National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/5945

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: 09/30/03
Route: GAVAGE                                     TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      Time: 12:03:03

                                                         FINAL #3/RATS




       Facility:  Battelle Columbus Laboratory

       Chemical CAS #:  57117-31-4

       Lock Date:  07/25/02

       Cage Range:  All

       Reasons For Removal:    25018 Dosing Accident                   25019 Moribund Sacrifice
                               25020 Natural Death                     25021 Terminal Sacrifice

       Removal Date Range:     All

       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: 09/30/03    
Route: GAVAGE                                     TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      Time: 12:03:03    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         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           
  Early Deaths                                                                                                                      
    Natural Death                                      7           10           10            8           14           11           
    Moribund Sacrifice                                21           20           17           19           19           19           
    Dosing Accident                                                 1            2            1                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                25           22           24           25           20           23           
                                                                                                                                    
  Animals Examined Microscopically                    53           53           53           53           53           53           
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Esophagus                                          (53)         (53)         (52)         (53)         (53)         (53)         
      Cyst                                                                                    2 [3.0]                               
      Perforation                                                   1 [0.0]      2 [3.0]      1 [4.0]                               
      Muscularis, Inflammation                                      2 [1.5]      1 [1.0]      1 [1.0]      1 [2.0]      1 [2.0]     
      Periesophageal Tissue, Inflammation                           1 [3.0]      2 [3.0]      2 [3.0]      1 [3.0]                  
   Intestine Large, Colon                             (53)         (53)         (53)         (53)         (51)         (53)         
      Edema                                                                                                1 [2.0]                  
      Inflammation                                                                                         1 [2.0]      1 [2.0]     
      Parasite Metazoan                                2                                                                            
   Intestine Large, Rectum                            (53)         (53)         (53)         (53)         (52)         (53)         
      Parasite Metazoan                                4            5            5            1            1            1           
      Artery, Inflammation, Chronic Active                          1 [3.0]                   1 [3.0]                               
   Intestine Large, Cecum                             (53)         (53)         (53)         (52)         (51)         (53)         
      Inflammation                                                                                         1 [2.0]                  
      Artery, Inflammation, Chronic Active                          1 [3.0]                                             2 [2.5]     
      Artery, Mineralization                                                                               1 [2.0]                  
   Intestine Small, Ileum                             (53)         (53)         (53)         (52)         (52)         (53)         
      Parasite Metazoan                                1                                                                            
   Liver                                              (53)         (53)         (53)         (52)         (53)         (53)         
      Angiectasis                                      6 [1.5]      3 [1.3]      4 [1.8]      1 [2.0]                   1 [2.0]     
      Basophilic Focus                                10           11            9           10           12            6           
      Basophilic Focus, Multiple                      12           12           11            6            3            1           
      Cholangiofibrosis                                             1 [1.0]                   3 [1.3]      3 [1.3]      5 [2.2]     
      Clear Cell Focus                                11            1            7            2                         3           
      Clear Cell Focus, Multiple                       2            5            3            1            6            8           
      Degeneration, Cystic                                                                                              1 [1.0]     
      Eosinophilic Focus                               7           11            9            9           11           10           
      Eosinophilic Focus, Multiple                     8            2            9            9           12           18           
      Fatty Change, Diffuse                            1 [1.0]      4 [1.3]     10 [1.4]     12 [1.1]     20 [1.1]     26 [1.3]     
                                                                                                                                    
