National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/6865

TDMS Study 99033-01 Pathology Tables

NTP Experiment-Test: 99033-01               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: 11:40:23

                                                           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 001    VEHICLE CONTROL
                               Include 002    3125 PPM
                               Include 003    6250 PPM
                               Include 004    12500   PPM
                               Include 005    25000   PPM
                               Include 006    50000   PPM
                               Include 008    VEHICLE CONTROL
                               Include 009    3125 PPM
                               Include 010    6250 PPM
                               Include 011    12500   PPM
                               Include 012    25000   PPM
                               Include 013    50000   PPM























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

                                                              Page   1


NTP Experiment-Test: 99033-01               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: 11:40:23  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         MICE:TGAC (FVB/N) HEMIZYGOUS 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                                                                                                                      
    Moribund Sacrifice                                 3            2            3            4            3            2           
    Natural Death                                      1            3            3            2            1            5           
  Survivors                                                                                                                         
    Terminal Sacrifice                                11           10            9            9           11            8           
                                                                                                                                    
  Animals Examined Microscopically                    15           15           15           15           15           15           
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Liver                                              (15)         (15)         (14)         (15)         (14)         (11)         
      Leukemia Erythrocytic                            1 (7%)       3 (20%)      1 (7%)                                 1 (9%)      
      Sarcoma Stromal, Metastatic, Uterus                                                     1 (7%)                                
   Salivary Glands                                    (15)                                   (1)                       (11)         
      Duct, Carcinoma                                                                         1 (100%)                  1 (9%)      
   Stomach, Forestomach                               (14)         (13)         (13)         (15)         (14)         (10)         
      Squamous Cell Papilloma                          2 (14%)      6 (46%)      1 (8%)       7 (47%)      3 (21%)      5 (50%)     
      Squamous Cell Papilloma, Multiple                2 (14%)      3 (23%)      3 (23%)                   4 (29%)                  
   Tooth                                              (4)          (4)          (2)          (5)          (5)          (1)          
      Odontoma                                         3 (75%)      4 (100%)     2 (100%)     5 (100%)     5 (100%)     1 (100%)    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Pituitary Gland                                    (13)         (11)         (12)         (10)         (11)         (9)          
      Leukemia Erythrocytic                                         1 (9%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   2                                                               
                                                                                                                                   
NTP Experiment-Test: 99033-01               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: 11:40:23  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         MICE:TGAC (FVB/N) HEMIZYGOUS FEMALE       VEHICLE      3125 PPM     6250 PPM     12500        25000        50000           
                                                   CONTROL                                PPM          PPM          PPM             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Ovary                                              (15)         (15)         (13)         (14)         (14)         (10)         
      Leukemia Erythrocytic                                         1 (7%)                                                          
   Uterus                                             (15)         (13)         (13)         (12)         (14)         (10)         
      Sarcoma Stromal                                                                         1 (8%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Lymph Node                                         (1)                                    (1)                                    
      Pancreatic, Sarcoma Stromal, Metastatic,                                                                                      
           Uterus                                                                             1 (100%)                              
   Lymph Node, Mediastinal                            (12)         (11)         (11)         (12)         (11)         (10)         
      Carcinoma, Metastatic, Salivary Glands                                                  1 (8%)                                
   Spleen                                             (15)         (14)         (14)         (12)         (14)         (11)         
      Leukemia Erythrocytic                            1 (7%)       3 (21%)      1 (7%)                                 1 (9%)      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (15)         (3)          (1)                       (3)          (12)         
      Squamous Cell Papilloma                                       2 (67%)      1 (100%)                                           
      Vulva, Squamous Cell Papilloma                   1 (7%)       1 (33%)                                2 (67%)                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (15)         (12)         (13)         (13)         (14)         (10)         
      Leukemia Erythrocytic                                         1 (8%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (15)         (14)         (14)         (15)         (14)         (10)         
      Alveolar/Bronchiolar Adenoma                     1 (7%)                                                                       
      Carcinoma, Metastatic, Salivary Glands                                                  1 (7%)                                
      Leukemia Erythrocytic                                         1 (7%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   3                                                               
                                                                                                                                   
NTP Experiment-Test: 99033-01               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: 11:40:23  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         MICE:TGAC (FVB/N) HEMIZYGOUS FEMALE       VEHICLE      3125 PPM     6250 PPM     12500        25000        50000           
                                                   CONTROL                                PPM          PPM          PPM             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (14)         (12)         (13)         (14)         (14)         (10)         
      Leukemia Erythrocytic                                         1 (8%)                                                          
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SYSTEMIC LESIONS                                                                                                                   
                                                                                                                                    
   Multiple Organs                                   *(15)        *(15)        *(15)        *(15)        *(15)        *(15)         
      Leukemia Erythrocytic                            1 (7%)       3 (20%)      1 (7%)                                 1 (7%)      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
     *   Number of animals with any tissue examined microscopically                                                                 
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   4                                                               
                                                                                                                                   
NTP Experiment-Test: 99033-01               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: 11:40:23  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         MICE:TGAC (FVB/N) HEMIZYGOUS FEMALE       VEHICLE      3125 PPM     6250 PPM     12500        25000        50000           
                                                   CONTROL                                PPM          PPM          PPM             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
TUMOR SUMMARY                                                                                                                       
                                                                                                                                    
   Total Animals with Primary Neoplasms (b)             7          12           8          11          11           7               
     Total Primary Neoplasms                           10          19           8          14          14           8               
                                                                                                                                    
   Total Animals with Benign Neoplasms                  7          12           7           9          11           5               
     Total Benign Neoplasms                             9          16           7          12          14           6               
                                                                                                                                    
   Total Animals with Malignant Neoplasms               1           3           1           2                       2               
     Total Malignant Neoplasms                          1           3           1           2                       2               
                                                                                                                                    
