (2%)                                
      Subcutaneous Tissue, Sarcoma                     3 (6%)       4 (8%)       2 (4%)       1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (50)         (50)         (50)         (50)                                   
      Carcinoma, Metastatic, Harderian Gland                                     1 (2%)                                             
      Osteosarcoma                                     1 (2%)                                 1 (2%)                                
   Skeletal Muscle                                    (2)                       (2)                                                 
      Osteosarcoma, Metastatic, Uncertain Primary                                                                                   
          Site                                                                   1 (50%)                                            
      Sarcoma, Metastatic, Uterus                      1 (50%)                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (49)         (50)         (50)                                   
      Histiocytic Sarcoma                                           2 (4%)                                                          
      Meningioma Malignant                                                                    1 (2%)                                
      Oligodendroglioma Benign                         1 (2%)                                                                       
      Sarcoma                                                       1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (50)         (50)         (50)                                   
      Alveolar/Bronchiolar Adenoma                     2 (4%)       2 (4%)       2 (4%)       1 (2%)                                
      Alveolar/Bronchiolar Adenoma, Multiple                        1 (2%)                                                          
      Alveolar/Bronchiolar Carcinoma                   1 (2%)       1 (2%)       1 (2%)       1 (2%)                                
      Carcinoma, Metastatic, Harderian Gland                                     1 (2%)       2 (4%)                                
      Hepatocellular Carcinoma, Metastatic, Liver      1 (2%)                    2 (4%)       2 (4%)                                
      Histiocytic Sarcoma                                           3 (6%)       1 (2%)       2 (4%)                                
      Liposarcoma, Metastatic, Skin                                                           1 (2%)                                
      Osteosarcoma, Metastatic, Uncertain Primary                                                                                   
          Site                                                                   1 (2%)                                             
      Sarcoma                                                       1 (2%)                                                          
      Sarcoma, Metastatic, Skin                                     3 (6%)       2 (4%)       1 (2%)                                
      Mediastinum, Osteosarcoma, Metastatic,                                                                                        
          Uncertain Primary Site                                                 1 (2%)                                             
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   5                                                               
                                                                                                                                   
NTP Experiment-Test: 88122-07  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                              ELMIRON                                          Date: 04/23/01  
Route: GAVAGE                                                                                                     Time: 15:05:34  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE FEMALE                        0 MG/KG      56 MG/KG     168          504                                       
                                                                             MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
RESPIRATORY SYSTEM - cont                                                                                                           
   Nose                                               (50)         (50)         (50)         (50)                                   
      Histiocytic Sarcoma                                           1 (2%)                                                          
   Pleura                                                          (1)                                                              
      Sarcoma, Metastatic, Lung                                     1 (100%)                                                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Harderian Gland                                    (48)         (41)         (50)         (46)                                   
      Adenoma                                          3 (6%)       3 (7%)       4 (8%)       3 (7%)                                
      Carcinoma                                                     2 (5%)       2 (4%)       2 (4%)                                
      Bilateral, Adenoma                               1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (48)         (49)         (48)         (46)                                   
      Histiocytic Sarcoma                                           4 (8%)       1 (2%)       1 (2%)                                
      Sarcoma, Metastatic, Mesentery                                1 (2%)                                                          
      Sarcoma, Metastatic, Skin                                     1 (2%)                                                          
      Transitional Epithelium, Carcinoma                            1 (2%)                                                          
   Urinary Bladder                                    (43)         (46)         (47)         (46)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SYSTEMIC LESIONS                                                                                                                   
                                                                                                                                    
   Multiple Organs                                   *(50)        *(50)        *(50)        *(50)                                   
      Histiocytic Sarcoma                                           4 (8%)       1 (2%)       3 (6%)                                
      Lymphoma Malignant                               7 (14%)      8 (16%)      6 (12%)     16 (32%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
     *   Number of animals with any tissue examined microscopically                                                                 
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   6                                                               
                                                                                                                                   
NTP Experiment-Test: 88122-07  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                              ELMIRON                                          Date: 04/23/01  
Route: GAVAGE                                                                                                     Time: 15:05:34  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE FEMALE                        0 MG/KG      56 MG/KG     168          504                                       
                                                                             MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
TUMOR SUMMARY                                                                                                                       
                                                                                                                                    
   Total Animals with Primary Neoplasms (b)            29          34          29          40                                       
     Total Primary Neoplasms                           39          50          41          64                                       
                                                                                                                                    
   Total Animals with Benign Neoplasms                 17          16          14          26                                       
     Total Benign Neoplasms                            21          20          19          30                                       
                                                                                                                                    
   Total Animals with Malignant Neoplasms              17          22          19          28                                       
     Total Malignant Neoplasms                         18          30          22          34                                       
                                                                                                                                    