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: 09/30/03    
Route: GAVAGE                                     TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      Time: 12:03:03    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         SPRAGUE-DAWLEY RATS FEMALE                   0 NG/KG      6 NG/KG      20 NG/KG     44 NG/KG     92 NG/KG     200          
                                                                                                                       NG/KG        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Fatty Change, Focal                              5 [1.2]      6 [2.0]      5 [1.0]      6 [1.3]      6 [1.3]      4 [1.0]     
      Hematopoietic Cell Proliferation                24 [1.1]     28 [1.3]     27 [1.1]     24 [1.0]     39 [1.1]     31 [1.1]     
      Hemorrhage                                       1 [2.0]                                                                      
      Hepatodiaphragmatic Nodule                       3            3            3            1            1            1           
      Hyperplasia, Nodular                                                                    3            8           12           
      Inflammation                                    47 [1.1]     44 [1.2]     47 [1.1]     50 [1.2]     48 [1.2]     50 [1.3]     
      Mixed Cell Focus                                 5                         1            2            2            1           
      Mixed Cell Focus, Multiple                      28           24           23           27           25           25           
      Necrosis                                         4 [2.5]     10 [2.1]      3 [2.0]      3 [2.3]      6 [2.0]     18 [1.8]     
      Pigmentation                                    13 [1.1]     11 [1.1]     21 [1.3]     44 [1.5]     42 [1.8]     48 [1.9]     
      Toxic Hepatopathy                                             2 [1.0]      3 [1.0]      8 [1.1]     27 [1.1]     44 [1.7]     
      Artery, Inflammation, Chronic Active                                                                              1 [1.0]     
      Bile Duct, Cyst                                  7 [2.3]      4 [2.3]      2 [3.0]      3 [2.0]      2 [2.0]      7 [1.7]     
      Bile Duct, Fibrosis                              1 [1.0]      4 [1.8]      2 [1.0]      2 [1.5]      3 [1.0]      6 [1.3]     
      Bile Duct, Hyperplasia                           3 [1.3]      2 [1.0]      2 [1.0]      2 [1.0]      1 [1.0]     13 [1.6]     
      Centrilobular, Degeneration                      4 [2.0]      2 [1.5]      3 [2.3]      4 [1.5]      4 [2.3]      5 [2.4]     
      Hepatocyte, Hypertrophy                          2 [1.0]     13 [1.0]     17 [1.0]     17 [1.0]     24 [1.0]     34 [1.2]     
      Hepatocyte, Multinucleated                                                 4 [1.0]     13 [1.0]     18 [1.3]     35 [1.2]     
      Oval Cell, Hyperplasia                           1 [1.0]      4 [1.3]      2 [1.0]      6 [1.2]     15 [1.1]     35 [1.4]     
      Portal, Fibrosis                                                                                                  1 [1.0]     
   Mesentery                                          (1)          (2)          (1)          (3)          (2)          (4)          
      Inflammation                                                  1 [2.0]                                                         
      Necrosis                                                                   1 [3.0]                                            
      Artery, Inflammation, Chronic Active                          1 [3.0]                   2 [3.5]      1 [4.0]      4 [3.3]     
      Fat, Necrosis                                    1 [3.0]                                1 [2.0]      1 [3.0]                  
   Oral Mucosa                                        (52)         (53)         (52)         (53)         (53)         (53)         
      Gingival, Cyst                                                                          1 [3.0]                               
      Gingival, Hyperplasia                                                                   1 [1.0]                               
      Gingival, Hyperplasia, Squamous                 15 [1.1]     11 [1.4]     16 [1.4]     19 [1.2]     22 [1.1]     20 [1.4]     
   Pancreas                                           (53)         (53)         (53)         (52)         (52)         (52)         
      Cyst                                                                                                 1 [2.0]                  
      Cytoplasmic Alteration                                                                                            3 [2.0]     
      Inflammation, Chronic Active                     2 [1.0]      1 [2.0]      1 [1.0]      1 [1.0]                   4 [2.0]     
      Lipomatosis                                                                             1 [2.0]                               
      Acinus, Atrophy                                  3 [1.7]      1 [4.0]      1 [1.0]      1 [2.0]                   3 [2.7]     
      Acinus, Hyperplasia                                           1 [3.0]                                                         
      Acinus, Vacuolization Cytoplasmic                                                                    2 [1.0]     23 [1.1]     
      Artery, Inflammation, Chronic Active             1 [1.0]      2 [2.0]      1 [1.0]      2 [2.5]      4 [2.3]     11 [3.3]     
      Duct, Dilatation                                                                                                  1 [4.0]     
   Salivary Glands                                    (53)         (53)         (51)         (53)         (51)         (51)         
      Atrophy                                          1 [2.0]                                                          2 [1.5]     
      Duct, Inflammation                                            1 [3.0]                                                         
   Stomach, Forestomach                               (53)         (53)         (53)         (53)         (52)         (53)         
                                                                                                                                    
