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TDMS Study 99033-03 Pathology Tables

NTP Experiment-Test: 99033-03  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: SUBCHRON 26-WEEK                    TRANSGENIC MODEL EVALUATION II (ASPARTAME)                        Date: 03/05/03
Route: DOSED FEED                                                                                                 Time: 11:41:46

                                                      FINAL #3 TG:P16 MICE




       Facility:  BIORELIANCE

       Chemical CAS #:  22839-47-0

       Lock Date:  07/20/01

       Cage Range:  All

       Reasons For Removal:    All

       Removal Date Range:     All

       Treatment Groups:       Include All


































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

                                                              Page   1


NTP Experiment-Test: 99033-03  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: SUBCHRON 26-WEEK                    TRANSGENIC MODEL EVALUATION II (ASPARTAME)                        Date: 03/05/03  
Route: DOSED FEED                                                                                                 Time: 11:41:46  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         P16(INK4A)/(+/-) (C57BL/6) FEMALE         VEHICLE      3125 PPM     6250 PPM     12500        25000        50000           
                                                   CONTROL                                PPM          PPM          PPM             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially in Study                          15           15           15           15           15           15           
  Early Deaths                                                                                                                      
    Natural Death                                      2                         2                                                  
    Moribund Sacrifice                                                                                                  1           
  Survivors                                                                                                                         
    Terminal Sacrifice                                13           15           13           15           15           14           
                                                                                                                                    
  Animals Examined Microscopically                    15           15           15           15           15           15           
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Gallbladder                                        (12)         (1)                                                 (14)         
      Histiocytic Sarcoma                                           1 (100%)                                                        
   Intestine Large, Cecum                             (13)                      (1)                                    (15)         
      Leiomyoma                                                                  1 (100%)                                           
   Liver                                              (15)         (15)         (15)         (15)         (15)         (15)         
      Histiocytic Sarcoma                              2 (13%)      1 (7%)       1 (7%)                                 2 (13%)     
   Pancreas                                           (15)         (1)                                                 (15)         
      Histiocytic Sarcoma                                           1 (100%)                                            1 (7%)      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (15)         (15)         (15)         (15)         (15)         (15)         
      Hemangiosarcoma                                                            1 (7%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Medulla                                    (15)         (15)         (13)         (13)         (15)         (15)         
      Histiocytic Sarcoma                                                                                               1 (7%)      
   Pituitary Gland                                    (10)         (13)         (13)         (12)         (11)         (12)         
      Adenoma                                                       1 (8%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   2                                                               
                                                                                                                                   
NTP Experiment-Test: 99033-03  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: SUBCHRON 26-WEEK                    TRANSGENIC MODEL EVALUATION II (ASPARTAME)                        Date: 03/05/03  
Route: DOSED FEED                                                                                                 Time: 11:41:46  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         P16(INK4A)/(+/-) (C57BL/6) FEMALE         VEHICLE      3125 PPM     6250 PPM     12500        25000        50000           
                                                   CONTROL                                PPM          PPM          PPM             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Ovary                                              (15)         (15)         (15)         (15)         (15)         (15)         
      Histiocytic Sarcoma                              3 (20%)      2 (13%)      2 (13%)      2 (13%)      2 (13%)      2 (13%)     
   Uterus                                             (15)         (15)         (15)         (15)         (15)         (15)         
      Histiocytic Sarcoma                                           1 (7%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (15)                                                             (15)         
      Histiocytic Sarcoma                              4 (27%)                                                          3 (20%)     
   Lymph Node, Mandibular                             (14)         (15)         (13)         (15)         (15)         (15)         
      Histiocytic Sarcoma                              1 (7%)                                                                       
   Lymph Node, Mesenteric                             (14)         (15)         (14)         (15)         (15)         (14)         
      Histiocytic Sarcoma                              1 (7%)                                                                       
   Lymph Node, Mediastinal                            (14)         (15)         (12)         (13)         (12)         (12)         
      Histiocytic Sarcoma                              1 (7%)                                                                       
   Spleen                                             (15)         (15)         (14)         (15)         (15)         (15)         
      Hemangiosarcoma                                                            1 (7%)                                             
      Histiocytic Sarcoma                              1 (7%)                                                           2 (13%)     
   Thymus                                             (14)         (15)         (14)         (14)         (15)         (15)         
      Histiocytic Sarcoma                              1 (7%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (13)         (15)         (15)         (15)         (15)         (15)         
      Hemangiosarcoma                                                                                                   1 (7%)      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (15)         (14)         (14)         (15)         (15)         (15)         
      Meninges, Histiocytic Sarcoma                                                                                     1 (7%)      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   3                                                               
                                                                                                                                   