   Total Animals with Metastatic Neoplasms                                                  2                                       
     Total Metastatic Neoplasm                                                              4                                       
                                                                                                                                    
   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: 99033-01               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: 11:40:23  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         MICE:TGAC (FVB/N) HEMIZYGOUS 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                                      3                         3            1            1            1           
    Moribund Sacrifice                                 3            3            4            2            3            4           
  Survivors                                                                                                                         
    Terminal Sacrifice                                 9           12            8           12           11           10           
                                                                                                                                    
  Animals Examined Microscopically                    15           15           15           15           15           15           
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Liver                                              (13)         (15)         (14)         (15)         (14)         (14)         
      Leukemia Erythrocytic                            1 (8%)                    1 (7%)       2 (13%)                               
      Lymphoma Malignant                                                                                                1 (7%)      
   Salivary Glands                                    (13)                      (2)                       (2)          (14)         
      Duct, Carcinoma                                                            2 (100%)                  1 (50%)      1 (7%)      
   Stomach, Forestomach                               (12)         (15)         (13)         (14)         (14)         (14)         
      Squamous Cell Papilloma                          4 (33%)      1 (7%)       1 (8%)       3 (21%)      4 (29%)      5 (36%)     
      Squamous Cell Papilloma, Multiple                4 (33%)      4 (27%)      1 (8%)       2 (14%)      2 (14%)      1 (7%)      
   Tooth                                              (4)          (4)          (2)          (2)          (2)          (6)          
      Odontogenic Tumor                                2 (50%)      4 (100%)     2 (100%)     2 (100%)     2 (100%)     5 (83%)     
      Odontoma                                                                                                          1 (17%)     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (12)         (15)         (13)         (14)         (15)         (13)         
      Leukemia Erythrocytic                                                      1 (8%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   6                                                               
                                                                                                                                   
NTP Experiment-Test: 99033-01               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: 11:40:23  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         MICE:TGAC (FVB/N) HEMIZYGOUS MALE         VEHICLE      3125 PPM     6250 PPM     12500        25000        50000           
                                                   CONTROL                                PPM          PPM          PPM             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Lymph Node, Mandibular                             (12)         (15)         (13)         (14)         (14)         (14)         
      Lymphoma Malignant                                                                                                1 (7%)      
   Lymph Node, Mesenteric                             (13)         (15)         (13)         (14)         (15)         (14)         
      Lymphoma Malignant                                                                                                1 (7%)      
   Lymph Node, Mediastinal                            (11)         (13)         (11)         (10)         (14)         (13)         
      Leukemia Erythrocytic                                                      1 (9%)                                             
      Lymphoma Malignant                                                                                                1 (8%)      
   Spleen                                             (13)         (15)         (13)         (15)         (14)         (14)         
      Leukemia Erythrocytic                            1 (8%)                    1 (8%)       2 (13%)                               
   Thymus                                             (12)         (14)         (12)         (13)         (14)         (12)         
      Lymphoma Malignant                                                         1 (8%)                                 1 (8%)      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (13)         (2)                                    (1)          (14)         
      Squamous Cell Papilloma                                       2 (100%)                               1 (100%)                 
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (12)         (15)         (14)         (15)         (14)         (14)         
      Alveolar/Bronchiolar Adenoma                                               2 (14%)      1 (7%)       2 (14%)      2 (14%)     
      Leukemia Erythrocytic                                                      1 (7%)       1 (7%)                                
      Lymphoma Malignant                                                         1 (7%)                                 1 (7%)      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   7                                                               
                                                                                                                                   
NTP Experiment-Test: 99033-01               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: 11:40:23  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         MICE:TGAC (FVB/N) HEMIZYGOUS MALE         VEHICLE      3125 PPM     6250 PPM     12500        25000        50000           
                                                   CONTROL                                PPM          PPM          PPM             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Harderian Gland                                    (12)                                                             (14)         
      Adenoma                                                                                                           1 (7%)      
   Zymbal's Gland                                     (12)                                                (1)          (14)         
      Carcinoma                                                                                            1 (100%)                 
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (13)         (15)         (13)         (15)         (14)         (14)         
      Leukemia Erythrocytic                                                                   1 (7%)                                
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SYSTEMIC LESIONS                                                                                                                   
                                                                                                                                    
   Multiple Organs                                   *(15)        *(15)        *(15)        *(15)        *(15)        *(15)         
      Leukemia Erythrocytic                            1 (7%)                    1 (7%)       2 (13%)                               
      Lymphoma Malignant                                                         1 (7%)                                 1 (7%)      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
     *   Number of animals with any tissue examined microscopically                                                                 
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   8                                                               
                                                                                                                                   
NTP Experiment-Test: 99033-01               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: 11:40:23  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         MICE:TGAC (FVB/N) HEMIZYGOUS MALE         VEHICLE      3125 PPM     6250 PPM     12500        25000        50000           
                                                   CONTROL                                PPM          PPM          PPM             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
TUMOR SUMMARY                                                                                                                       
                                                                                                                                    
   Total Animals with Primary Neoplasms (b)            10           9           7           8          11          11               
     Total Primary Neoplasms                           11          11          10          10          13          17               
                                                                                                                                    
   Total Animals with Benign Neoplasms                  8           6           3           5           8           8               
     Total Benign Neoplasms                             8           7           4           6           9          10               
                                                                                                                                    
   Total Animals with Malignant Neoplasms               1                       4           2           2           2               
     Total Malignant Neoplasms                          1                       4           2           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                                  2           4           2           2           2           5               
     Total Uncertain Neoplasms                          2           4           2           2           2           5               
                                                                                                                                    
                                                                                                                                    
____________________________________________________________________________________________________________________________________
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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