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: 09/30/03    
Route: GAVAGE                                     TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      Time: 12:03:03    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         SPRAGUE-DAWLEY RATS FEMALE                   0 NG/KG      6 NG/KG      20 NG/KG     44 NG/KG     92 NG/KG     200          
                                                                                                                       NG/KG        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Cyst                                                                                                              1 [3.0]     
      Edema                                                         1 [2.0]                                                         
      Hyperkeratosis                                                             1 [2.0]                                            
      Hyperplasia, Squamous                            4 [1.8]      1 [1.0]      5 [1.4]      6 [2.5]      3 [2.7]     10 [2.1]     
      Inflammation                                     1 [2.0]      1 [1.0]                   2 [2.5]      2 [2.5]      2 [2.0]     
      Mineralization                                                                          1 [2.0]                               
      Ulcer                                                         1 [1.0]      2 [1.5]      2 [2.0]      1 [3.0]      1 [2.0]     
      Artery, Inflammation, Chronic Active                                                                 1 [2.0]      3 [2.7]     
   Stomach, Glandular                                 (53)         (53)         (53)         (53)         (52)         (53)         
      Erosion                                                                    1 [2.0]      2 [2.0]      1 [2.0]                  
      Hyperplasia                                                                             1 [2.0]                               
      Inflammation                                     1 [2.0]                                1 [2.0]                               
      Mineralization                                   2 [1.0]      9 [1.1]      1 [1.0]      3 [1.3]      2 [2.0]      4 [1.5]     
      Ulcer                                            1 [2.0]                                                                      
      Artery, Inflammation, Chronic Active                                                                 1 [3.0]      1 [2.0]     
      Serosa, Inflammation                                          1 [2.0]                                                         
   Tooth                                              (33)         (25)         (22)         (30)         (29)         (29)         
      Peridontal Tissue, Inflammation                 33 [1.6]     25 [1.4]     22 [1.1]     30 [1.6]     29 [1.1]     29 [1.3]     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Blood Vessel                                       (53)         (53)         (53)         (53)         (53)         (53)         
      Aorta, Mineralization                                         1 [3.0]                   1 [3.0]      2 [2.5]                  
      Aorta, Adventitia, Inflammation, Chronic                                                                                      
        Active                                                                                             1 [4.0]                  
   Heart                                              (53)         (53)         (52)         (53)         (53)         (52)         
      Cardiomyopathy                                  15 [1.1]     12 [1.0]     19 [1.1]     13 [1.0]     18 [1.0]     24 [1.1]     
      Hemorrhage                                       2 [2.0]                                                                      
      Infiltration Cellular, Mononuclear Cell                                                                           1 [1.0]     
      Inflammation                                     1 [2.0]                   1 [3.0]      1 [2.0]                               
      Mineralization                                                                          1 [2.0]      1 [2.0]      1 [2.0]     
      Artery, Inflammation, Chronic Active                                                                 1 [2.0]      2 [1.5]     
      Epicardium, Inflammation                                      1 [3.0]                                             1 [2.0]     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (53)         (53)         (53)         (52)         (53)         (53)         
      Angiectasis                                     31 [1.5]     37 [1.4]     30 [1.4]     33 [1.4]     27 [1.2]     35 [1.3]     
      Atrophy                                          3 [3.3]                                1 [4.0]                   4 [2.3]     
      Degeneration, Cystic                             4 [2.0]     17 [1.9]     14 [2.3]     18 [2.2]     12 [2.1]     14 [2.4]     
      Hematopoietic Cell Proliferation                                           1 [2.0]                   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    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: 09/30/03    
Route: GAVAGE                                     TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      Time: 12:03:03    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         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                                                                                                             
      Hemorrhage                                       1 [4.0]                                1 [3.0]                               
      Hyperplasia                                      8 [2.4]     10 [2.0]     10 [2.1]      7 [2.3]     10 [2.1]     11 [1.8]     
      Hypertrophy                                     42 [1.7]     43 [1.9]     43 [2.1]     46 [2.1]     44 [2.1]     45 [2.1]     
      Necrosis                                         4 [2.3]                   2 [2.0]                   2 [2.0]                  
      Vacuolization Cytoplasmic                        9 [1.4]     13 [1.2]     14 [1.6]      7 [1.9]     17 [1.2]      9 [1.4]     
   Adrenal Medulla                                    (53)         (53)         (53)         (52)         (53)         (53)         
      Hyperplasia                                     11 [2.3]     12 [2.2]     14 [1.9]     14 [1.9]      7 [1.9]     10 [1.9]     
   Islets, Pancreatic                                 (53)         (53)         (53)         (52)         (52)         (52)         
      Hyperplasia                                                                                                       2 [2.5]     
   Parathyroid Gland                                  (49)         (51)         (44)         (51)         (49)         (49)         
      Hyperplasia                                                   1 [2.0]      1 [2.0]                   1 [2.0]      1 [2.0]     
      Hypertrophy                                                   1 [2.0]                                                         
   Pituitary Gland                                    (53)         (53)         (53)         (53)         (53)         (53)         
      Angiectasis                                     20 [1.9]     21 [2.5]     20 [2.5]     13 [2.4]     12 [2.4]     14 [2.2]     
      Atrophy                                          1 [4.0]                                                                      
      Cyst                                             2 [1.5]                                1 [2.0]      1 [3.0]      1 [2.0]     
      Cytoplasmic Alteration                           1 [1.0]                                             1 [1.0]                  
      Vacuolization Cytoplasmic                        2 [1.0]      2 [1.0]      1 [1.0]                                            
      Pars Distalis, Hyperplasia                      22 [2.4]     16 [2.4]     14 [2.3]     11 [2.5]     15 [2.3]     19 [2.6]     
      Pars Intermedia, Hyperplasia                     1 [2.0]                                                                      
      Rathke's Cleft, Pars Intermedia, Hyperplasia                                                         1 [2.0]                  
   Thyroid Gland                                      (53)         (53)         (51)         (53)         (51)         (51)         
      Inflammation                                                               1 [3.0]                                            
      C-Cell, Hyperplasia                             15 [2.1]     16 [2.2]      9 [2.3]     13 [1.9]      9 [2.0]     11 [1.8]     
      Follicle, Cyst                                   1 [2.0]                                1 [2.0]      1 [2.0]                  
      Follicular Cell, Hypertrophy                     7 [1.6]     13 [1.2]     24 [1.3]     24 [1.2]     24 [1.5]     22 [1.5]     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (53)         (51)         (53)         (53)         (50)         (53)         
      Hyperplasia, Squamous                                                      1 [2.0]                                            
      Inflammation                                    52 [1.7]     47 [1.8]     46 [1.7]     51 [1.7]     47 [1.5]     47 [1.5]     
      Duct, Cyst                                      40 [2.3]     37 [2.3]     34 [2.6]     41 [2.4]     44 [2.0]     40 [2.2]     
   Ovary                                              (53)         (53)         (53)         (52)         (52)         (53)         
      Atrophy                                         43 [4.0]     40 [4.0]     38 [4.0]     43 [4.0]     45 [4.0]     45 [3.9]     
      Cyst                                            11 [2.2]     18 [2.1]     20 [2.1]     17 [2.3]     18 [2.3]     13 [2.5]     
      Fibrosis                                                                                1 [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    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: 09/30/03    
Route: GAVAGE                                     TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      Time: 12:03:03    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         SPRAGUE-DAWLEY RATS FEMALE                   0 NG/KG      6 NG/KG      20 NG/KG     44 NG/KG     92 NG/KG     200          
                                                                                                                       NG/KG        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
GENITAL SYSTEM - CONT                                                                                                               
      Inflammation, Chronic Active                     1 [4.0]                                             1 [3.0]      1 [4.0]     
   Oviduct                                            (1)                                                 (1)                       
      Cyst                                             1 [3.0]                                                                      
      Inflammation, Chronic Active                                                                         1 [3.0]                  
   Uterus                                             (53)         (53)         (53)         (52)         (52)         (53)         
      Adenomyosis                                      1 [2.0]                                1 [2.0]      1 [3.0]                  
      Cyst                                                          1 [3.0]                                1 [2.0]                  
      Hemorrhage                                                                                           1 [2.0]      2 [2.5]     
      Inflammation, Chronic Active                                  5 [2.6]      3 [2.3]      3 [3.3]      4 [3.0]      3 [2.3]     
      Inflammation, Suppurative                        3 [1.7]      6 [1.3]      1 [1.0]      7 [1.4]      3 [1.7]      4 [1.0]     
      Metaplasia, Squamous                            17 [1.8]     25 [1.8]     21 [1.8]     36 [1.8]     31 [1.9]     35 [1.9]     
      Ulcer                                                                                   1 [3.0]      3 [2.7]      1 [2.0]     
      Cervix, Cyst                                                                                                      1 [3.0]     
      Endometrium, Hyperplasia, Cystic                31 [2.4]     29 [2.1]     29 [2.1]     33 [2.2]     39 [2.2]     37 [2.1]     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (53)         (53)         (53)         (53)         (53)         (53)         
      Atrophy                                                                    2 [2.0]                                            
      Hyperplasia                                     38 [2.8]     32 [2.9]     37 [3.1]     35 [2.9]     42 [2.9]     41 [2.8]     
      Hyperplasia, Reticulum Cell                                                             1 [3.0]                               
   Lymph Node                                         (5)          (4)          (4)          (4)          (3)          (7)          
      Hyperplasia, Plasma Cell                                                                                          1 [2.0]     
      Iliac, Ectasia                                                1 [3.0]                                                         
      Lumbar, Ectasia                                  2 [2.0]      1 [3.0]                                1 [2.0]                  
      Lumbar, Hemorrhage                               2 [2.5]      1 [2.0]                                                         
      Lumbar, Hyperplasia, Histiocytic                                                        1 [2.0]      1 [2.0]                  
      Lumbar, Hyperplasia, Plasma Cell                              1 [3.0]      1 [3.0]      1 [3.0]                   1 [2.0]     
      Mediastinal, Ectasia                                                                                 2 [1.5]      2 [2.0]     
      Mediastinal, Hemorrhage                                                    1 [2.0]                                1 [1.0]     
      Mediastinal, Hyperplasia, Lymphoid                                         1 [2.0]                                            
      Mediastinal, Hyperplasia, Plasma Cell                         1 [3.0]                   1 [3.0]      1 [3.0]      2 [1.5]     
      Popliteal, Ectasia                               1 [2.0]                                                                      
   Lymph Node, Mandibular                             (53)         (53)         (51)         (53)         (51)         (51)         
      Congestion                                                                 1 [2.0]                                            
      Ectasia                                                       1 [2.0]      2 [2.0]      1 [2.0]      1 [2.0]      1 [2.0]     
      Hyperplasia, Histiocytic                                      1 [2.0]                                                         
      Hyperplasia, Lymphoid                                                                   1 [3.0]                   1 [4.0]     
      Hyperplasia, Plasma Cell                        38 [2.1]     40 [2.2]     38 [2.1]     31 [2.1]     30 [2.2]     29 [2.2]     
   Lymph Node, Mesenteric                             (53)         (53)         (53)         (52)         (52)         (53)         
      Atrophy                                                                                 1 [3.0]                               
      Hemorrhage                                       1 [2.0]                   1 [2.0]                                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    6                                                              
                                                                                                                                   
