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TDMS Study 96007-05 Pathology Tables

NTP Experiment-Test: 96007-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 07/14/03
Route: GAVAGE                                     TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      Time: 15:05:14

                                                       53 WEEK SSAC RATS




       Facility:  Battelle Columbus Laboratory

       Chemical CAS #:  57117-31-4

       Lock Date:  07/25/02

       Cage Range:  All

       Reasons For Removal:    25017 Scheduled Sacrifice

       Removal Date Range:     04/06/00 - 04/07/00

       Treatment Groups:       Include All

































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: 96007-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 07/14/03    
Route: GAVAGE                                     TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      Time: 15:05:14    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         SPRAGUE-DAWLEY RATS FEMALE                   0 NG/KG      6 NG/KG      20 NG/KG     44 NG/KG     92 NG/KG     200          
                                                                                                                       NG/KG        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially In Study                          98           98           98           98           98           98           
                                                                                                                                    
  Scheduled Sacrifice                                 13           13           13           13           13           13           
  Early Deaths                                                                                                                      
  Survivors                                                                                                                         
                                                                                                                                    
  Animals Examined Microscopically                     8            8            8            8            8            8           
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Liver                                              (8)          (8)          (8)          (8)          (8)          (8)          
      Angiectasis                                      1 [1.0]                                                                      
      Basophilic Focus                                 1            1                         3                         1           
      Clear Cell Focus, Multiple                                                                                        1           
      Eosinophilic Focus                                                                                                1           
      Fatty Change, Diffuse                                                                                             3 [1.0]     
      Hepatodiaphragmatic Nodule                                    1                                                               
      Inflammation                                     8 [1.0]      8 [1.0]      8 [1.0]      7 [1.1]      8 [1.1]      8 [1.3]     
      Mixed Cell Focus                                 2            1            3            1            3                        
      Mixed Cell Focus, Multiple                       5            5            3            7            3            6           
      Necrosis                                         1 [1.0]      1 [1.0]      2 [1.0]                                            
      Pigmentation                                                  1 [1.0]      1 [1.0]      6 [1.0]      7 [1.0]      8 [1.4]     
      Toxic Hepatopathy                                                                                                 1 [1.0]     
      Bile Duct, Cyst                                                                                                   2 [1.0]     
      Bile Duct, Fibrosis                              1 [1.0]                   1 [1.0]      1 [1.0]                               
      Bile Duct, Hyperplasia                                                                               1 [1.0]      1 [1.0]     
      Hepatocyte, Hypertrophy                          1 [1.0]      3 [1.0]      3 [1.0]      3 [1.0]      5 [1.0]      7 [1.4]     
      Hepatocyte, Multinucleated                                                                           1 [1.0]      2 [1.0]     
   Pancreas                                           (8)                                                              (8)          
      Hyperplasia                                      1 [1.0]                                                                      
      Inflammation, Chronic Active                     1 [2.0]                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (8)                                                              (8)          
                                                                                                                                    
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: 96007-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 07/14/03    
Route: GAVAGE                                     TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      Time: 15:05:14    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         SPRAGUE-DAWLEY RATS FEMALE                   0 NG/KG      6 NG/KG      20 NG/KG     44 NG/KG     92 NG/KG     200          
                                                                                                                       NG/KG        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
      Degeneration, Cystic                                                                                              1 [2.0]     
      Hyperplasia                                      1 [1.0]                                                          2 [2.5]     
      Hypertrophy                                      4 [1.3]                                                          6 [1.2]     
      Vacuolization Cytoplasmic                                                                                         2 [1.5]     
   Pituitary Gland                                    (8)                                                              (8)          
      Hyperplasia                                                                                                       2 [2.0]     
      Pars Distalis, Hyperplasia                       1 [2.0]                                                                      
   Thyroid Gland                                      (8)          (8)          (7)          (8)          (8)          (8)          
      C-Cell, Hyperplasia                                                                                               2 [1.5]     
      Follicular Cell, Hypertrophy                     2 [1.0]      3 [1.0]      1 [1.0]      3 [1.0]      4 [1.0]      5 [1.4]     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Ovary                                              (8)          (1)          (2)          (1)                       (8)          
      Atrophy                                          8 [4.0]                                                          7 [4.0]     
      Cyst                                             1 [2.0]                   2 [2.0]                                            
   Oviduct                                                         (1)                                                              
      Cyst                                                          1 [3.0]                                                         
   Uterus                                             (8)          (1)          (2)          (1)          (1)          (8)          
      Inflammation, Chronic Active                                               2 [2.0]                   1 [2.0]                  
      Inflammation, Suppurative                        2 [1.5]                                                          1 [1.0]     
      Metaplasia, Squamous                             8 [2.1]      1 [4.0]      1 [4.0]                                7 [2.0]     
      Endometrium, Hyperplasia, Cystic                 6 [1.7]                                1 [4.0]      1 [4.0]      8 [1.6]     
      Epithelium, Hyperplasia                                                    2 [2.5]                                            
   Vagina                                             (8)                                                              (8)          
      Vacuolization Cytoplasmic                                                                                         1 [3.0]     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Spleen                                             (8)                                                              (8)          
      Pigmentation                                     8 [1.8]                                                          8 [2.0]     
   Thymus                                             (8)          (8)          (8)          (8)          (8)          (8)          
      Atrophy                                          5 [1.8]      4 [2.0]      6 [1.7]      6 [2.0]      5 [2.0]      7 [2.6]     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
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: 96007-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 07/14/03    
Route: GAVAGE                                     TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      Time: 15:05:14    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         SPRAGUE-DAWLEY RATS FEMALE                   0 NG/KG      6 NG/KG      20 NG/KG     44 NG/KG     92 NG/KG     200          
                                                                                                                       NG/KG        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (8)          (1)          (1)                       (2)          (8)          
      Cyst                                                                       1 [3.0]                   1 [3.0]      1 [3.0]     
      Hyperplasia                                                                                                       3 [1.0]     
      Inflammation, Chronic                                                      1 [2.0]                   1 [2.0]                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (8)          (1)                                                 (8)          
      Infiltration Cellular, Histiocyte                4 [1.0]      1 [1.0]                                             2 [1.0]     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (1)                                                                           
      Inflammation, Chronic                            1 [2.0]                                                                      
                                                                                                                                    
                                                                                                                                    
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: 96007-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 07/14/03    
Route: GAVAGE                                     TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      Time: 15:05:14    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         SPRAGUE-DAWLEY RATS FEMALE                   200 NG/                                                                       
                                                      KG STOP                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially In Study                          50                                                                            
  Early Deaths                                                                                                                      
  Survivors                                                                                                                         
                                                                                                                                    
  Animals Examined Microscopically                                                                                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY 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    5                                                              
                                                                                                                                   
NTP Experiment-Test: 96007-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 07/14/03    
Route: GAVAGE                                     TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      Time: 15:05:14    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         SPRAGUE-DAWLEY RATS FEMALE                   200 NG/                                                                       
                                                      KG STOP                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY 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                                                              
                                                                                                                                   
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