https://ntp.niehs.nih.gov/go/6883

TDMS Study 99033-01 Pathology Tables

NTP Experiment-Test: 99033-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18
Study Type: 26-39 WEEKS                              WITH AVERAGE SEVERITY GRADES[b]                              Date: 03/05/03
Route: DOSED FEED                                 TRANSGENIC MODEL EVALUATION II (ASPARTAME)                      Time: 11:31:30
                                                      FINAL #3 TG.AC 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
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
                                                              Page   1
NTP Experiment-Test: 99033-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: 26-39 WEEKS                              WITH AVERAGE SEVERITY GRADES[b]                              Date: 03/05/03    
Route: DOSED FEED                                 TRANSGENIC MODEL EVALUATION II (ASPARTAME)                      Time: 11:31:30    
____________________________________________________________________________________________________________________________________
         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                                                                                                                  
   Gallbladder                                        (14)                                                             (6)          
      Inflammation, Chronic Active                     1 [2.0]                                                                      
   Liver                                              (15)         (15)         (14)         (15)         (14)         (14)         
      Infiltration Cellular, Focal, Lymphocyte                      1 [1.0]                                                         
      Infiltration Cellular, Focal,                                                                                                 
        Polymorphonuclear                                                                     1 [1.0]                               
      Inflammation, Acute, Focal                       1 [2.0]                                             1 [1.0]      2 [1.0]     
      Inflammation, Chronic Active, Focal              2 [1.5]                                             1 [1.0]      1 [1.0]     
      Necrosis                                                                   1 [1.0]                                            
      Necrosis, Focal                                  1 [1.0]                                                          4 [1.5]     
      Hepatocyte, Necrosis, Focal                                   1 [1.0]                   4 [1.0]      1 [1.0]                  
   Stomach, Forestomach                               (15)         (13)         (13)         (15)         (14)         (11)         
      Infiltration Cellular, Focal, Lymphocyte                                   1 [1.0]                                            
      Muscularis, Inflammation, Acute, Focal                                     1 [1.0]                                            
   Tongue                                             (15)                                                             (15)         
      Ulcer                                            1 [1.0]                                                                      
____________________________________________________________________________________________________________________________________
 CARDIOVASCULAR SYSTEM                                                                                                              
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
 ENDOCRINE SYSTEM                                                                                                                   
   Adrenal Cortex                                     (15)         (12)         (13)         (13)         (14)         (15)         
      Accessory Adrenal Cortical Nodule                1 [1.0]                                                                      
      Atrophy                                          3 [2.0]      2 [2.0]      1 [1.0]      4 [1.0]      5 [1.6]      5 [1.4]     
      Capsule, Inflammation, Acute, Focal                                                                  1 [2.0]                  
      Subcapsular, Hyperplasia, Focal                 12 [1.0]      6 [1.0]      6 [1.0]      5 [1.0]      6 [1.0]      6 [1.0]     
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page    2                                                              
NTP Experiment-Test: 99033-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: 26-39 WEEKS                              WITH AVERAGE SEVERITY GRADES[b]                              Date: 03/05/03    
Route: DOSED FEED                                 TRANSGENIC MODEL EVALUATION II (ASPARTAME)                      Time: 11:31:30    
____________________________________________________________________________________________________________________________________
         TGAC (FVB/N) HEMIZYGOUS FEMALE               VEHICLE      3125 PPM     6250 PPM     12500        25000        50000        
                                                      CONTROL                                PPM          PPM          PPM          
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT                                                                                                             
      Zona Reticularis, Vacuolization Cytoplasmic     12 [2.2]      9 [1.7]      6 [2.3]      8 [1.9]      9 [2.4]      8 [1.4]     
   Pituitary Gland                                    (13)         (11)         (12)         (10)         (11)         (9)          
      Cyst                                             2                                                                            
      Pars Intermedia, Hypertrophy                                                                         1 [2.0]                  
   Thyroid Gland                                      (15)         (13)         (12)         (15)         (14)         (11)         
      Follicle, Cyst                                   1                                                                            