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: 09/30/03    
Route: GAVAGE                                     TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      Time: 12:03:03    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         SPRAGUE-DAWLEY RATS FEMALE                   0 NG/KG      6 NG/KG      20 NG/KG     44 NG/KG     92 NG/KG     200          
                                                                                                                       NG/KG        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Hyperplasia, Histiocytic                                                                                          1 [2.0]     
      Hyperplasia, Lymphoid                                         1 [3.0]      1 [2.0]                                1 [3.0]     
      Hyperplasia, Plasma Cell                                      1 [2.0]                                             1 [2.0]     
   Spleen                                             (53)         (53)         (53)         (52)         (52)         (51)         
      Accessory Spleen                                 1                         1                                                  
      Congestion                                                    1 [2.0]                                1 [3.0]                  
      Hematopoietic Cell Proliferation                49 [2.0]     49 [2.2]     48 [2.3]     51 [1.9]     46 [2.2]     50 [2.0]     
      Hemorrhage                                                    1 [2.0]                                                         
      Infarct                                                                    1 [2.0]                                            
      Necrosis                                                      1 [3.0]                                                         
      Pigmentation                                    52 [1.7]     45 [1.6]     50 [1.9]     48 [1.8]     49 [1.9]     51 [1.9]     
      Lymphatic, Angiectasis                                                     1 [2.0]                                            
      Lymphoid Follicle, Atrophy                       7 [2.0]      8 [2.1]      7 [2.3]      6 [2.7]     12 [2.4]      4 [2.3]     
      Red Pulp, Atrophy                                2 [2.0]                                                                      
      Red Pulp, Hyperplasia                                         1 [3.0]                                                         
   Thymus                                             (53)         (49)         (50)         (52)         (49)         (51)         
      Atrophy                                         43 [2.3]     36 [2.6]     36 [2.7]     44 [2.8]     39 [3.1]     48 [3.6]     
      Hemorrhage                                       1 [2.0]                   1 [2.0]                   1 [2.0]      1 [2.0]     
      Hyperplasia, Lymphoid                                                      1 [2.0]                                            
      Inflammation                                                  1 [3.0]                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (53)         (53)         (53)         (53)         (53)         (53)         
      Cyst                                             1 [3.0]      2 [2.5]                   5 [2.2]      4 [2.5]      3 [2.3]     
      Hyperplasia                                     33 [1.3]     29 [1.3]     26 [1.5]     20 [1.6]     20 [1.2]     17 [1.1]     
      Inflammation, Granulomatous                      2 [1.5]      4 [2.3]      3 [2.0]      4 [2.0]      4 [2.0]      3 [2.0]     
   Skin                                               (53)         (53)         (53)         (53)         (53)         (53)         
      Inflammation                                     2 [3.0]      1 [3.0]                                                         
      Ulcer                                            2 [3.0]      1 [3.0]                                                         
      Conjunctiva, Inflammation                                                                                         1 [2.0]     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (53)         (53)         (53)         (53)         (53)         (53)         
      Edema                                                                                   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    7                                                              
                                                                                                                                   
