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TDMS Study 88122-06 Pathology Tables

NTP Experiment-Test: 88122-06  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01
Route: GAVAGE                                                                                                     Time: 09:18:08

                                                            FINAL#1




       Facility:  Battelle Columbus Laboratory

       Chemical CAS #:  37319-17-8

       Lock Date:  06/01/00

       Cage Range:  All

       Reasons For Removal:    All

       Removal Date Range:     All

       Treatment Groups:       Include All


































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

                                                              Page   1


NTP Experiment-Test: 88122-06  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01  
Route: GAVAGE                                                                                                     Time: 09:18:08  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   0 MG/KG      28 MG/KG     84 MG/KG     252                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially in Study                          50           50           50           50                                     
  Early Deaths                                                                                                                      
    Natural Death                                     13           10            9            6                                     
    Moribund Sacrifice                                 6            8           11           11                                     
    Dosing Accident                                    1                         2            5                                     
    Accidently Killed                                               1                         1                                     
  Survivors                                                                                                                         
    Natural Death                                                                             1                                     
    Terminal Sacrifice                                30           31           28           26                                     
                                                                                                                                    
  Animals Examined Microscopically                    50           50           50           50                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large, Rectum                            (46)         (43)         (44)         (42)                                   
      Leiomyosarcoma, Metastatic, Vagina                                         1 (2%)                                             
   Liver                                              (50)         (50)         (50)         (50)                                   
      Fibrous Histiocytoma                                                       1 (2%)                                             
      Hepatocellular Carcinoma                         1 (2%)                                                                       
      Leiomyosarcoma, Metastatic, Uterus               1 (2%)                                                                       
   Mesentery                                          (8)          (4)          (6)          (9)                                    
      Liposarcoma                                      1 (13%)                                                                      
   Pancreas                                           (50)         (50)         (50)         (50)                                   
      Adenoma                                          1 (2%)                                                                       
   Salivary Glands                                    (50)         (50)         (50)         (50)                                   
   Stomach, Forestomach                               (50)         (50)         (50)         (50)                                   
   Stomach, Glandular                                 (50)         (50)         (50)         (50)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (50)         (50)         (50)         (50)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (50)         (50)         (50)         (50)                                   
      Adenoma                                          1 (2%)                                                                       
   Adrenal Medulla                                    (50)         (50)         (50)         (50)                                   
      Pheochromocytoma Benign                          2 (4%)       1 (2%)                    3 (6%)                                
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   2                                                               
                                                                                                                                   
NTP Experiment-Test: 88122-06  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01  
Route: GAVAGE                                                                                                     Time: 09:18:08  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   0 MG/KG      28 MG/KG     84 MG/KG     252                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - cont                                                                                                             
      Bilateral, Pheochromocytoma Malignant            1 (2%)                                                                       
   Islets, Pancreatic                                 (50)         (50)         (50)         (50)                                   
      Adenoma                                                       1 (2%)       2 (4%)                                             
   Parathyroid Gland                                  (46)         (44)         (46)         (45)                                   
      Adenoma                                          1 (2%)                                                                       
   Pituitary Gland                                    (50)         (50)         (50)         (50)                                   
      Pars Distalis, Adenoma                          21 (42%)     21 (42%)     26 (52%)     19 (38%)                               
      Pars Intermedia, Adenoma                                                   1 (2%)                                             
   Thyroid Gland                                      (50)         (50)         (50)         (50)                                   
      Bilateral, C-Cell, Adenoma                                                 1 (2%)                                             
      C-Cell, Adenoma                                 11 (22%)      7 (14%)      9 (18%)      9 (18%)                               
      C-Cell, Adenoma, Multiple                                     1 (2%)                                                          
      Follicle, Carcinoma                              1 (2%)                                 1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (50)         (50)         (50)         (49)                                   
      Adenoma                                          3 (6%)                                 4 (8%)                                
   Ovary                                              (50)         (50)         (50)         (50)                                   
      Granulosa Cell Tumor Malignant                                1 (2%)                                                          
   Uterus                                             (50)         (50)         (50)         (50)                                   
      Adenocarcinoma                                                             1 (2%)                                             
      Leiomyoma                                                                               1 (2%)                                
      Leiomyosarcoma                                   1 (2%)                                                                       
      Polyp Stromal                                    7 (14%)      8 (16%)      7 (14%)      5 (10%)                               
      Sarcoma Stromal                                                            1 (2%)                                             
      Endometrium, Polyp Stromal                                                              1 (2%)                                
      Endometrium, Sarcoma Stromal                                                            1 (2%)                                
   Vagina                                                                       (2)          (2)                                    
      Leiomyosarcoma                                                             1 (50%)      1 (50%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   3                                                               
                                                                                                                                   
