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TDMS Study 05002-06 Pathology Tables

                              INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)
                                                        GAMMA-BUTYROLACTONE
NTP Experiment-Test: 05002-06                                                                                     Report: PEIRPT05
Study Type: CHRONIC                                                                                               Date: 09/02/94
Route: GAVAGE                                                                                                     Time: 19:44:38
       Facility:  Southern Research Institute
       Chemical CAS #:  96-48-0
       Lock Date:  None
       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: 05002-06  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                        GAMMA-BUTYROLACTONE                                    Date: 09/02/94  
Route: GAVAGE                                                                                                     Time: 19:44:38  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE FEMALE                        VEHICLE      262.         525.                                                   
                                                   CONTROL      MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially in Study                          50           50           50                                                  
  Early Deaths                                                                                                                      
    Moribund                                           8           11            9                                                  
    Dead                                               4            5            3                                                  
  Survivors                                                                                                                         
    Terminal Sacrifice                                38           34           38                                                  
  Animals Examined Microscopically                    50           50           50                                                  
____________________________________________________________________________________________________________________________________
 ALIMENTARY SYSTEM                                                                                                                  
   Gallbladder                                        (47)                      (47)                                                
      Leiomyosarcoma, Metastatic, Mesentery                                      1 (2%)                                             
   Intestine Large, Colon                             (50)         (1)          (49)                                                
   Intestine Small, Duodenum                          (49)                      (49)                                                
      Leiomyosarcoma, Metastatic, Mesentery                                      1 (2%)                                             
      Polyp                                                                      1 (2%)                                             
   Intestine Small, Ileum                             (48)         (1)          (49)                                                
      Carcinoma                                                                  1 (2%)                                             
   Intestine Small, Jejunum                           (49)                      (49)                                                
   Liver                                              (50)         (50)         (50)                                                
      Fibrosarcoma, Metastatic, Skin                                1 (2%)                                                          
      Hepatocellular Carcinoma                         4 (8%)       2 (4%)       1 (2%)                                             
      Hepatocellular Adenoma                           5 (10%)                   3 (6%)                                             
   Mesentery                                          (3)          (5)          (5)                                                 
      Hemangiosarcoma                                               2 (40%)      1 (20%)                                            
      Leiomyosarcoma                                                             1 (20%)                                            
   Pancreas                                           (50)         (50)         (48)                                                
      Leiomyosarcoma, Metastatic, Mesentery                                      1 (2%)                                             
   Salivary Glands                                    (50)                      (50)                                                
   Stomach, Forestomach                               (50)         (49)         (50)                                                
      Leiomyosarcoma, Metastatic, Mesentery                                      1 (2%)                                             
      Squamous Cell Papilloma                          2 (4%)       5 (10%)      4 (8%)                                             
   Stomach, Glandular                                 (50)         (50)         (50)                                                
____________________________________________________________________________________________________________________________________
 CARDIOVASCULAR SYSTEM                                                                                                              
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                             Page   2                                                               
NTP Experiment-Test: 05002-06  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                        GAMMA-BUTYROLACTONE                                    Date: 09/02/94  
Route: GAVAGE                                                                                                     Time: 19:44:38  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE FEMALE                        VEHICLE      262.         525.                                                   
                                                   CONTROL      MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
 ENDOCRINE SYSTEM                                                                                                                   
   Adrenal Gland, Cortex                              (50)         (1)          (50)                                                
      Spindle Cell, Adenoma                            1 (2%)                                                                       
   Adrenal Gland, Medulla                             (50)                      (49)                                                
      Pheochromocytoma Malignant                                                 1 (2%)                                             
      Pheochromocytoma Benign                                                    1 (2%)                                             
   Islets, Pancreatic                                 (50)         (49)         (47)                                                
      Adenoma                                          1 (2%)                    2 (4%)                                             
      Carcinoma                                                     1 (2%)                                                          
   Pituitary Gland                                    (48)         (48)         (43)                                                
      Pars Distalis, Adenoma                           3 (6%)       5 (10%)      7 (16%)                                            
      Pars Intermedia, Adenoma                         1 (2%)                                                                       