   Total Animals with Metastatic Neoplasms              4           5           7           6                                       
     Total Metastatic Neoplasm                          7          13          24           9                                       
                                                                                                                                    
   Total Animals with Malignant Neoplasms                                       1                                                   
   Uncertain Primary Site                                                                                                           
                                                                                                                                    
   Total Animals with Neoplasms Uncertain-                                                                                          
   Benign or Malignant                                                                                                              
     Total Uncertain Neoplasms                                                                                                      
                                                                                                                                    
                                                                                                                                    
____________________________________________________________________________________________________________________________________
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Primary tumors: all tumors except metastatic tumors                                                                              
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   7                                                               
                                                                                                                                   
NTP Experiment-Test: 88122-07  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                              ELMIRON                                          Date: 04/23/01  
Route: GAVAGE                                                                                                     Time: 15:05:34  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         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                                                                                                                  
                                                                                                                                    
   Intestine Large, Colon                             (50)         (47)         (47)         (42)                                   
      Sarcoma, Metastatic, Liver                       1 (2%)                                                                       
   Intestine Large, Cecum                             (49)         (47)         (46)         (39)                                   
      Carcinoma                                                                  1 (2%)                                             
      Mast Cell Tumor Malignant, Metastatic, Bone                                                                                   
          Marrow                                                    1 (2%)                                                          
   Intestine Small, Duodenum                          (47)         (47)         (44)         (40)                                   
      Carcinoma                                                                  1 (2%)                                             
      Polyp Adenomatous                                                                       1 (3%)                                
   Intestine Small, Jejunum                           (47)         (47)         (44)         (38)                                   
      Carcinoma                                        4 (9%)       1 (2%)                                                          
      Polyp Adenomatous                                             1 (2%)                                                          
      Sarcoma, Metastatic, Liver                       1 (2%)                                                                       
   Liver                                              (50)         (50)         (50)         (50)                                   
      Hemangiosarcoma                                  2 (4%)                    4 (8%)       9 (18%)                               
      Hepatoblastoma                                   1 (2%)       1 (2%)                                                          
      Hepatocellular Carcinoma                         7 (14%)     12 (24%)     11 (22%)     11 (22%)                               
      Hepatocellular Carcinoma, Multiple               4 (8%)       1 (2%)       4 (8%)       2 (4%)                                
      Hepatocellular Adenoma                          10 (20%)     12 (24%)     10 (20%)     10 (20%)                               
      Hepatocellular Adenoma, Multiple                 9 (18%)      3 (6%)       5 (10%)     10 (20%)                               
      Histiocytic Sarcoma                              1 (2%)                                 2 (4%)                                
      Mast Cell Tumor Malignant, Metastatic, Bone                                                                                   
          Marrow                                                    1 (2%)                                                          
      Squamous Cell Carcinoma, Metastatic, Stomach,                                                                                 
           Forestomach                                              1 (2%)                                                          
   Mesentery                                          (10)         (4)          (20)         (10)                                   
      Sarcoma                                                                    1 (5%)                                             
   Pancreas                                           (50)         (50)         (49)         (50)                                   
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   8                                                               
                                                                                                                                   
NTP Experiment-Test: 88122-07  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                              ELMIRON                                          Date: 04/23/01  
Route: GAVAGE                                                                                                     Time: 15:05:34  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE MALE                          0 MG/KG      56 MG/KG     168          504                                       
                                                                             MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - cont                                                                                                            
      Histiocytic Sarcoma                              1 (2%)                                                                       
      Squamous Cell Carcinoma, Metastatic, Stomach,                                                                                 
           Forestomach                                              1 (2%)                                                          
   Stomach, Forestomach                               (49)         (50)         (50)         (50)                                   
      Mast Cell Tumor Malignant, Metastatic, Bone                                                                                   
          Marrow                                                    1 (2%)                                                          
      Squamous Cell Carcinoma                                       1 (2%)                                                          
      Squamous Cell Papilloma                                                    2 (4%)                                             
   Stomach, Glandular                                 (49)         (49)         (48)         (46)                                   
      Mast Cell Tumor Malignant, Metastatic, Bone                                                                                   
          Marrow                                                    1 (2%)                                                          
      Sarcoma, Metastatic, Liver                       1 (2%)                                                                       
      Squamous Cell Carcinoma, Metastatic, Stomach,                                                                                 
           Forestomach                                              1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (50)         (50)         (50)         (50)                                   
      Hemangiosarcoma                                                                         1 (2%)                                
      Hepatocellular Carcinoma, Metastatic, Liver                                1 (2%)                                             
      Sarcoma, Metastatic, Liver                       1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (50)         (50)         (50)         (49)                                   
      Adenoma                                                                    1 (2%)                                             
      Mast Cell Tumor Malignant, Metastatic, Bone                                                                                   
          Marrow                                                    1 (2%)                                                          
      Subcapsular, Adenoma                             2 (4%)                                                                       
   Adrenal Medulla                                    (50)         (50)         (50)         (49)                                   
      Pheochromocytoma Benign                                                    1 (2%)                                             
      Squamous Cell Carcinoma, Metastatic, Stomach,                                                                                 
           Forestomach                                              1 (2%)                                                          
   Islets, Pancreatic                                 (50)         (50)         (49)         (50)                                   
      Adenoma                                                                    2 (4%)                                             
   Pituitary Gland                                    (47)         (48)         (49)         (48)                                   
      Pars Intermedia, Adenoma                                                                1 (2%)                                
   Thyroid Gland                                      (48)         (49)         (50)         (49)                                   
      C-Cell, Carcinoma                                             1 (2%)                                                          
      Follicular Cell, Adenoma                                                                1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   9                                                               
                                                                                                                                   
