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TDMS Study 99033-03 Pathology Tables

NTP Experiment-Test: 99033-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: SUBCHRON 26-WEEK                    TRANSGENIC MODEL EVALUATION II (ASPARTAME)                        Date: 03/05/03
Route: DOSED FEED                                                                                                 Time: 11:40:00

                                                      FINAL #3 TG:P16 MICE




       Facility:  BIORELIANCE

       Chemical CAS #:  22839-47-0

       Lock Date:  07/20/01

       Cage Range:  All

       Reasons For Removal:    All

       Removal Date Range:     All

       Treatment Groups:       Include All


































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

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NTP Experiment-Test: 99033-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: SUBCHRON 26-WEEK                    TRANSGENIC MODEL EVALUATION II (ASPARTAME)                        Date: 03/05/03    
Route: DOSED FEED                                                                                                 Time: 11:40:00    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         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                                                                                                                  
                                                                                                                                    
   Liver                                              (15)         (15)         (15)         (15)         (15)         (15)         
      Hematopoietic Cell Proliferation                                                                                  2 (13%)     
      Infiltration Cellular, Focal, Lymphocyte                                                                          1 (7%)      
      Infiltration Cellular, Lymphocyte                1 (7%)                                                                       
      Inflammation, Chronic Active                     1 (7%)                                                                       
      Necrosis, Focal                                                                                      1 (7%)       2 (13%)     
      Hepatocyte, Necrosis, Focal                                   1 (7%)                                                          
      Hepatocyte, Periportal, Vacuolization                                                                                         
        Cytoplasmic                                                                                                     2 (13%)     
   Salivary Glands                                    (15)                                                             (15)         
      Infiltration Cellular, Focal, Lymphocyte         4 (27%)                                                          5 (33%)     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (15)         (15)         (15)         (15)         (15)         (15)         
      Myocardium, Necrosis, Focal                                                1 (7%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (15)         (15)         (13)         (15)         (15)         (15)         
      Accessory Adrenal Cortical Nodule                                                                    1 (7%)                   
      Subcapsular, Hyperplasia, Focal                 14 (93%)     15 (100%)    12 (92%)     15 (100%)    15 (100%)    15 (100%)    
   Thyroid Gland                                      (15)         (15)         (15)         (15)         (15)         (15)         
      Ectopic Thymus                                                                          2 (13%)                               
      Ultimobranchial Cyst                             1 (7%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                                                                                                    
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NTP Experiment-Test: 99033-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: SUBCHRON 26-WEEK                    TRANSGENIC MODEL EVALUATION II (ASPARTAME)                        Date: 03/05/03    
Route: DOSED FEED                                                                                                 Time: 11:40:00    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         P16(INK4A)/(+/-) (C57BL/6) FEMALE         VEHICLE      3125 PPM     6250 PPM     12500        25000        50000           
                                                   CONTROL                                PPM          PPM          PPM             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   Tissue NOS                                                                   (1)                                                 
      Abdominal, Fat, Hemorrhage, Focal                                          1 (100%)                                           
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Ovary                                              (15)         (15)         (15)         (15)         (15)         (15)         
      Cyst                                                                                    1 (7%)                                
   Uterus                                             (15)         (15)         (15)         (15)         (15)         (15)         
      Endometrium, Hyperplasia, Cystic                14 (93%)     13 (87%)     13 (87%)     15 (100%)    15 (100%)    14 (93%)     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Lymph Node, Mandibular                             (14)         (15)         (13)         (15)         (15)         (15)         
      Hyperplasia                                                                                                       1 (7%)      
      Inflammation, Chronic Active                     1 (7%)                                                                       
   Lymph Node, Mesenteric                             (14)         (15)         (14)         (15)         (15)         (14)         
      Hyperplasia, Histiocytic                                                                                          1 (7%)      
   Spleen                                             (15)         (15)         (14)         (15)         (15)         (15)         
      Accessory Spleen                                                                        1 (7%)                                
      Hematopoietic Cell Proliferation                 5 (33%)      2 (13%)      4 (29%)      3 (20%)      2 (13%)      3 (20%)     
      Pigmentation                                     1 (7%)                                                                       
   Thymus                                             (14)         (15)         (14)         (14)         (15)         (15)         
      Atrophy, Diffuse                                 1 (7%)                                                                       
      Atrophy, Focal                                                1 (7%)       1 (7%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (15)                                                             (15)         
      Cranium, Osteoporosis                            1 (7%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (15)         (14)         (14)         (15)         (15)         (15)         
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
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NTP Experiment-Test: 99033-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: SUBCHRON 26-WEEK                    TRANSGENIC MODEL EVALUATION II (ASPARTAME)                        Date: 03/05/03    
Route: DOSED FEED                                                                                                 Time: 11:40:00    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         P16(INK4A)/(+/-) (C57BL/6) FEMALE         VEHICLE      3125 PPM     6250 PPM     12500        25000        50000           
                                                   CONTROL                                PPM          PPM          PPM             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
NERVOUS SYSTEM - CONT                                                                                                               
      Granuloma                                        1 (7%)                                                                       
      Cerebellum, Medulla, Vacuolization                                                                                            
        Cytoplasmic                                    1 (7%)                                                                       
   Spinal Cord                                                                                                         (1)          
      Vacuolization Cytoplasmic                                                                                         1 (100%)    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (15)         (14)         (14)         (15)         (15)         (15)         
      Alveolar Epithelium, Hyperplasia, Focal          1 (7%)                                                                       
      Alveolus, Crystals                               1 (7%)                                                                       
   Nose                                               (15)                                                             (15)         
      Olfactory Epithelium, Atrophy                                                                                     1 (7%)      
      Olfactory Epithelium, Hyaline Droplet            2 (13%)                                                          3 (20%)     
      Respiratory Epithelium, Hyaline Droplet          1 (7%)                                                           2 (13%)     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (14)                                                             (15)         
      Cataract                                         1 (7%)                                                                       
   Harderian Gland                                    (15)                                                             (15)         
      Hyperplasia                                                                                                       1 (7%)      
      Infiltration Cellular, Lymphocyte                                                                                 1 (7%)      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (15)         (15)         (13)         (15)         (15)         (15)         
      Nephropathy                                      1 (7%)                                                           1 (7%)      
      Glomerulus, Hyalinization                                                                                         1 (7%)      
      Renal Tubule, Dilatation, Diffuse                1 (7%)       1 (7%)                                 1 (7%)                   
      Renal Tubule, Dilatation, Focal                 10 (67%)      7 (47%)      5 (38%)      5 (33%)      5 (33%)      9 (60%)     
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
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NTP Experiment-Test: 99033-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: SUBCHRON 26-WEEK                    TRANSGENIC MODEL EVALUATION II (ASPARTAME)                        Date: 03/05/03    
Route: DOSED FEED                                                                                                 Time: 11:40:00    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         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)         
      Infiltration Cellular, Focal, Lymphocyte         3 (20%)                                                          1 (7%)      
      Inflammation, Acute                              2 (13%)                                                                      
      Necrosis, Focal                                  2 (13%)                   3 (20%)                   1 (7%)       4 (27%)     
      Hepatocyte, Necrosis, Focal                                   1 (7%)       1 (7%)                    1 (7%)       1 (7%)      
      Hepatocyte, Vacuolization Cytoplasmic,                                                                                        
        Diffuse                                                                               1 (7%)                                
      Hepatocyte, Periportal, Vacuolization                                                                                         
        Cytoplasmic                                    6 (40%)     11 (73%)     14 (93%)      8 (57%)     13 (87%)     13 (87%)     
   Salivary Glands                                    (15)                                                             (15)         
      Infiltration Cellular, Focal, Lymphocyte        12 (80%)                                                         11 (73%)     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (15)         (15)         (15)         (14)         (15)         (15)         
      Accessory Adrenal Cortical Nodule                                                                                 1 (7%)      
      Subcapsular, Hyperplasia, Focal                  2 (13%)      1 (7%)                                 1 (7%)       4 (27%)     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                                                                                                    
                                                             Page    5                                                              
                                                                                                                                   