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: 09/30/03    
Route: GAVAGE                                     TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      Time: 12:03:03    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         SPRAGUE-DAWLEY RATS FEMALE                   0 NG/KG      6 NG/KG      20 NG/KG     44 NG/KG     92 NG/KG     200          
                                                                                                                       NG/KG        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
NERVOUS SYSTEM - CONT                                                                                                               
      Gliosis                                                                                 1 [2.0]                               
      Hemorrhage                                       1 [3.0]                                                          1 [3.0]     
      Hydrocephalus                                    1 [2.0]                                1 [2.0]                   1 [2.0]     
   Peripheral Nerve                                                                          (1)                       (1)          
      Radicular Neuropathy                                                                                              1 [2.0]     
   Spinal Cord                                                                               (1)                       (1)          
      Degeneration                                                                                                      1 [3.0]     
      Hemorrhage                                                                              1 [3.0]                               
      Necrosis                                                                                1 [2.0]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (53)         (53)         (53)         (53)         (53)         (52)         
      Edema                                                                                                1 [2.0]                  
      Hemorrhage                                                                                           1 [4.0]                  
      Infiltration Cellular, Histiocyte               44 [1.7]     44 [1.7]     40 [1.7]     40 [1.7]     41 [1.6]     36 [1.6]     
      Inflammation                                     5 [1.4]      8 [1.4]      7 [1.3]      6 [1.5]      7 [1.9]      8 [1.6]     
      Metaplasia, Squamous                                                                    2 [1.0]      4 [1.5]      3 [1.7]     
      Mineralization                                                                          1 [2.0]      1 [2.0]                  
      Alveolar Epithelium, Hyperplasia                14 [1.1]     17 [1.1]     12 [1.2]     20 [1.2]      8 [1.1]      3 [1.0]     
      Alveolar Epithelium, Metaplasia, Bronchiolar     5 [1.0]      6 [1.0]      5 [1.2]      9 [1.3]     23 [1.6]     28 [1.5]     
      Alveolus, Metaplasia, Squamous                                             1 [1.0]                                            
   Nose                                               (53)         (53)         (53)         (53)         (53)         (53)         
      Inflammation                                     8 [1.1]      3 [1.3]      8 [1.1]     11 [1.2]      7 [1.1]      6 [1.3]     
      Mineralization                                   1 [1.0]                                                                      
      Olfactory Epithelium, Metaplasia                                           1 [2.0]                                            
      Respiratory Epithelium, Hyperplasia              1 [2.0]      1 [1.0]      2 [1.5]      1 [2.0]      6 [2.0]      3 [2.0]     
      Respiratory Epithelium, Metaplasia                                                                                1 [2.0]     
      Septum, Inflammation                             1 [1.0]      2 [1.0]      3 [1.0]      2 [1.0]      5 [1.4]      3 [1.7]     
      Squamous Epithelium, Hyperplasia                 1 [1.0]      1 [2.0]      1 [1.0]                                            
   Trachea                                            (53)         (53)         (52)         (53)         (53)         (53)         
      Inflammation                                                                                         1 [3.0]      1 [2.0]     
      Artery, Peritracheal Tissue, Inflammation,                                                                                    
         Chronic Active                                                                                                 1 [3.0]     
      Peritracheal Tissue, Inflammation                             1 [3.0]      2 [3.0]      1 [3.0]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (53)         (53)         (52)         (53)         (52)         (52)         
      Hemorrhage                                                    1 [3.0]                                                         
      Inflammation                                                  1 [3.0]                                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    8                                                              
                                                                                                                                   
