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TDMS Study 99039-02 Pathology Tables

NTP Experiment-Test: 99039-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: 26-39 WEEKS                    TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)                 Date: 02/21/03
Route: DOSED FEED                                                                                                 Time: 10:29:10

                                                      FINAL#3/P53 +/- MICE




       Facility:  BIORELIANCE

       Chemical CAS #:  55589-62-3

       Lock Date:  07/20/01

       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: 99039-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: 26-39 WEEKS                    TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)                 Date: 02/21/03    
Route: DOSED FEED                                                                                                 Time: 10:29:10    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         P53+/-(C57BL/6) FEMALE                    VEHICLE      0.3 %        1.0 %        3.0 %                                     
                                                   CONTROL                                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially In Study                          15           15           15           15                                     
  Early Deaths                                                                                                                      
    Moribund Sacrifice                                 1                         1                                                  
    Natural Death                                                   1                         1                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                11           14           14           13                                     
    Accidently Killed                                  3                                      1                                     
                                                                                                                                    
  Animals Examined Microscopically                    15            1            2           15                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Liver                                              (15)                                   (14)                                   
      Infiltration Cellular, Focal, Lymphocyte         2 (13%)                                1 (7%)                                
      Inflammation, Chronic Active                     6 (40%)                                7 (50%)                               
      Hepatocyte, Necrosis, Focal                      1 (7%)                                                                       
   Salivary Glands                                    (15)                                   (14)                                   
      Infiltration Cellular, Focal, Lymphocyte        10 (67%)                                9 (64%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (15)                                   (14)                                   
      Hyperplasia, Focal                               2 (13%)                                2 (14%)                               
      Subcapsular, Hyperplasia, Focal                 13 (87%)                               12 (86%)                               
   Thyroid Gland                                      (15)                                   (14)                                   
      Ectopic Thymus                                                                          1 (7%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    2                                                              
                                                                                                                                   
NTP Experiment-Test: 99039-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: 26-39 WEEKS                    TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)                 Date: 02/21/03    
Route: DOSED FEED                                                                                                 Time: 10:29:10    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         P53+/-(C57BL/6) FEMALE                    VEHICLE      0.3 %        1.0 %        3.0 %                                     
                                                   CONTROL                                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
GENITAL SYSTEM - CONT                                                                                                               
   Uterus                                             (15)                      (1)          (14)                                   
      Endometrium, Hyperplasia, Cystic                13 (87%)                   1 (100%)    13 (93%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Lymph Node, Mandibular                             (15)                                   (14)                                   
      Hyperplasia                                      1 (7%)                                                                       
   Spleen                                             (15)                                   (14)                                   
      Hematopoietic Cell Proliferation                 2 (13%)                                1 (7%)                                
   Thymus                                             (15)                                   (14)                                   
      Atrophy                                          6 (40%)                                2 (14%)                               
      Atrophy, Diffuse                                 1 (7%)                                                                       
      Atrophy, Focal                                                                          4 (29%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (15)                      (1)          (13)                                   
      Inflammation, Acute                              1 (7%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (15)                                   (15)                                   
      Infiltration Cellular, Lymphocyte                1 (7%)                                 1 (7%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Harderian Gland                                    (15)                                   (14)                                   
      Inflammation, Chronic Active                     1 (7%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    3                                                              
                                                                                                                                   
NTP Experiment-Test: 99039-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: 26-39 WEEKS                    TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)                 Date: 02/21/03    
Route: DOSED FEED                                                                                                 Time: 10:29:10    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         P53+/-(C57BL/6) FEMALE                    VEHICLE      0.3 %        1.0 %        3.0 %                                     
                                                   CONTROL                                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (15)                                   (14)                                   
      Inflammation, Chronic Active                                                            1 (7%)                                
      Renal Tubule, Dilatation, Focal                  6 (40%)                                2 (14%)                               
      Renal Tubule, Nephropathy                        1 (7%)                                                                       
   Urinary Bladder                                    (14)                                   (14)                                   
      Infiltration Cellular, Focal, Lymphocyte                                                1 (7%)                                
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page    4                                                              
                                                                                                                                   
NTP Experiment-Test: 99039-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: 26-39 WEEKS                    TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)                 Date: 02/21/03    
Route: DOSED FEED                                                                                                 Time: 10:29:10    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         P53+/-(C57BL/6) MALE                      VEHICLE      0.3 %        1.0 %        3.0 %                                     
                                                   CONTROL                                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially In Study                          15           15           15           15                                     
  Early Deaths                                                                                                                      
    Moribund Sacrifice                                 1                                      1                                     
  Survivors                                                                                                                         
    Accidently Killed                                  3                         1                                                  
    Terminal Sacrifice                                11           15           14           14                                     
                                                                                                                                    