NTP Experiment-Test: 88122-07  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                              ELMIRON                                          Date: 04/23/01  
Route: GAVAGE                                                                                                     Time: 15:05:34  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE MALE                          0 MG/KG      56 MG/KG     168          504                                       
                                                                             MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   Peritoneum                                                      (1)                                                              
      Mast Cell Tumor Malignant, Metastatic, Bone                                                                                   
          Marrow                                                    1 (100%)                                                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Preputial Gland                                    (49)         (50)         (49)         (50)                                   
      Hemangiosarcoma                                  1 (2%)                                                                       
   Seminal Vesicle                                    (50)         (50)         (50)         (49)                                   
      Sarcoma, Metastatic, Liver                       1 (2%)                                                                       
      Squamous Cell Carcinoma, Metastatic, Stomach,                                                                                 
           Forestomach                                              1 (2%)                                                          
   Testes                                             (50)         (50)         (49)         (50)                                   
      Hemangiosarcoma                                  1 (2%)                                                                       
      Interstitial Cell, Adenoma                                    1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (50)         (49)         (50)                                   
      Hemangiosarcoma                                  2 (4%)                    2 (4%)       1 (2%)                                
      Histiocytic Sarcoma                                                                     2 (4%)                                
      Mast Cell Tumor Malignant                                     1 (2%)                                                          
      Sarcoma                                                                    1 (2%)                                             
   Lymph Node                                         (1)          (1)          (1)          (1)                                    
      Mediastinal, Mast Cell Tumor Malignant,                                                                                       
          Metastatic, Bone Marrow                                   1 (100%)                                                        
   Lymph Node, Mandibular                             (28)         (29)         (30)         (30)                                   
      Mast Cell Tumor Malignant, Metastatic, Bone                                                                                   
          Marrow                                                    1 (3%)                                                          
   Lymph Node, Mesenteric                             (48)         (46)         (45)         (41)                                   
      Hemangiosarcoma                                                                         1 (2%)                                
      Histiocytic Sarcoma                              1 (2%)                                                                       
      Sarcoma, Metastatic, Mesentery                                             1 (2%)                                             
      Squamous Cell Carcinoma, Metastatic, Stomach,                                                                                 
           Forestomach                                              1 (2%)                                                          
   Spleen                                             (49)         (50)         (49)         (49)                                   
      Hemangiosarcoma                                                            1 (2%)       2 (4%)                                
      Histiocytic Sarcoma                                                                     1 (2%)                                
      Mast Cell Tumor Malignant, Metastatic, Bone                                                                                   
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page  10                                                               
                                                                                                                                   