NTP Experiment-Test: 88122-06  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01  
Route: GAVAGE                                                                                                     Time: 09:18:08  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   0 MG/KG      28 MG/KG     84 MG/KG     252                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (50)         (50)         (50)                                   
   Lymph Node                                         (7)          (19)         (14)         (13)                                   
   Lymph Node, Mandibular                             (3)          (8)          (3)          (2)                                    
   Lymph Node, Mesenteric                             (50)         (50)         (50)         (49)                                   
   Spleen                                             (50)         (50)         (50)         (50)                                   
   Thymus                                             (45)         (41)         (46)         (41)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (50)         (50)         (50)         (50)                                   
      Adenolipoma                                                                             1 (2%)                                
      Adenoma                                                                    1 (2%)       1 (2%)                                
      Carcinoma                                        1 (2%)       1 (2%)       1 (2%)       3 (6%)                                
      Fibroadenoma                                    11 (22%)     21 (42%)     16 (32%)     17 (34%)                               
      Fibroadenoma, Multiple                           4 (8%)       2 (4%)       8 (16%)      4 (8%)                                
   Skin                                               (50)         (50)         (50)         (50)                                   
      Basal Cell Adenoma                               1 (2%)                                                                       
      Keratoacanthoma                                                            1 (2%)                                             
      Subcutaneous Tissue, Fibroma                     1 (2%)                    2 (4%)                                             
      Subcutaneous Tissue, Fibrous Histiocytoma                                  1 (2%)                                             
      Subcutaneous Tissue, Lipoma                      1 (2%)       1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Skeletal Muscle                                                              (1)                                                 
      Leiomyosarcoma, Metastatic, Vagina                                         1 (100%)                                           
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (50)         (50)         (50)                                   
      Astrocytoma Malignant                                                      1 (2%)                                             
      Oligodendroglioma Malignant                                                             1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   4                                                               
                                                                                                                                   
NTP Experiment-Test: 88122-06  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01  
Route: GAVAGE                                                                                                     Time: 09:18:08  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   0 MG/KG      28 MG/KG     84 MG/KG     252                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (50)         (50)         (50)                                   
      Alveolar/Bronchiolar Carcinoma                                1 (2%)                                                          
      Fibrous Histiocytoma                                                       1 (2%)                                             
      Leiomyosarcoma, Metastatic, Uterus               1 (2%)                                                                       
      Pheochromocytoma Malignant, Metastatic,                                                                                       
          Adrenal Medulla                              1 (2%)                                                                       
   Nose                                               (50)         (50)         (50)         (50)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Zymbal's Gland                                     (1)                                                                           
      Adenoma                                          1 (100%)                                                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (50)         (50)         (50)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SYSTEMIC LESIONS                                                                                                                   
                                                                                                                                    
   Multiple Organs                                   *(50)        *(50)        *(50)        *(50)                                   
      Adenolipoma                                                                             1 (2%)                                
      Leukemia Mononuclear                             7 (14%)     14 (28%)      8 (16%)     10 (20%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
     *   Number of animals with any tissue examined microscopically                                                                 
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   5                                                               
                                                                                                                                   
