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TDMS Study 99039-01 Pathology Tables

NTP Experiment-Test: 99039-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: 26-39 WEEKS                    TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)                 Date: 02/21/03
Route: DOSED FEED                                                                                                 Time: 10:22:02

                                                       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

                                                              Page   1


NTP Experiment-Test: 99039-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: 26-39 WEEKS                    TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)                 Date: 02/21/03  
Route: DOSED FEED                                                                                                 Time: 10:22:02  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         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)                                   
   Stomach, Forestomach                               (14)         (9)          (10)         (14)                                   
      Squamous Cell Papilloma                          7 (50%)      6 (67%)      9 (90%)      8 (57%)                               
      Squamous Cell Papilloma, Multiple                2 (14%)      1 (11%)                                                         
   Tongue                                             (15)         (1)                       (15)                                   
      Squamous Cell Carcinoma, Metastatic,                                                                                          
          Uncertain Primary Site                       1 (7%)                                                                       
   Tooth                                              (2)          (1)          (6)          (4)                                    
      Odontogenic Tumor                                2 (100%)                  6 (100%)     3 (75%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Pituitary Gland                                    (12)                                   (14)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   2                                                               
                                                                                                                                   
NTP Experiment-Test: 99039-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: 26-39 WEEKS                    TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)                 Date: 02/21/03  
Route: DOSED FEED                                                                                                 Time: 10:22:02  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS FEMALE            VEHICLE      0.3 %        1.0%         3.0%                                      
                                                   CONTROL                                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Uterus                                             (13)         (2)          (1)          (14)                                   
      Sarcoma Stromal                                                                         1 (7%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Spleen                                             (15)                      (3)          (15)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (15)         (5)          (6)          (15)                                   
      Squamous Cell Papilloma                          1 (7%)       2 (40%)      3 (50%)      1 (7%)                                
      Lip, Squamous Cell Papilloma                                               2 (33%)                                            
      Vulva, Squamous Cell Papilloma                   2 (13%)      2 (40%)      2 (33%)      3 (20%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (15)                                   (15)                                   
      Alveolar/Bronchiolar Adenoma                     1 (7%)                                 1 (7%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Harderian Gland                                    (14)         (1)                       (15)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   3                                                               
                                                                                                                                   
NTP Experiment-Test: 99039-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: 26-39 WEEKS                    TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)                 Date: 02/21/03  
Route: DOSED FEED                                                                                                 Time: 10:22:02  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS FEMALE            VEHICLE      0.3 %        1.0%         3.0%                                      
                                                   CONTROL                                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (15)         (1)                       (15)                                   
   Urinary Bladder                                    (13)                                   (15)                                   
      Transitional Epithelium, Papilloma                                                      1 (7%)                                
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SYSTEMIC LESIONS                                                                                                                   
                                                                                                                                    
   Multiple Organs                                   *(15)        *(14)        *(14)        *(15)                                   
      Leukemia Erythrocytic                            2 (13%)      1 (7%)                    1 (7%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
     *   Number of animals with any tissue examined microscopically                                                                 
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   4                                                               
                                                                                                                                   
NTP Experiment-Test: 99039-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: 26-39 WEEKS                    TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)                 Date: 02/21/03  
Route: DOSED FEED                                                                                                 Time: 10:22:02  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS FEMALE            VEHICLE      0.3 %        1.0%         3.0%                                      
                                                   CONTROL                                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
TUMOR SUMMARY                                                                                                                       
                                                                                                                                    
   Total Animals with Primary Neoplasms (b)            12          10          13          13                                       
     Total Primary Neoplasms                           17          12          22          19                                       
                                                                                                                                    
   Total Animals with Benign Neoplasms                 11           9          10          10                                       
     Total Benign Neoplasms                            13          11          16          14                                       
                                                                                                                                    
   Total Animals with Malignant Neoplasms               2           1                       2                                       
     Total Malignant Neoplasms                          2           1                       2                                       
                                                                                                                                    
   Total Animals with Metastatic Neoplasms              1                                                                           
     Total Metastatic Neoplasm                          1                                                                           
                                                                                                                                    
   Total Animals with Malignant Neoplasms               1                                                                           
   Uncertain Primary Site                                                                                                           
                                                                                                                                    
   Total Animals with Neoplasms Uncertain-                                                                                          
   Benign or Malignant                                  2                       6           3                                       
     Total Uncertain Neoplasms                          2                       6           3                                       
                                                                                                                                    
