National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/11425

TDMS Study 99039-02 Pathology Tables

NTP Experiment-Test: 99039-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18
Study Type: 26-39 WEEKS                              WITH AVERAGE SEVERITY GRADES[b]                              Date: 02/21/03
Route: DOSED FEED                            TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)               Time: 10:33:21

                                                      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
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)

                                                              Page   1


NTP Experiment-Test: 99039-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: 26-39 WEEKS                              WITH AVERAGE SEVERITY GRADES[b]                              Date: 02/21/03    
Route: DOSED FEED                            TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)               Time: 10:33:21    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         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 [1.0]                                1 [1.0]                               
      Inflammation, Chronic Active                     6 [1.2]                                7 [1.0]                               
      Hepatocyte, Necrosis, Focal                      1 [1.0]                                                                      
   Salivary Glands                                    (15)                                   (14)                                   
      Infiltration Cellular, Focal, Lymphocyte        10 [1.1]                                9 [1.3]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (15)                                   (14)                                   
      Hyperplasia, Focal                               2 [1.0]                                2 [1.5]                               
      Subcapsular, Hyperplasia, Focal                 13 [1.2]                               12 [1.1]                               
   Thyroid Gland                                      (15)                                   (14)                                   
      Ectopic Thymus                                                                          1 [1.0]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                                                                                                    
                                                             Page    2                                                              
                                                                                                                                   
NTP Experiment-Test: 99039-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: 26-39 WEEKS                              WITH AVERAGE SEVERITY GRADES[b]                              Date: 02/21/03    
Route: DOSED FEED                            TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)               Time: 10:33:21    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         P53+/-(C57BL/6) FEMALE                       VEHICLE      0.3 %        1.0 %        3.0 %                                  
                                                      CONTROL                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
GENITAL SYSTEM - CONT                                                                                                               
   Uterus                                             (15)                      (1)          (14)                                   
      Endometrium, Hyperplasia, Cystic                13 [1.8]                   1 [4.0]     13 [1.3]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Lymph Node, Mandibular                             (15)                                   (14)                                   
      Hyperplasia                                      1 [2.0]                                                                      
   Spleen                                             (15)                                   (14)                                   
      Hematopoietic Cell Proliferation                 2 [2.0]                                1 [1.0]                               
   Thymus                                             (15)                                   (14)                                   
      Atrophy                                          6 [1.0]                                2 [1.0]                               
      Atrophy, Diffuse                                 1 [4.0]                                                                      
      Atrophy, Focal                                                                          4 [1.0]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (15)                      (1)          (13)                                   
      Inflammation, Acute                              1 [2.0]                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (15)                                   (15)                                   
      Infiltration Cellular, Lymphocyte                1 [1.0]                                1 [2.0]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Harderian Gland                                    (15)                                   (14)                                   
      Inflammation, Chronic Active                     1 [1.0]                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                                                                                                    
                                                             Page    3                                                              
                                                                                                                                   
NTP Experiment-Test: 99039-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: 26-39 WEEKS                              WITH AVERAGE SEVERITY GRADES[b]                              Date: 02/21/03    
Route: DOSED FEED                            TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)               Time: 10:33:21    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         P53+/-(C57BL/6) FEMALE                       VEHICLE      0.3 %        1.0 %        3.0 %                                  
                                                      CONTROL                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (15)                                   (14)                                   
      Inflammation, Chronic Active                                                            1 [2.0]                               
      Renal Tubule, Dilatation, Focal                  6 [1.0]                                2 [1.0]                               
      Renal Tubule, Nephropathy                        1 [1.0]                                                                      
   Urinary Bladder                                    (14)                                   (14)                                   
      Infiltration Cellular, Focal, Lymphocyte                                                1 [1.0]                               
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page    4                                                              
                                                                                                                                   