NTP Experiment-Test: 88122-07  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                              ELMIRON                                          Date: 04/23/01  
Route: GAVAGE                                                                                                     Time: 15:05:34  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE MALE                          0 MG/KG      56 MG/KG     168          504                                       
                                                                             MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - cont                                                                                                         
          Marrow                                                    1 (2%)                                                          
      Squamous Cell Carcinoma, Metastatic, Stomach,                                                                                 
           Forestomach                                              1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (49)         (50)         (50)         (50)                                   
      Keratoacanthoma                                                            1 (2%)                                             
      Subcutaneous Tissue, Fibrous Histiocytoma                                               1 (2%)                                
      Subcutaneous Tissue, Melanoma Malignant                       1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (50)         (50)         (50)         (50)                                   
      Chondroma                                        1 (2%)                                                                       
      Mast Cell Tumor Malignant, Metastatic, Bone                                                                                   
          Marrow                                                    1 (2%)                                                          
   Skeletal Muscle                                                 (2)                       (1)                                    
      Alveolar/Bronchiolar Carcinoma, Metastatic,                                                                                   
           Lung                                                                               1 (100%)                              
      Mast Cell Tumor Malignant, Metastatic, Bone                                                                                   
          Marrow                                                    1 (50%)                                                         
      Squamous Cell Carcinoma, Metastatic, Stomach,                                                                                 
           Forestomach                                              1 (50%)                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (50)         (50)         (50)                                   
      Carcinoma, Metastatic, Harderian Gland                                                  1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (50)         (50)         (50)                                   
      Alveolar/Bronchiolar Adenoma                     9 (18%)      3 (6%)       8 (16%)      5 (10%)                               
      Alveolar/Bronchiolar Adenoma, Multiple           1 (2%)                                                                       
      Alveolar/Bronchiolar Carcinoma                   4 (8%)       3 (6%)       5 (10%)      4 (8%)                                
      Alveolar/Bronchiolar Carcinoma, Multiple         1 (2%)                                                                       
      Hepatocellular Carcinoma, Metastatic, Liver      7 (14%)      3 (6%)      10 (20%)      5 (10%)                               
      Histiocytic Sarcoma                              1 (2%)                                                                       
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page  11                                                               
                                                                                                                                   
NTP Experiment-Test: 88122-07  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                              ELMIRON                                          Date: 04/23/01  
Route: GAVAGE                                                                                                     Time: 15:05:34  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE MALE                          0 MG/KG      56 MG/KG     168          504                                       
                                                                             MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
RESPIRATORY SYSTEM - cont                                                                                                           
      Mediastinum, Mast Cell Tumor Malignant,                                                                                       
          Metastatic, Bone Marrow                                   1 (2%)                                                          
   Nose                                               (50)         (50)         (50)         (47)                                   
      Mast Cell Tumor Malignant, Metastatic, Bone                                                                                   
          Marrow                                                    1 (2%)                                                          
   Pleura                                                                                    (1)                                    
      Alveolar/Bronchiolar Carcinoma, Metastatic,                                                                                   
           Lung                                                                               1 (100%)                              
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Harderian Gland                                    (49)         (48)         (49)         (48)                                   
      Adenoma                                          6 (12%)      9 (19%)      4 (8%)       6 (13%)                               
      Carcinoma                                                                  1 (2%)       2 (4%)                                
      Bilateral, Adenoma                                                         1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (50)         (50)         (49)                                   
      Histiocytic Sarcoma                                                                     1 (2%)                                
      Squamous Cell Carcinoma, Metastatic, Stomach,                                                                                 
           Forestomach                                              1 (2%)                                                          
   Urinary Bladder                                    (50)         (49)         (49)         (49)                                   
      Hemangiosarcoma                                                            1 (2%)                                             
      Transitional Epithelium, Papilloma                                         1 (2%)                                             
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SYSTEMIC LESIONS                                                                                                                   
                                                                                                                                    
   Multiple Organs                                   *(50)        *(50)        *(50)        *(50)                                   
      Histiocytic Sarcoma                              1 (2%)                                 3 (6%)                                
      Lymphoma Malignant                               3 (6%)       1 (2%)       2 (4%)       4 (8%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
     *   Number of animals with any tissue examined microscopically                                                                 
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page  12                                                               
                                                                                                                                   
NTP Experiment-Test: 88122-07  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                              ELMIRON                                          Date: 04/23/01  
Route: GAVAGE                                                                                                     Time: 15:05:34  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE MALE                          0 MG/KG      56 MG/KG     168          504                                       
                                                                             MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
TUMOR SUMMARY                                                                                                                       
                                                                                                                                    
   Total Animals with Primary Neoplasms (b)            38          32          41          42                                       
     Total Primary Neoplasms                           69          52          71          75                                       
                                                                                                                                    
   Total Animals with Benign Neoplasms                 29          24          29          27                                       
     Total Benign Neoplasms                            38          29          36          34                                       
                                                                                                                                    
   Total Animals with Malignant Neoplasms              24          20          27          30                                       
     Total Malignant Neoplasms                         31          23          35          41                                       
                                                                                                                                    
   Total Animals with Metastatic Neoplasms              8           5          11           6                                       
     Total Metastatic Neoplasm                         12          25          12           8                                       
                                                                                                                                    
   Total Animals with Malignant Neoplasms                                                                                           
   Uncertain Primary Site                                                                                                           
                                                                                                                                    
   Total Animals with Neoplasms Uncertain-                                                                                          
   Benign or Malignant                                                                                                              
     Total Uncertain Neoplasms                                                                                                      
                                                                                                                                    
                                                                                                                                    
____________________________________________________________________________________________________________________________________
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Primary tumors: all tumors except metastatic tumors                                                                              
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page  13                                                               
                                                                                                                                   
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