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TDMS Study 05102-05 Pathology Tables

                              INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)
                                                       BENZETHONIUM CHLORIDE
NTP Experiment-Test: 05102-05                                                                                     Report: PEIRPT05
Study Type: CHRONIC                                                                                               Date: 05/19/95
Route: DERMAL,SOLUTION                                                                                            Time: 18:13:29
       Facility:  Battelle Columbus Laboratory
       Chemical CAS #:  121-54-0
       Lock Date:  01/24/92
       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: 05102-05  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                       BENZETHONIUM CHLORIDE                                   Date: 05/19/95  
Route: DERMAL,SOLUTION                                                                                            Time: 18:13:29  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                    0MG/KG      .15MG/KG     0.5MG/KG     1.5MG/KG                                  
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially in Study                          60           60           60           60                                     
  Scheduled Sacrifice                                  9            7            9            7                                     
  Early Deaths                                                                                                                      
    Moribund Sacrifice                                13           11           13           13                                     
    Natural Death                                     14            9           12           16                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                24           33           26           24                                     
  Animals Examined Microscopically                    60           60           60           60                                     
____________________________________________________________________________________________________________________________________
 ALIMENTARY SYSTEM                                                                                                                  
   Intestine Small, Jejunum                           (1)                                                                           
   Liver                                              (60)                                   (60)                                   
   Mesentery                                          (4)                                    (4)                                    
      Fat, Liposarcoma                                 1 (25%)                                                                      
   Pancreas                                           (60)                                   (60)                                   
   Salivary Glands                                    (60)                                   (60)                                   
____________________________________________________________________________________________________________________________________
 CARDIOVASCULAR SYSTEM                                                                                                              
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
 ENDOCRINE SYSTEM                                                                                                                   
   Adrenal Cortex                                     (19)                                   (21)                                   
      Adenoma                                                                                 1 (5%)                                
   Adrenal Medulla                                    (10)                                   (2)                                    
      Pheochromocytoma Benign                          3 (30%)                                                                      
      Bilateral, Pheochromocytoma Benign                                                      1 (50%)                               
   Islets, Pancreatic                                 (60)                                   (60)                                   
      Carcinoma                                                                               1 (2%)                                
   Pituitary Gland                                    (60)                                   (60)                                   
      Pars Distalis, Adenoma                          28 (47%)                               28 (47%)                               
      Pars Distalis, Adenoma, Multiple                 1 (2%)                                                                       
      Pars Distalis, Carcinoma                         2 (3%)                                 2 (3%)                                
   Thyroid Gland                                      (60)                                   (60)                                   
      Bilateral, C-Cell, Adenoma                       1 (2%)                                                                       
      C-Cell, Adenoma                                 10 (17%)                                5 (8%)                                
      C-Cell, Carcinoma                                1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                             Page   2                                                               
NTP Experiment-Test: 05102-05  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                       BENZETHONIUM CHLORIDE                                   Date: 05/19/95  
Route: DERMAL,SOLUTION                                                                                            Time: 18:13:29  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                    0MG/KG      .15MG/KG     0.5MG/KG     1.5MG/KG                                  
____________________________________________________________________________________________________________________________________
 GENERAL BODY SYSTEM                                                                                                                
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
 GENITAL SYSTEM                                                                                                                     
   Clitoral Gland                                     (59)                                   (59)                                   
      Adenoma                                          4 (7%)                                 4 (7%)                                
      Carcinoma                                                                               2 (3%)                                
   Ovary                                              (60)                                   (60)                                   
   Uterus                                             (60)                                   (60)                                   
      Polyp Stromal                                    3 (5%)                                 7 (12%)                               
____________________________________________________________________________________________________________________________________
 HEMATOPOIETIC SYSTEM                                                                                                               
   Bone Marrow                                        (60)                                   (59)                                   
   Lymph Node                                         (5)                                    (1)                                    
   Lymph Node, Mandibular                             (7)                                    (3)                                    
      Osteosarcoma, Metastatic, Bone                                                          1 (33%)                               
   Lymph Node, Mesenteric                             (5)                                    (3)                                    