____________________________________________________________________________________________________________________________________
 GENERAL BODY SYSTEM                                                                                                                
   Tissue NOS                                         (2)                                                                           
      Pigmentation                                     1 [1.0]                                                                      
      Abdominal, Fat, Necrosis, Focal                  1 [4.0]                                                                      
____________________________________________________________________________________________________________________________________
 GENITAL SYSTEM                                                                                                                     
   Ovary                                              (15)         (15)         (13)         (14)         (14)         (14)         
      Atrophy                                          2 [1.5]                   1 [3.0]                                            
      Cyst, Focal                                                                                          1 [1.0]                  
      Hemorrhage, Focal                                                                                    1 [2.0]                  
   Uterus                                             (15)         (13)         (13)         (12)         (14)         (14)         
      Cyst, Focal                                                                             1 [3.0]                               
      Hydrometra                                                                                           1 [1.0]                  
      Endometrium, Hyperplasia, Cystic                10 [1.6]      8 [1.6]      9 [1.4]     10 [1.5]     10 [1.9]     10 [1.4]     
____________________________________________________________________________________________________________________________________
 HEMATOPOIETIC SYSTEM                                                                                                               
   Lymph Node                                         (1)                                    (1)                                    
      Renal, Hyperplasia                               1 [2.0]                                                                      
   Lymph Node, Mandibular                             (15)         (14)         (12)         (12)         (14)         (12)         
      Hyperplasia                                                   2 [2.5]                   2 [2.0]      2 [3.5]                  
      Hyperplasia, Plasma Cell                         2 [2.0]                                                          1 [2.0]     
      Inflammation, Acute, Focal                                                                           1 [3.0]                  
   Lymph Node, Mediastinal                            (12)         (11)         (11)         (12)         (11)         (11)         
      Hyperplasia                                      1 [2.0]                                             1 [2.0]                  
   Spleen                                             (15)         (14)         (14)         (12)         (14)         (14)         
      Accessory Spleen                                              1 [2.0]                                                         
      Hematopoietic Cell Proliferation                10 [1.6]      4 [1.8]      7 [1.6]      6 [1.7]      8 [2.0]      5 [1.2]     
      Pigmentation                                    10 [1.3]     10 [1.1]     11 [1.1]     10 [1.2]     11 [1.3]      9 [1.0]     
   Thymus                                             (15)         (13)         (12)         (12)         (13)         (11)         
      Atrophy, Diffuse                                 3 [3.7]      1 [4.0]      1 [3.0]      2 [3.5]      2 [4.0]      2 [3.5]     
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page    3                                                              
NTP Experiment-Test: 99033-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: 26-39 WEEKS                              WITH AVERAGE SEVERITY GRADES[b]                              Date: 03/05/03    
Route: DOSED FEED                                 TRANSGENIC MODEL EVALUATION II (ASPARTAME)                      Time: 11:31:30    
____________________________________________________________________________________________________________________________________
         TGAC (FVB/N) HEMIZYGOUS FEMALE               VEHICLE      3125 PPM     6250 PPM     12500        25000        50000        
                                                      CONTROL                                PPM          PPM          PPM          
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Atrophy, Focal                                   2 [1.5]      1 [2.0]      1 [2.0]                                1 [2.0]     
      Hyperplasia, Diffuse                                          1 [4.0]                                                         
____________________________________________________________________________________________________________________________________
 INTEGUMENTARY SYSTEM                                                                                                               
   Skin                                               (15)         (3)          (1)                       (3)          (15)         
      Lip, Control Epidermis, Hyperplasia, Focal                                                           1 [3.0]                  
____________________________________________________________________________________________________________________________________
 MUSCULOSKELETAL SYSTEM                                                                                                             
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
 NERVOUS SYSTEM                                                                                                                     
   Brain                                              (15)         (12)         (13)         (13)         (14)         (11)         
      Abscess, Focal                                                                                       1 [3.0]                  
      Inflammation, Acute, Focal                                                                           1 [3.0]                  
