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TDMS Study 99039-01 Pathology Tables

NTP Experiment-Test: 99039-01         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: 10:21:47

                                                       FINAL#3/TG.AC 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 001    VEHICLE CONTROL
                               Include 002    0.3%
                               Include 003    1.0 %
                               Include 004    3.0 %
                               Include 006    VEHICLE CONTROL
                               Include 007    0.3 %
                               Include 008    1.0%
                               Include 009    3.0%



























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

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NTP Experiment-Test: 99039-01         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: 10:21:47    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS FEMALE            VEHICLE      0.3 %        1.0%         3.0%                                      
                                                   CONTROL                                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially In Study                          15           15           15           15                                     
  Early Deaths                                                                                                                      
    Moribund Sacrifice                                 1                         2            2                                     
    Natural Death                                      2            3            1            1                                     
  Survivors                                                                                                                         
    Accidently Killed                                  4            3            1                                                  
    Terminal Sacrifice                                 8            9           11           12                                     
                                                                                                                                    
  Animals Examined Microscopically                    15           14           14           15                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Liver                                              (15)         (2)                       (15)                                   
      Inflammation, Chronic                            2 (13%)                                3 (20%)                               
      Necrosis, Focal                                  1 (7%)                                                                       
      Tension Lipidosis, Focal                                                                1 (7%)                                
      Hepatocyte, Inflammation, Chronic                1 (7%)                                                                       
      Hepatocyte, Necrosis, Focal                      2 (13%)                                3 (20%)                               
   Mesentery                                          (2)                       (1)                                                 
      Fat, Inflammation, Acute, Focal                                            1 (100%)                                           
      Fat, Necrosis, Focal                             2 (100%)                                                                     
   Tongue                                             (15)         (1)                       (15)                                   
      Ulcer                                            1 (7%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (14)         (1)                       (15)                                   
      Subcapsular, Hyperplasia, Focal                  9 (64%)                                6 (40%)                               
      Zona Reticularis, Vacuolization Cytoplasmic      9 (64%)                               10 (67%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    2                                                              
                                                                                                                                   
NTP Experiment-Test: 99039-01         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: 10:21:47    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS FEMALE            VEHICLE      0.3 %        1.0%         3.0%                                      
                                                   CONTROL                                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Uterus                                             (13)         (2)          (1)          (14)                                   
      Endometrium, Hyperplasia, Cystic                 7 (54%)      2 (100%)     1 (100%)    10 (71%)                               
   Vagina                                             (13)                                   (15)                                   
      Hyperplasia                                      1 (8%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Lymph Node, Mandibular                             (12)         (1)                       (15)                                   
      Hyperplasia                                      1 (8%)                                 3 (20%)                               
   Spleen                                             (15)                      (3)          (15)                                   
      Hematopoietic Cell Proliferation                12 (80%)                   3 (100%)    13 (87%)                               
      Pigmentation                                     3 (20%)                                2 (13%)                               
   Thymus                                             (11)         (1)                       (14)                                   
      Atrophy, Diffuse                                 1 (9%)                                 1 (7%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (14)         (2)          (1)          (15)                                   
      Mandible, Inflammation, Chronic Active                        1 (50%)                   1 (7%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (15)                                   (15)                                   
      Hemorrhage, Focal                                                                       1 (7%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    3                                                              
                                                                                                                                   
NTP Experiment-Test: 99039-01         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: 10:21:47    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS FEMALE            VEHICLE      0.3 %        1.0%         3.0%                                      
                                                   CONTROL                                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
SPECIAL SENSES SYSTEM - CONT                                                                                                        
   Eye                                                (13)                                   (14)                                   
      Retina, Atrophy                                 13 (100%)                              14 (100%)                              
   Harderian Gland                                    (14)         (1)                       (15)                                   
      Infiltration Cellular, Focal, Lymphocyte         1 (7%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (15)         (1)                       (15)                                   
      Renal Tubule, Dilatation, Focal                                                         1 (7%)                                
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page    4                                                              
                                                                                                                                   
NTP Experiment-Test: 99039-01         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: 10:21:47    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS MALE              VEHICLE      0.3%         1.0 %        3.0 %                                     
                                                   CONTROL                                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially In Study                          15           15           15           15                                     
  Early Deaths                                                                                                                      
    Moribund Sacrifice                                 2            4            2            1                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                 6            9            7           11                                     
    Accidently Killed                                  7            2            6            3                                     
                                                                                                                                    
  Animals Examined Microscopically                    15           15           15           15                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Liver                                              (15)                      (1)          (15)                                   
      Hematopoietic Cell Proliferation                 1 (7%)                                                                       
      Inflammation, Chronic                            1 (7%)                                                                       
      Hepatocyte, Necrosis, Focal                      1 (7%)                                                                       
   Mesentery                                          (2)                                    (2)                                    
      Fat, Necrosis, Focal                             2 (100%)                               2 (100%)                              
   Pancreas                                           (15)                                   (15)                                   
      Inflammation, Chronic Active                     1 (7%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (14)                                   (15)                                   
      Atrophy                                         10 (71%)                               11 (73%)                               
      Hypertrophy, Focal                               9 (64%)                                5 (33%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Preputial Gland                                    (15)                      (1)          (15)                                   
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    5                                                              
                                                                                                                                   
NTP Experiment-Test: 99039-01         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: 10:21:47    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS MALE              VEHICLE      0.3%         1.0 %        3.0 %                                     
                                                   CONTROL                                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
GENITAL SYSTEM - CONT                                                                                                               
      Cyst                                             1 (7%)                    1 (100%)                                           
   Testes                                             (15)                                   (15)                                   
      Germinal Epithelium, Degeneration, Focal         1 (7%)                                 1 (7%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (15)                                   (15)                                   
      Hyperplasia                                                                             1 (7%)                                
   Lymph Node, Mandibular                             (14)                                   (15)                                   
      Hyperplasia                                      2 (14%)                                2 (13%)                               
   Spleen                                             (15)         (1)          (1)          (15)                                   
      Atrophy                                          1 (7%)                                                                       
      Hematopoietic Cell Proliferation                10 (67%)      1 (100%)                  7 (47%)                               
   Thymus                                             (15)                                   (14)                                   
      Atrophy, Diffuse                                 3 (20%)                                2 (14%)                               
      Atrophy, Focal                                   2 (13%)                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (15)         (7)          (8)          (15)                                   
      Sebaceous Gland, Hyperplasia, Focal              1 (7%)                                                                       
      Subcutaneous Tissue, Pinna, Inflammation,                                                                                     
         Acute, Focal                                               1 (14%)                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (15)         (15)         (15)         (15)                                   
      Alveolar Epithelium, Alveolus, Inflammation,                                                                                  
         Chronic Active, Focal                                                                1 (7%)                                
   Nose                                               (15)                                   (15)                                   
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    6                                                              
                                                                                                                                   
NTP Experiment-Test: 99039-01         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: 10:21:47    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS MALE              VEHICLE      0.3%         1.0 %        3.0 %                                     
                                                   CONTROL                                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
RESPIRATORY SYSTEM - CONT                                                                                                           
      Glands, Hyperplasia                              1 (7%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (15)                                   (15)                                   
      Retina, Atrophy                                 15 (100%)                              14 (93%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (15)         (1)                       (15)                                   
      Infiltration Cellular, Plasma Cell                            1 (100%)                                                        
      Renal Tubule, Dilatation, Diffuse                                                       1 (7%)                                
      Renal Tubule, Dilatation, Focal                                                         2 (13%)                               
   Urinary Bladder                                    (15)                                   (15)                                   
      Edema                                            1 (7%)                                                                       
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
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