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: 09/30/03    
Route: GAVAGE                                     TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      Time: 12:03:03    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         SPRAGUE-DAWLEY RATS FEMALE                   0 NG/KG      6 NG/KG      20 NG/KG     44 NG/KG     92 NG/KG     200          
                                                                                                                       NG/KG        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
SPECIAL SENSES SYSTEM - CONT                                                                                                        
      Cornea, Inflammation                                                                                              1 [2.0]     
      Lens, Degeneration                                            1 [3.0]                                                         
      Retina, Atrophy                                                            1 [2.0]                                            
      Retina, Degeneration                                          1 [3.0]                                                         
   Harderian Gland                                    (53)         (53)         (53)         (53)         (52)         (52)         
      Inflammation                                    16 [1.0]      9 [1.0]     10 [1.0]     13 [1.1]      8 [1.1]      6 [1.0]     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (53)         (53)         (53)         (52)         (53)         (53)         
      Accumulation, Hyaline Droplet                                 1 [1.0]                                                         
      Calculus Micro Observation Only                  5            2            4            1            2            3           
      Cyst                                                                                    1 [2.0]      2 [2.0]      1 [2.0]     
      Fibrosis                                                                                                          1 [3.0]     
      Hemorrhage                                                                                           1 [2.0]                  
      Inflammation, Chronic Active                                                                         1 [3.0]      1 [1.0]     
      Inflammation, Suppurative                        2 [1.0]      1 [1.0]      1 [1.0]      3 [1.0]      2 [1.0]      2 [1.5]     
      Mineralization                                  37 [1.0]     45 [1.0]     42 [1.0]     43 [1.1]     43 [1.0]     31 [1.1]     
      Necrosis                                                                                             2 [2.5]                  
      Nephropathy                                     34 [1.1]     39 [1.2]     35 [1.2]     42 [1.4]     36 [1.4]     45 [1.5]     
      Pigmentation                                     2 [2.0]                                                                      
      Artery, Inflammation, Chronic Active                                                    1 [3.0]      1 [2.0]                  
      Capsule, Hemorrhage                              1 [3.0]                                                                      
      Pelvis, Dilatation                                            1 [3.0]                                2 [2.0]      1 [3.0]     
      Pelvis, Inflammation                             1 [2.0]      1 [2.0]                                5 [2.0]      1 [2.0]     
      Renal Tubule, Dilatation                                                   1 [2.0]                                            
      Renal Tubule, Hyperplasia                                                  1 [1.0]                                            
      Renal Tubule, Necrosis                                        1 [2.0]                                                         
      Renal Tubule, Nephropathy                                                                                         1 [1.0]     
      Transitional Epithelium, Hyperplasia             2 [1.0]      2 [1.5]      1 [1.0]      2 [1.0]      6 [2.7]      5 [2.0]     
   Urinary Bladder                                    (53)         (52)         (53)         (53)         (51)         (53)         
      Infiltration Cellular, Lymphoid                                                                                   1 [3.0]     
      Inflammation                                     2 [2.5]      3 [1.7]      1 [2.0]      1 [1.0]      6 [1.5]      1 [2.0]     
      Transitional Epithelium, Hyperplasia                          1 [2.0]                                4 [2.5]      4 [1.5]     
      Transitional Epithelium, Metaplasia, Squamous                                                        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    9                                                              
                                                                                                                                   
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: 09/30/03    
Route: GAVAGE                                     TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      Time: 12:03:03    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         SPRAGUE-DAWLEY RATS FEMALE                   200 NG/                                                                       
                                                      KG STOP                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially In Study                          50                                                                            
  Early Deaths                                                                                                                      
    Moribund Sacrifice                                25                                                                            
    Natural Death                                     10                                                                            
  Survivors                                                                                                                         
    Terminal Sacrifice                                15                                                                            
                                                                                                                                    