      Cerebellum, Corpus Callosum, Pons,                                                                                            
        Vacuolization Cytoplasmic, Focal                                         1 [1.0]                                            
      Cortex, Cerebrum, Degeneration, Focal                                                                             1 [1.0]     
      Cortex, Cerebrum, Neuron, Necrosis                                         1 [1.0]                                            
      Medulla, Vacuolization Cytoplasmic                                                                   1 [1.0]                  
      Pyramidal Cell, Hippocampus, Necrosis                                      1 [1.0]                                            
____________________________________________________________________________________________________________________________________
 RESPIRATORY SYSTEM                                                                                                                 
   Lung                                               (15)         (14)         (14)         (15)         (14)         (14)         
      Hemorrhage, Focal                                1 [1.0]                                                                      
      Infiltration Cellular, Focal, Lymphocyte         1 [1.0]                                                                      
      Inflammation, Chronic Active, Focal              1 [2.0]                                                                      
      Alveolar Epithelium, Hyperplasia, Focal          1 [1.0]      1 [2.0]                                                         
      Perivascular, Infiltration Cellular,                                                                                          
        Lymphocyte                                                                            1 [1.0]      1 [1.0]                  
____________________________________________________________________________________________________________________________________
 SPECIAL SENSES SYSTEM                                                                                                              
   Eye                                                (15)                                                             (10)         
      Retina, Atrophy                                 15 [3.0]                                                         10 [3.0]     
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page    4                                                              
NTP Experiment-Test: 99033-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: 26-39 WEEKS                              WITH AVERAGE SEVERITY GRADES[b]                              Date: 03/05/03    
Route: DOSED FEED                                 TRANSGENIC MODEL EVALUATION II (ASPARTAME)                      Time: 11:31:30    
____________________________________________________________________________________________________________________________________
         TGAC (FVB/N) HEMIZYGOUS FEMALE               VEHICLE      3125 PPM     6250 PPM     12500        25000        50000        
                                                      CONTROL                                PPM          PPM          PPM          
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM - CONT                                                                                                        
   Harderian Gland                                    (15)                                                             (15)         
      Inflammation, Chronic Active                                                                                      1 [1.0]     
____________________________________________________________________________________________________________________________________
 URINARY SYSTEM                                                                                                                     
   Kidney                                             (15)         (12)         (13)         (14)         (14)         (14)         
      Infiltration Cellular, Focal, Lymphocyte         1 [1.0]                                                                      
      Inflammation, Acute, Focal                                                                           1 [4.0]                  
      Mineralization, Focal                                                                                             1 [1.0]     
      Nephropathy                                      1 [1.0]                                                          1 [1.0]     
      Renal Tubule, Dilatation, Focal                  1 [1.0]      2 [1.0]      1 [1.0]                                1 [1.0]     
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page    5                                                              
NTP Experiment-Test: 99033-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: 26-39 WEEKS                              WITH AVERAGE SEVERITY GRADES[b]                              Date: 03/05/03    
Route: DOSED FEED                                 TRANSGENIC MODEL EVALUATION II (ASPARTAME)                      Time: 11:31:30    
____________________________________________________________________________________________________________________________________
         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                                              (15)         (15)         (14)         (15)         (14)         (15)         
      Hematopoietic Cell Proliferation                                                        1 [1.0]                   1 [2.0]     
      Infiltration Cellular, Focal, Lymphocyte         1 [2.0]                                                          1 [1.0]     
      Inflammation, Acute, Focal                       1 [1.0]                                                                      
      Necrosis, Focal                                                                                                   2 [1.0]     
   Stomach, Forestomach                               (12)         (15)         (13)         (14)         (14)         (14)         
      Epithelium, Hyperplasia                          1 [1.0]                                                                      