NTP Experiment-Test: 88122-06  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01  
Route: GAVAGE                                                                                                     Time: 09:18:08  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   0 MG/KG      28 MG/KG     84 MG/KG     252                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
TUMOR SUMMARY                                                                                                                       
                                                                                                                                    
   Total Animals with Primary Neoplasms (b)            42          45          44          40                                       
     Total Primary Neoplasms                           79          80          90          82                                       
                                                                                                                                    
   Total Animals with Benign Neoplasms                 37          41          41          35                                       
     Total Benign Neoplasms                            66          63          74          65                                       
                                                                                                                                    
   Total Animals with Malignant Neoplasms              12          17          14          15                                       
     Total Malignant Neoplasms                         13          17          16          17                                       
                                                                                                                                    
   Total Animals with Metastatic Neoplasms              2                       1                                                   
     Total Metastatic Neoplasm                          3                       2                                                   
                                                                                                                                    
   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   6                                                               
                                                                                                                                   
NTP Experiment-Test: 88122-06  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01  
Route: GAVAGE                                                                                                     Time: 09:18:08  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     0 MG/KG      14 MG/KG     42 MG/KG     126                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially in Study                          50           50           50           50                                     
  Early Deaths                                                                                                                      
    Natural Death                                      7            9            8            5                                     
    Moribund Sacrifice                                15           10           17           12                                     
    Dosing Accident                                    2            2                         5                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                26           29           25           28                                     
                                                                                                                                    
  Animals Examined Microscopically                    50           50           50           50                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large, Colon                             (50)         (50)         (50)         (50)                                   
   Intestine Large, Rectum                            (48)         (48)         (49)         (45)                                   
      Histiocytic Sarcoma                                                        1 (2%)                                             
      Polyp Adenomatous                                1 (2%)       1 (2%)       1 (2%)                                             
   Intestine Small, Duodenum                          (50)         (50)         (50)         (50)                                   
   Liver                                              (50)         (50)         (50)         (50)                                   
      Histiocytic Sarcoma                                                        1 (2%)                                             
   Mesentery                                          (9)          (11)         (9)          (13)                                   
      Schwannoma Malignant                                          1 (9%)                                                          
   Pancreas                                           (50)         (50)         (50)         (50)                                   
      Acinus, Adenoma                                                            1 (2%)                                             
      Acinus, Carcinoma                                             1 (2%)                                                          
   Salivary Glands                                    (50)         (50)         (49)         (50)                                   
      Schwannoma Malignant                             1 (2%)       2 (4%)       1 (2%)       1 (2%)                                
   Stomach, Forestomach                               (50)         (50)         (50)         (50)                                   
   Stomach, Glandular                                 (50)         (50)         (50)         (50)                                   
      Leiomyosarcoma                                   1 (2%)                                                                       
   Tongue                                                          (1)                                                              
      Squamous Cell Papilloma                                       1 (100%)                                                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (50)         (50)         (50)         (50)                                   
      Histiocytic Sarcoma                                                        1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   7                                                               
                                                                                                                                   