   Thyroid Gland                                      (49)         (48)         (50)                                                
      Follicular Cell, Adenoma                                      3 (6%)       1 (2%)                                             
____________________________________________________________________________________________________________________________________
 GENERAL BODY SYSTEM                                                                                                                
   Tissue NOS                                                      (1)                                                              
____________________________________________________________________________________________________________________________________
 GENITAL SYSTEM                                                                                                                     
   Ovary                                              (48)         (49)         (46)                                                
      Cystadenoma                                      1 (2%)       1 (2%)       4 (9%)                                             
      Granulosa-Theca Tumor Malignant                  1 (2%)                    1 (2%)                                             
      Leiomyosarcoma, Metastatic, Mesentery                                      1 (2%)                                             
   Uterus                                             (50)         (41)         (50)                                                
      Adenoma                                                       1 (2%)                                                          
      Carcinoma                                                     2 (5%)                                                          
      Deciduoma Benign                                              1 (2%)                                                          
      Granulosa-Theca Tumor Malignant, Metastatic,                                                                                  
           Ovary                                       1 (2%)                                                                       
      Hemangioma                                       1 (2%)                                                                       
      Hemangiosarcoma                                  1 (2%)                    1 (2%)                                             
      Polyp Stromal                                    1 (2%)       1 (2%)       1 (2%)                                             
      Sarcoma Stromal                                  1 (2%)       1 (2%)                                                          
   Vagina                                             (2)                       (1)                                                 
      Leiomyosarcoma                                   1 (50%)                                                                      
      Polyp                                            1 (50%)                                                                      
____________________________________________________________________________________________________________________________________
                                                             Page   3                                                               
NTP Experiment-Test: 05002-06  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                        GAMMA-BUTYROLACTONE                                    Date: 09/02/94  
Route: GAVAGE                                                                                                     Time: 19:44:38  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE FEMALE                        VEHICLE      262.         525.                                                   
                                                   CONTROL      MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
 HEMATOPOIETIC SYSTEM                                                                                                               
   Bone Marrow                                        (50)         (50)         (50)                                                
      Hemangiosarcoma                                               1 (2%)                                                          
   Lymph Node                                         (50)         (6)          (49)                                                
      Bronchial, Leiomyosarcoma, Metastatic,                                                                                        
          Mesentery                                                              1 (2%)                                             
      Mediastinal, Alveolar/Bronchiolar Carcinoma,                                                                                  
           Metastatic, Lung                                         1 (17%)                                                         
   Lymph Node, Mandibular                             (47)         (1)          (45)                                                
   Lymph Node, Mesenteric                             (49)         (5)          (43)                                                
   Spleen                                             (50)         (14)         (50)                                                
   Thymus                                             (47)         (2)          (44)                                                
      Alveolar/Bronchiolar Carcinoma, Metastatic,                                                                                   
           Lung                                        1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
 INTEGUMENTARY SYSTEM                                                                                                               
   Mammary Gland                                      (50)         (48)         (50)                                                
      Carcinoma                                        2 (4%)       1 (2%)       1 (2%)                                             
   Skin                                               (50)         (47)         (50)                                                
      Subcutaneous Tissue, Fibroma                                               1 (2%)                                             
      Subcutaneous Tissue, Fibrosarcoma                1 (2%)       3 (6%)                                                          
      Subcutaneous Tissue, Hemangiosarcoma                          1 (2%)                                                          
      Subcutaneous Tissue, Schwannoma Benign                        1 (2%)                                                          
      Subcutaneous Tissue, Schwannoma Malignant                                  1 (2%)                                             
____________________________________________________________________________________________________________________________________
 MUSCULOSKELETAL SYSTEM                                                                                                             
   Bone                                               (50)         (50)         (50)                                                
      Osteosarcoma                                     1 (2%)                                                                       
   Skeletal Muscle                                    (1)          (4)                                                              
      Alveolar/Bronchiolar Carcinoma, Metastatic,                                                                                   
           Lung                                                     1 (25%)                                                         
      Fibrosarcoma, Metastatic, Skin                                1 (25%)                                                         
