https://ntp.niehs.nih.gov/go/40990

P18 - Incidence Rates of Non-Neoplastic Lesions (Rats)

NTP Experiment-Test: 60946-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18
Study Type: SUBCHRON 90-DAY                          WITH AVERAGE SEVERITY GRADES[b]                              Date: 10/08/03
Route: GAVAGE                                                     ESTRAGOLE                                       Time: 09:17:23
                                                           FINAL/RATS
       Facility:  Battelle Columbus Laboratory
       Chemical CAS #:  140-67-0
       Lock Date:  09/03/02
       Cage Range:  All
       Reasons For Removal:    All
       Removal Date Range:     All
       Treatment Groups:       Include All
a  Number of animals examined microscopically at site and number of animals with lesion
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
                                                              Page   1
NTP Experiment-Test: 60946-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: SUBCHRON 90-DAY                          WITH AVERAGE SEVERITY GRADES[b]                              Date: 10/08/03    
Route: GAVAGE                                                     ESTRAGOLE                                       Time: 09:17:23    
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                      0 MG/KG      37.5         75           150          300          600          
                                                                   MG/KG        MG/KG        MG/KG        MG/KG        MG/KG        
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially In Study                          10           10           10           10           10           10           
  Early Deaths                                                                                                                      
  Survivors                                                                                                                         
    Terminal Sacrifice                                10           10           10           10           10           10           
  Animals Examined Microscopically                    10           10           10           10           10           10           
____________________________________________________________________________________________________________________________________
 ALIMENTARY SYSTEM                                                                                                                  
   Liver                                              (10)         (10)         (10)         (10)         (10)         (10)         
      Basophilic Focus                                                           3            6           10           10           
      Cholangiofibrosis                                                                                                 1 [2.0]     
      Clear Cell Focus                                                                                                  1           
      Eosinophilic Focus                                                                                               10           
      Hepatodiaphragmatic Nodule                       2            2            2            1            2                        
      Inflammation, Chronic                            4 [1.0]      4 [1.0]      5 [1.0]      6 [1.0]      3 [1.0]                  
      Mixed Cell Focus                                                           1            6           10           10           
      Bile Duct, Hyperplasia                                       10 [1.0]     10 [1.0]     10 [1.0]     10 [2.0]     10 [2.0]     
      Hepatocyte, Hypertrophy                                                                10 [1.0]     10 [2.0]     10 [4.0]     
      Oval Cell, Hyperplasia                                       10 [1.0]     10 [1.0]     10 [1.0]     10 [2.0]     10 [3.0]     
      Periportal, Infiltration Cellular, Histiocyte                                          10 [1.0]     10 [2.0]     10 [2.0]     
      Periportal, Inflammation, Chronic                             5 [1.0]     10 [1.0]     10 [1.0]     10 [2.0]     10 [2.0]     
   Mesentery                                                                                 (1)                                    
      Accessory Spleen                                                                        1 [1.0]                               
      Fat, Necrosis                                                                           1 [1.0]                               
   Salivary Glands                                    (10)         (10)         (10)         (10)         (10)         (10)         
      Submandibular Gland, Cytoplasmic Alteration                               10 [1.0]     10 [1.0]     10 [2.0]     10 [2.0]     
   Stomach, Glandular                                 (10)         (10)         (10)         (10)         (10)         (10)         
      Mineralization                                                                          1 [1.0]      2 [1.0]                  
      Necrosis, Focal                                               1 [1.0]                                                         
      Epithelium, Glands, Atrophy                                                             8 [1.0]     10 [1.3]     10 [2.0]     
____________________________________________________________________________________________________________________________________
 CARDIOVASCULAR SYSTEM                                                                                                              
   Heart                                              (10)                                                             (10)         
      Infiltration Cellular, Mononuclear Cell                                                                           1 [1.0]     
      Myocardium, Infiltration Cellular,                                                                                            
        Mononuclear Cell                               2 [1.0]                                                          2 [1.0]     
____________________________________________________________________________________________________________________________________
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page    2                                                              
NTP Experiment-Test: 60946-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: SUBCHRON 90-DAY                          WITH AVERAGE SEVERITY GRADES[b]                              Date: 10/08/03    
Route: GAVAGE                                                     ESTRAGOLE                                       Time: 09:17:23    