NTP Experiment-Test: 88122-06  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01  
Route: GAVAGE                                                                                                     Time: 09:18:08  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     0 MG/KG      14 MG/KG     42 MG/KG     126                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (50)         (50)         (50)         (50)                                   
   Adrenal Medulla                                    (50)         (50)         (50)         (50)                                   
      Pheochromocytoma Malignant                       1 (2%)                    3 (6%)       1 (2%)                                
      Pheochromocytoma Benign                          6 (12%)      6 (12%)      2 (4%)       8 (16%)                               
      Bilateral, Pheochromocytoma Benign               1 (2%)       1 (2%)       1 (2%)                                             
   Islets, Pancreatic                                 (50)         (50)         (50)         (50)                                   
      Adenoma                                          1 (2%)       1 (2%)       1 (2%)                                             
      Carcinoma                                                     1 (2%)                                                          
   Pituitary Gland                                    (50)         (50)         (50)         (50)                                   
      Pars Distalis, Adenoma                          19 (38%)     18 (36%)     18 (36%)     13 (26%)                               
      Pars Distalis, Carcinoma                         1 (2%)                                                                       
      Pars Intermedia, Adenoma                         1 (2%)                                                                       
   Thyroid Gland                                      (50)         (50)         (50)         (50)                                   
      Schwannoma Malignant, Metastatic, Salivary                                                                                    
          Glands                                                                 1 (2%)                                             
      Bilateral, C-Cell, Adenoma                       1 (2%)       1 (2%)                                                          
      Bilateral, C-Cell, Carcinoma                     1 (2%)                                                                       
      Bilateral, Follicle, Carcinoma                                1 (2%)                                                          
      C-Cell, Adenoma                                  5 (10%)      7 (14%)      8 (16%)      6 (12%)                               
      C-Cell, Adenoma, Multiple                        2 (4%)                                 1 (2%)                                
      C-Cell, Carcinoma                                1 (2%)       1 (2%)                    1 (2%)                                
      Follicle, Adenoma                                             1 (2%)       1 (2%)       3 (6%)                                
      Follicle, Carcinoma                              2 (4%)                                 1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (50)         (50)         (50)         (50)                                   
   Preputial Gland                                    (50)         (50)         (50)         (50)                                   
      Adenoma                                          1 (2%)       1 (2%)       1 (2%)       2 (4%)                                
      Carcinoma                                        1 (2%)                                                                       
   Prostate                                           (50)         (50)         (50)         (49)                                   
      Histiocytic Sarcoma                                                        1 (2%)                                             
   Seminal Vesicle                                    (50)         (50)         (50)         (49)                                   
   Testes                                             (50)         (50)         (50)         (50)                                   
      Bilateral, Interstitial Cell, Adenoma           35 (70%)     37 (74%)     37 (74%)     35 (70%)                               
      Interstitial Cell, Adenoma                       9 (18%)      6 (12%)      6 (12%)      5 (10%)                               
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   8                                                               
                                                                                                                                   
NTP Experiment-Test: 88122-06  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01  
Route: GAVAGE                                                                                                     Time: 09:18:08  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     0 MG/KG      14 MG/KG     42 MG/KG     126                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
GENITAL SYSTEM - cont                                                                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (50)         (50)         (50)                                   
   Lymph Node                                         (11)         (17)         (10)         (13)                                   
      Deep Cervical, Carcinoma, Metastatic,                                                                                         
          Thyroid Gland                                1 (9%)                                 1 (8%)                                
      Mediastinal, Carcinoma, Metastatic, Thyroid                                                                                   
          Gland                                        1 (9%)                                                                       
   Lymph Node, Mandibular                             (5)          (5)          (9)          (2)                                    
   Lymph Node, Mesenteric                             (50)         (50)         (50)         (49)                                   
   Spleen                                             (50)         (50)         (50)         (50)                                   
   Thymus                                             (45)         (44)         (43)         (43)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (49)         (49)         (50)         (48)                                   
      Adenoma                                          1 (2%)                                                                       
      Fibroadenoma                                     2 (4%)       1 (2%)       3 (6%)       5 (10%)                               
      Fibroma                                          1 (2%)                                                                       
   Skin                                               (50)         (50)         (50)         (50)                                   
      Basal Cell Adenoma                               1 (2%)                                                                       
      Keratoacanthoma                                  2 (4%)       3 (6%)       3 (6%)       1 (2%)                                
      Squamous Cell Carcinoma                                       1 (2%)       1 (2%)                                             
      Squamous Cell Papilloma                          1 (2%)                                                                       
      Sebaceous Gland, Adenoma                         1 (2%)       1 (2%)       1 (2%)       2 (4%)                                
      Sebaceous Gland, Carcinoma                                                 1 (2%)       1 (2%)                                
      Subcutaneous Tissue, Fibroma                     1 (2%)       1 (2%)       3 (6%)       1 (2%)                                
      Subcutaneous Tissue, Fibrosarcoma                2 (4%)       2 (4%)       1 (2%)       1 (2%)                                
      Subcutaneous Tissue, Hemangiosarcoma                          1 (2%)                                                          
      Subcutaneous Tissue, Lipoma                      1 (2%)       1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (50)         (50)         (50)         (50)                                   
      Osteosarcoma                                                                            1 (2%)                                
      Vertebra, Chordoma                               1 (2%)                                                                       
   Skeletal Muscle                                                              (1)          (2)                                    
      Histiocytic Sarcoma                                                        1 (100%)                                           
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   9                                                               
                                                                                                                                   