      Hemangiosarcoma                                  1 (100%)     1 (25%)                                                         
____________________________________________________________________________________________________________________________________
 NERVOUS SYSTEM                                                                                                                     
   Brain                                              (50)         (50)         (50)                                                
____________________________________________________________________________________________________________________________________
                                                             Page   4                                                               
NTP Experiment-Test: 05002-06  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                        GAMMA-BUTYROLACTONE                                    Date: 09/02/94  
Route: GAVAGE                                                                                                     Time: 19:44:38  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE FEMALE                        VEHICLE      262.         525.                                                   
                                                   CONTROL      MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
 RESPIRATORY SYSTEM                                                                                                                 
   Lung                                               (50)         (50)         (50)                                                
      Alveolar/Bronchiolar Adenoma                     5 (10%)      3 (6%)       3 (6%)                                             
      Alveolar/Bronchiolar Carcinoma                   2 (4%)       1 (2%)       1 (2%)                                             
      Carcinoma, Metastatic, Harderian Gland           1 (2%)                    1 (2%)                                             
      Carcinoma, Metastatic, Uterus                                 1 (2%)                                                          
      Fibrosarcoma, Metastatic, Skin                                1 (2%)                                                          
      Granulosa-Theca Tumor Malignant, Metastatic,                                                                                  
           Ovary                                                                 1 (2%)                                             
      Osteosarcoma, Metastatic, Bone                   1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
 SPECIAL SENSES SYSTEM                                                                                                              
   Harderian Gland                                    (2)          (43)         (4)                                                 
      Adenoma                                          1 (50%)      2 (5%)       3 (75%)                                            
      Carcinoma                                        1 (50%)                   1 (25%)                                            
____________________________________________________________________________________________________________________________________
 URINARY SYSTEM                                                                                                                     
   Kidney                                             (50)         (50)         (50)                                                
      Fibrosarcoma, Metastatic, Skin                                1 (2%)                                                          
      Leiomyosarcoma, Metastatic, Mesentery                                      1 (2%)                                             
   Urinary Bladder                                    (50)         (1)          (49)                                                
      Carcinoma, Metastatic, Uterus                                 1 (100%)                                                        
____________________________________________________________________________________________________________________________________
 SYSTEMIC LESIONS                                                                                                                   
   Multiple Organs                                   *(50)        *(50)        *(50)                                                
      Lymphoma Malignant Histiocytic                   1 (2%)       1 (2%)                                                          
      Lymphoma Malignant Lymphocytic                   2 (4%)       1 (2%)       1 (2%)                                             
      Lymphoma Malignant Mixed                         8 (16%)      7 (14%)      8 (16%)                                            
____________________________________________________________________________________________________________________________________
     *   Number of animals with any tissue examined microscopically                                                                 
                                                             Page   5                                                               
NTP Experiment-Test: 05002-06  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                        GAMMA-BUTYROLACTONE                                    Date: 09/02/94  
Route: GAVAGE                                                                                                     Time: 19:44:38  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE FEMALE                        VEHICLE      262.         525.                                                   
                                                   CONTROL      MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY                                                                                                                       
   Total Animals with Primary Neoplasms (b)            33          31          35                                                   
     Total Primary Neoplasms                           50          48          51                                                   
   Total Animals with Benign Neoplasms                 17          21          25                                                   
     Total Benign Neoplasms                            23          23          31                                                   
   Total Animals with Malignant Neoplasms              24          20          16                                                   
     Total Malignant Neoplasms                         27          25          20                                                   
   Total Animals with Metastatic Neoplasms              4           3           3                                                   
     Total Metastatic Neoplasm                          4           8           9                                                   
   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: 05002-06  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                        GAMMA-BUTYROLACTONE                                    Date: 09/02/94  
Route: GAVAGE                                                                                                     Time: 19:44:38  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE MALE                          VEHICLE      262.         525.                                                   
                                                   CONTROL      MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially in Study                          50           50           50                                                  
  Early Deaths                                                                                                                      
    Moribund                                          13            8           23                                                  
    Dead                                               2           12           12                                                  