NTP Experiment-Test: 99039-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: 26-39 WEEKS                              WITH AVERAGE SEVERITY GRADES[b]                              Date: 02/21/03    
Route: DOSED FEED                            TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)               Time: 10:33:21    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         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 [1.0]                                5 [1.0]                               
      Hepatocyte, Inflammation, Chronic Active         1 [1.0]                                                                      
      Hepatocyte, Necrosis, Focal                      1 [1.0]                                                                      
      Hepatocyte, Centrilobular, Hypertrophy                                                  1 [1.0]                               
   Mesentery                                          (1)                                    (1)                                    
      Fat, Inflammation, Chronic Active, Focal         1 [2.0]                                                                      
      Fat, Necrosis, Focal                                                                    1 [4.0]                               
   Salivary Glands                                    (15)                                   (15)                                   
      Infiltration Cellular, Focal, Lymphocyte        10 [1.1]                                8 [1.1]                               
   Tongue                                             (15)                                   (15)                                   
      Inflammation                                     1 [2.0]                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (15)                                   (15)                                   
      Hypertrophy, Focal                                                                      1 [2.0]                               
      Capsule, Inflammation, Chronic Active,                                                                                        
        Diffuse                                        1 [2.0]                                                                      
      Subcapsular, Hyperplasia, Focal                  1 [1.0]                                1 [1.0]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                                                                                                    
                                                             Page    5                                                              
                                                                                                                                   
NTP Experiment-Test: 99039-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: 26-39 WEEKS                              WITH AVERAGE SEVERITY GRADES[b]                              Date: 02/21/03    
Route: DOSED FEED                            TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)               Time: 10:33:21    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         P53+/-(C57BL/6) MALE                         VEHICLE      0.3 %        1.0 %        3.0 %                                  
                                                      CONTROL                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (15)                                   (15)                                   
      Infiltration Cellular, Lymphocyte                1 [2.0]                                                                      
      Polyarteritis                                                                           1 [2.0]                               
      Epithelium, Degeneration, Focal                  1 [2.0]                                                                      
   Testes                                             (15)                                   (15)                                   
      Mineralization, Focal                            1 [1.0]                                                                      
      Sertoli Cell, Germinal Epithelium,                                                                                            
        Degeneration, Focal                            1 [2.0]                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Lymph Node                                                                                (1)                                    
      Inguinal, Hyperplasia                                                                   1 [2.0]                               
   Lymph Node, Mandibular                             (15)                                   (15)                                   
      Hyperplasia                                                                             2 [2.0]                               
   Lymph Node, Mediastinal                            (1)                                                                           
      Edema                                            1 [2.0]                                                                      
      Inflammation, Chronic Active, Diffuse            1 [3.0]                                                                      
   Spleen                                             (15)                                   (15)                                   
      Hematopoietic Cell Proliferation                 1 [2.0]                                1 [1.0]                               
   Thymus                                             (15)                                   (14)                                   
      Atrophy                                          2 [1.0]                                2 [1.0]                               
      Atrophy, Focal                                                                          1 [1.0]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (15)                      (1)          (15)                                   
      Subcutaneous Tissue, Inflammation, Chronic                                                                                    
        Active, Focal                                  1 [1.0]                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page    6                                                              
                                                                                                                                   
NTP Experiment-Test: 99039-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: 26-39 WEEKS                              WITH AVERAGE SEVERITY GRADES[b]                              Date: 02/21/03    
Route: DOSED FEED                            TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)               Time: 10:33:21    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         P53+/-(C57BL/6) MALE                         VEHICLE      0.3 %        1.0 %        3.0 %                                  
                                                      CONTROL                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (15)                                   (15)                                   
      Inflammation, Chronic Active                     1 [2.0]                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (15)                                   (15)                                   
      Alveolar Epithelium, Inflammation, Chronic                                                                                    
        Active, Focal                                  1 [1.0]                                1 [1.0]                               
   Nose                                               (15)                                   (15)                                   
      Inflammation, Chronic Active                     1 [2.0]                                                                      
      Inflammation, Granulomatous                      1 [2.0]                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Harderian Gland                                    (15)                                   (15)                                   
      Infiltration Cellular, Lymphocyte                                                       1 [1.0]                               
      Inflammation, Chronic Active                     4 [1.3]                                2 [1.0]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (15)                                   (15)                                   
      Inflammation, Chronic Active                     1 [2.0]                                                                      
      Renal Tubule, Dilatation, Focal                  1 [2.0]                                2 [1.0]                               
      Renal Tubule, Nephropathy                        1 [1.0]                                                                      
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
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