   Spleen                                             (60)                                   (60)                                   
   Thymus                                             (54)                                   (56)                                   
____________________________________________________________________________________________________________________________________
 INTEGUMENTARY SYSTEM                                                                                                               
   Mammary Gland                                      (60)                                   (60)                                   
      Adenoma                                          2 (3%)                                 2 (3%)                                
      Adenoma, Multiple                                1 (2%)                                                                       
      Carcinoma                                                                               1 (2%)                                
      Fibroadenoma                                    14 (23%)                               12 (20%)                               
      Fibroadenoma, Multiple                           3 (5%)                                 5 (8%)                                
      Fibroma                                                                                 1 (2%)                                
   Skin                                               (60)         (60)         (60)         (60)                                   
      Basosquamous Tumor Malignant                                                            1 (2%)                                
      Basosquamous Tumor Benign                        1 (2%)                                                                       
      Trichoepithelioma                                                          1 (2%)                                             
      Subcutaneous Tissue, Lipoma                      1 (2%)                                 1 (2%)                                
      Subcutaneous Tissue, Neurofibrosarcoma                                     1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                             Page   3                                                               
NTP Experiment-Test: 05102-05  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                       BENZETHONIUM CHLORIDE                                   Date: 05/19/95  
Route: DERMAL,SOLUTION                                                                                            Time: 18:13:29  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                    0MG/KG      .15MG/KG     0.5MG/KG     1.5MG/KG                                  
____________________________________________________________________________________________________________________________________
 MUSCULOSKELETAL SYSTEM                                                                                                             
   Bone                                               (60)                                   (60)                                   
      Mandible, Osteosarcoma                                                                  1 (2%)                                
____________________________________________________________________________________________________________________________________
 NERVOUS SYSTEM                                                                                                                     
   Brain                                              (60)                                   (60)                                   
      Carcinoma, Metastatic, Pituitary Gland           2 (3%)                                 2 (3%)                                
____________________________________________________________________________________________________________________________________
 RESPIRATORY SYSTEM                                                                                                                 
   Lung                                               (60)                                   (60)                                   
      Carcinoma, Metastatic, Thyroid Gland             1 (2%)                                                                       
   Nose                                               (60)                                   (60)                                   
      Nares, Squamous Cell Papilloma                   1 (2%)                                                                       
      Vomeronasal Organ, Squamous Cell Carcinoma       1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
 SPECIAL SENSES SYSTEM                                                                                                              
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
 URINARY SYSTEM                                                                                                                     
   Kidney                                             (60)                                   (60)                                   
   Urinary Bladder                                    (60)                                   (60)                                   
____________________________________________________________________________________________________________________________________
 SYSTEMIC LESIONS                                                                                                                   
   Multiple Organs                                   *(60)        *(60)        *(60)        *(60)                                   
      Leukemia Mononuclear                            18 (30%)                               18 (30%)                               
____________________________________________________________________________________________________________________________________
     *   Number of animals with any tissue examined microscopically                                                                 
                                                             Page   4                                                               
NTP Experiment-Test: 05102-05  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                       BENZETHONIUM CHLORIDE                                   Date: 05/19/95  
Route: DERMAL,SOLUTION                                                                                            Time: 18:13:29  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                    0MG/KG      .15MG/KG     0.5MG/KG     1.5MG/KG                                  
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY                                                                                                                       
   Total Animals with Primary Neoplasms (b)            46                       2          50                                       
     Total Primary Neoplasms                           96                       2          93                                       
   Total Animals with Benign Neoplasms                 41                       1          42                                       
     Total Benign Neoplasms                            73                       1          67                                       
   Total Animals with Malignant Neoplasms              23                       1          21                                       
     Total Malignant Neoplasms                         23                       1          26                                       
   Total Animals with Metastatic Neoplasms              3                                   3                                       
     Total Metastatic Neoplasm                          3                                   3                                       
   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   5                                                               
NTP Experiment-Test: 05102-05  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                       BENZETHONIUM CHLORIDE                                   Date: 05/19/95  
Route: DERMAL,SOLUTION                                                                                            Time: 18:13:29  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                      0MG/KG      .15MG/KG     0.5MG/KG     1.5MG/KG                                  