  Animals Examined Microscopically                    50                                                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large, Rectum                            (50)                                                                          
      Parasite Metazoan                                2                                                                            
   Liver                                              (50)                                                                          
      Angiectasis                                      1 [2.0]                                                                      
      Basophilic Focus                                 9                                                                            
      Basophilic Focus, Multiple                       4                                                                            
      Cholangiofibrosis                                3 [2.7]                                                                      
      Clear Cell Focus                                 4                                                                            
      Clear Cell Focus, Multiple                       2                                                                            
      Degeneration, Cystic                             1 [2.0]                                                                      
      Eosinophilic Focus                               8                                                                            
      Eosinophilic Focus, Multiple                    14                                                                            
      Fatty Change, Diffuse                            6 [1.2]                                                                      
      Fatty Change, Focal                              7 [1.1]                                                                      
      Hematopoietic Cell Proliferation                31 [1.1]                                                                      
      Hepatodiaphragmatic Nodule                       1                                                                            
      Inflammation                                    48 [1.1]                                                                      
      Mixed Cell Focus                                 5                                                                            
      Mixed Cell Focus, Multiple                      19                                                                            
      Necrosis                                        11 [2.1]                                                                      
      Pigmentation                                    48 [1.6]                                                                      
      Toxic Hepatopathy                                9 [1.0]                                                                      
      Bile Duct, Cyst                                  2 [2.0]                                                                      
      Bile Duct, Fibrosis                              1 [1.0]                                                                      
      Bile Duct, Hyperplasia                           1 [2.0]                                                                      
      Centrilobular, Degeneration                      7 [2.4]                                                                      
      Hepatocyte, Hypertrophy                         14 [1.0]                                                                      
      Hepatocyte, Multinucleated                      25 [1.2]                                                                      
      Oval Cell, Hyperplasia                           3 [1.0]                                                                      
   Mesentery                                          (2)                                                                           
                                                                                                                                    
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   10                                                              
                                                                                                                                   
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: 09/30/03    
Route: GAVAGE                                     TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      Time: 12:03:03    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         SPRAGUE-DAWLEY RATS FEMALE                   200 NG/                                                                       
                                                      KG STOP                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Inflammation, Chronic Active                     1 [3.0]                                                                      
      Necrosis                                         1 [3.0]                                                                      
   Oral Mucosa                                        (50)                                                                          
      Gingival, Hyperplasia, Squamous                 14 [1.2]                                                                      
   Pancreas                                           (49)                                                                          
      Acinus, Vacuolization Cytoplasmic                2 [1.0]                                                                      
      Artery, Inflammation, Chronic Active             1 [2.0]                                                                      
   Stomach, Forestomach                               (50)                                                                          
      Erosion                                          1 [2.0]                                                                      
      Hyperkeratosis                                   1 [2.0]                                                                      
      Hyperplasia, Squamous                            5 [2.2]                                                                      
      Inflammation                                     1 [3.0]                                                                      
      Ulcer                                            1 [2.0]                                                                      
   Stomach, Glandular                                 (50)                                                                          
      Mineralization                                   3 [1.3]                                                                      
   Tooth                                              (24)                                                                          
      Peridontal Tissue, Inflammation                 24 [1.2]                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (50)                                                                          
      Cardiomyopathy                                  13 [1.1]                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (48)                                                                          
      Angiectasis                                     29 [1.4]                                                                      
      Degeneration, Cystic                            12 [1.8]                                                                      
      Hyperplasia                                      7 [2.3]                                                                      
      Hypertrophy                                     36 [2.1]                                                                      
      Necrosis                                         3 [2.3]                                                                      
      Vacuolization Cytoplasmic                       10 [1.3]                                                                      
      Bilateral, Inflammation, Chronic Active          1 [3.0]                                                                      
   Adrenal Medulla                                    (48)                                                                          
      Hyperplasia                                      7 [1.9]                                                                      
   Parathyroid Gland                                  (47)                                                                          
      Fibrosis                                         1 [3.0]                                                                      
   Pituitary Gland                                    (49)                                                                          
      Angiectasis                                     13 [2.3]                                                                      
      Cyst                                             1 [3.0]                                                                      
      Cytoplasmic Alteration                           2 [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   11                                                              
                                                                                                                                   