                                                                                                                                    
____________________________________________________________________________________________________________________________________
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Primary tumors: all tumors except metastatic tumors                                                                              
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   5                                                               
                                                                                                                                   
NTP Experiment-Test: 99039-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: 26-39 WEEKS                    TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)                 Date: 02/21/03  
Route: DOSED FEED                                                                                                 Time: 10:22:02  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         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)                                   
   Stomach, Forestomach                               (15)         (6)          (3)          (15)                                   
      Squamous Cell Papilloma                          5 (33%)      4 (67%)      2 (67%)      6 (40%)                               
   Tooth                                              (4)          (3)                       (2)                                    
      Odontogenic Tumor                                4 (100%)     3 (100%)                  1 (50%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Thyroid Gland                                      (15)                                   (15)                                   
      Adenoma                                          1 (7%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   6                                                               
                                                                                                                                   
NTP Experiment-Test: 99039-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: 26-39 WEEKS                    TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)                 Date: 02/21/03  
Route: DOSED FEED                                                                                                 Time: 10:22:02  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS MALE              VEHICLE      0.3%         1.0 %        3.0 %                                     
                                                   CONTROL                                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (15)                                   (15)                                   
   Spleen                                             (15)         (1)          (1)          (15)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (15)         (7)          (8)          (15)                                   
      Squamous Cell Papilloma                          1 (7%)       1 (14%)      2 (25%)      4 (27%)                               
      Dermis, Mast Cell Tumor Benign                   1 (7%)                                                                       
      Lip, Squamous Cell Papilloma                     2 (13%)      3 (43%)      5 (63%)      2 (13%)                               
      Pinna, Squamous Cell Papilloma                                             1 (13%)                                            
      Prepuce, Squamous Cell Papilloma                 1 (7%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (15)         (15)         (15)         (15)                                   
      Alveolar/Bronchiolar Adenoma                     1 (7%)       1 (7%)                    2 (13%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Harderian Gland                                    (15)                                   (15)                                   
      Adenoma                                                                                 1 (7%)                                
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   7                                                               
                                                                                                                                   
NTP Experiment-Test: 99039-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: 26-39 WEEKS                    TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)                 Date: 02/21/03  
Route: DOSED FEED                                                                                                 Time: 10:22:02  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS MALE              VEHICLE      0.3%         1.0 %        3.0 %                                     
                                                   CONTROL                                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 SYSTEMIC LESIONS                                                                                                                   
                                                                                                                                    
   Multiple Organs                                   *(15)        *(15)        *(15)        *(15)                                   
      Leukemia Erythrocytic                                                      1 (7%)       1 (7%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
     *   Number of animals with any tissue examined microscopically                                                                 
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   8                                                               
                                                                                                                                   
NTP Experiment-Test: 99039-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: 26-39 WEEKS                    TRANSGENIC MODEL EVALUATION II  (ACESULFAME POTASSIUM)                 Date: 02/21/03  
Route: DOSED FEED                                                                                                 Time: 10:22:02  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS MALE              VEHICLE      0.3%         1.0 %        3.0 %                                     
                                                   CONTROL                                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
TUMOR SUMMARY                                                                                                                       
                                                                                                                                    
   Total Animals with Primary Neoplasms (b)            12          10          10          10                                       
     Total Primary Neoplasms                           16          12          11          17                                       
                                                                                                                                    
   Total Animals with Benign Neoplasms                  9           8           9           9                                       
     Total Benign Neoplasms                            12           9          10          15                                       
                                                                                                                                    
   Total Animals with Malignant Neoplasms                                       1           1                                       
     Total Malignant Neoplasms                                                  1           1                                       
                                                                                                                                    
   Total Animals with Metastatic Neoplasms                                                                                          
     Total Metastatic Neoplasm                                                                                                      
                                                                                                                                    
   Total Animals with Malignant Neoplasms                                                                                           
   Uncertain Primary Site                                                                                                           
                                                                                                                                    
   Total Animals with Neoplasms Uncertain-                                                                                          
   Benign or Malignant                                  4           3                       1                                       
     Total Uncertain Neoplasms                          4           3                       1                                       
                                                                                                                                    
                                                                                                                                    
____________________________________________________________________________________________________________________________________
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Primary tumors: all tumors except metastatic tumors                                                                              
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   9                                                               
                                                                                                                                   
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