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                      0 MG/KG      37.5         75           150          300          600          
                                                                   MG/KG        MG/KG        MG/KG        MG/KG        MG/KG        
____________________________________________________________________________________________________________________________________
 ENDOCRINE SYSTEM                                                                                                                   
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
 GENERAL BODY SYSTEM                                                                                                                
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
 GENITAL SYSTEM                                                                                                                     
   Uterus                                             (10)                                                             (10)         
      Endometrium, Hyperplasia, Cystic                 3 [1.7]                                                                      
____________________________________________________________________________________________________________________________________
 HEMATOPOIETIC SYSTEM                                                                                                               
   Bone Marrow                                        (10)                                                             (10)         
      Hyperplasia                                      1 [1.0]                                                                      
   Lymph Node                                                                                                          (4)          
      Pancreatic, Hyperplasia, Lymphoid                                                                                 4 [2.0]     
      Pancreatic, Infiltration Cellular, Histiocyte                                                                     4 [2.3]     
   Lymph Node, Mesenteric                             (10)         (10)         (10)         (10)         (10)         (10)         
      Hyperplasia, Lymphoid                                                                                             3 [1.7]     
      Infiltration Cellular, Histiocyte                                                       1 [1.0]                   1 [2.0]     
____________________________________________________________________________________________________________________________________
 INTEGUMENTARY SYSTEM                                                                                                               
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
 MUSCULOSKELETAL SYSTEM                                                                                                             
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
 NERVOUS SYSTEM                                                                                                                     
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page    3                                                              
NTP Experiment-Test: 60946-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: SUBCHRON 90-DAY                          WITH AVERAGE SEVERITY GRADES[b]                              Date: 10/08/03    
Route: GAVAGE                                                     ESTRAGOLE                                       Time: 09:17:23    
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS FEMALE                      0 MG/KG      37.5         75           150          300          600          
                                                                   MG/KG        MG/KG        MG/KG        MG/KG        MG/KG        
____________________________________________________________________________________________________________________________________
 RESPIRATORY SYSTEM                                                                                                                 
   Lung                                               (10)         (10)         (10)         (10)         (10)         (10)         
      Inflammation, Chronic                            5 [1.0]      6 [1.0]      3 [1.0]      4 [1.0]      8 [1.0]     10 [1.0]     
      Bronchiole, Bronchus, Hyperplasia, Lymphoid                                1 [2.0]                                            
   Nose                                               (10)         (10)         (10)         (10)         (10)         (10)         
      Olfactory Epithelium, Degeneration                                         1 [1.0]      2 [1.0]     10 [1.6]     10 [2.1]     
____________________________________________________________________________________________________________________________________
 SPECIAL SENSES SYSTEM                                                                                                              
   Harderian Gland                                    (10)                                                             (10)         
      Hyperplasia, Focal                                                                                                1 [1.0]     
____________________________________________________________________________________________________________________________________
 URINARY SYSTEM                                                                                                                     
   Kidney                                             (10)         (10)         (10)         (10)         (10)         (10)         
      Infiltration Cellular, Lymphocyte                                                                    1 [1.0]      3 [1.0]     
      Cortex, Renal Tubule, Mineralization             2 [1.0]      1 [1.0]      4 [1.0]      4 [1.0]      1 [1.0]      1 [1.0]     
      Medulla, Renal Tubule, Mineralization                                                                1 [1.0]                  
      Papilla, Renal Tubule, Mineralization            3 [1.0]      4 [1.0]      6 [1.0]      7 [1.0]      9 [1.0]      7 [1.0]     
      Renal Tubule, Regeneration                       1 [1.0]      2 [1.0]      1 [1.0]      1 [1.0]      3 [1.0]      6 [1.0]     
      Renal Tubule, Epithelium, Regeneration                                     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: 60946-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: SUBCHRON 90-DAY                          WITH AVERAGE SEVERITY GRADES[b]                              Date: 10/08/03    
Route: GAVAGE                                                     ESTRAGOLE                                       Time: 09:17:23    