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially in Study                          60           60           60           60                                     
  Scheduled Sacrifice                                  8            8            5            4                                     
  Early Deaths                                                                                                                      
    Natural Death                                     12            7           11           15                                     
    Moribund Sacrifice                                25           34           34           25                                     
    Accidently Killed                                                            1                                                  
  Survivors                                                                                                                         
    Natural Death                                                                1                                                  
    Terminal Sacrifice                                15           11            8           16                                     
  Animals Examined Microscopically                    60           60           60           60                                     
____________________________________________________________________________________________________________________________________
 ALIMENTARY SYSTEM                                                                                                                  
   Intestine Large, Colon                                                                    (1)                                    
      Adenoma                                                                                 1 (100%)                              
   Intestine Large, Cecum                             (1)                                                                           
   Intestine Small, Duodenum                                                                 (3)                                    
   Intestine Small, Jejunum                           (2)                                    (1)                                    
      Adenocarcinoma                                                                          1 (100%)                              
      Adenoma                                          1 (50%)                                                                      
   Liver                                              (60)                                   (60)                                   
      Histiocytic Sarcoma                              1 (2%)                                                                       
   Mesentery                                          (8)                                    (8)                                    
      Lipoma                                           1 (13%)                                                                      
      Fat, Histiocytic Sarcoma                         1 (13%)                                                                      
   Pancreas                                           (60)                                   (60)                                   
   Pharynx                                            (1)                                                                           
      Palate, Squamous Cell Papilloma                  1 (100%)                                                                     
   Salivary Glands                                    (60)                                   (60)                                   
      Sarcoma                                          1 (2%)                                                                       
   Stomach, Forestomach                               (10)                                   (13)                                   
      Squamous Cell Papilloma                          1 (10%)                                                                      
   Tooth                                              (2)                                                                           
      Gingiva, Squamous Cell Carcinoma                 1 (50%)                                                                      
____________________________________________________________________________________________________________________________________
 CARDIOVASCULAR SYSTEM                                                                                                              
   Heart                                              (59)                                   (60)                                   
____________________________________________________________________________________________________________________________________
                                                             Page   6                                                               
NTP Experiment-Test: 05102-05  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                       BENZETHONIUM CHLORIDE                                   Date: 05/19/95  
Route: DERMAL,SOLUTION                                                                                            Time: 18:13:29  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                      0MG/KG      .15MG/KG     0.5MG/KG     1.5MG/KG                                  
____________________________________________________________________________________________________________________________________
 ENDOCRINE SYSTEM                                                                                                                   
   Adrenal Cortex                                     (29)                                   (24)                                   
      Adenoma                                          1 (3%)                                                                       
      Squamous Cell Carcinoma, Metastatic, Lung                                               1 (4%)                                
   Adrenal Medulla                                    (27)                                   (29)                                   
      Pheochromocytoma Malignant                                                              1 (3%)                                
      Pheochromocytoma Benign                          3 (11%)                                4 (14%)                               
      Bilateral, Pheochromocytoma Benign               2 (7%)                                 3 (10%)                               
   Islets, Pancreatic                                 (60)                                   (60)                                   
      Adenoma                                          1 (2%)                                 3 (5%)                                
   Parathyroid Gland                                  (58)                                   (58)                                   
      Adenoma                                          1 (2%)                                                                       
   Pituitary Gland                                    (60)                                   (60)                                   
      Pars Distalis, Adenoma                          34 (57%)                               25 (42%)                               
      Pars Intermedia, Adenoma                         1 (2%)                                                                       
   Thyroid Gland                                      (59)                                   (60)                                   
      C-Cell, Adenoma                                  6 (10%)                                9 (15%)                               
      C-Cell, Adenoma, Multiple                        1 (2%)                                                                       
      Follicular Cell, Adenoma                         1 (2%)                                 2 (3%)                                
____________________________________________________________________________________________________________________________________
 GENERAL BODY SYSTEM                                                                                                                