   Stomach, Glandular                                 (12)         (15)         (13)         (14)         (14)         (14)         
      Inflammation, Acute                                                                                               1 [1.0]     
____________________________________________________________________________________________________________________________________
 CARDIOVASCULAR SYSTEM                                                                                                              
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
 ENDOCRINE SYSTEM                                                                                                                   
   Adrenal Cortex                                     (13)         (15)         (13)         (14)         (15)         (13)         
      Atrophy                                         10 [2.1]     12 [1.6]      8 [1.4]      9 [1.2]      8 [1.5]      6 [1.2]     
      Hypertrophy, Focal                               9 [1.0]      5 [1.0]      5 [1.0]      6 [1.0]      7 [1.0]      5 [1.0]     
      Subcapsular, Hyperplasia, Focal                                                                                   1 [1.0]     
   Thyroid Gland                                      (13)         (15)         (13)         (14)         (14)         (14)         
      Follicle, Cyst                                   2 [2.0]                                                                      
____________________________________________________________________________________________________________________________________
 GENERAL BODY SYSTEM                                                                                                                
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page    6                                                              
NTP Experiment-Test: 99033-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: 26-39 WEEKS                              WITH AVERAGE SEVERITY GRADES[b]                              Date: 03/05/03    
Route: DOSED FEED                                 TRANSGENIC MODEL EVALUATION II (ASPARTAME)                      Time: 11:31:30    
____________________________________________________________________________________________________________________________________
         TGAC (FVB/N) HEMIZYGOUS MALE                 VEHICLE      3125 PPM     6250 PPM     12500        25000        50000        
                                                      CONTROL                                PPM          PPM          PPM          
____________________________________________________________________________________________________________________________________
 GENITAL SYSTEM                                                                                                                     
   Coagulating Gland                                                            (1)                                    (1)          
      Cyst                                                                       1 [3.0]                                            
   Epididymis                                         (15)         (15)         (15)         (15)         (15)         (15)         
      Bilateral, Aspermia                                           1                                                               
      Bilateral, Spermatozoa, Degeneration                                                    1 [1.0]                   1 [2.0]     
      Unilateral, Aspermia                             1            3            4            2            3            2           
      Unilateral, Cyst                                 1 [3.0]                   1 [3.0]                                1 [2.0]     
      Unilateral, Inflammation, Chronic Active                                   2 [2.5]                                            
      Unilateral, Duct, Hyperplasia, Regenerative      1 [2.0]                                             1 [2.0]                  
      Unilateral, Spermatozoa, Degeneration                                                                             1 [2.0]     
   Preputial Gland                                    (12)         (1)          (1)                                    (12)         
      Cyst                                             1 [2.0]      1 [2.0]      1 [3.0]                                            
   Prostate                                           (13)         (15)         (15)         (15)         (15)         (14)         
      Inflammation, Acute, Focal                                    1 [3.0]                                                         
   Seminal Vesicle                                    (13)                                                (1)          (14)         
      Dilatation                                                                                           1 [4.0]                  
   Testes                                             (15)         (15)         (15)         (14)         (15)         (15)         
      Cyst                                                                       1 [2.0]      1 [1.0]      1 [2.0]                  
      Bilateral, Germinal Epithelium, Degeneration                  2 [3.0]                   1 [1.0]                   1 [2.0]     
      Unilateral, Cyst                                 1 [1.0]      2 [2.5]      3 [2.3]      2 [2.0]      2 [2.0]      1 [2.0]     
      Unilateral, Germinal Epithelium, Degeneration    1 [3.0]      2 [3.0]      4 [2.5]      2 [2.5]      3 [2.3]      3 [2.7]     
____________________________________________________________________________________________________________________________________
 HEMATOPOIETIC SYSTEM                                                                                                               
   Bone Marrow                                        (14)                                                             (14)         
      Hyperplasia                                                                                                       2 [2.0]     
   Lymph Node, Mandibular                             (12)         (15)         (13)         (14)         (14)         (14)         
      Hyperplasia                                                   2 [2.0]                   2 [2.5]                               