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                        0 MG/KG      37.5         75           150          300          600          
                                                                   MG/KG        MG/KG        MG/KG        MG/KG        MG/KG        
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially In Study                          10           10           10           10           10           10           
  Early Deaths                                                                                                                      
  Survivors                                                                                                                         
    Terminal Sacrifice                                10           10           10           10           10           10           
  Animals Examined Microscopically                    10           10           10           10           10           10           
____________________________________________________________________________________________________________________________________
 ALIMENTARY SYSTEM                                                                                                                  
   Esophagus                                          (10)                                                             (10)         
      Inflammation, Chronic                                                                                             1 [1.0]     
   Intestine Large, Rectum                            (10)                                                             (10)         
      Parasite Metazoan                                1                                                                            
   Liver                                              (10)         (10)         (10)         (10)         (10)         (10)         
      Angiectasis, Focal                                                                                   2 [1.5]                  
      Basophilic Focus                                                                        6            9            6           
      Cholangiofibrosis                                                                                                10 [2.6]     
      Clear Cell Focus                                                                        3            1            1           
      Eosinophilic Focus                                                                      1           10           10           
      Hepatodiaphragmatic Nodule                       1            3                         1            3                        
      Inflammation, Chronic                            1 [1.0]      2 [1.0]      1 [1.0]      1 [1.0]      3 [1.0]                  
      Mixed Cell Focus                                                           1            9           10            8           
      Bile Duct, Hyperplasia                                       10 [1.0]     10 [1.0]     10 [1.0]     10 [2.0]     10 [2.0]     
      Centrilobular, Vacuolization Cytoplasmic         1 [1.0]                                                                      
      Hepatocyte, Hypertrophy                                                   10 [1.0]     10 [2.0]     10 [3.0]     10 [4.0]     
      Oval Cell, Hyperplasia                                       10 [1.0]     10 [1.1]     10 [2.0]     10 [3.0]     10 [3.0]     
      Periportal, Infiltration Cellular, Histiocyte                10 [1.0]     10 [1.1]     10 [2.0]     10 [2.0]     10 [2.0]     
      Periportal, Inflammation, Chronic                            10 [1.0]     10 [1.0]     10 [2.0]     10 [2.0]     10 [2.0]     
   Pancreas                                           (10)                                                             (10)         
      Acinus, Atrophy                                                                                                   1 [1.0]     
   Salivary Glands                                    (10)         (10)         (10)         (10)         (10)         (10)         
      Submandibular Gland, Cytoplasmic Alteration                               10 [1.0]     10 [1.0]     10 [2.0]     10 [2.0]     
   Stomach, Glandular                                 (10)         (10)         (10)         (10)         (10)         (10)         
      Mineralization                                                                          1 [1.0]                               
      Epithelium, Glands, Atrophy                                                2 [1.0]     10 [1.0]     10 [1.7]     10 [2.2]     
____________________________________________________________________________________________________________________________________
 CARDIOVASCULAR SYSTEM                                                                                                              
   Heart                                              (10)                                                             (10)         
      Infiltration Cellular, Mononuclear Cell          2 [1.0]                                                          3 [1.0]     
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page    5                                                              
NTP Experiment-Test: 60946-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: SUBCHRON 90-DAY                          WITH AVERAGE SEVERITY GRADES[b]                              Date: 10/08/03    
Route: GAVAGE                                                     ESTRAGOLE                                       Time: 09:17:23    
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                        0 MG/KG      37.5         75           150          300          600          
                                                                   MG/KG        MG/KG        MG/KG        MG/KG        MG/KG        
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM - CONT                                                                                                        
      Myocardium, Infiltration Cellular,                                                                                            
        Mononuclear Cell                               6 [1.0]                                                          3 [1.0]     
____________________________________________________________________________________________________________________________________
 ENDOCRINE SYSTEM                                                                                                                   
   Pituitary Gland                                    (10)         (10)         (10)         (10)         (10)         (10)         
      Pars Distalis, Chromophobe Cell, Hypertrophy                                                        10 [1.8]     10 [1.6]     
