https://ntp.niehs.nih.gov/go/9532

TDMS Study 99033-03 Pathology Tables

NTP Experiment-Test: 99033-03               INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a)                     Report: PEIRPT02
Study Type: SPECIAL STUDY                       TRANSGENIC MODEL EVALUATION II(ASPARTAME)                         Date: 06/05/02
Route: DOSED FEED                                                                                                 Time: 11:51:20
                                                           FINAL/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 (a)                     Report: PEIRPT02
Study Type: SPECIAL STUDY                       TRANSGENIC MODEL EVALUATION II(ASPARTAME)                         Date: 06/05/02  
Route: DOSED FEED                                                                                                 Time: 11:51:20  
____________________________________________________________________________________________________________________________________
         MICE: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                             (14)                      (1)                                    (15)         
      Leiomyoma                                                                  1 (100%)                                           
   Liver                                              (15)         (15)         (15)         (15)         (15)         (15)         
      Histiocytic Sarcoma                              2 (13%)      1 (7%)       1 (7%)                                 2 (13%)     
      Leukemia Erythrocytic                                                                                1 (7%)                   
   Pancreas                                           (14)         (1)                                                 (15)         
      Histiocytic Sarcoma                                           1 (100%)                                            1 (7%)      
____________________________________________________________________________________________________________________________________
 CARDIOVASCULAR SYSTEM                                                                                                              
   Heart                                              (15)         (15)         (15)         (15)         (15)         (15)         
      Hemangiosarcoma                                                            1 (7%)                                             
____________________________________________________________________________________________________________________________________
 ENDOCRINE SYSTEM                                                                                                                   
   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 (a)                     Report: PEIRPT02
Study Type: SPECIAL STUDY                       TRANSGENIC MODEL EVALUATION II(ASPARTAME)                         Date: 06/05/02  
Route: DOSED FEED                                                                                                 Time: 11:51:20  
____________________________________________________________________________________________________________________________________
         MICE:P16(INK4A)/(+/-) (C57BL/6) FEMALE    VEHICLE      3125 PPM     6250 PPM     12500        25000        50000           
                                                   CONTROL                                PPM          PPM          PPM             
____________________________________________________________________________________________________________________________________
 GENITAL SYSTEM                                                                                                                     
   Ovary                                              (14)         (15)         (15)         (15)         (15)         (15)         
      Histiocytic Sarcoma                              2 (14%)      1 (7%)                                              2 (13%)     
   Uterus                                             (14)         (15)         (15)         (15)         (15)         (15)         
      Histiocytic Sarcoma                                           1 (7%)                                                          
____________________________________________________________________________________________________________________________________
 HEMATOPOIETIC SYSTEM                                                                                                               
   Bone Marrow                                        (14)                                                             (15)         
      Histiocytic Sarcoma                              4 (29%)                                                          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                                             (14)         (15)         (14)         (15)         (15)         (15)         
      Hemangiosarcoma                                                            1 (7%)                                             
      Histiocytic Sarcoma                              1 (7%)                                                           2 (13%)     
      Leukemia Erythrocytic                                                                                1 (7%)                   
   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                                              (14)         (14)         (14)         (15)         (15)         (15)         
      Meninges, Histiocytic Sarcoma                                                                                     1 (7%)      
____________________________________________________________________________________________________________________________________
                                                             Page   3                                                               
NTP Experiment-Test: 99033-03               INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (a)                     Report: PEIRPT02
Study Type: SPECIAL STUDY                       TRANSGENIC MODEL EVALUATION II(ASPARTAME)                         Date: 06/05/02  
Route: DOSED FEED                                                                                                 Time: 11:51:20  
____________________________________________________________________________________________________________________________________
         MICE:P16(INK4A)/(+/-) (C57BL/6) FEMALE    VEHICLE      3125 PPM     6250 PPM     12500        25000        50000           
                                                   CONTROL                                PPM          PPM          PPM             
____________________________________________________________________________________________________________________________________
 RESPIRATORY SYSTEM                                                                                                                 
   Lung                                               (14)         (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                                    (14)                                                             (15)         
      Adenoma                                                                                                           1 (7%)      
____________________________________________________________________________________________________________________________________
 URINARY SYSTEM                                                                                                                     
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
 SYSTEMIC LESIONS                                                                                                                   
   Multiple Organs                                   *(15)        *(15)        *(15)        *(15)        *(15)        *(15)         
      Histiocytic Sarcoma                              5 (33%)      1 (7%)       1 (7%)                                 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 (a)                     Report: PEIRPT02
Study Type: SPECIAL STUDY                       TRANSGENIC MODEL EVALUATION II(ASPARTAME)                         Date: 06/05/02  
Route: DOSED FEED                                                                                                 Time: 11:51:20  
____________________________________________________________________________________________________________________________________
         MICE: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           2           4                       1           6               
     Total Primary Neoplasms                            6           2           4                       1           6               
   Total Animals with Benign Neoplasms                  1           1           1                                   1               
     Total Benign Neoplasms                             1           1           1                                   1               
   Total Animals with Malignant Neoplasms               5           1           3                       1           5               
     Total Malignant Neoplasms                          5           1           3                       1           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 (a)                     Report: PEIRPT02
Study Type: SPECIAL STUDY                       TRANSGENIC MODEL EVALUATION II(ASPARTAME)                         Date: 06/05/02  
Route: DOSED FEED                                                                                                 Time: 11:51:20  
____________________________________________________________________________________________________________________________________
         MICE: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 (a)                     Report: PEIRPT02
Study Type: SPECIAL STUDY                       TRANSGENIC MODEL EVALUATION II(ASPARTAME)                         Date: 06/05/02  
Route: DOSED FEED                                                                                                 Time: 11:51:20  
____________________________________________________________________________________________________________________________________
         MICE:P16(INK4A)/(+/-) (C57BL/6) MALE      VEHICLE      3125 PPM     6250 PPM     12500        25000        50000           
                                                   CONTROL                                PPM          PPM          PPM             
____________________________________________________________________________________________________________________________________
 HEMATOPOIETIC SYSTEM                                                                                                               
   Bone Marrow                                        (14)                                                             (15)         
      Histiocytic Sarcoma                              2 (14%)                                                                      
   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 (a)                     Report: PEIRPT02
Study Type: SPECIAL STUDY                       TRANSGENIC MODEL EVALUATION II(ASPARTAME)                         Date: 06/05/02  
Route: DOSED FEED                                                                                                 Time: 11:51:20  
____________________________________________________________________________________________________________________________________
         MICE: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 (a)                     Report: PEIRPT02
Study Type: SPECIAL STUDY                       TRANSGENIC MODEL EVALUATION II(ASPARTAME)                         Date: 06/05/02  
Route: DOSED FEED                                                                                                 Time: 11:51:20  
____________________________________________________________________________________________________________________________________
         MICE: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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