      Hyperplasia, Plasma Cell                         1 [3.0]                                                          1 [3.0]     
      Necrosis                                         2 [1.0]                                                                      
   Lymph Node, Mesenteric                             (13)         (15)         (13)         (14)         (15)         (14)         
      Hyperplasia                                                                1 [2.0]                                            
      Necrosis                                         1 [1.0]                                                                      
   Lymph Node, Mediastinal                            (11)         (13)         (11)         (10)         (14)         (13)         
      Hyperplasia                                                                             1 [4.0]                               
   Spleen                                             (14)         (15)         (13)         (15)         (14)         (14)         
      Hematopoietic Cell Proliferation                 3 [1.7]      3 [1.0]      8 [1.4]      2 [3.5]      8 [1.5]      4 [2.0]     
      Pigmentation                                     9 [1.0]     12 [1.0]      8 [1.0]     12 [1.2]     13 [1.0]     11 [1.0]     
      Lymphoid Follicle, Depletion Cellular                         1 [1.0]                                                         
   Thymus                                             (12)         (14)         (12)         (13)         (14)         (12)         
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page    7                                                              
NTP Experiment-Test: 99033-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: 26-39 WEEKS                              WITH AVERAGE SEVERITY GRADES[b]                              Date: 03/05/03    
Route: DOSED FEED                                 TRANSGENIC MODEL EVALUATION II (ASPARTAME)                      Time: 11:31:30    
____________________________________________________________________________________________________________________________________
         TGAC (FVB/N) HEMIZYGOUS MALE                 VEHICLE      3125 PPM     6250 PPM     12500        25000        50000        
                                                      CONTROL                                PPM          PPM          PPM          
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Atrophy, Diffuse                                 1 [4.0]                   1 [3.0]                   4 [3.0]                  
      Atrophy, Focal                                                                          1 [1.0]      2 [1.0]      2 [1.0]     
____________________________________________________________________________________________________________________________________
 INTEGUMENTARY SYSTEM                                                                                                               
   Skin                                               (15)         (2)                                    (1)          (15)         
      Control Epidermis, Hyperplasia, Focal                                                                1 [4.0]                  
____________________________________________________________________________________________________________________________________
 MUSCULOSKELETAL SYSTEM                                                                                                             
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
 NERVOUS SYSTEM                                                                                                                     
   Brain                                              (15)         (15)         (13)         (14)         (14)         (15)         
      Cortex, Cerebrum, Degeneration, Focal                                                                             1 [1.0]     
____________________________________________________________________________________________________________________________________
 RESPIRATORY SYSTEM                                                                                                                 
   Lung                                               (14)         (15)         (14)         (15)         (14)         (14)         
      Hemorrhage, Focal                                             3 [1.0]                                1 [1.0]                  
      Alveolar Epithelium, Hyperplasia, Focal                                                                           1 [1.0]     
____________________________________________________________________________________________________________________________________
 SPECIAL SENSES SYSTEM                                                                                                              
   Eye                                                (12)                                                             (14)         
      Retina, Atrophy                                 12 [3.0]                                                         14 [3.0]     
____________________________________________________________________________________________________________________________________
 URINARY SYSTEM                                                                                                                     
   Kidney                                             (15)         (15)         (13)         (15)         (14)         (15)         
      Dilatation, Diffuse                                                        1 [1.0]                                            
      Nephropathy                                      3 [1.0]                                                          1 [1.0]     
      Renal Tubule, Cyst                                                                                                1           
      Renal Tubule, Dilatation, Diffuse                                                       1 [2.0]                   1 [2.0]     
      Renal Tubule, Dilatation, Focal                  1 [1.0]                   1 [1.0]                                            
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page    8                                                              
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