____________________________________________________________________________________________________________________________________
 GENERAL BODY SYSTEM                                                                                                                
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
 GENITAL SYSTEM                                                                                                                     
   Epididymis                                         (10)         (10)         (10)         (10)         (10)         (10)         
      Hypospermia                                      1 [4.0]                                                                      
      Bilateral, Hypospermia                                                                              10 [3.4]     10 [4.0]     
   Testes                                             (10)         (10)         (10)         (10)         (10)         (10)         
      Bilateral, Germinal Epithelium, Degeneration                                                        10 [3.9]     10 [4.0]     
      Germinal Epithelium, Degeneration                1 [4.0]                                2 [2.5]                               
      Germinal Epithelium, Mineralization                                                     1 [1.0]                               
____________________________________________________________________________________________________________________________________
 HEMATOPOIETIC SYSTEM                                                                                                               
   Bone Marrow                                        (10)         (10)         (10)         (10)         (10)         (10)         
      Hyperplasia                                                                4 [1.0]      3 [1.0]     10 [1.0]     10 [2.0]     
   Lymph Node                                                                                             (3)          (3)          
      Pancreatic, Hyperplasia, Lymphoid                                                                    2 [2.0]      3 [2.3]     
      Pancreatic, Infiltration Cellular, Histiocyte                                                        3 [2.7]      3 [2.7]     
   Lymph Node, Mesenteric                             (10)         (10)         (10)         (10)         (7)          (10)         
      Hyperplasia, Lymphoid                                         1 [1.0]                                2 [2.0]      2 [2.0]     
      Infiltration Cellular, Histiocyte                                                       1 [1.0]      1 [3.0]      1 [3.0]     
____________________________________________________________________________________________________________________________________
 INTEGUMENTARY SYSTEM                                                                                                               
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                             Page    6                                                              
NTP Experiment-Test: 60946-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: SUBCHRON 90-DAY                          WITH AVERAGE SEVERITY GRADES[b]                              Date: 10/08/03    
Route: GAVAGE                                                     ESTRAGOLE                                       Time: 09:17:23    
____________________________________________________________________________________________________________________________________
         FISCHER 344 RATS MALE                        0 MG/KG      37.5         75           150          300          600          
                                                                   MG/KG        MG/KG        MG/KG        MG/KG        MG/KG        
____________________________________________________________________________________________________________________________________
 MUSCULOSKELETAL SYSTEM                                                                                                             
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
 NERVOUS SYSTEM                                                                                                                     
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
 RESPIRATORY SYSTEM                                                                                                                 
   Lung                                               (10)         (10)         (10)         (10)         (10)         (10)         
      Inflammation, Chronic                            5 [1.0]      3 [1.0]      6 [1.0]      7 [1.0]      6 [1.0]      8 [1.0]     
      Inflammation, Granulomatous                                   1 [1.0]                                4 [1.3]                  
   Nose                                               (10)         (10)         (10)         (10)         (10)         (10)         
      Inflammation, Chronic                                                                   2 [1.0]                               
      Olfactory Epithelium, Degeneration                                                                   9 [1.3]     10 [2.1]     
____________________________________________________________________________________________________________________________________
 SPECIAL SENSES SYSTEM                                                                                                              
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
 URINARY SYSTEM                                                                                                                     
   Kidney                                             (10)         (10)         (10)         (10)         (10)         (10)         
      Infiltration Cellular, Lymphocyte                1 [1.0]                   1 [1.0]      2 [1.0]      7 [1.0]                  
      Cortex, Renal Tubule, Pigmentation                                                     10 [1.0]     10 [1.0]     10 [2.0]     
      Medulla, Renal Tubule, Mineralization                                      1 [1.0]                                            
      Papilla, Renal Tubule, Mineralization            4 [1.0]      2 [1.0]      2 [1.0]      8 [1.0]     10 [1.0]     10 [1.9]     
      Renal Tubule, Cyst                                                         1 [1.0]                                            
      Renal Tubule, Regeneration                       7 [1.0]      7 [1.0]     10 [1.0]     10 [1.0]     10 [1.0]      8 [1.1]     
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                                                              
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