NTP Experiment-Test: 99033-03  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: SUBCHRON 26-WEEK                    TRANSGENIC MODEL EVALUATION II (ASPARTAME)                        Date: 03/05/03  
Route: DOSED FEED                                                                                                 Time: 11:41:46  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         P16(INK4A)/(+/-) (C57BL/6) FEMALE         VEHICLE      3125 PPM     6250 PPM     12500        25000        50000           
                                                   CONTROL                                PPM          PPM          PPM             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (15)         (14)         (14)         (15)         (15)         (15)         
      Alveolar/Bronchiolar Adenoma                     1 (7%)                                                                       
      Alveolar/Bronchiolar Carcinoma                                                                                    1 (7%)      
      Histiocytic Sarcoma                              1 (7%)                    1 (7%)                                 2 (13%)     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Harderian Gland                                    (15)                                                             (15)         
      Adenoma                                                                                                           1 (7%)      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SYSTEMIC LESIONS                                                                                                                   
                                                                                                                                    
   Multiple Organs                                   *(15)        *(15)        *(15)        *(15)        *(15)        *(15)         
      Histiocytic Sarcoma                              5 (33%)      2 (13%)      2 (13%)      2 (13%)      2 (13%)      3 (20%)     
      Leukemia Erythrocytic                                                                                1 (7%)                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
     *   Number of animals with any tissue examined microscopically                                                                 
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   4                                                               
                                                                                                                                   
NTP Experiment-Test: 99033-03  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: SUBCHRON 26-WEEK                    TRANSGENIC MODEL EVALUATION II (ASPARTAME)                        Date: 03/05/03  
Route: DOSED FEED                                                                                                 Time: 11:41:46  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         P16(INK4A)/(+/-) (C57BL/6) FEMALE         VEHICLE      3125 PPM     6250 PPM     12500        25000        50000           
                                                   CONTROL                                PPM          PPM          PPM             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
TUMOR SUMMARY                                                                                                                       
                                                                                                                                    
   Total Animals with Primary Neoplasms (b)             6           3           5           2           3           6               
     Total Primary Neoplasms                            6           3           5           2           3           6               
                                                                                                                                    
   Total Animals with Benign Neoplasms                  1           1           1                                   1               
     Total Benign Neoplasms                             1           1           1                                   1               
                                                                                                                                    
   Total Animals with Malignant Neoplasms               5           2           4           2           3           5               
     Total Malignant Neoplasms                          5           2           4           2           3           5               
                                                                                                                                    
   Total Animals with Metastatic Neoplasms                                                                                          
     Total Metastatic Neoplasm                                                                                                      
                                                                                                                                    
   Total Animals with Malignant Neoplasms                                                                                           
   Uncertain Primary Site                                                                                                           
                                                                                                                                    
   Total Animals with Neoplasms Uncertain-                                                                                          
   Benign or Malignant                                                                                                              
     Total Uncertain Neoplasms                                                                                                      
                                                                                                                                    
                                                                                                                                    
____________________________________________________________________________________________________________________________________
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Primary tumors: all tumors except metastatic tumors                                                                              
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   5                                                               
                                                                                                                                   
NTP Experiment-Test: 99033-03  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: SUBCHRON 26-WEEK                    TRANSGENIC MODEL EVALUATION II (ASPARTAME)                        Date: 03/05/03  
Route: DOSED FEED                                                                                                 Time: 11:41:46  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         P16(INK4A)/(+/-) (C57BL/6) MALE           VEHICLE      3125 PPM     6250 PPM     12500        25000        50000           
                                                   CONTROL                                PPM          PPM          PPM             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially in Study                          15           15           15           15           15           15           
  Early Deaths                                                                                                                      
    Natural Death                                      1            1                         1            1                        
  Survivors                                                                                                                         
    Terminal Sacrifice                                14           14           15           14           14           15           
                                                                                                                                    