    Accident                                                                     1                                                  
    Natural Death                                                                1                                                  
    Moribund Sacrifice                                                           1                                                  
  Survivors                                                                                                                         
    Terminal Sacrifice                                35           30           12                                                  
  Animals Examined Microscopically                    50           50           50                                                  
____________________________________________________________________________________________________________________________________
 ALIMENTARY SYSTEM                                                                                                                  
   Intestine Small, Jejunum                           (47)         (45)         (45)                                                
   Liver                                              (50)         (50)         (50)                                                
      Hemangiosarcoma                                  2 (4%)       1 (2%)                                                          
      Hepatocellular Carcinoma                        16 (32%)      2 (4%)       8 (16%)                                            
      Hepatocellular Adenoma                           8 (16%)      6 (12%)      1 (2%)                                             
   Pancreas                                           (50)         (49)         (49)                                                
   Salivary Glands                                    (48)         (50)         (48)                                                
      Fibrosarcoma, Metastatic, Skin                   1 (2%)                                                                       
   Stomach, Forestomach                               (50)         (49)         (49)                                                
      Squamous Cell Papilloma                          7 (14%)      2 (4%)       1 (2%)                                             
   Stomach, Glandular                                 (50)         (49)         (49)                                                
____________________________________________________________________________________________________________________________________
 CARDIOVASCULAR SYSTEM                                                                                                              
   Heart                                              (50)         (50)         (50)                                                
      Hemangiosarcoma                                               1 (2%)                                                          
____________________________________________________________________________________________________________________________________
 ENDOCRINE SYSTEM                                                                                                                   
   Adrenal Gland, Cortex                              (48)         (50)         (50)                                                
      Adenoma                                          3 (6%)       3 (6%)                                                          
      Spindle Cell, Adenoma                                                      1 (2%)                                             
   Adrenal Gland, Medulla                             (48)         (50)         (50)                                                
      Pheochromocytoma Malignant                       1 (2%)       1 (2%)                                                          
      Pheochromocytoma Benign                          1 (2%)       4 (8%)       1 (2%)                                             
      Bilateral, Pheochromocytoma Benign                            1 (2%)                                                          
   Islets, Pancreatic                                 (50)         (49)         (48)                                                
      Adenoma                                          1 (2%)                                                                       
                                                             Page   7                                                               
NTP Experiment-Test: 05002-06  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                        GAMMA-BUTYROLACTONE                                    Date: 09/02/94  
Route: GAVAGE                                                                                                     Time: 19:44:38  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE MALE                          VEHICLE      262.         525.                                                   
                                                   CONTROL      MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - cont                                                                                                             
   Thyroid Gland                                      (49)         (50)         (48)                                                
      Follicular Cell, Adenoma                         1 (2%)       2 (4%)       2 (4%)                                             
      Follicular Cell, Carcinoma                       1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
 GENERAL BODY SYSTEM                                                                                                                
   Tissue NOS                                         (1)                       (1)                                                 
____________________________________________________________________________________________________________________________________
 GENITAL SYSTEM                                                                                                                     
   Epididymis                                         (50)         (50)         (49)                                                
   Prostate                                           (49)         (48)         (48)                                                
      Fibrosarcoma, Metastatic, Skin                                             1 (2%)                                             
   Seminal Vesicle                                    (8)          (5)          (9)                                                 
   Testes                                             (50)         (50)         (50)                                                
      Interstitial Cell, Adenoma                       1 (2%)                    1 (2%)                                             
____________________________________________________________________________________________________________________________________
 HEMATOPOIETIC SYSTEM                                                                                                               
   Blood                                              (7)          (2)          (1)                                                 
   Bone Marrow                                        (50)         (50)         (49)                                                
   Lymph Node                                         (50)         (50)         (49)                                                
      Inguinal, Hemangiosarcoma                        1 (2%)                                                                       
   Lymph Node, Mandibular                             (45)         (46)         (46)                                                
   Lymph Node, Mesenteric                             (48)         (46)         (41)                                                
      Hemangiosarcoma                                  1 (2%)                                                                       