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
 GENITAL SYSTEM                                                                                                                     
   Epididymis                                         (60)                                   (60)                                   
   Preputial Gland                                    (60)                                   (60)                                   
      Adenoma                                                                                 1 (2%)                                
      Carcinoma                                        1 (2%)                                                                       
      Bilateral, Carcinoma                             1 (2%)                                                                       
   Prostate                                           (60)                                   (60)                                   
   Seminal Vesicle                                    (60)                                   (60)                                   
   Testes                                             (60)                                   (60)                                   
      Bilateral, Interstitial Cell, Adenoma           24 (40%)                               30 (50%)                               
      Interstitial Cell, Adenoma                      21 (35%)                               10 (17%)                               
____________________________________________________________________________________________________________________________________
 HEMATOPOIETIC SYSTEM                                                                                                               
   Bone Marrow                                        (59)                                   (60)                                   
      Femoral, Histiocytic Sarcoma                     1 (2%)                                                                       
   Lymph Node                                         (8)                                    (14)                                   
      Mediastinal, Histiocytic Sarcoma                 1 (13%)                                                                      
      Renal, Histiocytic Sarcoma                       1 (13%)                                                                      
                                                             Page   7                                                               
NTP Experiment-Test: 05102-05  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                       BENZETHONIUM CHLORIDE                                   Date: 05/19/95  
Route: DERMAL,SOLUTION                                                                                            Time: 18:13:29  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                      0MG/KG      .15MG/KG     0.5MG/KG     1.5MG/KG                                  
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont                                                                                                         
      Thoracic, Squamous Cell Carcinoma,                                                                                            
          Metastatic, Lung                                                                    1 (7%)                                
   Lymph Node, Mandibular                             (13)                                   (17)                                   
      Hemangiosarcoma                                  1 (8%)                                                                       
   Lymph Node, Mesenteric                             (9)                                    (14)                                   
   Spleen                                             (60)                                   (60)                                   
      Hemangiosarcoma                                  1 (2%)                                                                       
      Histiocytic Sarcoma                              2 (3%)                                 1 (2%)                                
   Thymus                                             (52)                                   (51)                                   
      Squamous Cell Carcinoma, Metastatic, Lung                                               1 (2%)                                
____________________________________________________________________________________________________________________________________
 INTEGUMENTARY SYSTEM                                                                                                               
   Mammary Gland                                      (55)                                   (53)                                   
      Adenoma                                          1 (2%)                                                                       
      Fibroadenoma                                     1 (2%)                                 3 (6%)                                
      Fibroma                                          3 (5%)                                 1 (2%)                                
      Histiocytic Sarcoma                              1 (2%)                                                                       
   Skin                                               (60)         (60)         (60)         (60)                                   
      Basal Cell Adenoma                                                         1 (2%)                                             
      Basosquamous Tumor Benign                                                  1 (2%)                                             
      Histiocytic Sarcoma                              1 (2%)                                                                       
      Keratoacanthoma                                  1 (2%)                    3 (5%)                                             
      Squamous Cell Papilloma                          1 (2%)                                 1 (2%)                                
      Sebaceous Gland, Lip, Carcinoma                  1 (2%)                                                                       
      Subcutaneous Tissue, Fibroma                                               1 (2%)       1 (2%)                                
      Subcutaneous Tissue, Fibrosarcoma                             1 (2%)                                                          
      Subcutaneous Tissue, Fibrous Histiocytoma                     1 (2%)                                                          
      Subcutaneous Tissue, Histiocytic Sarcoma                                                1 (2%)                                
      Subcutaneous Tissue, Neurofibroma                1 (2%)                                                                       
   Skin, Site of Application-Mass                     (5)                       (3)          (4)                                    
      Keratoacanthoma                                                            1 (33%)      1 (25%)                               
      Sebaceous Gland, Carcinoma                                                 1 (33%)                                            
   Skin, Site of Application-No Mass                  (2)          (1)          (8)          (16)                                   
      Subcutaneous Tissue, Histiocytic Sarcoma         1 (50%)                                                                      
   Skin, Site of Application-Mass                     (5)                       (3)          (4)                                    
      Subcutaneous Tissue, Histiocytic Sarcoma         1 (20%)                                                                      
   Skin, Site of Application-No Mass                  (2)          (1)          (8)          (16)                                   
      Subcutaneous Tissue, Histiocytic Sarcoma                      1 (100%)                                                        
   Skin, Site of Application-Mass                     (5)                       (3)          (4)                                    
