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TDMS Study 96007-04 Pathology Tables

NTP Experiment-Test: 96007-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 04/22/03
Route: GAVAGE                                TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE)                 Time: 10:47:09

                                                      53 WEEK SSAC/FINAL#1




       Facility:  Battelle Columbus Laboratory

       Chemical CAS #:  TEFDIOXINMIX

       Lock Date:  09/12/01

       Cage Range:  All

       Reasons For Removal:    25017 Scheduled Sacrifice

       Removal Date Range:     06/16/99 - 06/19/99

       Treatment Groups:       Include 001    TERT.MIXCONTROL
                               Include 002    TERT.MIXTEQ=10
                               Include 003    TERT.MIXTEQ=22
                               Include 004    TERT.MIXTEQ=46
                               Include 005    TERT.MIXTEQ=100





























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: 96007-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 04/22/03    
Route: GAVAGE                                TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE)                 Time: 10:47:09    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         SPRAGUE-DAWLEY RATS FEMALE                   TERT.MIX     TERT.MIX     TERT.MIX     TERT.MIX     TERT.MIX                  
                                                      CONTROL      TEQ=10       TEQ=22       TEQ=46       TEQ=100                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially In Study                          98           98           98           98           98                        
                                                                                                                                    
  Scheduled Sacrifice                                 13           13           13           13           13                        
  Early Deaths                                                                                                                      
  Survivors                                                                                                                         
                                                                                                                                    
  Animals Examined Microscopically                     8            8            8            8            8                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Liver                                              (8)          (8)          (8)          (8)          (8)                       
      Basophilic Focus                                 1                                                   1                        
      Cholangiofibrosis                                                                       2 [1.0]      1 [1.0]                  
      Clear Cell Focus                                 1            1                                      1                        
      Eosinophilic Focus                                                         1                         1                        
      Eosinophilic Focus, Multiple                                  1                                                               
      Fatty Change, Diffuse                                                                                2 [1.0]                  
      Fatty Change, Focal                                                                     3 [1.0]      4 [1.3]                  
      Inflammation                                     8 [1.0]      8 [1.0]      8 [1.1]      8 [1.4]      8 [1.9]                  
      Mixed Cell Focus                                 2            2            4            1                                     
      Mixed Cell Focus, Multiple                       1            2            3            5            7                        
      Pigmentation                                                  4 [1.0]      8 [1.3]      8 [1.0]      8 [2.0]                  
      Regeneration                                                                                         1                        
      Toxic Hepatopathy                                                                       3 [1.3]      8 [1.6]                  
      Bile Duct, Fibrosis                                                                                  1 [1.0]                  
      Bile Duct, Hyperplasia                                                                               6 [1.0]                  
      Bile Duct, Inflammation, Chronic Active                                                 1 [1.0]      1 [1.0]                  
      Hepatocyte, Hypertrophy                                       5 [1.2]      7 [1.4]      8 [1.5]      8 [2.5]                  
      Hepatocyte, Multinucleated                                                 3 [1.0]                   8 [1.8]                  
   Pancreas                                           (8)          (8)          (8)          (8)          (8)                       
      Basophilic Focus                                                                                     1                        
      Inflammation, Chronic Active                                                            1 [3.0]      1 [1.0]                  
      Acinus, Atrophy                                                                         1 [2.0]      1 [2.0]                  
      Acinus, Vacuolization Cytoplasmic                                                       2 [1.0]      7 [1.6]                  
   Stomach, Glandular                                 (8)                                    (1)          (8)                       
      Cyst, Squamous                                   1 [1.0]                                                                      
      Developmental Malformation                                                              1 [2.0]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
                                                                                                                                    
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: 96007-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 04/22/03    
Route: GAVAGE                                TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE)                 Time: 10:47:09    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         SPRAGUE-DAWLEY RATS FEMALE                   TERT.MIX     TERT.MIX     TERT.MIX     TERT.MIX     TERT.MIX                  
                                                      CONTROL      TEQ=10       TEQ=22       TEQ=46       TEQ=100                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (8)          (8)          (8)          (8)          (8)                       
      Degeneration, Cystic                             1 [2.0]                                             2 [1.5]                  
      Hyperplasia                                                                2 [2.0]      1 [1.0]      2 [2.0]                  
      Hypertrophy                                      3 [1.7]      7 [1.0]      5 [1.0]      3 [1.0]      5 [1.6]                  
      Vacuolization Cytoplasmic                                                                            1 [1.0]                  
   Thyroid Gland                                      (8)          (8)          (8)          (8)          (8)                       
      C-Cell, Hyperplasia                                                        1 [1.0]                                            
      Follicular Cell, Hypertrophy                     2 [1.0]      2 [1.5]      3 [1.0]      3 [1.7]      4 [2.3]                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Ovary                                              (8)          (8)          (8)          (8)          (8)                       
      Atrophy                                          8 [3.9]      8 [4.0]      8 [4.0]      6 [4.0]      8 [3.8]                  
      Cyst                                                                                    1 [2.0]                               
      Inflammation, Suppurative                        1 [3.0]                                                                      
   Uterus                                             (8)          (8)          (8)          (8)          (8)                       
      Inflammation, Suppurative                        1 [1.0]                                                                      
      Metaplasia, Squamous                             8 [2.1]      8 [2.1]      8 [2.1]      6 [2.5]      7 [2.1]                  
      Endometrium, Hyperplasia, Cystic                 6 [1.7]                                             2 [4.0]                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Spleen                                             (8)                                                 (8)                       
      Pigmentation                                     8 [1.6]                                             8 [2.1]                  
   Thymus                                             (8)          (8)          (8)          (8)          (6)                       
      Atrophy                                          3 [2.0]      7 [1.7]      8 [2.0]      8 [3.4]      6 [3.7]                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (8)          (1)          (1)          (1)          (8)                       
      Cyst                                             3 [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    3                                                              
                                                                                                                                   
NTP Experiment-Test: 96007-04         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 04/22/03    
Route: GAVAGE                                TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE)                 Time: 10:47:09    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         SPRAGUE-DAWLEY RATS FEMALE                   TERT.MIX     TERT.MIX     TERT.MIX     TERT.MIX     TERT.MIX                  
                                                      CONTROL      TEQ=10       TEQ=22       TEQ=46       TEQ=100                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
INTEGUMENTARY SYSTEM - CONT                                                                                                         
      Hyperplasia                                      1 [1.0]                                             1 [1.0]                  
   Skin                                                                         (1)                                                 
      Ulcer                                                                      1 [2.0]                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (8)          (8)          (8)          (8)          (8)                       
      Infiltration Cellular, Histiocyte                6 [1.2]      5 [1.0]      5 [1.0]      4 [1.0]      6 [1.0]                  
      Inflammation                                                  1 [1.0]                                                         
      Inflammation, Chronic Active                                                            1 [1.0]                               
      Alveolar Epithelium, Metaplasia, Bronchiolar                  1 [1.0]      2 [1.5]      4 [1.0]      6 [1.3]                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                                                       (1)          (1)                                    
      Inflammation, Chronic Active                                               1 [2.0]      1 [3.0]                               
      Nephropathy                                                                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    4                                                              
                                                                                                                                   
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