NTP Experiment-Test: 99033-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: SUBCHRON 26-WEEK                    TRANSGENIC MODEL EVALUATION II (ASPARTAME)                        Date: 03/05/03    
Route: DOSED FEED                                                                                                 Time: 11:40:00    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         P16(INK4A)/(+/-) (C57BL/6) MALE           VEHICLE      3125 PPM     6250 PPM     12500        25000        50000           
                                                   CONTROL                                PPM          PPM          PPM             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (15)         (15)         (15)         (15)         (15)         (15)         
      Inflammation, Chronic Active, Focal                                        1 (7%)                                             
      Bilateral, Spermatozoa, Degeneration             1 (7%)                                                                       
   Testes                                             (15)         (15)         (15)         (14)         (14)         (15)         
      Germinal Epithelium, Degeneration                             1 (7%)       1 (7%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Lymph Node, Mandibular                             (15)         (15)         (15)         (14)         (14)         (15)         
      Hyperplasia                                      1 (7%)                                 1 (7%)                                
      Necrosis                                         1 (7%)                                                                       
   Lymph Node, Mesenteric                             (15)         (15)         (15)         (14)         (14)         (15)         
      Hyperplasia                                                                2 (13%)                                            
   Spleen                                             (15)         (15)         (15)         (14)         (15)         (15)         
      Atrophy, Diffuse                                 1 (7%)                                              1 (7%)                   
      Hematopoietic Cell Proliferation                              1 (7%)       2 (13%)      3 (21%)                   1 (7%)      
      Pigmentation                                                                                                      1 (7%)      
      Lymphoid Follicle, Atrophy                       1 (7%)                                                                       
   Thymus                                             (15)         (14)         (15)         (13)         (15)         (15)         
      Atrophy, Diffuse                                 1 (7%)                    1 (7%)                    1 (7%)                   
      Atrophy, Focal                                   1 (7%)       2 (14%)                                1 (7%)                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (15)         (15)         (15)         (14)         (15)         (15)         
      Cerebellum, Medulla, Vacuolization                                                                                            
        Cytoplasmic                                    1 (7%)       1 (7%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                                                                                                    
                                                             Page    6                                                              
                                                                                                                                   
NTP Experiment-Test: 99033-03         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: SUBCHRON 26-WEEK                    TRANSGENIC MODEL EVALUATION II (ASPARTAME)                        Date: 03/05/03    
Route: DOSED FEED                                                                                                 Time: 11:40:00    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         P16(INK4A)/(+/-) (C57BL/6) MALE           VEHICLE      3125 PPM     6250 PPM     12500        25000        50000           
                                                   CONTROL                                PPM          PPM          PPM             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (15)         (15)         (15)         (15)         (15)         (15)         
      Infiltration Cellular, Focal, Lymphocyte                      1 (7%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Harderian Gland                                    (15)                                                             (15)         
      Infiltration Cellular, Lymphocyte                2 (13%)                                                          2 (13%)     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (15)         (15)         (15)         (14)         (15)         (15)         
      Nephropathy                                      2 (13%)                                                          7 (47%)     
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
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