NTP Experiment-Test: 88122-06  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01  
Route: GAVAGE                                                                                                     Time: 09:18:08  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     0 MG/KG      14 MG/KG     42 MG/KG     126                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (50)         (50)         (50)                                   
      Astrocytoma Malignant                                                                   1 (2%)                                
      Carcinoma, Metastatic, Pituitary Gland           1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (50)         (50)         (50)                                   
      Alveolar/Bronchiolar Adenoma                                  1 (2%)       1 (2%)       2 (4%)                                
      Alveolar/Bronchiolar Carcinoma                   1 (2%)                                 1 (2%)                                
      Alveolar/Bronchiolar Carcinoma, Multiple         1 (2%)                                                                       
      Carcinoma, Metastatic, Thyroid Gland             1 (2%)       1 (2%)                    1 (2%)                                
      Chordoma, Metastatic, Bone                       1 (2%)                                                                       
      Histiocytic Sarcoma                                                        1 (2%)                                             
      Pheochromocytoma Malignant, Metastatic,                                                                                       
          Adrenal Medulla                              1 (2%)                                                                       
      Schwannoma Malignant, Metastatic, Salivary                                                                                    
          Glands                                                    1 (2%)                                                          
   Nose                                               (50)         (50)         (50)         (50)                                   
      Respiratory Epithelium, Adenoma                               1 (2%)                                                          
   Trachea                                            (50)         (50)         (50)         (50)                                   
      Schwannoma Malignant, Metastatic, Salivary                                                                                    
          Glands                                                                 1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (50)         (50)         (50)                                   
   Ureter                                             (1)                                                                           
   Urinary Bladder                                    (50)         (50)         (50)         (49)                                   
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page  10                                                               
                                                                                                                                   
NTP Experiment-Test: 88122-06  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01  
Route: GAVAGE                                                                                                     Time: 09:18:08  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     0 MG/KG      14 MG/KG     42 MG/KG     126                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 SYSTEMIC LESIONS                                                                                                                   
                                                                                                                                    
   Multiple Organs                                   *(50)        *(50)        *(50)        *(50)                                   
      Histiocytic Sarcoma                                                        1 (2%)                                             
      Leukemia Mononuclear                            15 (30%)     16 (32%)     12 (24%)     16 (32%)                               
      Mesothelioma Malignant                           2 (4%)                    2 (4%)       4 (8%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
     *   Number of animals with any tissue examined microscopically                                                                 
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page  11                                                               
                                                                                                                                   
NTP Experiment-Test: 88122-06  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                              ELMIRON                                          Date: 06/12/01  
Route: GAVAGE                                                                                                     Time: 09:18:08  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     0 MG/KG      14 MG/KG     42 MG/KG     126                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
TUMOR SUMMARY                                                                                                                       
                                                                                                                                    
   Total Animals with Primary Neoplasms (b)            49          48          50          45                                       
     Total Primary Neoplasms                          124         117         110         113                                       
                                                                                                                                    
   Total Animals with Benign Neoplasms                 49          47          49          45                                       
     Total Benign Neoplasms                            93          90          88          84                                       
                                                                                                                                    
   Total Animals with Malignant Neoplasms              29          25          22          25                                       
     Total Malignant Neoplasms                         31          27          22          29                                       
                                                                                                                                    
   Total Animals with Metastatic Neoplasms              4           2           1           1                                       
     Total Metastatic Neoplasm                          6           2           2           2                                       
                                                                                                                                    
   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  12                                                               
                                                                                                                                   
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