      Subcutaneous Tissue, Histiocytic Sarcoma                                   1 (33%)                                            
   Skin, Site of Application-No Mass                  (2)          (1)          (8)          (16)                                   
      Subcutaneous Tissue, Histiocytic Sarcoma                                                1 (6%)                                
____________________________________________________________________________________________________________________________________
                                                             Page   8                                                               
NTP Experiment-Test: 05102-05  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                       BENZETHONIUM CHLORIDE                                   Date: 05/19/95  
Route: DERMAL,SOLUTION                                                                                            Time: 18:13:29  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                      0MG/KG      .15MG/KG     0.5MG/KG     1.5MG/KG                                  
____________________________________________________________________________________________________________________________________
 MUSCULOSKELETAL SYSTEM                                                                                                             
   Bone                                               (59)                                   (60)                                   
      Maxilla, Osteosarcoma                            1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
 NERVOUS SYSTEM                                                                                                                     
   Brain                                              (60)                                   (60)                                   
      Astrocytoma NOS                                                                         1 (2%)                                
____________________________________________________________________________________________________________________________________
 RESPIRATORY SYSTEM                                                                                                                 
   Lung                                               (59)                                   (60)                                   
      Histiocytic Sarcoma                              1 (2%)                                                                       
      Squamous Cell Carcinoma                                                                 1 (2%)                                
____________________________________________________________________________________________________________________________________
 SPECIAL SENSES SYSTEM                                                                                                              
   Ear                                                (3)                                                                           
      Squamous Cell Papilloma                          3 (100%)                                                                     
   Zymbal's Gland                                     (2)                                                                           
      Carcinoma                                        2 (100%)                                                                     
____________________________________________________________________________________________________________________________________
 URINARY SYSTEM                                                                                                                     
   Kidney                                             (60)                                   (60)                                   
      Transitional Epithelium, Carcinoma               1 (2%)                                                                       
   Urinary Bladder                                    (60)                                   (60)                                   
      Transitional Epithelium, Papilloma                                                      1 (2%)                                
____________________________________________________________________________________________________________________________________
 SYSTEMIC LESIONS                                                                                                                   
   Multiple Organs                                   *(60)        *(60)        *(60)        *(60)                                   
      Histiocytic Sarcoma                              3 (5%)       1 (2%)       1 (2%)       3 (5%)                                
      Leukemia Mononuclear                            23 (38%)                               30 (50%)                               
      Mesothelioma Benign                                                                     1 (2%)                                
      Mesothelioma Malignant                           1 (2%)                                 1 (2%)                                
____________________________________________________________________________________________________________________________________
     *   Number of animals with any tissue examined microscopically                                                                 
                                                             Page   9                                                               
NTP Experiment-Test: 05102-05  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                       BENZETHONIUM CHLORIDE                                   Date: 05/19/95  
Route: DERMAL,SOLUTION                                                                                            Time: 18:13:29  
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                      0MG/KG      .15MG/KG     0.5MG/KG     1.5MG/KG                                  
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY                                                                                                                       
   Total Animals with Primary Neoplasms (b)            57           3           8          57                                       
     Total Primary Neoplasms                          149           3           9         135                                       
   Total Animals with Benign Neoplasms                 55                       7          54                                       
     Total Benign Neoplasms                           111                       7          97                                       
   Total Animals with Malignant Neoplasms              30           3           2          33                                       
     Total Malignant Neoplasms                         38           3           2          37                                       
   Total Animals with Metastatic Neoplasms                                                  1                                       
     Total Metastatic Neoplasm                                                              3                                       
   Total Animals with Malignant Neoplasms                                                                                           
   Uncertain Primary Site                                                                                                           
   Total Animals with Neoplasms Uncertain-                                                                                          
   Benign or Malignant                                                                      1                                       
     Total Uncertain Neoplasms                                                              1                                       
____________________________________________________________________________________________________________________________________
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Primary tumors: all tumors except metastatic tumors                                                                              
                                                             Page  10                                                               
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