  Animals Examined Microscopically                    15           15           15           15           15           15           
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Liver                                              (15)         (15)         (15)         (14)         (15)         (15)         
      Histiocytic Sarcoma                                           1 (7%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (15)         (15)         (15)         (15)         (15)         (15)         
      Histiocytic Sarcoma                                           1 (7%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   6                                                               
                                                                                                                                   
NTP Experiment-Test: 99033-03  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: SUBCHRON 26-WEEK                    TRANSGENIC MODEL EVALUATION II (ASPARTAME)                        Date: 03/05/03  
Route: DOSED FEED                                                                                                 Time: 11:41:46  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         P16(INK4A)/(+/-) (C57BL/6) MALE           VEHICLE      3125 PPM     6250 PPM     12500        25000        50000           
                                                   CONTROL                                PPM          PPM          PPM             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (15)                                                             (15)         
      Histiocytic Sarcoma                              2 (13%)                                                                      
   Lymph Node, Mandibular                             (15)         (15)         (15)         (14)         (14)         (15)         
      Histiocytic Sarcoma                                           1 (7%)                                                          
   Lymph Node, Mesenteric                             (15)         (15)         (15)         (14)         (14)         (15)         
      Histiocytic Sarcoma                                           1 (7%)                                                          
   Spleen                                             (15)         (15)         (15)         (14)         (15)         (15)         
      Hemangiosarcoma                                               1 (7%)                                                          
      Histiocytic Sarcoma                                           1 (7%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (15)         (15)         (15)         (15)         (15)         (15)         
      Alveolar/Bronchiolar Adenoma                                                            1 (7%)                    1 (7%)      
      Histiocytic Sarcoma                                           1 (7%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   7                                                               
                                                                                                                                   
NTP Experiment-Test: 99033-03  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: SUBCHRON 26-WEEK                    TRANSGENIC MODEL EVALUATION II (ASPARTAME)                        Date: 03/05/03  
Route: DOSED FEED                                                                                                 Time: 11:41:46  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         P16(INK4A)/(+/-) (C57BL/6) MALE           VEHICLE      3125 PPM     6250 PPM     12500        25000        50000           
                                                   CONTROL                                PPM          PPM          PPM             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (15)         (15)         (15)         (14)         (15)         (15)         
      Histiocytic Sarcoma                                           1 (7%)                                                          
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SYSTEMIC LESIONS                                                                                                                   
                                                                                                                                    
   Multiple Organs                                   *(15)        *(15)        *(15)        *(15)        *(15)        *(15)         
      Histiocytic Sarcoma                              2 (13%)      1 (7%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
     *   Number of animals with any tissue examined microscopically                                                                 
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   8                                                               
                                                                                                                                   
NTP Experiment-Test: 99033-03  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: SUBCHRON 26-WEEK                    TRANSGENIC MODEL EVALUATION II (ASPARTAME)                        Date: 03/05/03  
Route: DOSED FEED                                                                                                 Time: 11:41:46  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         P16(INK4A)/(+/-) (C57BL/6) MALE           VEHICLE      3125 PPM     6250 PPM     12500        25000        50000           
                                                   CONTROL                                PPM          PPM          PPM             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
TUMOR SUMMARY                                                                                                                       
                                                                                                                                    
   Total Animals with Primary Neoplasms (b)             2           2                       1                       1               
     Total Primary Neoplasms                            2           2                       1                       1               
                                                                                                                                    
   Total Animals with Benign Neoplasms                                                      1                       1               
     Total Benign Neoplasms                                                                 1                       1               
                                                                                                                                    
   Total Animals with Malignant Neoplasms               2           2                                                               
     Total Malignant Neoplasms                          2           2                                                               
                                                                                                                                    
   Total Animals with Metastatic Neoplasms                                                                                          
     Total Metastatic Neoplasm                                                                                                      
                                                                                                                                    
   Total Animals with Malignant Neoplasms                                                                                           
   Uncertain Primary Site                                                                                                           
                                                                                                                                    
   Total Animals with Neoplasms Uncertain-                                                                                          
   Benign or Malignant                                                                                                              
     Total Uncertain Neoplasms                                                                                                      
                                                                                                                                    
                                                                                                                                    
____________________________________________________________________________________________________________________________________
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Primary tumors: all tumors except metastatic tumors                                                                              
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   9                                                               
                                                                                                                                   
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                             ----------              END OF REPORT             ----------                                           
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