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: 09/30/03    
Route: GAVAGE                                     TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      Time: 12:03:03    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         SPRAGUE-DAWLEY RATS FEMALE                   200 NG/                                                                       
                                                      KG STOP                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
      Vacuolization Cytoplasmic                        2 [1.5]                                                                      
      Pars Distalis, Hyperplasia                      19 [2.6]                                                                      
   Thyroid Gland                                      (48)                                                                          
      C-Cell, Hyperplasia                             15 [1.7]                                                                      
      Follicular Cell, Hypertrophy                    23 [1.3]                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (50)                                                                          
      Inflammation                                    48 [1.8]                                                                      
      Duct, Cyst                                      39 [2.3]                                                                      
   Ovary                                              (47)                                                                          
      Atrophy                                         39 [4.0]                                                                      
      Cyst                                            12 [2.3]                                                                      
   Uterus                                             (49)                                                                          
      Congestion                                       1 [2.0]                                                                      
      Hemorrhage                                       1 [2.0]                                                                      
      Inflammation, Chronic Active                     7 [1.9]                                                                      
      Inflammation, Suppurative                        3 [1.3]                                                                      
      Metaplasia, Squamous                            28 [2.1]                                                                      
      Endometrium, Hyperplasia, Cystic                35 [2.5]                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)                                                                          
      Hyperplasia                                     43 [3.0]                                                                      
   Lymph Node                                         (3)                                                                           
      Iliac, Ectasia                                   1 [3.0]                                                                      
      Iliac, Hyperplasia, Plasma Cell                  1 [3.0]                                                                      
      Lumbar, Ectasia                                  1 [2.0]                                                                      
      Lumbar, Hyperplasia, Plasma Cell                 1 [3.0]                                                                      
      Renal, Ectasia                                   1 [2.0]                                                                      
      Renal, Hyperplasia, Plasma Cell                  1 [2.0]                                                                      
   Lymph Node, Mandibular                             (49)                                                                          
      Ectasia                                          1 [2.0]                                                                      
      Hyperplasia, Lymphoid                            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   12                                                              
                                                                                                                                   
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: 09/30/03    
Route: GAVAGE                                     TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      Time: 12:03:03    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         SPRAGUE-DAWLEY RATS FEMALE                   200 NG/                                                                       
                                                      KG STOP                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Hyperplasia, Plasma Cell                        29 [2.0]                                                                      
   Spleen                                             (49)                                                                          
      Hematopoietic Cell Proliferation                49 [2.2]                                                                      
      Pigmentation                                    48 [1.7]                                                                      
      Lymphoid Follicle, Atrophy                       2 [2.0]                                                                      
   Thymus                                             (49)                                                                          
      Atrophy                                         44 [2.9]                                                                      
      Hemorrhage                                       1 [3.0]                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (50)                                                                          
      Cyst                                             3 [2.3]                                                                      
      Hyperplasia                                     19 [1.4]                                                                      
      Inflammation                                     1 [3.0]                                                                      
      Inflammation, Granulomatous                      1 [2.0]                                                                      
   Skin                                               (50)                                                                          
      Hyperkeratosis                                   1 [1.0]                                                                      
      Lip, Inflammation, Chronic Active                1 [4.0]                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (50)                                                                          
      Osteopetrosis                                    1 [2.0]                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (49)                                                                          
      Mineralization                                   1 [1.0]                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)                                                                          
      Congestion                                       1 [3.0]                                                                      
      Hemorrhage                                       2 [2.0]                                                                      
      Infiltration Cellular, Histiocyte               30 [1.4]                                                                      
      Inflammation                                     5 [1.6]                                                                      
      Metaplasia, Squamous                             1 [3.0]                                                                      
      Mineralization                                   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   13                                                              
                                                                                                                                   
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: 09/30/03    
Route: GAVAGE                                     TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      Time: 12:03:03    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         SPRAGUE-DAWLEY RATS FEMALE                   200 NG/                                                                       
                                                      KG STOP                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
RESPIRATORY SYSTEM - CONT                                                                                                           
      Alveolar Epithelium, Hyperplasia                 6 [1.0]                                                                      
      Alveolar Epithelium, Metaplasia, Bronchiolar     7 [1.1]                                                                      
   Nose                                               (50)                                                                          
      Inflammation                                     7 [1.0]                                                                      
      Nasolacrimal Duct, Inflammation                  1 [3.0]                                                                      
      Respiratory Epithelium, Hyperplasia              2 [2.0]                                                                      
   Trachea                                            (50)                                                                          
      Inflammation                                     1 [2.0]                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (49)                                                                          
      Retina, Atrophy                                  1 [2.0]                                                                      
   Harderian Gland                                    (49)                                                                          
      Inflammation                                     6 [1.3]                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (48)                                                                          
      Accumulation, Hyaline Droplet                    3 [2.0]                                                                      
      Calculus Micro Observation Only                  1                                                                            
      Infarct                                          1 [3.0]                                                                      
      Inflammation                                     1 [4.0]                                                                      
      Inflammation, Suppurative                        2 [1.0]                                                                      
      Mineralization                                  41 [1.0]                                                                      
      Nephropathy                                     35 [1.1]                                                                      
      Pelvis, Dilatation                               1 [3.0]                                                                      
      Pelvis, Inflammation                             1 [2.0]                                                                      
      Transitional Epithelium, Hyperplasia             3 [1.7]                                                                      
   Urinary Bladder                                    (50)                                                                          
      Inflammation                                     2 [3.0]                                                                      
      Transitional Epithelium, Hyperplasia             3 [1.7]                                                                      
                                                                                                                                    
                                                                                                                                    
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)                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
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NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.