  Animals Examined Microscopically                    15                         1           15                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Liver                                              (15)                                   (15)                                   
      Inflammation, Chronic Active                     1 (7%)                                 5 (33%)                               
      Hepatocyte, Inflammation, Chronic Active         1 (7%)                                                                       
      Hepatocyte, Necrosis, Focal                      1 (7%)                                                                       
      Hepatocyte, Centrilobular, Hypertrophy                                                  1 (7%)                                
   Mesentery                                          (1)                                    (1)                                    
      Fat, Inflammation, Chronic Active, Focal         1 (100%)                                                                     
      Fat, Necrosis, Focal                                                                    1 (100%)                              
   Salivary Glands                                    (15)                                   (15)                                   
      Infiltration Cellular, Focal, Lymphocyte        10 (67%)                                8 (53%)                               
   Tongue                                             (15)                                   (15)                                   
      Inflammation                                     1 (7%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (15)                                   (15)                                   
      Hypertrophy, Focal                                                                      1 (7%)                                
      Capsule, Inflammation, Chronic Active,                                                                                        
        Diffuse                                        1 (7%)                                                                       
      Subcapsular, Hyperplasia, Focal                  1 (7%)                                 1 (7%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    5                                                              
                                                                                                                                   
NTP Experiment-Test: 99039-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: 26-39 WEEKS                    TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)                 Date: 02/21/03    
Route: DOSED FEED                                                                                                 Time: 10:29:10    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         P53+/-(C57BL/6) MALE                      VEHICLE      0.3 %        1.0 %        3.0 %                                     
                                                   CONTROL                                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (15)                                   (15)                                   
      Infiltration Cellular, Lymphocyte                1 (7%)                                                                       
      Polyarteritis                                                                           1 (7%)                                
      Epithelium, Degeneration, Focal                  1 (7%)                                                                       
   Testes                                             (15)                                   (15)                                   
      Mineralization, Focal                            1 (7%)                                                                       
      Sertoli Cell, Germinal Epithelium,                                                                                            
        Degeneration, Focal                            1 (7%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Lymph Node                                                                                (1)                                    
      Inguinal, Hyperplasia                                                                   1 (100%)                              
   Lymph Node, Mandibular                             (15)                                   (15)                                   
      Hyperplasia                                                                             2 (13%)                               
   Lymph Node, Mediastinal                            (1)                                                                           
      Edema                                            1 (100%)                                                                     
      Inflammation, Chronic Active, Diffuse            1 (100%)                                                                     
   Spleen                                             (15)                                   (15)                                   
      Hematopoietic Cell Proliferation                 1 (7%)                                 1 (7%)                                
   Thymus                                             (15)                                   (14)                                   
      Atrophy                                          2 (13%)                                2 (14%)                               
      Atrophy, Focal                                                                          1 (7%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (15)                      (1)          (15)                                   
      Subcutaneous Tissue, Inflammation, Chronic                                                                                    
        Active, Focal                                  1 (7%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                                                                                                    
                                                             Page    6                                                              
                                                                                                                                   
NTP Experiment-Test: 99039-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: 26-39 WEEKS                    TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)                 Date: 02/21/03    
Route: DOSED FEED                                                                                                 Time: 10:29:10    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         P53+/-(C57BL/6) MALE                      VEHICLE      0.3 %        1.0 %        3.0 %                                     
                                                   CONTROL                                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (15)                                   (15)                                   
      Inflammation, Chronic Active                     1 (7%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (15)                                   (15)                                   
      Alveolar Epithelium, Inflammation, Chronic                                                                                    
        Active, Focal                                  1 (7%)                                 1 (7%)                                
   Nose                                               (15)                                   (15)                                   
      Inflammation, Chronic Active                     1 (7%)                                                                       
      Inflammation, Granulomatous                      1 (7%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Harderian Gland                                    (15)                                   (15)                                   
      Infiltration Cellular, Lymphocyte                                                       1 (7%)                                
      Inflammation, Chronic Active                     4 (27%)                                2 (13%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (15)                                   (15)                                   
      Inflammation, Chronic Active                     1 (7%)                                                                       
      Renal Tubule, Dilatation, Focal                  1 (7%)                                 2 (13%)                               
      Renal Tubule, Nephropathy                        1 (7%)                                                                       
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page    7                                                              
                                                                                                                                   
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