   Spleen                                             (50)         (50)         (48)                                                
      Hemangiosarcoma                                  1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
 INTEGUMENTARY SYSTEM                                                                                                               
   Skin                                               (50)         (50)         (50)                                                
      Adenoma                                                                    1 (2%)                                             
      Basosquamous Tumor Benign                                     1 (2%)                                                          
      Carcinoma                                                                  1 (2%)                                             
      Subcutaneous Tissue, Fibroma                     1 (2%)       1 (2%)                                                          
      Subcutaneous Tissue, Fibrosarcoma                9 (18%)      6 (12%)      6 (12%)                                            
      Subcutaneous Tissue, Hemangiosarcoma                                       1 (2%)                                             
      Subcutaneous Tissue, Lipoma                                                1 (2%)                                             
      Subcutaneous Tissue, Schwannoma Malignant                     1 (2%)       1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                             Page   8                                                               
NTP Experiment-Test: 05002-06  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                        GAMMA-BUTYROLACTONE                                    Date: 09/02/94  
Route: GAVAGE                                                                                                     Time: 19:44:38  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE MALE                          VEHICLE      262.         525.                                                   
                                                   CONTROL      MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
 MUSCULOSKELETAL SYSTEM                                                                                                             
   Skeletal Muscle                                    (1)          (4)          (2)                                                 
      Schwannoma Malignant                                          1 (25%)                                                         
____________________________________________________________________________________________________________________________________
 NERVOUS SYSTEM                                                                                                                     
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
 RESPIRATORY SYSTEM                                                                                                                 
   Lung                                               (50)         (50)         (50)                                                
      Alveolar/Bronchiolar Adenoma                    10 (20%)      9 (18%)      6 (12%)                                            
      Hepatocellular Carcinoma, Metastatic, Liver      2 (4%)                    1 (2%)                                             
   Nose                                               (50)         (50)         (49)                                                
      Hemangiosarcoma                                               1 (2%)                                                          
____________________________________________________________________________________________________________________________________
 SPECIAL SENSES SYSTEM                                                                                                              
   Harderian Gland                                    (9)          (48)                                                             
      Adenoma                                          8 (89%)      1 (2%)                                                          
____________________________________________________________________________________________________________________________________
 URINARY SYSTEM                                                                                                                     
   Kidney                                             (50)         (50)         (50)                                                
      Adenoma                                                       1 (2%)                                                          
   Urinary Bladder                                    (50)         (48)         (48)                                                
____________________________________________________________________________________________________________________________________
 SYSTEMIC LESIONS                                                                                                                   
   Multiple Organs                                   *(50)        *(50)        *(50)                                                
      Lymphoma Malignant Histiocytic                                1 (2%)       1 (2%)                                             
      Lymphoma Malignant Lymphocytic                   1 (2%)                                                                       
      Lymphoma Malignant Mixed                         2 (4%)       2 (4%)                                                          
      Lymphoma Malignant Undifferentiated Cell         1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
     *   Number of animals with any tissue examined microscopically                                                                 
                                                             Page   9                                                               
NTP Experiment-Test: 05002-06  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                                        GAMMA-BUTYROLACTONE                                    Date: 09/02/94  
Route: GAVAGE                                                                                                     Time: 19:44:38  
____________________________________________________________________________________________________________________________________
         B6C3F1 MICE MALE                          VEHICLE      262.         525.                                                   
                                                   CONTROL      MG/KG        MG/KG                                                  
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY                                                                                                                       
   Total Animals with Primary Neoplasms (b)            40          31          23                                                   
     Total Primary Neoplasms                           77          48          33                                                   
   Total Animals with Benign Neoplasms                 25          26          12                                                   
     Total Benign Neoplasms                            41          31          15                                                   
   Total Animals with Malignant Neoplasms              29          12          16                                                   
     Total Malignant Neoplasms                         36          17          18                                                   
   Total Animals with Metastatic Neoplasms              3                       2                                                   
     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  10                                                               
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